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Sample records for randomly chosen groups

  1. The signature of positive selection at randomly chosen loci.

    Science.gov (United States)

    Przeworski, Molly

    2002-03-01

    In Drosophila and humans, there are accumulating examples of loci with a significant excess of high-frequency-derived alleles or high levels of linkage disequilibrium, relative to a neutral model of a random-mating population of constant size. These are features expected after a recent selective sweep. Their prevalence suggests that positive directional selection may be widespread in both species. However, as I show here, these features do not persist long after the sweep ends: The high-frequency alleles drift to fixation and no longer contribute to polymorphism, while linkage disequilibrium is broken down by recombination. As a result, loci chosen without independent evidence of recent selection are not expected to exhibit either of these features, even if they have been affected by numerous sweeps in their genealogical history. How then can we explain the patterns in the data? One possibility is population structure, with unequal sampling from different subpopulations. Alternatively, positive selection may not operate as is commonly modeled. In particular, the rate of fixation of advantageous mutations may have increased in the recent past.

  2. Student-Chosen Criteria for Peer Assessment of Tertiary Rock Groups in Rehearsal and Performance: What's Important?

    Science.gov (United States)

    Blom, Diana; Encarnacao, John

    2012-01-01

    The study investigates criteria chosen by music students for peer and self assessment of both the rehearsal process and performance outcome of their rock groups. The student-chosen criteria and their explanations of these criteria were analysed in relation to Birkett's skills taxonomy of "soft" and "hard" skills. In the rehearsal process, students…

  3. Random walks on reductive groups

    CERN Document Server

    Benoist, Yves

    2016-01-01

    The classical theory of Random Walks describes the asymptotic behavior of sums of independent identically distributed random real variables. This book explains the generalization of this theory to products of independent identically distributed random matrices with real coefficients. Under the assumption that the action of the matrices is semisimple – or, equivalently, that the Zariski closure of the group generated by these matrices is reductive - and under suitable moment assumptions, it is shown that the norm of the products of such random matrices satisfies a number of classical probabilistic laws. This book includes necessary background on the theory of reductive algebraic groups, probability theory and operator theory, thereby providing a modern introduction to the topic.

  4. Groups, graphs and random walks

    CERN Document Server

    Salvatori, Maura; Sava-Huss, Ecaterina

    2017-01-01

    An accessible and panoramic account of the theory of random walks on groups and graphs, stressing the strong connections of the theory with other branches of mathematics, including geometric and combinatorial group theory, potential analysis, and theoretical computer science. This volume brings together original surveys and research-expository papers from renowned and leading experts, many of whom spoke at the workshop 'Groups, Graphs and Random Walks' celebrating the sixtieth birthday of Wolfgang Woess in Cortona, Italy. Topics include: growth and amenability of groups; Schrödinger operators and symbolic dynamics; ergodic theorems; Thompson's group F; Poisson boundaries; probability theory on buildings and groups of Lie type; structure trees for edge cuts in networks; and mathematical crystallography. In what is currently a fast-growing area of mathematics, this book provides an up-to-date and valuable reference for both researchers and graduate students, from which future research activities will undoubted...

  5. Methods and analysis of realizing randomized grouping.

    Science.gov (United States)

    Hu, Liang-Ping; Bao, Xiao-Lei; Wang, Qi

    2011-07-01

    Randomization is one of the four basic principles of research design. The meaning of randomization includes two aspects: one is to randomly select samples from the population, which is known as random sampling; the other is to randomly group all the samples, which is called randomized grouping. Randomized grouping can be subdivided into three categories: completely, stratified and dynamically randomized grouping. This article mainly introduces the steps of complete randomization, the definition of dynamic randomization and the realization of random sampling and grouping by SAS software.

  6. Duration of bed occupancy as calculated at a random chosen day in an acute care ward. Implications for the use of scarce resources in psychiatric care

    Directory of Open Access Journals (Sweden)

    Restan Asbjørn

    2005-05-01

    Full Text Available Abstract Background Psychiatric acute wards are obliged to admit patients without delay according to the Act on Compulsive Psychiatric Care. Residential long term treatment facilities and rehabilitation facilities may use a waiting list. Patients, who may not be discharged from the acute ward or should not wait there, then occupy acute ward beds. Materials and methods Bed occupancy in one acute ward at a random day in 2002 was registered (n = 23. Successively, the length of stay of all patients was registered, together with information on waiting time after a decision was made on further treatment needs. Eleven patients waited for further resident treatment. The running cost of stay was calculated for the acute ward and in the different resident follow-up facilities. Twenty-three patients consumed a total of 776 resident days. 425 (54.8% of these were waiting days. Patients waited up to 86 days. Results Total cost of treatment was 0.69 million Euro (0.90 mill. $, waiting costs were 54.8% of this, 0.38 million Euro (0.50 million $. The difference between acute care costs and the costs in the relevant secondary resident facility was defined as the imputed loss. Net loss by waiting was 0.20 million Euro (0.26 million $ or 28.8% of total cost. Discussion This point estimate study indicates that treating patients too sick to be released to anything less than some other intramural facility locks a sizable amount of the resources of a psychiatric acute ward. The method used minimized the chance of financially biased treatment decisions. Costs of frustration to staff and family members, and delayed effect of treatment was set to zero. Direct extrapolation to costs per year is not warranted, but it is suggested that our findings would be comparable to other acute wards as well. The study shows how participant observation and cost effectiveness analysis may be combined.

  7. Randomized clinical trial: group counseling based on tinnitus retraining therapy

    National Research Council Canada - National Science Library

    Henry, James A; Loovis, Carl; Montero, Melissa; Kaelin, Christine; Anselmi, Kathryn-Anne; Coombs, Rebecca; Hensley, June; James, Kenneth E

    2007-01-01

    .... We conducted a randomized clinical trial to test the hypothesis that group educational counseling based on TRT principles would effectively treat veterans who have clinically significant tinnitus...

  8. Group theory for embedded random matrix ensembles

    Science.gov (United States)

    Kota, V. K. B.

    2015-04-01

    Embedded random matrix ensembles are generic models for describing statistical properties of finite isolated quantum many-particle systems. For the simplest spinless fermion (or boson) systems with say m fermions (or bosons) in N single particle states and interacting with say k-body interactions, we have EGUE(k) [embedded GUE of k-body interactions) with GUE embedding and the embedding algebra is U(N). In this paper, using EGUE(k) representation for a Hamiltonian that is fc-body and an independent EGUE(t) representation for a transition operator that is t-body and employing the embedding U(N) algebra, finite-N formulas for moments up to order four are derived, for the first time, for the transition strength densities (transition strengths multiplied by the density of states at the initial and final energies). In the asymptotic limit, these formulas reduce to those derived for the EGOE version and establish that in general bivariate transition strength densities take bivariate Gaussian form for isolated finite quantum systems. Extension of these results for other types of transition operators and EGUE ensembles with further symmetries are discussed.

  9. Controllability of the better chosen partial networks

    Science.gov (United States)

    Liu, Xueming; Pan, Linqiang

    2016-08-01

    How to control large complex networks is a great challenge. Recent studies have proved that the whole network can be sufficiently steered by injecting control signals into a minimum set of driver nodes, and the minimum numbers of driver nodes for many real networks are high, indicating that it is difficult to control them. For some large natural and technological networks, it is impossible and not feasible to control the full network. For example, in biological networks like large-scale gene regulatory networks it is impossible to control all the genes. This prompts us to explore the question how to choose partial networks that are easy for controlling and important in networked systems. In this work, we propose a method to achieve this goal. By computing the minimum driver nodes densities of the partial networks of Erdös-Rényi (ER) networks, scale-free (SF) networks and 23 real networks, we find that our method performs better than random method that chooses nodes randomly. Moreover, we find that the nodes chosen by our method tend to be the essential elements of the whole systems, via studying the nodes chosen by our method of a real human signaling network and a human protein interaction network and discovering that the chosen nodes from these networks tend to be cancer-associated genes. The implementation of our method shows some interesting connections between the structure and the controllability of networks, improving our understanding of the control principles of complex systems.

  10. Relaxing Chosen-Ciphertext Security

    DEFF Research Database (Denmark)

    Canetti, Ran; Krawczyk, Hugo; Nielsen, Jesper Buus

    2003-01-01

    Security against adaptive chosen ciphertext attacks (or, CCA security) has been accepted as the standard requirement from encryption schemes that need to withstand active attacks. In particular, it is regarded as the appropriate security notion for encryption schemes used as components within...... general protocols and applications. Indeed, CCA security was shown to suffice in a large variety of contexts. However, CCA security often appears to be somewhat too strong: there exist encryption schemes (some of which come up naturally in practice) that are not CCA secure, but seem sufficiently secure...... “for most practical purposes.” We propose a relaxed variant of CCA security, called Replayable CCA (RCCA) security. RCCA security accepts as secure the non-CCA (yet arguably secure) schemes mentioned above; furthermore, it suffices for most existing applications of CCA security. We provide three...

  11. A Search for Alternatives to Random Assignment to Treatment Groups.

    Science.gov (United States)

    Halasa, Ofelia

    In a public school setting administrators are frequently under local pressure to make a new project service available to all eligible children. However, comparable control groups for project evaluation are often absent, and although random assignment to treatment groups remains the most systematic method of providing controls, this is not often…

  12. Modeling fiber type grouping by a binary Markov random field

    NARCIS (Netherlands)

    Venema, H. W.

    1992-01-01

    A new approach to the quantification of fiber type grouping is presented, in which the distribution of histochemical type in a muscle cross section is regarded as a realization of a binary Markov random field (BMRF). Methods for the estimation of the parameters of this model are discussed. The first

  13. Effect of the chosen incision on corneal astigmatism after implantable collamer lens surgery

    Directory of Open Access Journals (Sweden)

    Xia Jiang

    2014-06-01

    Full Text Available AIM: To evaluate the effect of the chosen incision on corneal astigmatism after implantable collamer lens(ICLsurgery.METHODS: The study included 195 eyes of 102 patients, and all eyes were randomly divided into two groups: the chosen incision group(Group A, 97 eyesand temporal corneal incision(Group B, 98 eyes. Before the operation, and 1wk,1mo and 3mo after the operation, each patient was examined with corneal topography to observe the changes of corneal astigmatism. RESULTS: Preoperative corneal astigmatisms were(1.26±0.35D in group A and(1.28±0.38D in group B, thus there was no statistically significant difference(P>0.05. One week postoperatively, the astigmatism were(0.93±0.29D in group A and(1.32±0.33D in group B. One month postoperatively, the astigmatism were(0.85±0.16D in group A and(1.27±0.18D in group B. Three months postoperatively, the astigmatism were(0.80±0.13D in group A and(1.25±0.20D in group B. The differences between the two groups were statistically significant(PCONCLUSION: The chosen incision can reduce postoperative astigmatism to a certain extent after ICL surgery.

  14. Randomized trial of group musi therapy with Chinese prisoners

    DEFF Research Database (Denmark)

    Chen, Xi Jing; Hannibal, Niels; Gold, Christian

    2016-01-01

    This study investigated the effects of group music therapy on improving anxiety, depression, and self-esteem in Chinese prisoners. Two hundred male prisoners were randomly assigned to music therapy (n = 100) or standard care (n = 100). The music therapy had 20 sessions of group therapy compared...... to standard care. Anxiety (STAI), depression (BDI) and self-esteem (TSBI, RSI) were measured by standardized scales at baseline, mid-program and post-program. Data were analyzed based on the intention to treat principle. Compared to standard care, anxiety and depression in the music therapy condition...... decreased significantly at mid-test and post-test; self-esteem improved significantly at mid-test (TSBI) and at post-test (TSBI, RSI). Improvements were greater in younger participants (STAI-Trait, RSI) and/or those with a lower level of education (STAI-State, STAI-Trait). Group music therapy seems...

  15. Comparing groups randomization and bootstrap methods using R

    CERN Document Server

    Zieffler, Andrew S; Long, Jeffrey D

    2011-01-01

    A hands-on guide to using R to carry out key statistical practices in educational and behavioral sciences research Computing has become an essential part of the day-to-day practice of statistical work, broadening the types of questions that can now be addressed by research scientists applying newly derived data analytic techniques. Comparing Groups: Randomization and Bootstrap Methods Using R emphasizes the direct link between scientific research questions and data analysis. Rather than relying on mathematical calculations, this book focus on conceptual explanations and

  16. Random Vector and Matrix Theories: A Renormalization Group Approach

    Science.gov (United States)

    Zinn-Justin, Jean

    2014-09-01

    Random matrices in the large N expansion and the so-called double scaling limit can be used as toy models for quantum gravity: 2D quantum gravity coupled to conformal matter. This has generated a tremendous expansion of random matrix theory, tackled with increasingly sophisticated mathematical methods and number of matrix models have been solved exactly. However, the somewhat paradoxical situation is that either models can be solved exactly or little can be said. Since the solved models display critical points and universal properties, it is tempting to use renormalization group ideas to determine universal properties, without solving models explicitly. Initiated by Br\\'ezin and Zinn-Justin, the approach has led to encouraging results, first for matrix integrals and then quantum mechanics with matrices, but has not yet become a universal tool as initially hoped. In particular, general quantum field theories with matrix fields require more detailed investigations. To better understand some of the encountered difficulties, we first apply analogous ideas to the simpler O(N) symmetric vector models, models that can be solved quite generally in the large N limit. Unlike other attempts, our method is a close extension of Br\\'ezin and Zinn-Justin. Discussing vector and matrix models with similar approximation scheme, we notice that in all cases (vector and matrix integrals, vector and matrix path integrals in the local approximation), at leading order, non-trivial fixed points satisfy the same universal algebraic equation, and this is the main result of this work. However, its precise meaning and role have still to be better understood.

  17. Random Group Problem-Based Learning in Engineering Dynamics

    CERN Document Server

    Fleischfresser, Luciano

    2014-01-01

    Dynamics problem solving is highly specific to the problem at hand and to develop the general mind framework to become an effective problem solver requires ingenuity and creativity on top of a solid grounding on theoretical and conceptual knowledge. A blended approach with prototype demo, problem-based learning, and an opinion questionnaire was used during first semester of 2013. Students working in randomly selected teams had to interact with classmates while solving a randomly selected problem. The approach helps improve awareness of what is important to learn in this class while reducing grading load. It also provides a more rewarding contact time for both pupils and instructor.

  18. Imagery intelligence from low altitudes: chosen aspects

    Science.gov (United States)

    Walczykowski, P.; Kedzierski, M.

    2017-04-01

    Remote acquisition of information about phenomena and objects from an imagery is the main objective of remote sensing. The ability to realize aims of image intelligence depends on the quality of acquired remote sensing data. The imagery intelligence can be carried out from different altitudes- from satellite level to terrestrial platforms. In this article, authors are focused on chosen aspects of imagery intelligence from low altitudes. Unfortunately the term low altitudes is not precise defined, therefore, for the purpose of this article is assumed that low altitudes, are altitudes in which operate the mini unmanned aerial vehicles (mini UAVs).The quality of imagery acquired determines the level of analysis that can be performed. The imagery quality depends on many factors, such as platforms on which the sensor is mounted, imaging sensors, height from which the data are acquired and object that is investigated. The article will also present the methods for assessing the quality of imagery in terms of detection, identification, description and technical analysis of investigated objects, as well as in terms of the accuracy of their location in the images (targeting).

  19. Nutrient adequacy during weight loss interventions: a randomized study in women comparing the dietary intake in a meal replacement group with a traditional food group

    Directory of Open Access Journals (Sweden)

    Bovee Vicki

    2007-06-01

    Full Text Available Abstract Background Safe and effective weight control strategies are needed to stem the current obesity epidemic. The objective of this one-year study was to document and compare the macronutrient and micronutrient levels in the foods chosen by women following two different weight reduction interventions. Methods Ninety-six generally healthy overweight or obese women (ages 25–50 years; BMI 25–35 kg/m2 were randomized into a Traditional Food group (TFG or a Meal Replacement Group (MRG incorporating 1–2 meal replacement drinks or bars per day. Both groups had an energy-restricted goal of 5400 kJ/day. Dietary intake data was obtained using 3-Day Food records kept by the subjects at baseline, 6 months and one-year. For more uniform comparisons between groups, each diet intervention consisted of 18 small group sessions led by the same Registered Dietitian. Results Weight loss for the 73% (n = 70 completing this one-year study was not significantly different between the groups, but was significantly different (p ≤ .05 within each group with a mean (± standard deviation weight loss of -6.1 ± 6.7 kg (TFG, n = 35 vs -5.0 ± 4.9 kg (MRG, n = 35. Both groups had macronutrient (Carbohydrate:Protein:Fat ratios that were within the ranges recommended (50:19:31, TFG vs 55:16:29, MRG. Their reported reduced energy intake was similar (5729 ± 1424 kJ, TFG vs 5993 ± 2016 kJ, MRG. There was an improved dietary intake pattern in both groups as indicated by decreased intake of saturated fat (≤ 10%, cholesterol ( Conclusion In this one-year university-based intervention, both dietitian-led groups successfully lost weight while improving overall dietary adequacy. The group incorporating fortified meal replacements tended to have a more adequate essential nutrient intake compared to the group following a more traditional food group diet. This study supports the need to incorporate fortified foods and/or dietary supplements while following an energy

  20. Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

    Science.gov (United States)

    Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

    2014-01-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This "preliminary" randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive…

  1. A Discrete Group Search Optimizer for Hybrid Flowshop Scheduling Problem with Random Breakdown

    National Research Council Canada - National Science Library

    Cui, Zhe; Gu, Xingsheng

    2014-01-01

    ...) together with a discrete group search optimizer algorithm (DGSO). In particular, two different working cases, preempt-resume case, and preempt-repeat case are considered under random breakdown...

  2. Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions

    National Research Council Canada - National Science Library

    Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E

    2011-01-01

    To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials...

  3. Cognitive-behavioral group therapy versus group psychotherapy for social anxiety disorder among college students: a randomized controlled trial.

    Science.gov (United States)

    Bjornsson, Andri S; Bidwell, L Cinnamon; Brosse, Alisha L; Carey, Gregory; Hauser, Monika; Mackiewicz Seghete, Kristen L; Schulz-Heik, R Jay; Weatherley, Donald; Erwin, Brigette A; Craighead, W Edward

    2011-11-01

    In this randomized controlled trial, cognitive-behavioral group therapy (CBGT) for social anxiety disorder (SAD) was compared to group psychotherapy (GPT), a credible, structurally equivalent control condition that included only nonspecific factors of group treatment (such as group dynamics). Participants were 45 college students at the University of Colorado with a primary diagnosis of SAD. Each treatment condition comprised eight group sessions lasting 2 hr each. Independent assessors (blind to treatment assignment) assessed participants at baseline and posttreatment with the Clinical Global Impression Scale (CGI) and the Liebowitz Social Anxiety Scale (LSAS). Both treatments were found to be equally credible. There were five noncompleters in the CBGT condition (21.7%) and only one in the GPT condition (4.3%). There were no statistically significant differences posttreatment (controlling for pretreatment scores) between the two treatment conditions, and both treatments were found to be efficacious. Effect sizes for CBGT were similar to earlier studies, and adherence ratings revealed excellent adherence. Treatment of SAD appears to be moving toward individual CBT, partly because of high attrition rates and underutilization of group dynamics in group CBT. However, group therapy has unique therapeutic ingredients, and it may be too early to give up on group treatment altogether. Discussion of these findings included future directions with this treatment modality, especially whether these two types of group treatment could be combined and whether such combination might serve to decrease attrition, enhance efficacy, and facilitate dissemination. © 2011 Wiley Periodicals, Inc.

  4. Programming a randomized dependent group contingency and common stimuli to promote durable behavior change.

    Science.gov (United States)

    Cariveau, Tom; Kodak, Tiffany

    2017-01-01

    Low levels of academic engagement may impede students' acquisition of skills. Intervening on student behavior using group contingencies may be a feasible way to increase academic engagement during group instruction. The current study examined the effect of a randomized dependent group contingency on levels of academic engagement for second-grade participants receiving small-group reading and writing instruction. The results showed that a randomized dependent group contingency increased the academic engagement of primary participants and several of the other participants during small-group instruction. The findings also showed that high levels of academic engagement were maintained when common stimuli were present and the dependent group contingency was withdrawn. © 2016 Society for the Experimental Analysis of Behavior.

  5. The Influence of Randomly Allocated Group Membership when Developing Student Task Work and Team Work Capabilities

    Science.gov (United States)

    McClelland, Giles Peter

    2012-01-01

    This study explores whether randomly assigning group membership enhances the student learning experience. The paper starts with a critical analysis of the approaches to student learning within higher education and how these approaches conflict with findings from applied psychology on group behaviour. The study adopts a serendipitous qualitative…

  6. Efficacy of meaning-centered group psychotherapy for cancer survivors : a randomized controlled trial

    NARCIS (Netherlands)

    van der Spek, N; Vos, J; van Uden-Kraan, C F; Breitbart, W.; Cuijpers, P; Holtmaat, K; Witte, B I; Tollenaar, R.A.E.M.; Verdonck-de Leeuw, I M

    BACKGROUND: The aim of this study was to assess the efficacy of meaning-centered group psychotherapy for cancer survivors (MCGP-CS) to improve personal meaning, compared with supportive group psychotherapy (SGP) and care as usual (CAU). METHOD: A total of 170 cancer survivors were randomly assigned

  7. Cultural differences in music chosen for pain relief.

    Science.gov (United States)

    Good, M; Picot, B L; Salem, S G; Chin, C C; Picot, S F; Lane, D

    2000-09-01

    Nurses use music therapeutically but often assume that all patients will equally appreciate the same type of music. Cultural differences in music preferences are compared across five pain studies. Music preferences for pain relief are described as the most frequently chosen type of music for each culture. Findings indicate that in four studies, musical choices were related to cultural background (p = .002 to .049). Although the majority in each group chose among the other types of music, Caucasians most frequently chose orchestra music, African Americans chose jazz, and Taiwanese chose harp music. For culturally congruent care, nurses should become aware of cultural differences in music preference and provide culturally specific selections among other music expected to have a therapeutic effect.

  8. "Right from the Start": Randomized Trial Comparing an Attachment Group Intervention to Supportive Home Visiting

    Science.gov (United States)

    Niccols, Alison

    2008-01-01

    Background: Infant attachment security is a protective factor for future mental health, and may be promoted by individual interventions. Given service demands, it is important to determine if a group-based intervention for parents could be used to enhance infant attachment security. Methods: In a randomized trial involving 76 mothers, an 8-session…

  9. Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

    Science.gov (United States)

    Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

    2015-03-01

    ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

  10. Does Family Group Decision Making Affect Child Welfare Outcomes? Findings from a Randomized Control Study

    Science.gov (United States)

    Berzin, Stephanie Cosner; Cohen, Ed; Thomas, Karen; Dawson, William C.

    2008-01-01

    This article describes the evaluation of two family group decision-making programs administered under the California Title IV-E Waiver Demonstration Project. This is the only evaluation using random assignment to examine FGDM. Overall, results did not indicate more positive outcomes for children receiving the intervention, but did indicate that…

  11. Group support for patients with metastatic cancer. A randomized outcome study.

    Science.gov (United States)

    Spiegel, D; Bloom, J R; Yalom, I

    1981-05-01

    The effects of weekly supportive group meetings for women with metastatic carcinoma of the breast were systematically evaluated in a one-year, randomized, prospective outcome study. The groups focused on the problems of terminal illness, including improving relationships with family, friends, and physicians and living as fully as possible in the face of death. We hypothesized that this invention would lead to improved mood, coping strategies, and self-esteem among those in the treatment group. Eighty-six patients were tested at four-month intervals. The treatment group had significantly lower mood-disturbance scores on the Profile of Mood States scale, had fewer maladaptive coping responses, and were less phobic than the control group. This study provides objective evidence that a supportive group intervention for patients with metastatic cancer results in psychological benefit. Mechanisms underlying the effectiveness of this group intervention are explored.

  12. Random-effects regression analysis of correlated grouped-time survival data.

    Science.gov (United States)

    Hedeker, D; Siddiqui, O; Hu, F B

    2000-04-01

    Random-effects regression modelling is proposed for analysis of correlated grouped-time survival data. Two analysis approaches are considered. The first treats survival time as an ordinal outcome, which is either right-censored or not. The second approach treats survival time as a set of dichotomous indicators of whether the event occurred for time periods up to the period of the event or censor. For either approach both proportional hazards and proportional odds versions of the random-effects model are developed, while partial proportional hazards and odds generalizations are described for the latter approach. For estimation, a full-information maximum marginal likelihood solution is implemented using numerical quadrature to integrate over the distribution of multiple random effects. The quadrature solution allows some flexibility in the choice of distributions for the random effects; both normal and rectangular distributions are considered in this article. An analysis of a dataset where students are clustered within schools is used to illustrate features of random-effects analysis of clustered grouped-time survival data.

  13. Special quasirandom structures for binary/ternary group IV random alloys

    KAUST Repository

    Chroneos, Alexander I.

    2010-06-01

    Simulation of defect interactions in binary/ternary group IV semiconductor alloys at the density functional theory level is difficult due to the random distribution of the constituent atoms. The special quasirandom structures approach is a computationally efficient way to describe the random nature. We systematically study the efficacy of the methodology and generate a number of special quasirandom cells for future use. In order to demonstrate the applicability of the technique, the electronic structures of E centers in Si1-xGex and Si1-x -yGexSny alloys are discussed for a range of nearest neighbor environments. © 2010 Elsevier B.V. All rights reserved.

  14. Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.

    Science.gov (United States)

    Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E

    2011-05-01

    To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.

  15. A phylogenetic analysis of Schistosoma haematobium group species based on randomly amplified polymorphic DNA.

    Science.gov (United States)

    Kaukas, A; Dias Neto, E; Simpson, A J; Southgate, V R; Rollinson, D

    1994-04-01

    Randomly amplified polymorphic DNA (RAPD) profiles were produced using four oligonucleotide primers with genomic DNA from 15 isolates of schistosome. Both inter- and intraspecific variation were noted. Intraspecific variation was greater for two species of the S. haematobium group (S. haematobium and S. intercalatum) than for S. mansoni. The inferred phylogeny placed S. curassoni and S. bovis as sister groups to S. mansoni-S. rodhaini group. S. mattheei and S. leiperi formed a separate lineage. The results confirm that RAPD profiles may be used for both strain and species differentiation and for the generation of phylogenetic trees.

  16. A single blind randomized control trial on support groups for Chinese persons with mild dementia.

    Science.gov (United States)

    Young, Daniel K W; Kwok, Timothy C Y; Ng, Petrus Y N

    2014-01-01

    Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59%) of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48) to 7.35 (standard deviation =2.18), which was significant (Wilcoxon signed-rank test; P=0.017, Pcontrol group's participants did not show any significant change. This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants.

  17. Chosen-Prefix Collisions for MD5 and Applications

    NARCIS (Netherlands)

    M.M.J. Stevens (Marc); A.K. Lenstra (Arjen); B. de Weger (Benne)

    2012-01-01

    textabstractWe present a novel, automated way to find differential paths for MD5. Its main application is in the construction of \\emph{chosen-prefix collisions}. We have shown how, at an approximate expected cost of $2^{39}$ calls to the MD5 compression function, for any two chosen

  18. Does group training during pregnancy prevent lumbopelvic pain? A randomized clinical trial.

    Science.gov (United States)

    Mørkved, Siv; Salvesen, Kjell Asmund; Schei, Berit; Lydersen, Stian; Bø, Kari

    2007-01-01

    Prevention of lumbopelvic pain in pregnancy has been sparsely studied. One aim of this study was to assess if a 12-week training program during pregnancy can prevent and/or treat lumbopelvic pain. A randomized controlled trial was conducted at Trondheim University Hospital and three outpatient physiotherapy clinics. Three hundred and one healthy nulliparous women were included at 20 weeks of pregnancy and randomly allocated to a training group (148) or a control group (153). The outcome measures were self-reported symptoms of lumbopelvic pain (once per week or more), sick leave, and functional status. Pain drawing was used to document the painful area of the body. The intervention included daily pelvic floor muscle training at home, and weekly group training over 12 weeks including aerobic exercises, pelvic floor muscle and additional exercises, and information related to pregnancy. At 36 weeks of gestation women in the training group were significantly less likely to report lumbopelvic pain: 65/148 (44%) versus 86/153 (56%) (p=0.03). Three months after delivery the difference was 39/148 (26%) in the training group versus 56/153 (37%) in the control group (p=0.06). There was no difference in sick leave during pregnancy, but women in the training group had significantly (p=0.01) higher scores on functional status. A 12-week specially designed training program during pregnancy was effective in preventing lumbopelvic pain in pregnancy.

  19. Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: a preliminary randomized controlled trial.

    Science.gov (United States)

    Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

    2014-08-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6-8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p autism spectrum disorder. The interventions' similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. © The Author(s) 2013.

  20. Group cognitive remediation therapy for chronic schizophrenia: A randomized controlled trial.

    Science.gov (United States)

    Tan, Shuping; Zou, Yizhuang; Wykes, Til; Reeder, Clare; Zhu, Xiaolin; Yang, Fude; Zhao, Yanli; Tan, Yunlong; Fan, Fengmei; Zhou, Dongfeng

    2016-07-28

    Individual-level cognitive remediation therapy (CRT) has been shown to be effective for cognitive improvement and social function amelioration. Here, we aimed to test the efficacy of group-based CRT in Chinese subjects with schizophrenia. One-hundred and four inpatients were randomly assigned to either 40 sessions of small-group CRT therapy or therapeutic contact-matched Musical and Dancing Therapy (MDT). Cognitive and social functioning, as well as clinical symptoms, were evaluated over the course of treatment. Specifically, cognitive function was evaluated using a battery of cognitive measurements, clinical symptoms were evaluated using the Positive and Negative Syndrome Scale, and social function was evaluated using the Nurse's Observation Scale for Inpatient Evaluation-30. All patients were evaluated pre- and post-treatment. Forty-four individuals in the CRT group and 46 in the MDT group completed all of the planned treatments and analyses. Cognitive functions, especially cognitive flexibility and memory, showed significant improvement in the CRT group over the course of the study. The MDT group also showed improvement in several cognitive flexibility assessments, but the degree of improvement was significantly greater in the CRT group. Several social-function factors exhibited a significant improvement in the CRT group, but not in the MDT group. Cognitive function improvement correlated positively with social function without predicting social function change. We conclude that group-based CRT is an effective and promising therapy. Copyright © 2016. Published by Elsevier Ireland Ltd.

  1. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups.

    Science.gov (United States)

    Haake, Michael; Müller, Hans-Helge; Schade-Brittinger, Carmen; Basler, Heinz D; Schäfer, Helmut; Maier, Christoph; Endres, Heinz G; Trampisch, Hans J; Molsberger, Albrecht

    2007-09-24

    To our knowledge, verum acupuncture has never been directly compared with sham acupuncture and guideline-based conventional therapy in patients with chronic low back pain. A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean +/- SD age, 50 +/- 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n = 387) according to principles of traditional Chinese medicine; sham acupuncture (n = 387) consisting of superficial needling at nonacupuncture points; or conventional therapy, a combination of drugs, physical therapy, and exercise (n = 388). Five additional sessions were offered to patients who had a partial response to treatment (10%-50% reduction in pain intensity). Primary outcome was response after 6 months, defined as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire. Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement. At 6 months, response rate was 47.6% in the verum acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group. Differences among groups were as follows: verum vs sham, 3.4% (95% confidence interval, -3.7% to 10.3%; P = .39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4% to 26.7%; P vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P acupuncture treatment for at least 6 months. Effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy.

  2. Calculation of the mean differential group delay of periodically spun, randomly birefringent fibers.

    Science.gov (United States)

    Galtarossa, Andrea; Griggio, Paola; Pizzinat, Anna; Palmieri, Luca

    2002-05-01

    Spinning is one of the most effective and well-known ways to reduce polarization mode dispersion of optical fibers. In spite of the popularity of spinning, a detailed theory of spin effects is still lacking. We report an analytical expression for the mean differential group delay of a randomly birefringent spun fiber. The result holds for any periodic spin function with a period shorter than the fiber's beat length.

  3. Effectiveness of an online group course for depression in adolescents and young adults: a randomized trial.

    Science.gov (United States)

    van der Zanden, Rianne; Kramer, Jeannet; Gerrits, Rob; Cuijpers, Pim

    2012-06-07

    Depression is a serious mental health problem, whose first onset is usually in adolescence. Online treatment may offer a solution for the current undertreatment of depression in youth. For adults with depressive symptoms, the effectiveness of Internet-based cognitive behavioral therapy has been demonstrated. This study is one of the first randomized controlled trials to investigate the effectiveness online depression treatment for young people with depressive complaints and the first to focus on an online group course. To evaluate and discuss the effectiveness of a guided Web-based group course called Grip op Je Dip (Master Your Mood [MYM]), designed for young people aged 16 to 25 years with depressive symptoms, in comparison with a wait-listed control group. We randomly assigned 244 young people with depressive symptoms to the online MYM course or to a waiting-list control condition. The primary outcome measure was treatment outcome after 3 months on the Center for Epidemiologic Studies Depression Scale. Secondary outcomes were anxiety (measured by the Hospital Anxiety and Depression Scale) and mastery (Mastery Scale). We studied the maintenance of effects in the MYM group 6 months after baseline. Missing data were imputed. The MYM group (n = 121) showed significantly greater improvement in depressive symptoms at 3 months than the control group (n = 123) (t(187 )= 6.62, P limitation is the infeasibility of comparing the 6-month outcomes of the MYM and control groups, as the controls had access to MYM after 3 months. The online group course MYM was effective in reducing depressive symptoms and anxiety and in increasing mastery in young people. These effects persisted in the MYM group at 6 months.

  4. A Group-Based Yoga Therapy Intervention for Urinary Incontinence in Women: A Pilot Randomized Trial

    Science.gov (United States)

    Huang, Alison J.; Jenny, Hillary E.; Chesney, Margaret A.; Schembri, Michael; Subak, Leslee L.

    2015-01-01

    Objective To examine the feasibility, efficacy, and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence. Methods We conducted a pilot randomized trial of ambulatory women aged 40 years and older with stress, urgency, or mixed-type incontinence. Women were randomized to a 6-week yoga therapy program (N=10) consisting of twice weekly group classes and once weekly home practice or a waitlist control group (N=9). All participants also received written pamphlets about standard behavioral self-management strategies for incontinence. Changes in incontinence were assessed by 7-day voiding diaries. Results Mean (±SD) age was 61.4 (±8.2) years, and mean baseline frequency of incontinence was 2.5 (±1.3) episodes/day. After 6 weeks, total incontinence frequency decreased by 66% (1.8 [±0.9] fewer episodes/day) in the yoga therapy versus 13% (0.3 [±1.7] fewer episodes/day) in the control group (P=0.049). Participants in the yoga therapy group also reported an average 85% decrease in stress incontinence frequency (0.7 [±0.8] fewer episodes/day) compared to a 25% increase in controls (0.2 [± 1.1] more episodes/day) (P=0.039). No significant differences in reduction in urgency incontinence were detected between the yoga therapy versus control groups (1.0 [±1.0] versus 0.5 [±0.5] fewer episodes/day, P=0.20). All women starting the yoga therapy program completed at least 90% of group classes and practice sessions. Two participants in each group reported adverse events unrelated to the intervention. Conclusions Findings provide preliminary evidence to support the feasibility, efficacy, and safety of a group-based yoga therapy intervention to improve urinary incontinence in women. PMID:24763156

  5. A prospective randomized trial of content expertise versus process expertise in small group teaching.

    Science.gov (United States)

    Peets, Adam D; Cooke, Lara; Wright, Bruce; Coderre, Sylvain; McLaughlin, Kevin

    2010-10-14

    Effective teaching requires an understanding of both what (content knowledge) and how (process knowledge) to teach. While previous studies involving medical students have compared preceptors with greater or lesser content knowledge, it is unclear whether process expertise can compensate for deficient content expertise. Therefore, the objective of our study was to compare the effect of preceptors with process expertise to those with content expertise on medical students' learning outcomes in a structured small group environment. One hundred and fifty-one first year medical students were randomized to 11 groups for the small group component of the Cardiovascular-Respiratory course at the University of Calgary. Each group was then block randomized to one of three streams for the entire course: tutoring exclusively by physicians with content expertise (n = 5), tutoring exclusively by physicians with process expertise (n = 3), and tutoring by content experts for 11 sessions and process experts for 10 sessions (n = 3). After each of the 21 small group sessions, students evaluated their preceptors' teaching with a standardized instrument. Students' knowledge acquisition was assessed by an end-of-course multiple choice (EOC-MCQ) examination. Students rated the process experts significantly higher on each of the instrument's 15 items, including the overall rating. Students' mean score (±SD) on the EOC-MCQ exam was 76.1% (8.1) for groups taught by content experts, 78.2% (7.8) for the combination group and 79.5% (9.2) for process expert groups (p = 0.11). By linear regression student performance was higher if they had been taught by process experts (regression coefficient 2.7 [0.1, 5.4], p teach first year medical students within a structured small group environment; preceptors with process expertise result in at least equivalent, if not superior, student outcomes in this setting.

  6. Pilot study of the Korean Parent Training Program using a partial group randomized experimental study

    Science.gov (United States)

    Kim, Eunjung; Cain, Kevin; Boutain, Doris; Chun, Jin-Joo; Kim, Sangho; Im, Hyesang

    2017-01-01

    Problems Korean American (KA) children experience mental health problems due to difficulties in parenting dysfunction complicated by living in two cultures. Methods Korean Parent Training Program (KPTP) was pilot tested with 48 KA mothers of children (ages 3–8) using partial group randomized controlled experimental study design. Self-report survey and observation data were gathered. Findings Analyses using generalized estimating equation indicated the intervention group mothers increased effective parenting and their children decreased behavior problems and reported less acculturation conflict with mothers. Conclusions The KPTP is a promising way to promote effective parenting and increase positive child mental health in KA families. PMID:24645901

  7. Racial disparities in the type of postmastectomy reconstruction chosen.

    Science.gov (United States)

    Offodile, Anaeze C; Tsai, Thomas C; Wenger, Julia B; Guo, Lifei

    2015-05-01

    Racial disparities remain for women undergoing immediate breast reconstruction (IBR) after mastectomy. Understanding patterns of racial disparities in IBR utilization may present opportunities to tailor policies aimed at optimizing care across racial groups. The aim of this study was to determine if racial disparities exist for types of IBR chosen. A national, retrospective cohort study used the 2005-2011 American College of Surgeons National Surgical Quality Improvement Program database. Multivariable logistic regression models were created to detect the odds by race for receiving each subtype of IBR after mastectomy-prosthetic, pedicled-transfer autologous tissue, or free-transfer autologous tissue. Secondary outcome was trends in IBR rates over time. There were 44,597 women identified in the data set who underwent mastectomy. Thirty-seven percent of women (N = 16, 642) were noted to undergo IBR after mastectomy. Prosthetic reconstruction (84.4%, n = 37, 640) was the most common form of IBR compared with pedicled-autologous reconstruction (15.4%, n = 6868) and free transfer autologous reconstruction (4.9%, n = 2185), P Racial disparities persisted from 2005-2011; as minority patients were less likely to undergo IBR than whites (P disparities in access to high-quality care and underlying cultures. Strategies aimed at reducing racial disparities in IBR should be tailored to specific patterns of disparities among Asian, black, and Hispanic women. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Community-based group exercise for persons with Parkinson disease: a randomized controlled trial.

    Science.gov (United States)

    Combs, Stephanie A; Diehl, M Dyer; Chrzastowski, Casey; Didrick, Nora; McCoin, Brittany; Mox, Nicholas; Staples, William H; Wayman, Jessica

    2013-01-01

    The purpose of this study was to compare group boxing training to traditional group exercise on function and quality of life in persons with Parkinson disease (PD). A convenience sample of adults with PD (n = 31) were randomly assigned to boxing training or traditional exercise for 24-36 sessions, each lasting 90 minutes, over 12 weeks. Boxing training included: stretching, boxing (e.g. lateral foot work, punching bags), resistance exercises, and aerobic training. Traditional exercise included: stretching, resistance exercises, aerobic training, and balance activities. Participants were tested before and after completion of training on balance, balance confidence, mobility, gait velocity, gait endurance, and quality of life. The traditional exercise group demonstrated significantly greater gains in balance confidence than the boxing group (p exercise for persons with PD will be an important future consideration for rehabilitation professionals.

  9. Group cognitive behavior therapy for chronic posttraumatic stress disorder: an initial randomized pilot study.

    Science.gov (United States)

    Beck, J Gayle; Coffey, Scott F; Foy, David W; Keane, Terence M; Blanchard, Edward B

    2009-03-01

    Individuals with posttraumatic stress disorder (PTSD) related to a serious motor vehicle accident were randomly assigned to either group cognitive behavioral treatment(GCBT) or a minimum contact comparison group (MCC).Compared to the MCC participants (n=16), individuals who completed GCBT (n=17) showed significant reductions in PTSD symptoms, whether assessed using clinical interview or a self-report measure. Among treatment completers, 88.3% of GCBT participants did not satisfy criteria for PTSD at posttreatment assessment, relative to31.3% of the MCC participants. Examination of anxiety,depression, and pain measures did not show a unique advantage of GCBT. Treatment-related gains were maintained over a 3-month follow-up interval. Patients reported satisfaction with GCBT, and attrition from this treatment was comparable with individually administered CBTs.Results are discussed in light of modifications necessitated by the group treatment format, with suggestions for future study of this group intervention.

  10. Brief Group Intervention Using Emotional Freedom Techniques for Depression in College Students: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Dawson Church

    2012-01-01

    Full Text Available Two hundred thirty-eight first-year college students were assessed using the Beck Depression Inventory (BDI. Thirty students meeting the BDI criteria for moderate to severe depression were randomly assigned to either a treatment or control group. The treatment group received four 90-minute group sessions of EFT (Emotional Freedom Techniques, a novel treatment that combines exposure, cognitive reprocessing, and somatic stimulation. The control group received no treatment. Posttests were conducted 3 weeks later on those that completed all requirements (N=18. The EFT group (n=9 had significantly more depression at baseline than the control group (n=9 (EFT BDI mean=23.44, SD=2.1 versus control BDI mean=20.33, SD=2.1. After controlling for baseline BDI score, the EFT group had significantly less depression than the control group at posttest, with a mean score in the “nondepressed” range (P=.001; EFT BDI mean=6.08, SE=1.8 versus control BDI mean=18.04, SE=1.8. Cohen's d was 2.28, indicating a very strong effect size. These results are consistent with those noted in other studies of EFT that included an assessment for depression and indicate the clinical usefulness of EFT as a brief, cost-effective, and efficacious treatment.

  11. A single blind randomized control trial on support groups for Chinese persons with mild dementia

    Directory of Open Access Journals (Sweden)

    Young DKW

    2014-12-01

    Full Text Available Daniel KW Young,1 Timothy CY Kwok,2 Petrus YN Ng1 1Department of Social Work, Hong Kong Baptist University, Kowloon Tong, Hong Kong; 2Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong Purpose: Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Research methods: Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. Results: At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59% of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48 to 7.35 (standard deviation =2.18, which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05, while the control group’s participants did not show any significant change. Conclusion: This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants. Keywords: support group, mild dementia, Chinese, depression

  12. Random matrix theory, the exceptional Lie groups and L-functions

    Energy Technology Data Exchange (ETDEWEB)

    Keating, J P [School of Mathematics, University of Bristol, Bristol BS8 1TW, UK (United Kingdom); Linden, N [School of Mathematics, University of Bristol, Bristol BS8 1TW, UK (United Kingdom); Rudnick, Z [Raymond and Beverly Sackler School of Mathematical Sciences, Tel Aviv University, Tel Aviv 69978 (Israel)

    2003-03-28

    There has recently been interest in relating properties of matrices drawn at random from the classical compact groups to statistical characteristics of number-theoretical L-functions. One example is the relationship conjectured to hold between the value distributions of the characteristic polynomials of such matrices and value distributions within families of L-functions. These connections are extended here to non-classical groups. We focus on an explicit example: the exceptional Lie group G{sub 2}. The value distributions for characteristic polynomials associated with the 7- and 14-dimensional representations of G{sub 2}, defined with respect to the uniform invariant (Haar) measure, are calculated using two of the Macdonald constant term identities. A one-parameter family of L-functions over a finite field is described whose value distribution in the limit as the size of the finite field grows is related to that of the characteristic polynomials associated with the seven-dimensional representation of G{sub 2}. The random matrix calculations extend to all exceptional Lie groups.

  13. A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism.

    Science.gov (United States)

    Hardan, Antonio Y; Gengoux, Grace W; Berquist, Kari L; Libove, Robin A; Ardel, Christina M; Phillips, Jennifer; Frazier, Thomas W; Minjarez, Mendy B

    2015-08-01

    With rates of autism diagnosis continuing to rise, there is an urgent need for effective and efficient service delivery models. Pivotal Response Treatment (PRT) is considered an established treatment for autism spectrum disorder (ASD); however, there have been few well-controlled studies with adequate sample size. The aim of this study was to conduct a randomized controlled trial to evaluate PRT parent training group (PRTG) for targeting language deficits in young children with ASD. Fifty-three children with autism and significant language delay between 2 and 6 years old were randomized to PRTG (N = 27) or psychoeducation group (PEG; N = 26) for 12 weeks. The PRTG taught parents behavioral techniques to facilitate language development. The PEG taught general information about ASD (clinical trial NCT01881750; http://www.clinicaltrials.gov). Analysis of child utterances during the structured laboratory observation (primary outcome) indicated that, compared with children in the PEG, children in the PRTG demonstrated greater improvement in frequency of utterances (F(2, 43) = 3.53, p = .038, d = 0.42). Results indicated that parents were able to learn PRT in a group format, as the majority of parents in the PRTG (84%) met fidelity of implementation criteria after 12 weeks. Children also demonstrated greater improvement in adaptive communication skills (Vineland-II) following PRTG and baseline Mullen visual reception scores predicted treatment response to PRTG. This is the first randomized controlled trial of group-delivered PRT and one of the largest experimental investigations of the PRT model to date. The findings suggest that specific instruction in PRT results in greater skill acquisition for both parents and children, especially in functional and adaptive communication skills. Further research in PRT is warranted to replicate the observed results and address other core ASD symptoms. © 2014 Association for Child and Adolescent Mental Health.

  14. Heterogenic control groups in randomized, controlled, analgesic trials of total hip- and knee arthroplasty.

    Science.gov (United States)

    Karlsen, Anders P; Mathiesen, Ole; Dahl, Jørgen B

    2017-11-17

    Postoperative analgesic interventions are often tested adjunct to basic non- opioid analgesics in randomized controlled trials (RCTs). Consequently, treatment in control groups, and assay sensitivity, differs between trials. We hypothesized that postoperative opioid requirements and pain intensities varies between different control groups in analgesic trials. Control groups from RCTs investigating analgesic interventions after total hip and knee arthroplasty were categorized based on standardized basic analgesic treatment. Morphine consumption 0-24h postoperatively, and resting pain scores at 6 and 24 hours for subgroups of basic treatments, were compared with ANOVA. In an additional analysis, we compared pain and opioid requirements in trials where NSAID was administered as an intervention with trial where NSAID was administered in a control group. We included 171 RCTs employing 28 different control groups with large variability in pain scores and opioid requirements. Four types of control groups (comprising 78 trials) were eligi- ble for subgroup comparisons. These subgroups received: 'opioid', 'NSAID+opioid', 'acetamino- phen+opioid', or 'NSAID+acetaminophen+opioid'. Morphine consumption and pain scores varied substantially between these groups, with no consistent superior efficacy in any subgroup. Addi- tionally, trials administering NSAID as an intervention demonstrated lower pain scores and opioid requirements than trials where NSAID was administered in a control group. Analgesic treatment in RCT control groups varies considerably. Control groups receiving various combinations of opioid, NSAID and acetaminophen did not differ consistently in pain and opioid requirements. Pain and opioid requirements were lower in trials administering NSAID as an intervention compared with trials administering NSAID in a control group.

  15. Control group selection in critical care randomized controlled trials evaluating interventional strategies: An ethical assessment.

    Science.gov (United States)

    Silverman, Henry J; Miller, Franklin G

    2004-03-01

    Ethical concern has been raised with critical care randomized controlled trials in which the standard of care reflects a broad range of clinical practices. Commentators have argued that trials without an unrestricted control group, in which standard practices are implemented at the discretion of the attending physician, lack the ability to redefine the standard of care and might expose subjects to excessive harms due to an inability to stop early. To develop a framework for analyzing control group selection for critical care trials. Ethical analysis. A key ethical variable in trial design is the extent with which the control group adequately reflects standard care practices. Such a control group might incorporate either the "unrestricted" practices of physicians or a protocol that specifies and restricts the parameters of standard practices. Control group selection should be determined with respect to the following ethical objectives of trial design: 1) clinical value, 2) scientific validity, 3) efficiency and feasibility, and 4) protection of human subjects. Because these objectives may conflict, control group selection will involve trade-offs and compromises. Trials using a protocolized rather than an unrestricted standard care control group will likely have enhanced validity. However, if the protocolized control group lacks representativeness to standard care practices, then trials that use such groups will offer less clinical value and could provide less assurance of protecting subjects compared with trials that use unrestricted control groups. For trials evaluating contrasting strategies that do not adequately represent standard practices, use of a third group that is more representative of standard practices will enhance clinical value and increase the ability to stop early if needed to protect subjects. These advantages might come at the expense of efficiency and feasibility. Weighing and balancing the competing ethical objectives of trial design should be

  16. A Discrete Group Search Optimizer for Hybrid Flowshop Scheduling Problem with Random Breakdown

    Directory of Open Access Journals (Sweden)

    Zhe Cui

    2014-01-01

    Full Text Available The scheduling problems have been discussed in the literature extensively under the assumption that the machines are permanently available without any breakdown. However, in the real manufacturing environments, the machines could be unavailable inevitably for many reasons. In this paper, the authors introduce the hybrid flowshop scheduling problem with random breakdown (RBHFS together with a discrete group search optimizer algorithm (DGSO. In particular, two different working cases, preempt-resume case, and preempt-repeat case are considered under random breakdown. The proposed DGSO algorithm adopts the vector representation and several discrete operators, such as insert, swap, differential evolution, destruction, and construction in the producers, scroungers, and rangers phases. In addition, an orthogonal test is applied to configure the adjustable parameters in the DGSO algorithm. The computational results in both cases indicate that the proposed algorithm significantly improves the performances compared with other high performing algorithms in the literature.

  17. A national study of the psychological impact of bank robbery with a randomized control group

    DEFF Research Database (Denmark)

    Hansen, Maj; Armour, Cherie; Shevlin, Mark

    Despite, numerous annual bank robberies worldwide, research on the psychological sequelae of bank robberies is limited. We studied the prevalence of Acute Stress Disorder (ASD) (N = 458) and the prevalence of Posttraumatic Stress Disorder (PTSD) (n = 378) in a Danish national questionnaire survey...... of bank employees exposed to robbery (response rate: 73.6 %). Several related factors were also investigated including prior traumatic exposure, anxiety, and general traumatic symptoms. The results were compared to a randomized control group of bank employees never exposed to robbery (N= 303......). The estimated ASD rate was 11.1 % (n = 41), and the estimated PTSD rate was 6.2 % (n = 23). Both prevalence rates were limited by the avoidance diagnostic criteria. Preliminary results indicated that the control group scored significantly lower than the acute robbery group on general traumatization and anxiety...

  18. Behavioral and cognitive group treatment for fear of flying: a randomized controlled trial.

    Science.gov (United States)

    Van Gerwen, Lucas J; Spinhoven, Philip; Van Dyck, Richard

    2006-12-01

    In a long-standing fear-of-flying program, persons with fear of flying (N=150) were after a diagnostic assessment and individual preparation phase randomly assigned to either a 1-day behavioral group treatment (BGT) program, a 2-day cognitive-behavioral group treatment (CBGT) program or a waiting list (WL) control group. A post-treatment flight on a commercial airline measured participants' ability to fly. Different self-report flight anxiety questionnaires were completed before, during and after treatment at 3-, 6- and 12-month follow-up. Results indicated that both treatments were superior to the WL, and equally effective on the flying test and later independent flying, but also that the 2-day CBGT program was significantly more effective than the 1-day BGT program on subjective measures of fear and self-efficacy.

  19. Creating groups with similar expected behavioural response in randomized controlled trials: a fuzzy cognitive map approach.

    Science.gov (United States)

    Giabbanelli, Philippe J; Crutzen, Rik

    2014-12-12

    Controlling bias is key to successful randomized controlled trials for behaviour change. Bias can be generated at multiple points during a study, for example, when participants are allocated to different groups. Several methods of allocations exist to randomly distribute participants over the groups such that their prognostic factors (e.g., socio-demographic variables) are similar, in an effort to keep participants' outcomes comparable at baseline. Since it is challenging to create such groups when all prognostic factors are taken together, these factors are often balanced in isolation or only the ones deemed most relevant are balanced. However, the complex interactions among prognostic factors may lead to a poor estimate of behaviour, causing unbalanced groups at baseline, which may introduce accidental bias. We present a novel computational approach for allocating participants to different groups. Our approach automatically uses participants' experiences to model (the interactions among) their prognostic factors and infer how their behaviour is expected to change under a given intervention. Participants are then allocated based on their inferred behaviour rather than on selected prognostic factors. In order to assess the potential of our approach, we collected two datasets regarding the behaviour of participants (n = 430 and n = 187). The potential of the approach on larger sample sizes was examined using synthetic data. All three datasets highlighted that our approach could lead to groups with similar expected behavioural changes. The computational approach proposed here can complement existing statistical approaches when behaviours involve numerous complex relationships, and quantitative data is not readily available to model these relationships. The software implementing our approach and commonly used alternatives is provided at no charge to assist practitioners in the design of their own studies and to compare participants' allocations.

  20. Reading group rehabilitation for patients with psychosis: a randomized controlled study.

    Science.gov (United States)

    Volpe, Umberto; Torre, Fabiana; De Santis, Valeria; Perris, Francesco; Catapano, Francesco

    2015-01-01

    Group reading activities are often reported to be helpful in a variety of psychiatric conditions. However, data on the effects of structured reading rehabilitation activities, in both hospital and community settings for patients with psychosis, are still scarce. Our aim was to investigate the effects on clinical status, disability, psychosocial functioning and cognitive functioning of a structured group reading activity, in a sample of hospitalized patients with psychosis. We enrolled 41 consecutive patients with psychosis and randomly assigned them to a structured group reading programme. For all included patients, we psychometrically evaluated clinical symptomatology, psychosocial functioning and disability, as well as cognitive functioning. All evaluations were repeated at a 6-month follow-up. Repeated-measure multiple analyses of variance were used to test the effect of the group reading activities on the clinical, psychosocial and cognitive measures. We found that, after 6 months from discharge, structured group reading activities induced a statistically significant improvement of cognitive (p < 0.007) and psychosocial (p < 0.008) functioning in patients with psychosis and reduced their disability (p < 0.005), with respect to the control group. Furthermore, such programmes are easy to implement and were perceived as extremely 'interesting' and 'useful' by patients with psychosis. Rehabilitation programmes focusing on group reading activities should be regarded as a valid psychosocial rehabilitation tool for psychotic patients with severe mental disability. A structured group reading programme induced a significant symptomatological cognitive and psychosocial amelioration in hospitalized patients with psychosis. The improvement was sustained also at the 6-month follow-up, with respect to the control group. Structured group reading activities are perceived, by severely ill psychiatric patients, as highly useful, interesting and pleasant, while they are

  1. Whole body and local cryotherapy in restless legs syndrome: A randomized, single-blind, controlled parallel group pilot study.

    Science.gov (United States)

    Happe, Svenja; Evers, Stefan; Thiedemann, Christian; Bunten, Sabine; Siegert, Rudolf

    2016-11-15

    Treatment of restless legs syndrome (RLS) is primarily based on drugs. Since many patients report improvement of symptoms due to cooling their legs, we examined the efficacy of cryotherapy in RLS. 35 patients (28 women, 60.9±12.5years) with idiopathic RLS and symptoms starting not later than 6pm were randomized into three groups: cold air chamber at -60°C (n=12); cold air chamber at -10°C (n=12); local cryotherapy at -17°C (n=11). After a two week baseline, the different therapies were applied three minutes daily at 6pm over two weeks, followed by a four week observation period. The patients completed several questionnaires regarding RLS symptoms, sleep, and quality of life on a weekly basis (IRLS, ESS), VAS and sleep/morning protocol were completed daily, MOSS/RLS-QLI were completed once in each period. Additionally, the PLM index was measured by a mobile device at the end of baseline, intervention, and follow-up. The IRLS score was chosen as primary efficacy parameter. At the end of follow-up, significant improvement of RLS symptoms and quality of life could be observed only in the -60°C group as compared to baseline (IRLS: p=0.009; RLS-QLI: p=0.006; ESS: p=0.020). Local cryotherapy led to improvement in quality of life (VAS4: p=0.028; RLS-QLI: p=0.014) and sleep quality (MOSS: p=0.020; MOSS2: p=0.022) but not in IRLS and ESS. In the -10°C group, the only significant effect was shortening of number of wake phases per night. Serious side-effects were not reported. Whole body cryotherapy at -60°C and, to a less extent, local cryotherapy seem to be a treatment option for RLS in addition to conventional pharmacological treatment. However, the exact mode of cryotherapy needs to be established. Copyright © 2016. Published by Elsevier B.V.

  2. Improving insomnia in primary care patients: A randomized controlled trial of nurse-led group treatment.

    Science.gov (United States)

    Sandlund, Christina; Hetta, Jerker; Nilsson, Gunnar H; Ekstedt, Mirjam; Westman, Jeanette

    2017-07-01

    Insomnia is a common health problem, and most people who seek help for insomnia consult primary care. In primary care, insomnia treatment typically consists of hypnotic drugs, although cognitive behavioral therapy for insomnia is the recommended treatment. However, such treatment is currently available to few primary care patients. To evaluate the effects of a group treatment program for insomnia led by nurses in primary care. were the Insomnia Severity Index, a 2-week sleep diary, and a questionnaire on frequency of hypnotic drug use. A randomized controlled trial with pre- and post-treatment assessment and a 1-year post-treatment follow-up of the intervention group. Routine primary health care; 7 primary care centers in Stockholm, Sweden. Patients consulting primary care for insomnia were assessed for eligibility. To be included, patients had to have insomnia disorder and be 18 years or older. Patients were excluded if they if they worked night shifts or had severe untreated somatic and/or mental illness, bipolar disorder, or untreated sleep disorder other than insomnia. One-hundred and sixty-five patients 20 to 90 years were included. Most were women, and many had co-existing somatic and/or mental health problems. The post-treatment dropout rate was 20%. The intervention was a nurse-led group treatment for insomnia based on the techniques of cognitive behavioral therapy for insomnia. The nurses had 2days of training in how to deliver the program. Ninety patients were randomized to the intervention and 75 to the control group (treatment as usual). Data from 82 in the intervention and 71 in the control group were analyzed in accordance with intention-to-treat principles. Fifty-four of the 72 in the intervention group who participated in the group treatment program were followed up after 1year. Mean Insomnia Severity Index score decreased significantly from 18.4 to 10.7 after group treatment but remained unchanged after treatment as usual (17.0 to 16.6). The effect

  3. Effect of physical training on urinary incontinence: a randomized parallel group trial in nursing homes.

    Science.gov (United States)

    Vinsnes, Anne G; Helbostad, Jorunn L; Nyrønning, Signe; Harkless, Gene E; Granbo, Randi; Seim, Arnfinn

    2012-01-01

    Residents in nursing homes (NHs) are often frail older persons who have impaired physical activity. Urinary incontinence (UI) is a common complaint for residents in NHs. Reduced functional ability and residence in NHs are documented to be risk factors for UI. To investigate if an individualized training program designed to improve activity of daily living (ADL) and physical capacity among residents in nursing homes has any impact on UI. This randomized controlled trial was a substudy of a Nordic multicenter study. Participants had to be >65 years, have stayed in the NH for more than 3 months and in need of assistance in at least one ADL. A total of 98 residents were randomly allocated to either a training group (n = 48) or a control group (n = 50) after baseline registrations. The training program lasted for 3 months and included accommodated physical activity and ADL training. Personal treatment goals were elicited for each subject. The control group received their usual care. The main outcome measure was UI as measured by a 24-hour pad-weighing test. There was no statistically significant difference between the groups on this measure at baseline (P = 0.15). Changes were calculated from baseline to 3 months after the end of the intervention. Altogether, 68 participants were included in the analysis, 35 in the intervention group and 33 in the control group. The average age was 84.3 years. The 3 months' postintervention adjusted mean difference between groups according to amount of leakage was 191 g (P = 0.03). This result was statistically significant after adjusting for baseline level, age, sex, and functional status. The leakage increased in residents not receiving the experimental intervention, while UI in the training group showed improvement. The intervention group had significant better results compared with the control group after an individualized training program designed to improve ADL and physical capacity. Further studies are needed to evaluate the

  4. A Randomized Controlled Trial of Group Triple P With Chinese Parents in Mainland China.

    Science.gov (United States)

    Guo, Mingchun; Morawska, Alina; Sanders, Matthew R

    2016-11-01

    This study evaluated the effects of Group Triple P with Chinese parents on parenting and child outcomes as well as outcomes relating to child academic learning in Mainland China. Participants were 81 Chinese parents and their children in Shanghai, who were randomly allocated to an intervention group or wait-list control group. Parents in the intervention condition received Group Triple P training, and parents and children were assessed at three/two time points. Compared with the control group, parents in the intervention group reported significant improvements in child adjustment problems, parenting practices, parental adjustment, and parenting self-efficacy at post-assessment. Moreover, there was a significant increase in parents' satisfaction with children's academic achievement and a reduction in children's academic problem behaviors at post-intervention. All these effects were maintained at 6-month follow-up. There was also a significant increase in the child report of positive parenting at post-intervention. © The Author(s) 2016.

  5. Do randomized clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups?

    Science.gov (United States)

    Feys, Frederik; Bekkering, Geertruida E; Singh, Kavita; Devroey, Dirk

    2014-02-21

    Studies suggest that expectations powerfully shape clinical outcomes. For subjective outcomes in adequately blinded trials, health improvements are substantial and largely explained by non-specific factors.The objective of this study was to investigate if unblinding in randomized controlled trials (RCTs) is associated with enhanced placebo effects for intervention groups and nocebo effects for placebo groups. For these effects, a secondary objective was to explore potential moderating factors. We included RCTs that investigated the efficacy of phosphodiesterase-5 (PDE-5) inhibitors for male erectile dysfunction by comparing one PDE-5 inhibitor to placebo. In addition, to be included studies must have reported scores for change from baseline, or baseline and final International Index of Erectile Functioning-Erectile Functioning domain score (IIEF-EF), and be published in either English, French, Dutch, or German.We searched for both published and unpublished relevant trials using PUBMED, EMBASE, the Cochrane Central Register of Controlled Trials, a clinical trials register (clinicaltrials.gov) and the Food and Drug Administration clinical reviews through March 2012.We evaluated the blinding status of trials with the Cochrane Risk of Bias Tool, using the domains of allocation sequence concealment, blinding of participants, healthcare providers and outcome assessors. Across these four domains, studies that scored low risk of bias were judged to be adequately blinded and studies that scored unclear or high risk of bias were judged to be inadequately blinded. We included 110 studies (205 journal publications and 2 unpublished sources) that involved 23,877 participants; 93 (85%), 51 (46%), 93 (85%) and 93 (85%) studies were assessed with an unclear risk of bias for allocation concealment, blinding of participant, blinding of caregiver and blinding of outcome assessor, respectively. None of the studies reported testing of blinding.None of the 205 journal publications

  6. Associative self-anchoring interacts with obtainability of chosen objects

    Directory of Open Access Journals (Sweden)

    Dean eMobbs

    2016-01-01

    Full Text Available While there is evidence that implicit self-esteem transfers to chosen objects (associative self-anchoring, it is still unknown whether this phenomenon extends to explicit self-esteem. Moreover, whether the knowledge that these objects might belong to the self in the future or not affects the evaluation of these objects has yet to be tested. Here, we demonstrate that evaluations of chosen objects are further enhanced when they are obtainable as compared to when they are not in participants with high explicit self-esteem, whereas participants with low explicit self-esteem exhibit the opposite pattern. These findings extend previous results and shed new light on the role of self-esteem in altering preferences for chosen objects depending on their obtainability.

  7. A randomized trial of group parent training: reducing child conduct problems in real-world settings.

    Science.gov (United States)

    Kjøbli, John; Hukkelberg, Silje; Ogden, Terje

    2013-03-01

    Group-based Parent Management Training, the Oregon model (PMTO, 12 sessions) was delivered by the regular staff of municipal child and family services. PMTO is based on social interaction learning theory and promotes positive parenting skills in parents of children with conduct problems. This study examined the effectiveness of the group-based training intervention in real world settings both immediately following and six months after termination of the intervention. One hundred thirty-seven children (3-12 years) and their parents participated in this study. The families were randomly assigned to group-based training or a comparison group. Data were collected from parents and teachers. The caregiver assessments of parenting practices and child conduct problems and caregiver and teacher reported social competence revealed immediate and significant intervention effects. Short- and long-term beneficial effects were reported from parents, although no follow-up effects were evident on teacher reports. These effectiveness findings and the potential for increasing the number of families served to support the further dissemination and implementation of group-based parent training. Copyright © 2012 Elsevier Ltd. All rights reserved.

  8. Group behavioral activation for patients with severe obesity and binge eating disorder: a randomized controlled trial.

    Science.gov (United States)

    Alfonsson, Sven; Parling, Thomas; Ghaderi, Ata

    2015-03-01

    The aim of the present study was to assess whether behavioral activation (BA) is an efficacious treatment for decreasing eating disorder symptoms in patients with obesity and binge eating disorder (BED). Ninety-six patients with severe obesity and BED were randomized to either 10 sessions of group BA or wait-list control. The study was conducted at an obesity clinic in a regular hospital setting. The treatment improved some aspects of disordered eating and had a positive effect on depressive symptoms but there was no significant difference between the groups regarding binge eating and most other symptoms. Improved mood but lack of effect on binge eating suggests that dysfunctional eating (including BED) is maintained by other mechanisms than low activation and negative mood. However, future studies need to investigate whether effects of BA on binge eating might emerge later than at post-assessment, as in interpersonal psychotherapy for bulimia nervosa. © The Author(s) 2014.

  9. Exercises and Dry Needling for Subacromial Pain Syndrome: A Randomized Parallel-Group Trial.

    Science.gov (United States)

    Arias-Buría, José L; Fernández-de-Las-Peñas, César; Palacios-Ceña, María; Koppenhaver, Shane L; Salom-Moreno, Jaime

    2017-01-01

    This randomized clinical trial investigated the effectiveness of exercise versus exercise plus trigger point (TrP) dry needling (TrP-DN) in subacromial pain syndrome. A randomized parallel-group trial, with 1-year follow-up was conducted. Fifty subjects with subacromial pain syndrome were randomly allocated to receive exercise alone or exercise plus TrP-DN. Participants in both groups were asked to perform an exercise program of the rotator cuff muscles twice daily for 5 weeks. Further, patients allocated to the exercise plus TrP-DN group also received dry needling to active TrPs in the muscles reproducing shoulder symptoms during the second and fourth sessions. The primary outcome was pain-related disability assessed using the Disabilities of the Arm, Shoulder, and Hand questionnaire. Secondary outcomes included mean current pain and the worst pain experienced in the shoulder during the previous week. They were assessed at baseline, 1 week, and 3, 6, and 12 months after the end of treatment. Analysis was according to intention to treat with mixed analysis of covariance adjusted for baseline outcomes. At 12 months, 47 patients (94%) completed follow-up. Statistically larger improvements (all, P < .01) in shoulder disability was found for the exercise plus TrP-DN group at all follow-up periods (post: Δ -20.6 [95% confidence interval (CI) -23.8 to -17.4]; 3 months: Δ -23.2 [95% CI -28.3 to -18.1)]; 6 months: Δ -23.6 [95% CI -28.9 to -18.3]; 12 months: Δ -13.9 [95% CI -17.5 to -10.3]). Both groups exhibited similar improvements in shoulder pain outcomes at all follow-up periods. The inclusion of TrP-DN with an exercise program was effective for improving disability in subacromial pain syndrome. No greater improvements in shoulder pain were observed. This study found that the inclusion of 2 sessions of TrP-DN into an exercise program was effective for improving shoulder pain-related disability at short-, medium-, and long-term; however, no greater

  10. Group music therapy for severe mental illness: a randomized embedded-experimental mixed methods study.

    Science.gov (United States)

    Grocke, D; Bloch, S; Castle, D; Thompson, G; Newton, R; Stewart, S; Gold, C

    2014-08-01

    Music therapy is an innovative approach to support people with severe mental illness (SMI). The aim of the study was to determine whether group music therapy (GMT) positively impacted on quality of life (QoL), social enrichment, self-esteem, spirituality and psychiatric symptoms of participants with SMI and how they experienced the intervention. The primary outcome was QoL; secondary measures assessed social enrichment, self-esteem, spirituality and psychiatric symptoms. The 13-week intervention comprised singing familiar songs and composing original songs recorded in a professional studio. Qualitative data were generated from focus group interviews and song lyric analysis. Ninety-nine adults (57 female) were recruited, with an initial cohort (n = 75) randomized to either: weekly GMT followed by standard care (SC) or SC followed by GMT. Crossover occurred after 13 weeks. Measures were conducted at baseline, 13, 26 and 39 weeks. A second cohort (n = 24) could not be randomized and were assigned to GMT followed by SC. Intention-to-treat analysis showed a significant difference between GMT and SC on QoL and spirituality. This was robust to different assumptions about missing data (listwise deletion, last observation carried forward or multiple imputation). Per-protocol analysis suggested greater benefit for those receiving more sessions. Focus group interview and song lyric analyses suggested that GMT was enjoyable; self-esteem was enhanced; participants appreciated therapists and peers; and although challenges were experienced, the programme was recommended to others. Group music therapy may enhance QoL and spirituality of persons with SMI. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  11. Improving teacher perceptions of parent involvement patterns: Findings from a group randomized trial.

    Science.gov (United States)

    Herman, Keith C; Reinke, Wendy M

    2017-03-01

    For children with the most serious and persistent academic and behavior problems, parent involvement in education, particularly teacher perceptions of involvement, is essential to avert their expected long-term negative outcomes. Despite the widespread interest in and perceived importance of parent involvement in education, however, few experimental studies have evaluated programs and practices to promote it. In this group randomized trial, we examined the effects of the Incredible Years Teacher Classroom Management program (IY TCM) on teacher perceptions of contact and comfort with parents. One hundred five classrooms with 1818 students were randomly assigned to an IY TCM or to a control, business as usual condition. Measures of key constructs included teacher ratings of parent and student behaviors, direct observations in the classroom, and a standardized academic achievement test. Latent transition analysis (LTA) was used to identify patterns of involvement over time and to determine if intervention condition predicted postintervention patterns and transitions. Four patterns of involvement were identified at baseline and at follow-up; parents of students with academic and behavior problems were most likely to be in classes with the least adaptive involvement patterns. Intervention status predicted group membership at follow-up. Specifically, intervention classroom parents were significantly more likely to transition to more adaptive teacher-rated parenting profiles at follow-up compared to control classroom parents. This is the first randomized trial we are aware of that has found that teacher training can alter teacher perceptions of parent involvement patterns. Clinical implications for students with behavior and academic problems are discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  12. Brick tunnel randomization for unequal allocation to two or more treatment groups.

    Science.gov (United States)

    Kuznetsova, Olga M; Tymofyeyev, Yevgen

    2011-04-15

    Studies with unequal allocation to two or more treatment groups often require a large block size for permuted block allocation. This could present a problem in small studies, multi-center studies, or adaptive design dose-finding studies. In this paper, an allocation procedure, which generalizes the maximal procedure by Berger, Ivanova, and Knoll to the case of K≥2 treatment groups and any allocation ratio, is offered. Brick tunnel (BT) randomization requires the allocation path drawn in the k-dimensional space to stay close to the allocation ray that corresponds to the targeted allocation ratio. Specifically, it requires the allocation path to be confined to the set of the k-dimensional unitary cubes that are pierced by the allocation ray (the 'brick tunnel'). The important property of the BT randomization is that the transition probabilities at each node within the tunnel are defined in such a way that the unconditional allocation ratio is the same for every allocation step. This property is not necessarily met by other allocation procedures that implement unequal allocation. Copyright © 2011 John Wiley & Sons, Ltd.

  13. Group Versus Individual Physical Therapy for Veterans With Knee Osteoarthritis: Randomized Clinical Trial.

    Science.gov (United States)

    Allen, Kelli D; Bongiorni, Dennis; Bosworth, Hayden B; Coffman, Cynthia J; Datta, Santanu K; Edelman, David; Hall, Katherine S; Lindquist, Jennifer H; Oddone, Eugene Z; Hoenig, Helen

    2016-05-01

    Efficient approaches are needed for delivering nonpharmacological interventions for management of knee osteoarthritis (OA). This trial compared group-based versus individual physical therapy interventions for management of knee OA. Three hundred twenty patients with knee OA at the VA Medical Center in Durham, North Carolina, (mean age=60 years, 88% male, 58% nonwhite) were randomly assigned to receive either the group intervention (group physical therapy; six 1-hour sessions, typically 8 participants per group) or the individual intervention (individual physical therapy; two 1-hour sessions). Both programs included instruction in home exercise, joint protection techniques, and individual physical therapist evaluation. The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; range=0-96, higher scores indicate worse symptoms), measured at baseline, 12 weeks, and 24 weeks. The secondary outcome measure was the Short Physical Performance Battery (SPPB; range=0-12, higher scores indicate better performance), measured at baseline and 12 weeks. Linear mixed models assessed the difference in WOMAC scores between arms. At 12 weeks, WOMAC scores were 2.7 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% confidence interval [CI]=-5.9, 0.5; P=.10), indicating no between-group difference. At 24 weeks, WOMAC scores were 1.3 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-4.6, 2.0; P=.44), indicating no significant between-group difference. At 12 weeks, SPPB scores were 0.1 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-0.5, 0.2; P=.53), indicating no difference between groups. This study was conducted in one VA medical center. Outcome assessors were blinded, but participants and physical therapists were not blinded. Group physical therapy was not more effective

  14. Multidisciplinary group rehabilitation versus individual physiotherapy for chronic nonspecific low back pain: a randomized trial.

    Science.gov (United States)

    Kääpä, Eeva Helena; Frantsi, Kirsi; Sarna, Seppo; Malmivaara, Antti

    2006-02-15

    A randomized trial. To evaluate the effectiveness of a semi-intensive multidisciplinary rehabilitation for patients with chronic low back pain in an outpatient setting. Systematic reviews have shown that there is strong evidence that intensive multidisciplinary treatment (>100 hours), which includes functional restoration, improves function among chronic patients with low back pain, and moderate evidence that it reduces pain but contradictory evidence regarding improvement of working ability. However, there is paucity of data whether semi-intensive outpatient multidisciplinary rehabilitation in groups is more effective than individual physiotherapy. A total of 120 women employed as healthcare and social care professionals with nonspecific chronic low back pain were recruited from two occupational healthcare centers. The patients were randomized into two intervention programs. Multidisciplinary rehabilitation (n = 59) was conducted in groups and comprised of physical training, workplace interventions, back school, relaxation training, and cognitive-behavioral stress management methods for 70 hours. The individual physiotherapy (n = 61) included physical exercise and passive treatment methods administered for 10 hours. Main outcome measures were: back pain and sciatic pain intensity, disability, sick leaves, healthcare consumption, symptoms of depression, and beliefs of working ability after 2 years. There were no statistically significant differences between the two treatment groups in main outcome measures just after rehabilitation, at 6-, at 12-, or 24-month follow-up. In both intervention arms, however, the before-and-after comparison showed favorable effects, and the effects were still maintained at 2 years follow-up. The results of this study indicate that semilight outpatient multidisciplinary rehabilitation program for female chronic low back pain patients does not offer incremental benefits when compared with rehabilitation carried out by a physiotherapist

  15. Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial.

    Science.gov (United States)

    King, Laurie A; Wilhelm, Jennifer; Chen, Yiyi; Blehm, Ron; Nutt, John; Chen, Zunqiu; Serdar, Andrea; Horak, Fay B

    2015-10-01

    Comparative studies of exercise interventions for people with Parkinson disease (PD) rarely considered how one should deliver the intervention. The objective of this study was to compare the success of exercise when administered by (1) home exercise program, (2) individualized physical therapy, or (3) a group class. We examined if common comorbidities associated with PD impacted success of each intervention. Fifty-eight people (age = 63.9 ± 8 years) with PD participated. People were randomized into (1) home exercise program, (2) individual physical therapy, or (3) group class intervention. All arms were standardized and based on the Agility Boot Camp exercise program for PD, 3 times per week for 4 weeks. The primary outcome measure was the 7-item Physical Performance Test. Other measures of balance, gait, mobility, quality of life, balance confidence, depressions, apathy, self-efficacy and UPDRS-Motor, and activity of daily living scores were included. Only the individual group significantly improved in the Physical Performance Test. The individual exercise showed the most improvements in functional and balance measures, whereas the group class showed the most improvements in gait. The home exercise program improved the least across all outcomes. Several factors effected success, particularly for the home group. An unsupervised, home exercise program is the least effective way to deliver exercise to people with PD, and individual and group exercises have differing benefits. Furthermore, people with PD who also have other comorbidities did better in a program directly supervised by a physical therapist.Video Abstract available for additional insights from the authors (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A112).

  16. Effect of physical training on urinary incontinence: a randomized parallel group trial in nursing homes

    Directory of Open Access Journals (Sweden)

    Vinsnes AG

    2012-02-01

    Full Text Available Anne G Vinsnes1, Jorunn L Helbostad2, Signe Nyrønning3, Gene E Harkless1,4, Randi Granbo5, Arnfinn Seim61Faculty of Nursing, Sør-Trøndelag University College, 2Department of Neuroscience, Norwegian University of Science and Technology, 3Søbstad Community Hospital and Teaching Nursing Home, Trondheim, Norway; 4University of New Hampshire, College of Health and Social Services, Nursing Faculty, Durham, New Hampshire, USA; 5Department of Physiotherapy, Sør-Trøndelag University College, 6Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, NorwayBackground: Residents in nursing homes (NHs are often frail older persons who have impaired physical activity. Urinary incontinence (UI is a common complaint for residents in NHs. Reduced functional ability and residence in NHs are documented to be risk factors for UI.Objective: To investigate if an individualized training program designed to improve activity of daily living (ADL and physical capacity among residents in nursing homes has any impact on UI.Materials and methods: This randomized controlled trial was a substudy of a Nordic multicenter study. Participants had to be >65 years, have stayed in the NH for more than 3 months and in need of assistance in at least one ADL. A total of 98 residents were randomly allocated to either a training group (n = 48 or a control group (n = 50 after baseline registrations. The training program lasted for 3 months and included accommodated physical activity and ADL training. Personal treatment goals were elicited for each subject. The control group received their usual care. The main outcome measure was UI as measured by a 24-hour pad-weighing test. There was no statistically significant difference between the groups on this measure at baseline (P = 0.15. Changes were calculated from baseline to 3 months after the end of the intervention.Results: Altogether, 68 participants were included in the analysis

  17. Griffiths singularities in the random quantum Ising antiferromagnet: A tree tensor network renormalization group study

    Science.gov (United States)

    Lin, Yu-Ping; Kao, Ying-Jer; Chen, Pochung; Lin, Yu-Cheng

    2017-08-01

    The antiferromagnetic Ising chain in both transverse and longitudinal magnetic fields is one of the paradigmatic models of a quantum phase transition. The antiferromagnetic system exhibits a zero-temperature critical line separating an antiferromagnetic phase and a paramagnetic phase; the critical line connects an integrable quantum critical point at zero longitudinal field and a classical first-order transition point at zero transverse field. Using a strong-disorder renormalization group method formulated as a tree tensor network, we study the zero-temperature phase of the quantum Ising chain with bond randomness. We introduce a new matrix product operator representation of high-order moments, which provides an efficient and accurate tool for determining quantum phase transitions via the Binder cumulant of the order parameter. Our results demonstrate an infinite-randomness quantum critical point in zero longitudinal field accompanied by pronounced quantum Griffiths singularities, arising from rare ordered regions with anomalously slow fluctuations inside the paramagnetic phase. The strong Griffiths effects are signaled by a large dynamical exponent z >1 , which characterizes a power-law density of low-energy states of the localized rare regions and becomes infinite at the quantum critical point. Upon application of a longitudinal field, the quantum phase transition between the paramagnetic phase and the antiferromagnetic phase is completely destroyed. Furthermore, quantum Griffiths effects are suppressed, showing z <1 , when the dynamics of the rare regions is hampered by the longitudinal field.

  18. Acceptance and commitment group therapy (ACT-G) for health anxiety: a randomized controlled trial.

    Science.gov (United States)

    Eilenberg, T; Fink, P; Jensen, J S; Rief, W; Frostholm, L

    2016-01-01

    Severe health anxiety is frequent and costly, yet rarely diagnosed or treated. Earlier treatment studies show problems with recruitment, dropout and recovery. In the current study, the authors aimed to test the effect of acceptance and commitment group therapy (ACT-G) compared to waitlist in patients with severe health anxiety. During March 2010 to April 2012, 126 consecutively referred patients meeting research criteria for severe health anxiety were block-randomized (1:1) to ACT-G or a 10 months' waitlist (Clinicaltrials.gov, no. NCT01158430). Patients allocated to ACT-G were treated in seven groups of nine patients between December 2010 and October 2012 and received nine weekly 3-h group sessions and a booster session consisting of ACT techniques. The primary outcome was decided a priori as the mean change in self-reported illness worry on the Whiteley-7 Index (WI) from baseline to 10 months' follow-up. Secondary outcomes were improvement in emotional distress and health-related quality of life at 10 months' follow-up. Intention-to-treat analysis showed a statistically significant mean difference of 20.5 points [95% confidence interval (CI) 11.7-29.4, p accepted by the patients. ACT-G seems feasible, acceptable and effective in treating severe health anxiety.

  19. Randomized comparative trial of a social cognitive skills group for children with autism spectrum disorder.

    Science.gov (United States)

    Soorya, Latha V; Siper, Paige M; Beck, Todd; Soffes, Sarah; Halpern, Danielle; Gorenstein, Michelle; Kolevzon, Alexander; Buxbaum, Joseph; Wang, A Ting

    2015-03-01

    This study evaluated the efficacy of a targeted social skills training group in school-aged children with autism spectrum disorder (ASD). The intervention, Seaver-NETT (Nonverbal communication, Emotion recognition, and Theory of mind Training), is a 12-session cognitive-behavioral intervention (CBI) for verbal, school-aged children targeting ASD-specific social behavioral impairments. Sixty-nine children with ASD, 8 to 11 years of age, with verbal IQs greater than 70, participated in a randomized comparative trial to examine the efficacy of NETT relative to a facilitated play group. Treatment outcomes included caregiver reports of social behavior and neuropsychological assessments of social cognition conducted by blinded raters. Outcomes were collected at baseline, endpoint, and 3 months posttreatment. Significant improvements were found on social behavior outcomes such as nonverbal communication, empathic responding, and social relations in the NETT condition relative to the active control at endpoint. Verbal IQ moderated the interaction effect on social behavior, with higher verbal IQ associated with improvements in the CBI condition. No significant improvements were found on social cognitive outcomes. No significant group differences were found at 3-month follow-up conducted with approximately half the sample (n = 34). These data indicate that targeted CBI social skills groups such as NETT improve social communication deficits in verbal, school-aged children with ASD. The moderating effects of high verbal IQ suggest a need to consider participant and treatment characteristics associated with outcomes in future studies. Clinical trial registration information-Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder; https://clinicaltrials.gov; NCT01190917. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  20. Reflecting peer-support groups in the prevention of stress and burnout: randomized controlled trial.

    Science.gov (United States)

    Peterson, Ulla; Bergström, Gunnar; Samuelsson, Mats; Asberg, Marie; Nygren, Ake

    2008-09-01

    This paper is a report of a study to test the effect of participating in a reflecting peer-support group on self-reported health, burnout and on perceived changes in work conditions. Stress-related conditions are one of the most common causes for long-term sick-leave. There is limited evidence for the effectiveness of person-directed interventions aimed at reducing stress levels in healthcare workers. Prior research in the relationship between support and burnout show somewhat inconsistent results. A randomized controlled trial with peer-support groups as the intervention was conducted with 660 healthcare workers scoring above the 75th percentile on the exhaustion dimension of the Oldenburg Burnout Inventory. One hundred and fifty-one (22.9%) agreed to participate. The intervention started in 2002 with 51 participants (96.1% were women), 80 of whom constituted the control group. Potential differences in outcome measures 12 months after the intervention were compared using ancova, and data collected was completed in 2004. Qualitative content analyses were used to analyse reported experiences from group participation. Statistically significant intervention effects were found for general health, perceived quantitative demands at work, participation and development opportunities at work and in support at work. Seven categories of experiences from participating were identified: talking to others in a similar situation, knowledge, sense of belonging, self-confidence, structure, relief of symptoms and behavioural change. Peer-support groups using a problem-based method could be a useful and comparatively inexpensive tool in alleviating work-related stress and burnout.

  1. Studies with staggered starts: multiple baseline designs and group-randomized trials.

    Science.gov (United States)

    Rhoda, Dale A; Murray, David M; Andridge, Rebecca R; Pennell, Michael L; Hade, Erinn M

    2011-11-01

    Multiple baseline designs (MBDs) have been suggested as alternatives to group-randomized trials (GRT). We reviewed structural features of MBDs and considered their potential effectiveness in public health research. We also reviewed the effect of staggered starts on statistical power. We reviewed the MBD literature to identify key structural features, recent suggestions that MBDs be adopted in public health research, and the literature on power in GRTs with staggered starts. We also computed power for MBDs and GRTs. The features that have contributed to the success of small MBDs in some fields are not likely to translate well to public health research. MBDs can be more powerful than GRTs under some conditions, but those conditions involve assumptions that require careful evaluation in practice. MBDs will often serve better as a complement of rather than as an alternative to GRTs. GRTs may employ staggered starts for logistical or ethical reasons, but this will always increase their duration and will often increase their cost.

  2. Mindfulness Training Improves Attentional Task Performance in Incarcerated Youth: A Group Randomized Controlled Intervention Trial

    Directory of Open Access Journals (Sweden)

    Noelle R Leonard

    2013-11-01

    Full Text Available We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16 to 18, to a CBT/MT intervention (youth n = 147 or an active control intervention (youth n = 117. Both arms received approximately 750 minutes of intervention in a small-group setting over a 3-5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. Keywords: adolescent development, incarcerated adolescents, detained adolescents, stress, attention, mindfulness meditation.

  3. Efficient leadership and staff motivation in a chosen firm

    OpenAIRE

    VLÁŠKOVÁ, Dagmar

    2010-01-01

    This bachelor work deals with the leadership and staff motivation. The main object was a detection of the mistakes which the managers in a chosen firm make in this sphere. The alternate targets were to analyse the staff satisfaction with their leaders and to detect the managers´ style of leading. The close of my work contains my own suggestions and recommendations how to eliminate the detected mistakes and how to improve current situation in a firm.

  4. Chosen-Prefix Collisions for MD5 and Colliding X.509 Certificates for Different Identities

    Science.gov (United States)

    Stevens, Marc; Lenstra, Arjen; de Weger, Benne

    We present a novel, automated way to find differential paths for MD5. As an application we have shown how, at an approximate expected cost of 250 calls to the MD5 compression function, for any two chosen message prefixes P and P', suffixes S and S' can be constructed such that the concatenated values P||S and P'||S' collide under MD5. Although the practical attack potential of this construction of chosen-prefix collisions is limited, it is of greater concern than random collisions for MD5. To illustrate the practicality of our method, we constructed two MD5 based X.509 certificates with identical signatures but different public keys and different Distinguished Name fields, whereas our previous construction of colliding X.509 certificates required identical name fields. We speculate on other possibilities for abusing chosen-prefix collisions. More details than can be included here can be found on www.win.tue.nl/hashclash/ChosenPrefixCollisions/.

  5. Integrative group-based cognitive rehabilitation efficacy in multiple sclerosis: a randomized clinical trial.

    Science.gov (United States)

    Rilo, Oiane; Peña, Javier; Ojeda, Natalia; Rodríguez-Antigüedad, Alfredo; Mendibe-Bilbao, Mar; Gómez-Gastiasoro, Ainara; DeLuca, John; Chiaravalloti, Nancy; Ibarretxe-Bilbao, Naroa

    2018-01-01

    This study aimed to determine the efficacy of the integrative group-based cognitive rehabilitation programme, REHACOP, on improving cognitive functions in multiple sclerosis (MS). Fourty-two MS patients were randomized to the treatment programme REHACOP (n = 21) or waiting list control condition (n = 21). The REHACOP group received cognitive rehabilitation in group format for three months focused on attention, processing speed, learning and memory, language, executive functioning, and social cognition. Patients completed a neuropsychological assessment at baseline and follow-up, which included tests of attention, processing speed, working memory, verbal memory, verbal fluency, and executive functioning. Repeated measures multivariate analysis of covariance (MANCOVA) was used to determine the efficacy of the cognitive rehabilitation programme. Group × Time interactions revealed significant improvements in the REHACOP group as compared with the control group for processing speed (p = 0.011, np2 = 0.16), working memory (p = 0.014, np2 = 0.15), verbal memory (p = 0.025, np2 = 0.13), and executive functioning (p = 0.024, np2 = 0.13), showing medium-large effect sizes. Patients receiving REHACOP showed improvements in several cognitive domains. This preliminary study thus provides evidence supporting the efficacy of this integrative group-based cognitive rehabilitation intervention in MS. Future research should confirm these findings, examine the impact of the treatment on everyday life functioning and explore the presence of brain changes associated with cognitive rehabilitation. Implications for rehabilitation This study provides initial evidence for integrative group-based cognitive rehabilitation efficacy in MS patients through the implementation of the REHACOP cognitive rehabilitation programme. Patients received cognitive rehabilitation for three months (3 one-hour-sessions per week) focused on training attention

  6. Contributions of the European trials (European randomized screening group) in computed tomography lung cancer screening.

    Science.gov (United States)

    Heuvelmans, Marjolein A; Vliegenthart, Rozemarijn; Oudkerk, Matthijs

    2015-03-01

    Lung cancer is the leading cause of cancer-related death worldwide. In 2011, the largest lung cancer screening trial worldwide, the US National Lung Screening Trial, published a 20% decrease in lung cancer-specific mortality in the computed tomography (CT)-screened group, compared with the group screened by chest x-ray. On the basis of this trial, different US guidelines recently have recommended CT lung cancer screening. However, several questions regarding the implementation of lung cancer screening need to be answered. In Europe, several lung cancer screening trials are ongoing. It is planned to pool the results of the lung cancer screening trials in European randomized lung cancer CT screening (EUCT). By pooling of the data, EUCT hopes to be able to provide additional information for the discussion of some important issues regarding the implementation of lung cancer screening by low-dose CT, including: the determination of the optimal screen population, the comparison between a volume-based and diameter-based nodule management protocol, and the determination of optimal screen intervals.

  7. Myofascial Release Therapy in the Treatment of Occupational Mechanical Neck Pain: A Randomized Parallel Group Study.

    Science.gov (United States)

    Rodríguez-Fuentes, Iván; De Toro, Francisco Javier; Rodríguez-Fuentes, Gustavo; de Oliveira, Iris Machado; Meijide-Faílde, Rosa; Fuentes-Boquete, Isaac Manuel

    2016-07-01

    As myofascial release therapy is currently under development, the objective of this study was to compare the effectiveness of myofascial release therapy with manual therapy for treating occupational mechanical neck pain. A randomized, single-blind parallel group study was developed. The sample (n = 59) was divided into GI, treated with manual therapy, and GII, treated with myofascial release therapy. Variables studied were intensity of neck pain, cervical disability, quality of life, craniovertebral angle, and ranges of cervical motion. At five sessions, clinical significance was observed in both groups for all the variables studied, except for flexion in GI. At this time point, an intergroup statistical difference was observed, which showed that GII had better craniovertebral angle (P = 0.014), flexion (P = 0.021), extension (P = 0.003), right side bending (P = 0.001), and right rotation (P = 0.031). A comparative analysis between therapies after intervention showed statistical differences indicating that GII had better craniovertebral angle (P = 0.000), right (P = 0.000) and left (P = 0.009) side bending, right (P = 0.024) and left (P = 0.046) rotations, and quality of life. The treatment of occupational mechanical neck pain by myofascial release therapy seems to be more effective than manual therapy for correcting the advanced position of the head, recovering range of motion in side bending and rotation, and improving quality of life.

  8. Meaning-centered group psychotherapy for patients with advanced cancer: a pilot randomized controlled trial.

    Science.gov (United States)

    Breitbart, William; Rosenfeld, Barry; Gibson, Christopher; Pessin, Hayley; Poppito, Shannon; Nelson, Christian; Tomarken, Alexis; Timm, Anne Kosinski; Berg, Amy; Jacobson, Colleen; Sorger, Brooke; Abbey, Jennifer; Olden, Megan

    2010-01-01

    An increasingly important concern for clinicians who care for patients at the end of life is their spiritual well-being and sense of meaning and purpose in life. In response to the need for short-term interventions to address spiritual well-being, we developed Meaning Centered Group Psychotherapy (MCGP) to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives, even as they approach the end of life. Patients with advanced (stage III or IV) solid tumor cancers (N=90) were randomly assigned to either MCGP or a supportive group psychotherapy (SGP). Patients were assessed before and after completing the 8-week intervention, and again 2 months after completion. Outcome assessment included measures of spiritual well-being, meaning, hopelessness, desire for death, optimism/pessimism, anxiety, depression and overall quality of life. MCGP resulted in significantly greater improvements in spiritual well-being and a sense of meaning. Treatment gains were even more substantial (based on effect size estimates) at the second follow-up assessment. Improvements in anxiety and desire for death were also significant (and increased over time). There was no significant improvement on any of these variables for patients participating in SGP. MCGP appears to be a potentially beneficial intervention for patients' emotional and spiritual suffering at the end of life. Further research, with larger samples, is clearly needed to better understand the potential benefits of this novel intervention. (c) 2009 John Wiley & Sons, Ltd.

  9. Group Music Therapy as a Preventive Intervention for Young People at Risk: Cluster-Randomized Trial.

    Science.gov (United States)

    Gold, Christian; Saarikallio, Suvi; Crooke, Alexander Hew Dale; McFerran, Katrina Skewes

    2017-07-01

    Music forms an important part of the lives and identities of adolescents and may have positive or negative mental health implications. Music therapy can be effective for mental disorders such as depression, but its preventive potential is unknown. The aim of this study was to examine whether group music therapy (GMT) is an effective intervention for young people who may be at risk of developing mental health problems, as indicated via unhealthy music use. The main question was whether GMT can reduce unhealthy uses of music and increase potentials for healthy uses of music, compared to self-directed music listening (SDML). We were also interested in effects of GMT on depressive symptoms, psychosocial well-being, rumination, and reflection. In an exploratory cluster-randomized trial in Australian schools, 100 students with self-reported unhealthy music use were invited to GMT (weekly sessions over 8 weeks) or SDML. Changes in the Healthy-Unhealthy Music Scale (HUMS) and mental health outcomes were measured over 3 months. Both interventions were well accepted. No effects were found between GMT and SDML (all p > 0.05); both groups tended to show small improvements over time. Younger participants benefited more from GMT, and older ones more from SDML (p = 0.018). GMT was associated with similar changes as SDML. Further research is needed to improve the processes of selecting participants for targeted interventions; to determine optimal dosage; and to provide more reliable evidence of effects of music-based interventions for adolescents.

  10. A randomized controlled trial of a brief versus standard group parenting program for toddler aggression.

    Science.gov (United States)

    Tully, Lucy A; Hunt, Caroline

    2017-05-01

    Physical aggression (PA) in the toddler years is common and developmentally normal, however, longitudinal research shows that frequent PA is highly stable and associated with long-term negative outcomes. Significant research has demonstrated the efficacy of parenting interventions for reducing externalizing behavior in children yet their typical length may overburden families, leading to low participation rates and high attrition rates. To increase the reach of parenting interventions and impact on the prevalence of externalizing behavior problems, brief interventions are needed. This RCT compared a standard (8 session) group Triple P to a brief (3 session) discussion group and a waitlist control for reducing toddler PA, dysfunctional parenting and related aspects of parent functioning. Sixty-nine self-referred families of toddlers with PA were randomized to the respective conditions. At post-assessment, families in the standard intervention had significantly lower levels of observed child aversive behavior, mother reports of PA and dysfunctional parenting, and higher levels of mother- and partner-rated behavioral self-efficacy than the waitlist control. Families in the standard intervention also had significantly lower levels mother-rated dysfunctional parenting than the brief intervention, and the brief intervention had significantly lower levels of mother-rated dysfunctional parenting than waitlist. There were no significant group differences at post-assessment for measures of parental negative affect or satisfaction with the partner relationship. By 6 month follow-up, families in the brief and standard intervention did not differ significantly on any measure. The implications of the findings to delivery of brief parenting interventions are discussed. Aggr. Behav. 43:291-303, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  11. Comparison of tutored group with tutorless group in problem-based mixed learning sessions: a randomized cross-matched study

    Science.gov (United States)

    2013-01-01

    Background Problem-based learning (PBL) involves discussions among students who resolve loosely-structured problems to facilitate learning. In the PBL curriculum, faculty tutors are employed as facilitators for small groups of students. Because of lack of time and staff shortage, the effectiveness of tutorless PBL has been discussed as an alternate option. Methods Sessions in which tutored and tutorless PBL groups are mixed were presented by 1st-year medical students, who experienced both tutored and tutorless groups alternately in the two sessions of a year. To examine the effectiveness of tutored and tutorless PBL, written examination scores (WES) and self-contentment scores (SCS) were statistically analysed. Results WES averages did not significantly differ between the tutored and tutorless groups; however, a significantly greater variation was observed in WES in the tutorless group. SCS averages tended to be higher in the tutored PBL than in tutorless PBL groups. Conclusions Students in these tutorless PBL groups performed well in their written examinations, whereas those in the tutored PBL groups, achieved this and reported better self-contentment with their learning experience. Tutorless PBL sessions were considered to be comparable to tutored PBL sessions at least in the early stages. PMID:24289490

  12. Vulnerability to chosen-plaintext attack of optoelectronic information encryption with phase-shifting interferometry.

    Science.gov (United States)

    Qin, Wan; Peng, Xiang; Meng, Xiangfeng; Gao, Bruce Z

    2011-06-13

    The optical cryptosystem based on phase-shifting interferometry (PSI) is one of the most interesting optical cryptographic schemes in recent years. However, we find that the PSI technique provides an attractive method to record the ciphertext, but contributes little to the security level of the cryptosystem. From the cryptanalysis point of view, in a certain simplified case, an attacker is only required to crack two equivalent decryption keys instead of the original random phase keys and geometric key. Moreover, a chosen-plaintext attack method is proposed, in which an impulse function is chosen as a known plaintext. By using this attack, the attacker can effectively recover any plaintext from the corresponding ciphertext. The validity of the attack is verified by computer simulations.

  13. DEVELOPMENT OF SPA AND WELLNESS SERVICES IN A CHOSEN HOTEL

    OpenAIRE

    MARHOUNOVÁ, Iveta

    2017-01-01

    This work deals with the development of spas and wellness services in the chosen company called Wellness hotel Diamant. This company is one of the key ones, because it makes South Bohemia more attractive. This work proposes complementary services which can lead to improvement of the present ones and to filling up the current market needs. The aim of this work is to analyse economic conditions of the specific hotel, which is its situation on the economy market and what its competitiveness is l...

  14. Freely chosen cadence during a covert manipulation of ambient temperature.

    Science.gov (United States)

    Hartley, Geoffrey L; Cheung, Stephen S

    2013-01-01

    The present study investigated relationships between changes in power output (PO) to torque (TOR) or freely chosen cadence (FCC) during thermal loading. Twenty participants cycled at a constant rating of perceived exertion while ambient temperature (Ta) was covertly manipulated at 20-min intervals of 20 °C, 35 °C, and 20 °C. The magnitude responses of PO, FCC and TOR were analyzed using repeated-measures ANOVA, while the temporal correlations were analyzed using Auto-Regressive Integrated Moving Averages (ARIMA). Increases in Ta caused significant thermal strain (p stressors.

  15. Randomized controlled trial of traditional Chinese medicine (acupuncture and tuina) in cerebral palsy: part 1--any increase in seizure in integrated acupuncture and rehabilitation group versus rehabilitation group?

    Science.gov (United States)

    Wu, Yun; Zou, Li-Ping; Han, Tong-Li; Zheng, Hua; Caspi, Opher; Wong, Virginia; Su, Yani; Shen, Kun-Ling

    2008-10-01

    The objective of this study was to observe for any change in baseline seizure frequency with acupuncture in children with cerebral palsy. A randomized controlled study was conducted: Group I consisted of integrated acupuncture, tuina, and rehabilitation (physiotherapy, occupational therapy, and hydrotherapy) for 12 weeks; and Group II consisted of rehabilitation (physiotherapy, occupational therapy, and hydrotherapy) for 12 weeks. After a washout period of 4 weeks, Group II then received acupuncture and tuina for 12 weeks. Each subject received 5 daily acupuncture sessions per week for 12 weeks (total = 60 sessions). All children were assessed for any change in seizure frequency during treatment. One hundred and sixteen (116) children were recruited and randomized into Group I (N = 58) and Group II (N = 58). Thirty-three (33) children withdrew (9 from Group I and 24 from Group II). Of the remaining 83 children, Group I consisted of 49 and Group II of 34 children. For baseline, 5 children (6%; 5/83) had seizures. During phase 1 (12 weeks) of integrative treatment and subsequent 4-week follow-up, 3 children in Group I had seizures. Among those 3 children with seizures, 1 child with prior history of recurrent febrile seizure had 3 more recurrent febrile seizures during acupuncture treatment and 2 children without any prior history of seizures had new-onset seizures (1 with 3 recurrent febrile seizures and 1 with afebrile seizure). For Group I, 2 children with epilepsy had no increase in seizure frequency during acupuncture treatment. For Group II during the phase 2 acupuncture period, none had increase in seizure frequency. In both groups, 4 of 5 children (80%; 2 in Group I and 2 in Group II) with seizures had no increase in seizure frequency during acupuncture treatment and follow-up. The risk of increasing seizure is not increased with acupuncture treatment for cerebral palsy.

  16. Estimates of Intraclass Correlation Coefficients from Longitudinal Group-Randomized Trials of Adolescent HIV/STI/Pregnancy Prevention Programs

    Science.gov (United States)

    Glassman, Jill R.; Potter, Susan C.; Baumler, Elizabeth R.; Coyle, Karin K.

    2015-01-01

    Introduction: Group-randomized trials (GRTs) are one of the most rigorous methods for evaluating the effectiveness of group-based health risk prevention programs. Efficiently designing GRTs with a sample size that is sufficient for meeting the trial's power and precision goals while not wasting resources exceeding them requires estimates of the…

  17. Acceptance and Commitment Therapy and Cognitive-Behavioral Therapy as Treatments for Academic Procrastination: A Randomized Controlled Group Session

    Science.gov (United States)

    Wang, Shuo; Zhou, Ya; Yu, Shi; Ran, Li-Wen; Liu, Xiang-Ping; Chen, Yu-Fei

    2017-01-01

    Objective: This study tested the efficacy of Acceptance and Commitment Therapy (ACT), compared with Cognitive-Behavioral Therapy (CBT), in alleviating academic procrastination. Method: A total of 60 (53.3% male) undergraduates suffering from academic procrastination were randomly assigned to two treatment groups (ACT and CBT) and a control group.…

  18. Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: A Randomized Parallel-Group Trial.

    Science.gov (United States)

    Fernández-de-Las Peñas, César; Ortega-Santiago, Ricardo; de la Llave-Rincón, Ana I; Martínez-Perez, Almudena; Fahandezh-Saddi Díaz, Homid; Martínez-Martín, Javier; Pareja, Juan A; Cuadrado-Pérez, Maria L

    2015-11-01

    This randomized clinical trial investigated the effectiveness of surgery compared with physical therapy consisting of manual therapies including desensitization maneuvers in carpal tunnel syndrome (CTS). The setting was a public hospital and 2 physical therapy practices in Madrid, Spain. One hundred twenty women with CTS were enrolled between February 2013 and January 2014, with 1-year follow-up completed in January 2015. Interventions consisted of 3 sessions of manual therapies including desensitization maneuvers of the central nervous system (physical therapy group, n = 60) or decompression/release of the carpal tunnel (surgical group, n = 60). The primary outcome was pain intensity (mean pain and the worst pain), and secondary outcomes included functional status and symptoms severity subscales of the Boston Carpal Tunnel Questionnaire and the self-perceived improvement. They were assessed at baseline and 1, 3, 6, and 12 months by a blinded assessor. Analysis was by intention to treat. At 12 months, 111 (92%) women completed the follow-up (55/60 physical therapy, 56/60 surgery). Adjusted analyses showed an advantage (all, P physical therapy at 1 and 3 months in mean pain (Δ -2.0 [95% confidence interval (CI) -2.8 to -1.2]/-1.3 [95% CI -2.1 to -.6]), the worst pain (Δ -2.9 [-4.0 to -2.0]/-2.0 [-3.0 to -.9]), and function (Δ -.8 [-1.0 to -.6]/-.3 [-.5 to -.1]), respectively. Changes in pain and function were similar between the groups at 6 and 12 months. The 2 groups had similar improvements in the symptoms severity subscale of the Boston Carpal Tunnel Questionnaire at all follow-ups. In women with CTS, physical therapy may result in similar outcomes on pain and function to surgery. http://www.clinicaltrials.gov, ClinicalTrials.gov, NCT01789645. This study found that surgery and physical manual therapies including desensitization maneuvers of the central nervous system were similarly effective at medium-term and long-term follow-ups for improving pain and

  19. School-based prevention of acute rheumatic fever: a group randomized trial in New Zealand.

    Science.gov (United States)

    Lennon, Diana; Stewart, Joanna; Farrell, Elizabeth; Palmer, Anne; Mason, Henare

    2009-09-01

    Acute rheumatic fever (ARF) and its sequela, rheumatic heart disease is the commonest cause of childhood cardiac morbidity globally. The current approach to the prevention of a primary attack of rheumatic fever in children using oral medication for streptococcal pharyngitis is poorly supported. The efficacy of injectable penicillin, in high rheumatic fever incidence military environments is indisputable. To evaluate school-based control of rheumatic fever in an endemic area. Fifty-three schools ( approximately 22,000 students) from a rheumatic fever high incidence setting ( approximately 60/100,000) in Auckland, New Zealand were randomized. The control group received routine general practice care. The intervention was a school-based sore throat clinic program with free nurse-observed oral penicillin treatment of group A streptococcal pharyngitis. The outcome measure was ARF in any child attending a study school. Analysis A defined ARF cases using criteria derived from Jones Criteria 1965 (definite) and 1956 (probable) with more precise definitions. Analysis B was based on 1992 Jones criteria but also included echocardiography to determine definite cases. In Analysis A, 24 (55/100,000) cases occurred in clinic schools and 29 (67/100,000) in nonclinic schools, a 21% reduction when adjusted for demography and study design (P = 0.47). Analysis B revealed a 28% reduction 26 (59/100,000) and 33 (77/100,000) cases, respectively (P = 0.27). This study involving 86,874 person-years showed a nonsignificant reduction in the school-based sore throat clinic programs.

  20. Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial

    Science.gov (United States)

    Gimsing, Peter; Hjertner, Oyvind; Lenhoff, Stig; Laane, Edward; Remes, Kari; Steingrimsdottir, Hlif; Abildgaard, Niels; Ahlberg, Lucia; Blimark, Cecilie; Dahl, Inger Marie; Forsberg, Karin; Gedde-Dahl, Tobias; Gregersen, Henrik; Gruber, Astrid; Guldbrandsen, Nina; Haukås, Einar; Carlson, Kristina; Kvam, Ann Kristin; Nahi, Hareth; Lindås, Roald; Andersen, Niels Frost; Turesson, Ingemar; Waage, Anders; Westin, Jan; Gregersen, Henrik; Frost Andersen, Niels; Gimsing, Peter; Toffner-Clausen, Nilsaage; Abildgaard, Niels; Laane, Edward; Silvennoinen, Raija; Remes, Kari; Steingrimsdottir, Hlif; Lindås, Roald; Gedde-Dahl, Tobias; Guldbrandsen, Nina; Kristin Kvam, Ann; Haukås, Einar; Marie Dahl, Inger; Hjertner, Oyvind; Waage, Anders; Blimark, Cecilie; Mellqvist, Ulf-Henrik; Westin, Jan; Ahlberg, Lucia; Lenhoff, Stig; Turesson, Ingemar; Linder, Olle; Gruber, Astrid; Nahi, Hareth; Forsberg, Karin; Carlson, Kristina

    2013-01-01

    The Nordic Myeloma Study Group conducted an open randomized trial to compare bortezomib as consolidation therapy given after high-dose therapy and autologous stem cell transplantation (ASCT) with no consolidation in bortezomib-naive patients with newly diagnosed multiple myeloma. Overall, 370 patients were centrally randomly assigned 3 months after ASCT to receive 20 doses of bortezomib given during 21 weeks or no consolidation. The hypothesis was that consolidation therapy would prolong progression-free survival (PFS). The PFS after randomization was 27 months for the bortezomib group compared with 20 months for the control group (P = .05). Fifty-one of 90 patients in the treatment group compared with 32 of 90 controls improved their response after randomization (P = .007). No difference in overall survival was seen. Fatigue was reported more commonly by the bortezomib-treated patients in self-reported quality-of-life (QOL) questionnaires, whereas no other major differences in QOL were recorded between the groups. Consolidation therapy seemed to be beneficial for patients not achieving at least a very good partial response (VGPR) but not for patients in the ≥ VGPR category at randomization. Consolidation with bortezomib after ASCT in bortezomib-naive patients improves PFS without interfering with QOL. This trial was registered at www.clinicaltrials.gov as #NCT00417911. PMID:23616624

  1. Dopamine neurons learn relative chosen value from probabilistic rewards.

    Science.gov (United States)

    Lak, Armin; Stauffer, William R; Schultz, Wolfram

    2016-10-27

    Economic theories posit reward probability as one of the factors defining reward value. Individuals learn the value of cues that predict probabilistic rewards from experienced reward frequencies. Building on the notion that responses of dopamine neurons increase with reward probability and expected value, we asked how dopamine neurons in monkeys acquire this value signal that may represent an economic decision variable. We found in a Pavlovian learning task that reward probability-dependent value signals arose from experienced reward frequencies. We then assessed neuronal response acquisition during choices among probabilistic rewards. Here, dopamine responses became sensitive to the value of both chosen and unchosen options. Both experiments showed also the novelty responses of dopamine neurones that decreased as learning advanced. These results show that dopamine neurons acquire predictive value signals from the frequency of experienced rewards. This flexible and fast signal reflects a specific decision variable and could update neuronal decision mechanisms.

  2. Weight change among people randomized to minimal intervention control groups in weight loss trials.

    Science.gov (United States)

    Johns, David J; Hartmann-Boyce, Jamie; Jebb, Susan A; Aveyard, Paul

    2016-04-01

    Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12-month mean weight change using baseline observation carried forward. Meta-regression was conducted in STATA v12. Thirty studies met the inclusion criteria, twenty-nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was -0.8 kg (95% CI -1.1 to -0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of -0.53 kg (95% CI -0.96 to -0.09). Also in an unadjusted model, each additional weigh-in was associated with a weight change of -0.42 kg (95% CI -0.81 to -0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh-ins was associated with weight change. Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow-up. © 2016 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

  3. A Randomized Clinical Trial of an Integrative Group Therapy for Children With Severe Mood Dysregulation

    Science.gov (United States)

    Waxmonsky, James G.; Waschbusch, Daniel A.; Belin, Peter; Li, Tan; Babocsai, Lysett; Humphrey, Hugh; Pariseau, Meaghan E.; Babinski, Dara E.; Hoffman, Martin T.; Haak, Jenifer L.; Mazzant, Jessica A.; Fabiano, Gregory A.; Pettit, Jeremy W.; Fallahazad, Negar; Pelham, William E.

    2015-01-01

    Objective Non-episodic irritability is a common and impairing problem, leading to the development of the diagnoses severe mood dysregulation (SMD) and disruptive mood dysregulation disorder (DMDD). No psychosocial therapies have been formally evaluated for either, with medication being the most common treatment. This study examined the feasibility and efficacy of a joint parent–child intervention for SMD. Method Sixty-eight particpants ages 7–12 with attention-deficit/hyperactivity disorder (ADHD) and SMD were randomly assigned to the 11-week therapy or community-based psychosocial treatment. All participants were first stabilized on psychostimulant medication by study physicians. Fifty-six still manifested impairing SMD symptoms and entered the therapy phase. Masked evaluators assessed participants at baseline, midpoint, and endpoint, with therapy participants reassessed 6 weeks later. Results All but two therapy participants attended the majority of sessions (n=29), with families reporting high levels of satisfaction. The primary outcome of change in mood symptoms using the Mood Severity Index (MSI) did not reach significance except in the subset attending the majority of sessions (effect size [ES]=0.53). Therapy was associated with significantly greater improvement in parent-rated irritability (ES=0.63). Treatment effects for irritability but not MSI diminished after therapy stopped. Little impact on ADHD symptoms was seen. Results may not be generalizable to youth with SMD and different comorbidities than seen in this sample of children with ADHD and are limited by the lack of a gold standard for measuring change in SMD symptoms. Conclusion While failing to significantly improve mood symptoms versus community treatment, the integrative therapy was found to be a feasible and efficacious treatment for irritability in participants with SMD and ADHD. Clinical trial registration information Group-Based Behavioral Therapy Combined With Stimulant Medication for

  4. Group CBT versus MBSR for social anxiety disorder: A randomized controlled trial.

    Science.gov (United States)

    Goldin, Philippe R; Morrison, Amanda; Jazaieri, Hooria; Brozovich, Faith; Heimberg, Richard; Gross, James J

    2016-05-01

    The goal of this study was to investigate treatment outcome and mediators of cognitive-behavioral group therapy (CBGT) versus mindfulness-based stress reduction (MBSR) versus waitlist (WL) in patients with generalized social anxiety disorder (SAD). One hundred eight unmedicated patients (55.6% female; mean age = 32.7 years, SD = 8.0; 43.5% Caucasian, 39% Asian, 9.3% Hispanic, 8.3% other) were randomized to CBGT versus MBSR versus WL and completed assessments at baseline, posttreatment/WL, and at 1-year follow-up, including the Liebowitz Social Anxiety Scale-Self-Report (primary outcome; Liebowitz, 1987) as well as measures of treatment-related processes. Linear mixed model analysis showed that CBGT and MBSR both produced greater improvements on most measures compared with WL. Both treatments yielded similar improvements in social anxiety symptoms, cognitive reappraisal frequency and self-efficacy, cognitive distortions, mindfulness skills, attention focusing, and rumination. There were greater decreases in subtle avoidance behaviors following CBGT than MBSR. Mediation analyses revealed that increases in reappraisal frequency, mindfulness skills, attention focusing, and attention shifting, and decreases in subtle avoidance behaviors and cognitive distortions, mediated the impact of both CBGT and MBSR on social anxiety symptoms. However, increases in reappraisal self-efficacy and decreases in avoidance behaviors mediated the impact of CBGT (vs. MBSR) on social anxiety symptoms. CBGT and MBSR both appear to be efficacious for SAD. However, their effects may be a result of both shared and unique changes in underlying psychological processes. (c) 2016 APA, all rights reserved).

  5. New moves-preventing weight-related problems in adolescent girls a group-randomized study.

    Science.gov (United States)

    Neumark-Sztainer, Dianne R; Friend, Sarah E; Flattum, Colleen F; Hannan, Peter J; Story, Mary T; Bauer, Katherine W; Feldman, Shira B; Petrich, Christine A

    2010-11-01

    Weight-related problems are prevalent in adolescent girls. To evaluate New Moves, a school-based program aimed at preventing weight-related problems in adolescent girls. School-based group-randomized controlled design. 356 girls (mean age=15.8±1.2 years) from six intervention and six control high schools. More than 75% of the girls were racial/ethnic minorities and 46% were overweight or obese. Data were collected in 2007-2009 and analyzed in 2009-2010. An all-girls physical education class, supplemented with nutrition and self-empowerment components, individual sessions using motivational interviewing, lunch meetings, and parent outreach. Percentage body fat, BMI, physical activity, sedentary activity, dietary intake, eating patterns, unhealthy weight control behaviors, and body/self-image. New Moves did not lead to significant changes in the girls' percentage body fat or BMI but improvements were seen for sedentary activity, eating patterns, unhealthy weight control behaviors, and body/self-image. For example, in comparison to control girls, at 9-month follow-up, intervention girls decreased their sedentary behaviors by approximately one 30-minute block a day (p=0.050); girls increased their portion control behaviors (p=0.014); the percentage of girls using unhealthy weight control behaviors decreased by 13.7% (p=0.021); and improvements were seen in body image (p=0.045) and self-worth (p=0.031). Additionally, intervention girls reported more support by friends, teachers, and families for healthy eating and physical activity. New Moves provides a model for addressing the broad spectrum of weight-related problems among adolescent girls. Further work is needed to enhance the effectiveness of interventions to improve weight status of youth. Copyright © 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  6. Promoting physical activity among adolescent girls: the Girls in Sport group randomized trial.

    Science.gov (United States)

    Okely, Anthony D; Lubans, David R; Morgan, Philip J; Cotton, Wayne; Peralta, Louisa; Miller, Judith; Batterham, Marijka; Janssen, Xanne

    2017-06-21

    Slowing the decline in participation in physical activity among adolescent girls is a public health priority. This study reports the outcomes from a multi-component school-based intervention (Girls in Sport), focused on promoting physical activity among adolescent girls. Group randomized controlled trial in 24 secondary schools (12 intervention and 12 control). Assessments were conducted at baseline (2009) and at 18 months post-baseline (2010). The setting was secondary schools in urban, regional and rural areas of New South Wales, Australia. All girls in Grade 8 in 2009 who attended these schools were invited to participate in the study (N = 1769). Using a Health Promoting Schools and Action Learning Frameworks, each school formed a committee and developed an action plan for promoting physical activity among Grade 8 girls. The action plan incorporated strategies in three main areas - i) the formal curriculum, ii) school environment, and iii) home/school/community links - based on the results of formative data from target girls and staff and on individual needs of the school. A member of the research team supported each school throughout the intervention. The main outcome measure was accelerometer-derived total physical activity (TPA) spent in physical activity. Data were analyzed from December 2011 to March 2012. 1518 girls (mean age 13.6y ±0.02) were assessed at baseline. There was a significant decline in TPA from baseline to 18-month follow-up with no differences between girls in the intervention and control schools. Only one-third of schools (4/12) implemented the intervention as per their action plan. Per-protocol analyses on these schools revealed a smaller decline in percentage of time spent in MVPA among girls in the intervention group (adjusted difference 0.5%, 95% CI = -0.01, 0.99, P = 0.05). The Girls in Sport intervention was not effective in reducing the decline in physical activity among adolescent girls. Lack of implementation by most

  7. The rise and fall of Chosen Soren : its effect on Japan's relations on the Korean Peninsula

    OpenAIRE

    Creamer, Dewayne J.

    2003-01-01

    Approved for public release; distribution is unlimited The Korean Diaspora in Japan is a legacy of Japan's colonization of Korea in the first half of the 20th century and has always been the largest group of foreign residents in an otherwise ethnically homogenous Japan. A major issue is the role that Koreans in Japan play in supporting North Korea. Although a very small segment of the population, Koreans affiliated with the organization known as Chosen Soren have figured prominently in the...

  8. The impact of group music therapy on depression and cognition in elderly persons with dementia: a randomized controlled study.

    Science.gov (United States)

    Chu, Hsin; Yang, Chyn-Yng; Lin, Yu; Ou, Keng-Liang; Lee, Tso-Ying; O'Brien, Anthony Paul; Chou, Kuei-Ru

    2014-04-01

    The aims of this study were to determine the effectiveness of group music therapy for improving depression and delaying the deterioration of cognitive functions in elderly persons with dementia. The study had a prospective, parallel-group design with permuted-block randomization. Older persons with dementia (N = 104) were randomly assigned to the experimental or control group. The experimental group received 12 sessions of group music therapy (two 30-min sessions per week for 6 weeks), and the control group received usual care. Data were collected 4 times: (1) 1 week before the intervention, (2) the 6th session of the intervention, (3) the 12th session of the intervention, and (4) 1 month after the final session. Group music therapy reduced depression in persons with dementia. Improvements in depression occurred immediately after music therapy and were apparent throughout the course of therapy. The cortisol level did not significantly decrease after the group music therapy. Cognitive function significantly improved slightly at the 6th session, the 12th session, and 1 month after the sessions ended; in particular, short-term recall function improved. The group music therapy intervention had the greatest impact in subjects with mild and moderate dementia. The group music intervention is a noninvasive and inexpensive therapy that appeared to reduce elders' depression. It also delayed the deterioration of cognitive functions, particularly short-term recall function. Group music therapy may be an appropriate intervention among elderly persons with mild and moderate dementia.

  9. Attention bias modification augments cognitive-behavioral group therapy for social anxiety disorder: a randomized controlled trial.

    Science.gov (United States)

    Lazarov, Amit; Marom, Sofi; Yahalom, Naomi; Pine, Daniel S; Hermesh, Haggai; Bar-Haim, Yair

    2017-12-20

    Cognitive-behavioral group therapy (CBGT) is a first-line treatment for social anxiety disorder (SAD). However, since many patients remain symptomatic post-treatment, there is a need for augmenting procedures. This randomized controlled trial (RCT) examined the potential augmentation effect of attention bias modification (ABM) for CBGT. Fifty patients with SAD from three therapy groups were randomized to receive an 18-week standard CBGT with either ABM designed to shift attention away from threat (CBGT + ABM), or a placebo protocol not designed to modify threat-related attention (CBGT + placebo). Therapy groups took place in a large mental health center. Clinician and self-report measures of social anxiety and depression were acquired pre-treatment, post-treatment, and at 3-month follow-up. Attention bias was assessed at pre- and post-treatment. Patients randomized to the CBGT + ABM group, relative to those randomized to the CBGT + placebo group, showed greater reductions in clinician-rated SAD symptoms post-treatment, with effects maintained at 3-month follow-up. Group differences were not evident for self-report or attention-bias measures, with similar reductions in both groups. Finally, reduction in attention bias did not mediate the association between group and reduction in Liebowitz Social Anxiety Scale Structured Interview (LSAS) scores. This is the first RCT to examine the possible augmenting effect of ABM added to group-based cognitive-behavioral therapy for adult SAD. Training patients' attention away from threat might augment the treatment response to standard CBGT in SAD, a possibility that could be further evaluated in large-scale RCTs.

  10. Effectiveness of interactive discussion group in suicide risk assessment among general nurses in Taiwan: a randomized controlled trial.

    Science.gov (United States)

    Wu, Chia-Yi; Lin, Yi-Yin; Yeh, Mei Chang; Huang, Lian-Hua; Chen, Shaw-Ji; Liao, Shih-Cheng; Lee, Ming-Been

    2014-11-01

    The evidence of suicide prevention training for nurses is scarce. Strategies to enhance general nurses' ability in suicide risk assessment are critical to develop effective training programs in general medical settings. This study was aimed to examine the effectiveness of an interactive discussion group in a suicide prevention training program for general nurses. In this randomized study with two groups of pre-post study design, the sample was recruited from the Medical, Surgical, and Emergency/Intensive Care Sectors of a 2000-bed general hospital via stratified randomization. Among the 111 nurses, 57 participants randomly assigned to the control group received a two-hour baseline suicide gatekeeper lecture, and 54 participants assigning to the experimental group received an additional five-hour group discussion about suicide risk assessment skills. Using a case vignette, the nurses discussed and assessed suicide risk factors specified in a 10-item Chinese SAD PERSONS Scale during a group discussion intervention. The findings revealed that the nurses achieved significant and consistent improvements of risk identification and assessment after the intervention without influencing their mental health status for assessing suicide risks. The result suggested an effective approach of interactive group discussion for facilitating critical thinking and learning suicide risk assessment skills among general nurses. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Dopamine neurons learn relative chosen value from probabilistic rewards

    Science.gov (United States)

    Lak, Armin; Stauffer, William R; Schultz, Wolfram

    2016-01-01

    Economic theories posit reward probability as one of the factors defining reward value. Individuals learn the value of cues that predict probabilistic rewards from experienced reward frequencies. Building on the notion that responses of dopamine neurons increase with reward probability and expected value, we asked how dopamine neurons in monkeys acquire this value signal that may represent an economic decision variable. We found in a Pavlovian learning task that reward probability-dependent value signals arose from experienced reward frequencies. We then assessed neuronal response acquisition during choices among probabilistic rewards. Here, dopamine responses became sensitive to the value of both chosen and unchosen options. Both experiments showed also the novelty responses of dopamine neurones that decreased as learning advanced. These results show that dopamine neurons acquire predictive value signals from the frequency of experienced rewards. This flexible and fast signal reflects a specific decision variable and could update neuronal decision mechanisms. DOI: http://dx.doi.org/10.7554/eLife.18044.001 PMID:27787196

  12. STUDIES OF CHOSEN TOXIC ELEMENTS CONCENTRATION IN MULTIFLOWER BEE HONEY

    Directory of Open Access Journals (Sweden)

    Ewa Popiela

    2011-04-01

    Full Text Available 72 544x376 Normal 0 21 false false false  The aim of the study was to determine the bioaccumulation level of chosen toxic elements (Zn, Cu, Pb, As and Cd in multiflower honey collected from Brzeg area. Biological material (honey was mineralized using the microwave technique at an elevated pressure in the microprocessor station of pressure in the type Mars 5. Quantitative analysis of elements (As, Cd, Cu, Pb and Zn was performed by plasma spectrometry method using a Varian ICP-AES apparatus. The presence of toxic elements was determined in examined biological materials. The elements fallowed the fallowing decreasing order with respect to their content of honey: Zn>Cu>Pb>As>Cd. The average concentrations of studied elements observed in multi-flower honey were as follows: 6.24 mg.kg-1 of zinc, 2.75 mg.kg-1 of copper, 0.53, 0.071, 0.042 mg.kg-1of lead, arsenic and cadmium, respectively. Lead was the most problematic in bee honey because its average content exceeded the maximum acceptable concentration. Additionally, this metal concentration was 60% higher in studied samples than allowable standard of lead content.doi:10.5219/134 

  13. Comparison of Collaboration and Performance in Groups of Learners Assembled Randomly or Based on Learners' Topic Preferences

    Science.gov (United States)

    Cela, Karina L.; Sicilia, Miguel Ángel; Sánchez, Salvador

    2015-01-01

    Teachers and instructional designers frequently incorporate collaborative learning approaches into their e-learning environments. A key factor of collaborative learning that may affect learner outcomes is whether the collaborative groups are assigned project topics randomly or based on a shared interest in the topic. This is a particularly…

  14. Headache : The placebo effects in the control groups in randomized clinical trials; An analysis of systematic reviews

    NARCIS (Netherlands)

    de Groot, Femke M.; Voogt-Bode, Annieke; Passchier, Jan; Berger, Marjolein Y.; Koes, Bart W.; Verhagen, Arianne P.

    Objective: The purpose of this study is to describe the effects in the placebo and "no treatment" arms in trials with headache patients. Method: This is a secondary analysis of randomized controlled trials from 8 systematic reviews and selected trials with a "no treatment" or placebo control group.

  15. Randomized Trial of Group Interventions to Reduce HIV/STD Risk and Change Theoretical Mediators among Detained Adolescents

    Science.gov (United States)

    Schmiege, Sarah J.; Broaddus, Michelle R.; Levin, Michael; Bryan, Angela D.

    2009-01-01

    Criminally involved adolescents engage in high levels of risky sexual behavior and alcohol use, and alcohol use may contribute to lack of condom use. Detained adolescents (n = 484) were randomized to (1) a theory-based sexual risk reduction intervention (GPI), (2) the GPI condition with a group-based alcohol risk reduction motivational enhancement…

  16. Improving the Design of Science Intervention Studies: An Empirical Investigation of Design Parameters for Planning Group Randomized Trials

    Science.gov (United States)

    Westine, Carl; Spybrook, Jessaca

    2013-01-01

    The capacity of the field to conduct power analyses for group randomized trials (GRTs) of educational interventions has improved over the past decade (Authors, 2009). However, a power analysis depends on estimates of design parameters. Hence it is critical to build the empirical base of design parameters for GRTs across a variety of outcomes and…

  17. Reducing Aggressive Behavior in Boys With a Social Cognitive Group Treatment: Results of a Randomized, Controlled Trial.

    NARCIS (Netherlands)

    van Manen, T.G.; Prins, P.J.M.; Emmelkamp, P.M.G.

    2004-01-01

    Objective: To evaluate the effectiveness of a social cognitive intervention program for Dutch aggressive boys and to compare it with a social skills training and a waitlist control group. Method: A randomized, controlled treatment outcome study with 97 aggressive boys (aged 9-13 years) was

  18. Effects of a comprehensive educational group intervention in older women with cognitive complaints: a randomized controlled trial

    NARCIS (Netherlands)

    Hoogenhout, Esther; De Groot, Renate; Van der Elst, Wim; Jolles, Jelle

    2012-01-01

    Hoogenhout, E. M., De Groot, R. H. M., Van der Elst, W., Jolles J. (2012). Effects of a comprehensive educational group intervention in older women with cognitive complaints: a randomized controlled trial. Aging & Mental Health, 16, 135-144. doi:10.1080/13607863.2011.598846

  19. Improving the Transition Behavior of High School Students with Emotional Behavioral Disorders Using a Randomized Interdependent Group Contingency

    Science.gov (United States)

    Hawkins, Renee O.; Haydon, Todd; Denune, Hilary; Larkin, Wallace; Fite, Nathan

    2015-01-01

    The current study evaluated the effects of an interdependent group contingency with randomized components on student behavior during the transition from lunch to class. The study was conducted in three high school classrooms in an alternative school setting for students with emotional and behavioral disorders and used an ABAB withdrawal design.…

  20. Effective group training for patients with unexplained physical symptoms: a randomized controlled trial with a non-randomized one-year follow-up.

    Directory of Open Access Journals (Sweden)

    Lyonne N L Zonneveld

    Full Text Available BACKGROUND: Although cognitive-behavioral therapy for Unexplained Physical Symptoms (UPS is effective in secondary care, studies done in primary care produced implementation problems and conflicting results. We evaluated the effectiveness of a cognitive-behavioral group training tailored to primary care patients and provided by a secondary community mental-health service reaching out into primary care. METHODOLOGY/PRINCIPAL FINDINGS: The effectiveness of this training was explored in a randomized controlled trial. In this trial, 162 patients with UPS classified as undifferentiated somatoform disorder or as chronic pain disorder were randomized either to the training or a waiting list. Both lasted 13 weeks. The preservation of the training's effect was analyzed in non-randomized follow-ups, for which the waiting group started the training after the waiting period. All patients attended the training were followed-up after three months and again after one year. The primary outcomes were the physical and the mental summary scales of the SF-36. Secondary outcomes were the other SF-36-scales and the SCL-90-R. The courses of the training's effects in the randomized controlled trial and the follow-ups were analyzed with linear mixed modeling. In the randomized controlled trial, the training had a significantly positive effect on the quality of life in the physical domain (Cohen's d = 0.38;p = .002, but this overall effect was not found in the mental domain. Regarding the secondary outcomes, the training resulted in reporting an improved physical (Cohen's d = 0.43;p = 0.01, emotional (Cohen's d = 0.44;p = 0.01, and social (Cohen's d = 0.36;p = 0.01 functioning, less pain and better functioning despite pain (Cohen's d = 0.51;p =

  1. Mindfulness-Based Stress Reduction and Group Support Decrease Stress in Adolescents with Cardiac Diagnoses: A Randomized Two-Group Study.

    Science.gov (United States)

    Freedenberg, Vicki A; Hinds, Pamela S; Friedmann, Erika

    2017-10-01

    Adolescents with cardiac diagnoses face unique challenges that can cause psychosocial distress. This study compares a Mindfulness-Based Stress Reduction (MBSR) program to a video online support group for adolescents with cardiac diagnoses. MBSR is a structured psycho-educational program which includes yoga, meditation, cognitive restructuring, and group support. A published feasibility study by our group showed significant reduction in anxiety following this intervention. Participants were randomized to MBSR or video online support group, and completed measures of anxiety, depression, illness-related stress, and coping pre- and post-6-session interventions. Qualitative data were obtained from post-intervention interviews. A total of 46 teens participated (mean 14.8 years; 63% female). Participants had congenital heart disease and/or cardiac device (52%), or postural orthostatic tachycardia syndrome (48%). Illness-related stress significantly decreased in both groups. Greater use of coping skills predicted lower levels of depression in both groups post-study completion. Higher baseline anxiety/depression scores predicted improved anxiety/depression scores in both groups. Each group reported the benefits of social support. The MBSR group further expressed benefits of learning specific techniques, strategies, and skills that they applied in real-life situations to relieve distress. Both the MBSR intervention and video support group were effective in reducing distress in this sample. Qualitative data elucidated the added benefits of using MBSR techniques to manage stress and symptoms. The video group format is useful for teens that cannot meet in person but can benefit from group support. Psychosocial interventions with stress management techniques and/or group support can reduce distress in adolescents with cardiac diagnoses.

  2. Effects of Group Training on Depression and Anxiety among Patients with Type I Diabetes: a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shanaz Rostami

    2016-05-01

    Full Text Available Background Depression and anxiety can have a significant impact on prognosis in diabetic patients. In this study we evaluate how the effect of group learning on anxiety and depression in adolescents with type 1 diabetes at clinics of Ahvaz Jundishapur University of Medical Science. Materials and Methods  This study was carried out via a pretest- posttest design on the adolescent 11-21 ages with type I diabetes. 74 patients were randomized in education group (n=37 either to the control group (n=37. Data collection tools included demographic and clinical status questionnaires, and the Beck anxiety and depression inventory. Group training intervention was done for intervention group and three months after study two groups filled questionnaires and inventories. Data analyzed using chi-square test and t-test using SPSS- 22 software. Results  Findings showed that there was a significant difference between patients mean of depression in intervention group before and after intervention (P

  3. A randomized clinical trial comparing general exercise, McKenzie treatment and a control group in patients with neck pain.

    Science.gov (United States)

    Kjellman, Görel; Oberg, Birgitta

    2002-07-01

    Seventy-seven patients with neck pain in the primary health care were included in a prospective, randomized clinical trial and randomly assigned to general exercise, McKenzie treatment, or a control group. Seventy patients completed the treatment; response rate 93% at 12-month follow-up. All three groups showed significant improvement regarding the main outcomes, pain intensity and Neck Disability Index, even at 12-month follow-up, but there was no significant difference between the groups. In all, 79% reported that they were better or completely restored after treatment, although 51% reported constant/daily pain. In the McKenzie group compared with the control group, a tendency toward greater improvement was noted for pain intensity at 3 weeks and at 6-month follow-up, and for post-treatment Neck Disability Index. Significant improvement in Distress and Risk Assessment Method scores was shown in the McKenzie group only. The three groups had similar recurrence rates, although after 12 months the McKenzie group showed a tendency toward fewer visits for additional health care. The study did not provide a definite evidence of treatment efficacy in patients with neck pain, however, there was a tendency toward a better outcome with the two active alternatives compared with the control group.

  4. Which factors determine the freely chosen cadence during submaximal cycling?

    Science.gov (United States)

    Vercruyssen, Fabrice; Brisswalter, Jeanick

    2010-03-01

    The present review of cycling science focuses on the identification of criteria that affect the freely chosen cadence (FCC) during submaximal exercise of short and prolonged durations. Cadence selection during submaximal cycling constitutes a potential parameter affecting the endurance performance in subjects of varying aerobic fitness level and experience. The activity constraints such as specificity (e.g. cycle bout of triathlon) and exercise duration may play an important role in the selection of cadence and must be taken into consideration in the task description. The 'holistic' approach of this review is based on a multifactorial analysis considering the cycling constraints, and the physiological and biomechanical factors of cadence selection so as to establish any interrelationships between these factors. During cycle bouts of short duration (<15 min), it has been well argued that experienced cyclists, trained runners and triathletes adopt high cadences (80-100 rpm) systematically above the energetically optimal cadence (EOC) at which the oxygen uptake is minimal (55-65 rpm). The choice of a high cadence has been shown to be dependent upon several factors, such as the aerobic fitness level, the reduction in forces applied to the cranks, the lower extremity net joint moments and minimal neuromuscular fatigue. However, with increasing exercise duration the FCC has been reported to be close to the EOC exclusively in endurance athletes practising a variety of activities, suggesting an impact of training mode on the muscular adaptations and the organisation of the movement pattern. Copyright 2009 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  5. Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bose Anuradha

    2010-05-01

    Full Text Available Abstract Background Studies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent. Methods Parents of children participating in a trial of nutritional supplementation were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents. Results A total of 128 parents were recruited and follow up was established with 118 (90.2% for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm. Conclusions The results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials. Trial Registration Clinical Trial Registry - India (CTRI: CTRI/2009/091/000612

  6. Random walks on three-strand braids and on related hyperbolic groups 05.40.-a Fluctuation phenomena, random processes, noise, and Brownian motion; 02.50.-r Probability theory, stochastic processes, and statistics; 02.40.Ky Riemannian geometries;

    CERN Document Server

    Nechaev, S

    2003-01-01

    We investigate the statistical properties of random walks on the simplest nontrivial braid group B sub 3 , and on related hyperbolic groups. We provide a method using Cayley graphs of groups allowing us to compute explicitly the probability distribution of the basic statistical characteristics of random trajectories - the drift and the return probability. The action of the groups under consideration in the hyperbolic plane is investigated, and the distribution of a geometric invariant - the hyperbolic distance - is analysed. It is shown that a random walk on B sub 3 can be viewed as a 'magnetic random walk' on the group PSL(2, Z).

  7. Random walks on three-strand braids and on related hyperbolic groups[05.40.-a Fluctuation phenomena, random processes, noise, and Brownian motion; 02.50.-r Probability theory, stochastic processes, and statistics; 02.40.Ky Riemannian geometries;

    Energy Technology Data Exchange (ETDEWEB)

    Nechaev, Sergei [Laboratoire de Physique Theorique et Modeles Statistiques, Universite Paris Sud, 91405 Orsay Cedex (France); Voituriez, Raphael [Laboratoire de Physique Theorique et Modeles Statistiques, Universite Paris Sud, 91405 Orsay Cedex (France)

    2003-01-10

    We investigate the statistical properties of random walks on the simplest nontrivial braid group B{sub 3}, and on related hyperbolic groups. We provide a method using Cayley graphs of groups allowing us to compute explicitly the probability distribution of the basic statistical characteristics of random trajectories - the drift and the return probability. The action of the groups under consideration in the hyperbolic plane is investigated, and the distribution of a geometric invariant - the hyperbolic distance - is analysed. It is shown that a random walk on B{sub 3} can be viewed as a 'magnetic random walk' on the group PSL(2, Z)

  8. Programming a randomized dependent group contingency and common stimuli to promote durable behavior change

    National Research Council Canada - National Science Library

    Cariveau, Tom; Kodak, Tiffany

    2017-01-01

    Low levels of academic engagement may impede students’ acquisition of skills. Intervening on student behavior using group contingencies may be a feasible way to increase academic engagement during group instruction...

  9. Group exercise training for balance, functional status, spasticity, fatigue and quality of life in multiple sclerosis: a randomized controlled trial.

    Science.gov (United States)

    Tarakci, Ela; Yeldan, Ipek; Huseyinsinoglu, Burcu E; Zenginler, Yonca; Eraksoy, Mefkure

    2013-09-01

    To determine the effectiveness of group exercise training on balance, functional status, spasticity, fatigue and quality of life in patients with multiple sclerosis. A randomized single-blind controlled study. University hospital, outpatient physical therapy department. Ambulatory patients with multiple sclerosis. Exercise group completed a 12-week group exercise programme under the physical therapists' supervision. Control group was included in the waiting list. The primary outcome measures were the Berg Balance Scale, 10-metre walk test, 10-steps climbing test and secondary outcome measures were the Modified Ashworth Scale, Fatigue Severity Scale and Multiple Sclerosis International Quality of Life. Ninety-nine patients completed the study. There were statistically significant improvements for all outcome measures in the group exercise group (n = 51) (p exercise group, while a decreased of 2.33 in control group. The 10-metre walk test duration (second) was decreased 2.72 in exercise group, while increased 1.44 in control group. In comparing inter-groups changes, both primary and secondary outcome mesures showed significant improvements in favour of the exercise group after the training (p exercise training is effective in improving balance, functional status, spasticity, fatigue and quality of life in moderately affected people with multiple sclerosis, with no worsening of their clinical status.

  10. The Effect of Group Psychoeducation Program on Medication Adherence in Patients with Bipolar Mood Disorders: a Randomized Controlled Trial.

    Science.gov (United States)

    Rahmani, Farnaz; Ebrahimi, Hossein; Ranjbar, Fatemeh; Razavi, Seyed Sajjad; Asghari, Elnaz

    2016-12-01

    Introduction: Medication nonadherence is highly prevalent in patients with bipolar disorders and often results in worsening disease prognosis. The purpose of this study was to investigate the effect of group psychoeducation on medication adherence in female patients with bipolar mood disorder type I. Methods: This randomized controlled trial was conducted on 76 patients with bipolar mood disorder admitted in female psychiatric wards of Razi teaching hospital, Tabriz, Iran. The participants were selected by convenience sampling method and were randomly assigned to experimental and control groups. Patients in experimental group received 10 continuous 90 minutes sessions of psychoeducation, two times a week. Medication adherence was measured using the medicine check list and medication adherence rating scale (MARS) before and after intervention. Data analysis was performed with SPSS ver.13. Results: There was no significant difference between two groups regarding medication adherence before the intervention. After the study intervention, the mean scores of medication adherence check list and medication adherence rating scale in the experimental group were significantly higher than the control group. Conclusion: Since group psychoeducation was effective in improving patients' medication adherence, it could be recommended for psychiatric nurses to apply this intervention in the clinical setting.

  11. The Effect of Group Psychoeducation Program on Medication Adherence in Patients with Bipolar Mood Disorders: a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Farnaz Rahmani

    2016-12-01

    Full Text Available Introduction: Medication nonadherence is highly prevalent in patients with bipolar disorders and often results in worsening disease prognosis. The purpose of this study was to investigate the effect of group psychoeducation on medication adherence in female patients with bipolar mood disorder type I. Methods: This randomized controlled trial was conducted on 76 patients with bipolar mood disorder admitted in female psychiatric wards of Razi teaching hospital, Tabriz, Iran. The participants were selected by convenience sampling method and were randomly assigned to experimental and control groups. Patients in experimental group received 10 continuous 90 minutes sessions of psychoeducation, two times a week. Medication adherence was measured using the medicine check list and medication adherence rating scale (MARS before and after intervention. Data analysis was performed with SPSS ver.13. Results: There was no significant difference between two groups regarding medication adherence before the intervention. After the study intervention, the mean scores of medication adherence check list and medication adherence rating scale in the experimental group were significantly higher than the control group. Conclusion: Since group psychoeducation was effective in improving patients' medication adherence, it could be recommended for psychiatric nurses to apply this intervention in the clinical setting.

  12. Randomized controlled trial of a cognitive-behavioral motivational intervention in a group versus individual format for substance use disorders.

    Science.gov (United States)

    Sobell, Linda Carter; Sobell, Mark B; Agrawal, Sangeeta

    2009-12-01

    Although group therapy is widely used for individuals with substance use disorders (SUDs), randomized clinical trials (RCTs) comparing the same treatment in a group versus individual format are rare. This paper presents the results of a RCT comparing guided self-change (GSC) treatment, a cognitive-behavioral motivational intervention, conducted in a group versus individual format with 212 alcohol abusers and 52 drug abusers who voluntarily sought outpatient treatment. Treatment outcomes demonstrated significant and large reductions in clients' alcohol and drug use during treatment and at the 12-month follow-up, with no significant differences between the group and individual therapy conditions. A therapist time ratio analysis found that it took 41.4% less therapist time to treat clients using the group versus the individual format. Participants' end-of-treatment group cohesion scores characterized the groups as having high engagement, low levels of interpersonal conflict, and low avoidance of group work, all desirable group characteristics. These findings suggest that the GSC treatment model was effectively integrated into a brief group treatment format. Health care cost containment compels further evaluations of the efficacy of group treatments for SUDs. Copyright 2009 APA

  13. Randomized Controlled Trial of Acupuncture for Women with Fibromyalgia: Group Acupuncture with Traditional Chinese Medicine Diagnosis-Based Point Selection.

    Science.gov (United States)

    Mist, Scott D; Jones, Kim Dupree

    2018-02-13

    Group acupuncture is a growing and cost-effective method for delivering acupuncture in the United States and is the practice model in China. However, group acupuncture has not been tested in a research setting. To test the treatment effect of group acupuncture vs group education in persons with fibromyalgia. Random allocation two-group study with repeated measures. Group clinic in an academic health center in Portland, Oregon. Women with confirmed diagnosis of fibromyalgia (American College of Radiology 1990 criteria) and moderate to severe pain levels. Twenty treatments of a manualized acupuncture treatment based on Traditional Chinese Medicine diagnosis or group education over 10 weeks (both 900 minutes total). Weekly Revised Fibromyalgia Impact Questionnaire (FIQR) and Global Fatigue Index at baseline, five weeks, and 10 weeks and a four-week follow-up were assessed. Thirty women were recruited, with 78% reporting symptoms for longer than 10 years. The mean attendance was 810 minutes for acupuncture and 861 minutes for education. FIQR total, FIQR pain, and Global Fatigue Index all had clinically and statistically significant improvement in the group receiving acupuncture at end of treatment and four weeks post-treatment but not in participants receiving group education between groups. Compared with education, group acupuncture improved global symptom impact, pain, and fatigue. Furthermore, it was a safe and well-tolerated treatment option, improving a broader proportion of patients than current pharmaceutical options.

  14. Fast Neutron Radiotherapy for Locally Advanced Prostate Cancer. Final Report of Radiation Therapy Oncology Group Randomized Clinical Trial.

    Energy Technology Data Exchange (ETDEWEB)

    Laramore, G. E. [Washington U.; Krall, J. M. [Unlisted, US, PA; Thomas, F. J. [Unlisted, US, OH; Russell, K. J. [Washington U.; Maor, M. H. [Unlisted, US, TX; Hendrickson, F. R. [Fermilab; Martz, K. L. [Unlisted, US, PA; Griffin, T. W. [Washington U.

    1993-01-01

    Between June 1977 and April 1983 the Radiation Therapy Oncology Group (RTOG) sponsored a Phase III randomized trial investigating the use of fast neutron radiotherapy for patients with locally advanced (Stages C and D1) adenocarcinoma of the prostate gland. Patients were randomized to receive either conventional photon radiation or fast neutron radiation used in a mixed-beam (neutron/photon) treatment schedule. A total of 91 analyzable patients were entered into the study, and the two patient groups were balanced with respect to the major prognostic variables. Actuarial curves are presented for local/regional control and "overall" survival. Ten-year results for clinically assessed local control are 70% for the mixed-beam group versus 58% for the photon group (p = 0.03) and for survival are 46% for the mixed-beam group versus 29% for the photon group (p = 0.04). This study suggests that a regional method of treatment can influence both local tumor control and survival in patients with locally advanced adenocarcinoma of the prostate gland.

  15. Testing the Efficacy of OurSpace, a Brief, Group Dynamics-Based Physical Activity Intervention: A Randomized Controlled Trial.

    Science.gov (United States)

    Irwin, Brandon; Kurz, Daniel; Chalin, Patrice; Thompson, Nicholas

    2016-05-06

    Emerging technologies (ie, mobile phones, Internet) may be effective tools for promoting physical activity (PA). However, few interventions have provided effective means to enhance social support through these platforms. Face-to-face programs that use group dynamics-based principles of behavior change have been shown to be highly effective in enhancing social support through promoting group cohesion and PA, but to date, no studies have examined their effects in Web-based programs. The aim was to explore proof of concept and test the efficacy of a brief, online group dynamics-based intervention on PA in a controlled experiment. We expected that the impact of the intervention on PA would be moderated by perceptions of cohesion and the partner's degree of presence in the online media. Participants (n=135) were randomized into same-sex dyads and randomly assigned to one of four experimental conditions: standard social support (standard), group dynamics-based-high presence, group dynamics-based-low presence, or individual control. Participants performed two sets of planking exercises (pre-post). Between sets, participants in partnered conditions interacted with a virtual partner using either a standard social support app or a group dynamics-based app (group dynamics-based-low presence and group dynamics-based-high presence), the latter of which they participated in a series of online team-building exercises. Individual participants were given an equivalent rest period between sets. To increase presence during the second set, participants in the group dynamics-based-high presence group saw a live video stream of their partner exercising. Perceptions of cohesion were measured using a modified PA Group Environment Questionnaire. Physical activity was calculated as the time persisted during set 2 after controlling for persistence in set 1. Perceptions of cohesion were higher in the group dynamics-based-low presence (overall mean 5.81, SD 1.04) condition compared to the

  16. Comparison between group and personal rehabilitation for dementia in a geriatric health service facility: single-blinded randomized controlled study.

    Science.gov (United States)

    Tanaka, Shigeya; Honda, Shin; Nakano, Hajime; Sato, Yuko; Araya, Kazufumi; Yamaguchi, Haruyasu

    2017-05-01

    The aim of this study was to compare the effects of rehabilitation involving group and personal sessions on demented participants. This single-blinded randomized controlled trial included 60 elderly participants with dementia in a geriatric health service facility, or R oken. Staff members, who did not participate in the intervention, examined cognitive function, mood, communication ability, severity of dementia, objective quality of life, vitality, and daily behaviour. After a baseline assessment, participants were randomly divided into three groups: (i) group intervention; (ii) personal intervention; and (iii) control. The 1-h group intervention (3-5 subjects) and 20-min personal intervention (one staff member per participant) were performed twice a week for 12 weeks (24 total sessions). The cognitive rehabilitation programme consisted of reminiscence, reality orientation, and physical exercise, and it was based on five principles of brain-activating rehabilitation; (i) pleasant atmosphere; (ii) communication; (iii) social roles; (iv) praising; and (v) errorless support. Data were analyzed after the second assessment. Outcome measures were analyzed in 43 participants-14 in the control group, 13 in group intervention, and 16 in personal intervention. Repeated measure ancova showed a significant interaction for cognitive function score (Mini-Mental State Examination) between group intervention and controls ( F  = 5.535, P = 0.029). In the post-hoc analysis, group intervention showed significant improvement (P = 0.016). Global severity of dementia tended to improve (P = 0.094) in group intervention compared to control (Mann-Whitney U -test). There were no significant interactions or improvements for other measurements. Group rehabilitation for dementia is more effective for improving cognitive function and global severity of dementia than personal rehabilitation in Roken. © 2016 Japanese Psychogeriatric Society.

  17. Comparing Acceptance and Commitment Group Therapy and 12-Steps Narcotics Anonymous in Addict's Rehabilitation Process: A Randomized Controlled Trial.

    Science.gov (United States)

    Azkhosh, Manoochehr; Farhoudianm, Ali; Saadati, Hemn; Shoaee, Fateme; Lashani, Leila

    2016-10-01

    Objective: Substance abuse is a socio-psychological disorder. The aim of this study was to compare the effectiveness of acceptance and commitment therapy with 12-steps Narcotics Anonymous on psychological well-being of opiate dependent individuals in addiction treatment centers in Shiraz, Iran. Method: This was a randomized controlled trial. Data were collected at entry into the study and at post-test and follow-up visits. The participants were selected from opiate addicted individuals who referred to addiction treatment centers in Shiraz. Sixty individuals were evaluated according to inclusion/ exclusion criteria and were divided into three equal groups randomly (20 participants per group). One group received acceptance and commitment group therapy (Twelve 90-minute sessions) and the other group was provided with the 12-steps Narcotics Anonymous program and the control group received the usual methadone maintenance treatment. During the treatment process, seven participants dropped out. Data were collected using the psychological well-being questionnaire and AAQ questionnaire in the three groups at pre-test, post-test and follow-up visits. Data were analyzed using repeated measure analysis of variance. Results: Repeated measure analysis of variance revealed that the mean difference between the three groups was significant (Pacceptance and commitment therapy group showed improvement relative to the NA and control groups on psychological well-being and psychological flexibility. Conclusion: The results of this study revealed that acceptance and commitment therapy can be helpful in enhancing positive emotions and increasing psychological well-being of addicts who seek treatment.

  18. Contributions of the European trials (European randomized screening group) in computed tomography lung cancer screening

    NARCIS (Netherlands)

    Heuvelmans, Marjolein A; Vliegenthart, Rozemarijn; Oudkerk, Matthijs

    Lung cancer is the leading cause of cancer-related death worldwide. In 2011, the largest lung cancer screening trial worldwide, the US National Lung Screening Trial, published a 20% decrease in lung cancer-specific mortality in the computed tomography (CT)-screened group, compared with the group

  19. Group-Based Randomized Trial of Contingencies for Health and Abstinence in HIV Patients

    Science.gov (United States)

    Petry, Nancy M.; Weinstock, Jeremiah; Alessi, Sheila M.; Lewis, Marilyn W.; Dieckhaus, Kevin

    2010-01-01

    Objective: Contingency management (CM) treatments are usually applied individually for drug abstinence, but CM can also be targeted toward health behaviors and implemented in groups. This study evaluated effects of a group-based CM intervention that focused on reinforcing health behaviors. Method: HIV-positive patients with cocaine or opioid use…

  20. Randomized controlled trial of group cognitive behavioral therapy compared to a discussion group for co-morbid anxiety and depression in older adults.

    Science.gov (United States)

    Wuthrich, V M; Rapee, R M; Kangas, M; Perini, S

    2016-03-01

    Co-morbid anxiety and depression in older adults is associated with worse physical and mental health outcomes and poorer response to psychological and pharmacological treatments in older adults. However, there is a paucity of research focused on testing the efficacy of the co-morbid treatment of anxiety and depression in older adults using psychological interventions. Accordingly, the primary objective of the current study was to test the effects of a group cognitive behavior therapy (CBT) program in treating co-morbid anxiety and depression in a sample of older age adults. A total of 133 community-dwelling participants aged ⩾60 years (mean age = 67.35, s.d. = 5.44, male = 59) with both an anxiety disorder and unipolar mood disorder, as assessed on the Anxiety Disorder Interview Schedule (ADIS), were randomly allocated to an 11-week CBT group or discussion group. Participants with Mini-Mental State Examination scores Depression Scale. Both conditions resulted in significant improvements over time on all diagnostic, symptom and wellbeing measures. Significant group × time interaction effects emerged at post-treatment only for diagnostic severity of the primary disorder, mean severity of all anxiety disorders, mood disorders, and all disorders, and recovery rates on primary disorder. Group CBT produced faster and sustained improvements in anxiety and depression on diagnostic severity and recovery rates compared to an active control in older adults.

  1. Increasing adherence to obstructive sleep apnea treatment with a group social cognitive therapy treatment intervention: a randomized trial.

    Science.gov (United States)

    Bartlett, Delwyn; Wong, Keith; Richards, Dianne; Moy, Emma; Espie, Colin A; Cistulli, Peter A; Grunstein, Ronald

    2013-11-01

    To examine whether a social cognitive therapy (SCT) intervention increases continuous positive airway pressure (CPAP) use compared to equivalent social interaction (SI) time. Individuals with obstructive sleep apnea (OSA) referred for CPAP therapy. Participants received a 30-min group education session regarding OSA and CPAP. Groups of three to four participants were then randomly assigned to an SCT session or social interaction. CPAP usage was assessed at 7 nights, then 1, 3, and 6 months. The two primary outcomes were adherence, usage ≥ 4 h per night at 6 months, and uptake of CPAP. Questionnaires were given pretreatment and posttreatment. Two hundred six individuals were randomized to SI (n = 97) or SCT (n = 109). CPAP uptake was not different between groups (82% in SI, 88% in SCT groups, P = 0.35). There were no differences between groups in adherence: 63-66% at 1 week, and at 6 months 55-47% (P = 0.36). Higher pretreatment apnea-hypopnea index, higher baseline self-efficacy, and use of CPAP (≥ 4 h) at 1 week were independent predictors of CPAP adherence at 6 months. CPAP adherence increased by a factor of 1.8 (odds ratio = 1.8, 95% confidence interval 1.1-3.0) for every one-unit increase in self-efficacy. There was no difference between groups postintervention in self-efficacy scores, sleepiness, mood, or sleep quality. In this randomized trial, a single SCT application did not increase adherence when compared with SI time. Although self-efficacy scores prior to CPAP predicted adherence, self-efficacy was not increased by the interventions. Increasing intensity and understanding of SCT interventions may be needed to improve CPAP adherence. Australian New Zealand Clinical Trials Registry, ACTRN12607000424404.

  2. A Social Media Peer Group for Mothers To Prevent Obesity from Infancy: The Grow2Gether Randomized Trial.

    Science.gov (United States)

    Fiks, Alexander G; Gruver, Rachel S; Bishop-Gilyard, Chanelle T; Shults, Justine; Virudachalam, Senbagam; Suh, Andrew W; Gerdes, Marsha; Kalra, Gurpreet K; DeRusso, Patricia A; Lieberman, Alexandra; Weng, Daniel; Elovitz, Michal A; Berkowitz, Robert I; Power, Thomas J

    2017-10-01

    Few studies have addressed obesity prevention among low-income families whose infants are at increased obesity risk. We tested a Facebook peer-group intervention for low-income mothers to foster behaviors promoting healthy infant growth. In this randomized controlled trial, 87 pregnant women (Medicaid insured, BMI ≥25 kg/m2) were randomized to the Grow2Gether intervention or text message appointment reminders. Grow2Gether participants joined a private Facebook group of 9-13 women from 2 months before delivery until infant age 9 months. A psychologist facilitated groups featuring a curriculum of weekly videos addressing feeding, sleep, parenting, and maternal well-being. Feasibility was assessed using the frequency and content of participation, and acceptability using surveys. Maternal beliefs and behaviors and infant growth were assessed at birth, 2, 4, 6, and 9 months. Differences in infant growth between study arms were explored. We conducted intention-to-treat analyses using quasi-least-squares regression. Eighty-eight percent (75/85) of intervention participants (42% (36/85) food insecure, 88% (75/85) black) reported the group was helpful. Participants posted 30 times/group/week on average. At 9 months, the intervention group had significant improvement in feeding behaviors (Infant Feeding Style Questionnaire) compared to the control group (p = 0.01, effect size = 0.45). Intervention group mothers were significantly less likely to pressure infants to finish food and, at age 6 months, give cereal in the bottle. Differences were not observed for other outcomes, including maternal feeding beliefs or infant weight-for-length. A social media peer-group intervention was engaging and significantly impacted certain feeding behaviors in families with infants at high risk of obesity.

  3. Metacognitive group training for schizophrenia spectrum patients with delusions : a randomized controlled trial

    NARCIS (Netherlands)

    van Oosterhout, B.; Krabbendam, L.; de Boer, K.; Ferwerda, J.; van der Helm, M.; Stant, A. D.; van der Gaag, M.

    2014-01-01

    Background. Metacognitive training (MCT) for patients with psychosis is a psychological group intervention that aims to educate patients about common cognitive biases underlying delusion formation and maintenance, and to highlight their negative consequences in daily functioning. Method. In this

  4. The influence of administering "effective microorganisms" to pullets on chosen haematological and biochemical blood indexes.

    Science.gov (United States)

    Sokół, R; Michalczyk, M; Spodniewska, A; Barski, D

    2009-01-01

    "Effective Microorganisms" (EM)--a mixture of lactic acid bacteria, photosynthetic bacteria, yeasts and fungi are used mainly in agriculture and organic waste treatment. Recently, they have also been added to water and feed for animals, as well as to processing their excrements into compost and to eliminate the stench. The objective of the present study was to assess the influence of a 14-day administration of an EM solution in drinking water to layer hens on chosen haematological and biochemical indexes. The research was carried out on 120 hens divided into two equal groups. The birds in the experimental group were given drinking water with dissolved EM (5% solution), and those in the control group--water without the preparation. On the 64th day of the aviculture, the hens were weighted and their blood was taken from the wing vein for haematological and biochemical examinations. Administering EM with water to hens did not influence significantly their body weight nor chosen haematological and biochemical indexes. A significant increase was found only in the number of platelets, the level of albumins, the content of total cholesterol and the LDH activity, however, a decrease in the ALT activity was observed.

  5. The effects of a group-based cognitive behavioral therapy on people with multiple sclerosis: a randomized controlled trial.

    Science.gov (United States)

    Graziano, Federica; Calandri, Emanuela; Borghi, Martina; Bonino, Silvia

    2014-03-01

    To evaluate the effectiveness of a cognitive behavioral group-based intervention aimed at reducing depression and fostering quality of life and psychological well-being of multiple sclerosis patients through the promotion of identity redefinition, sense of coherence, and self-efficacy. A randomized controlled trial. Non-medical setting, external to the Multiple Sclerosis Clinic Centre. Eighty-two patients: 64% women; mean age 40.5, SD = 9.4; 95% with relapsing-remitting multiple sclerosis; Expanded Disability Status Scale (EDSS) between 1 and 5.5 were included in the study. Patients were randomly assigned to an intervention group (five cognitive behavioral group-based sessions, n = 41) or to a control group (three informative sessions, n = 41). Depression (CES-D), Quality of life (MSQOL revised), Psychological well-being (PANAS), Identity Motives Scale, Sense of Coherence (SOC), and Self Efficacy in Multiple Sclerosis. Quality of life increased in the intervention group compared with the control at 6-months follow-up (mean change 0.72 vs. -1.76, p < 0.05). Well-being in the intervention group increased for males and slightly decreased for females at 6-months follow-up (mean change 6.58 vs. -0.82, p < 0.05). Contrasts revealed an increase in self-efficacy in the intervention group at posttreatment compared with the control (mean change 2.95 vs. -0.11, p < 0.05). Depression tended to lower, while identity and coherence increased in the intervention group compared with the control, though the differences were not significant. Preliminary evidence suggests that intervention promotes patients' quality of life and has an effect on psychological well-being and self-efficacy.

  6. Chosen sources of signal interference in HD-TVI technology

    Science.gov (United States)

    Królikowski, Marcin; Płaza, Mirosław; Szcześniak, Zbigniew

    2017-08-01

    The article presents characteristics of popular systems of CCTV and includes a description of basic groups of devices appearing in these systems. The research part contains analysis of interferences that may appear in HD-TVI technology which is one of the most modern technologies introduced in CCTV systems. There were examined video signal interferences caused by: impact of power supply, influence of the parameters of the transmission path and impact of external devices. There are discussed relevant methods of eliminating the examined irregularities.

  7. Reducing Delusional Conviction through a Cognitive-Based Group Training Game: A Multicentre Randomized Controlled Trial.

    Science.gov (United States)

    Khazaal, Yasser; Chatton, Anne; Dieben, Karen; Huguelet, Philippe; Boucherie, Maria; Monney, Gregoire; Lecardeur, Laurent; Salamin, Virginie; Bretel, Fethi; Azoulay, Silke; Pesenti, Elodie; Krychowski, Raoul; Costa Prata, Andreia; Bartolomei, Javier; Brazo, Perrine; Traian, Alexei; Charpeaud, Thomas; Murys, Elodie; Poupart, Florent; Rouvière, Serge; Zullino, Daniele; Parabiaghi, Alberto; Saoud, Mohamed; Favrod, Jérôme

    2015-01-01

    "Michael's game" (MG) is a card game targeting the ability to generate alternative hypotheses to explain a given experience. The main objective was to evaluate the effect of MG on delusional conviction as measured by the primary study outcome: the change in scores on the conviction subscale of the Peters delusions inventory (PDI-21). Other variables of interest were the change in scores on the distress and preoccupation subscales of the PDI-21, the brief psychiatric rating scale, the Beck cognitive insight scale, and belief flexibility assessed with the Maudsley assessment of delusions schedule (MADS). We performed a parallel, assessor-blinded, randomized controlled superiority trial comparing treatment as usual plus participation in MG with treatment as usual plus being on a waiting list (TAU) in a sample of adult outpatients with psychotic disorders and persistent positive psychotic symptoms at inclusion. The 172 participants were randomized, with 86 included in each study arm. Assessments were performed at inclusion (T1: baseline), at 3 months (T2: post-treatment), and at 6 months after the second assessment (T3: follow-up). At T2, a positive treatment effect was observed on the primary outcome, the PDI-21 conviction subscale (p = 0.005). At T3, a sustained effect was observed for the conviction subscale (p = 0.002). Further effects were also observed at T3 on the PDI-21 distress (p = 0.002) and preoccupation subscales (p = 0.001), as well as on one of the MADS measures of belief flexibility ("anything against the belief") (p = 0.001). The study demonstrated some significant beneficial effect of MG.

  8. DIFFERENTIATION OF DISTRICTS OF THE MAŁOPOLSKIE VOIVODESHIP WITH RESPECT TO CHOSEN SOCIAL PROBLEMS

    Directory of Open Access Journals (Sweden)

    Jadwiga Bożek

    2016-06-01

    Full Text Available The phenomenon of unemployment and exacerbating demographic situation can be seen as major social problem of nowadays in Poland. The paper is an attempt to compare districts of the Małopolskie voivodeship with respect to chosen features characterizing these phenomena. On the basis of the data from the Central Statistical Offi ce and with the help of taxonomic methods, grouping of districts has been carried out with respect to the level of features under investigation. The procedure allowed for distinguishing 5 groups of signifi - cant inter-group diff erentiation. The application of taxonomic methods resulted in obtaining a general and, at the same time, accurate picture of diff erentiation of the Małopolskie voivodeship with respect to social problems being analysed and distinction of districts with the most diffi cult situation in this area.

  9. Chosen biotic factors influencing raw cow milk freezing point

    Directory of Open Access Journals (Sweden)

    Oto Hanuš

    2011-01-01

    Full Text Available The milk freezing point depression (FPD is important physical property. FPD is influenced by milk composition especially by components with osmotic pressure activity and by other physiological factors. There is possible to indicate a foreign (extraneous water addition into milk by FPD. This is necessary to have a good estimated legislative FPD discrimination limit (FPD–L for purpose of milk quality control. This paper was aimed at obtaining information to improve such estimation. Impacts factors as season variations, estimated state of dairy cow nutrition and some milk components and properties on milk FPD and their relations to FPD were quantified (n 11 540 – 72 607 bulk raw cow milk samples. The highest FPD was in Spring (−0.52097 ± 0.004877 °C, the lowest in Autumn (−0.52516 ± 0.005725 °C; P < 0.001. Correlation between FPD and lactose was 0.35 (P < 0.001. 12% and 5.4% of FPD variability is explainable by lactose and casein variability. Relationship between FPD and urea (U was 0.26 (P < 0.001 in March. The worst FPD was in group with presupposed (according to milk urea and protein combination nitrogen matter (NM and energy (E insufficiency (−0.51855 ± 0.007288 °C. The best FPD was in group with presupposed NM and E surplus in feeding ration (−0.52536 ± 0.004785 °C; P < 0.001. The FPD was worse in suspicion on E deficiency (on the basis of fat/crude protein ratio as compared to presumption for balanced E nourishment of dairy herds (−0.52105 ± 0.006436 °C > −0.52244 ± 0.005367 °C; P < 0.001. Results can improve the estimation of objective FPD–L.

  10. Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Patricia Bourgault

    Full Text Available This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.A mixed-methods randomized controlled trial (intervention (INT vs. waitlist (WL was conducted with patients suffering from FMS. Data were collected at baseline (T0, at the end of the intervention (T1, and 3 months later (T2. The primary outcome was change in pain intensity (0-10. Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC, and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively than in the WL Group (8%, 12%, 20%. The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%. The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12% and 3 months post-intervention (33% vs 4%. Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.International Standard Randomized Controlled Trial Number

  11. Random Assignment of Schools to Groups in the Drug Resistance Strategies Rural Project: Some New Methodological Twists

    Science.gov (United States)

    Pettigrew, Jonathan; Miller-Day, Michelle; Krieger, Janice L.; Zhou, Jiangxiu; Hecht, Michael L.

    2014-01-01

    Random assignment to groups is the foundation for scientifically rigorous clinical trials. But assignment is challenging in group randomized trials when only a few units (schools) are assigned to each condition. In the DRSR project, we assigned 39 rural Pennsylvania and Ohio schools to three conditions (rural, classic, control). But even with 13 schools per condition, achieving pretest equivalence on important variables is not guaranteed. We collected data on six important school-level variables: rurality, number of grades in the school, enrollment per grade, percent white, percent receiving free/assisted lunch, and test scores. Key to our procedure was the inclusion of school-level drug use data, available for a subset of the schools. Also, key was that we handled the partial data with modern missing data techniques. We chose to create one composite stratifying variable based on the seven school-level variables available. Principal components analysis with the seven variables yielded two factors, which were averaged to form the composite inflate-suppress (CIS) score which was the basis of stratification. The CIS score was broken into three strata within each state; schools were assigned at random to the three program conditions from within each stratum, within each state. Results showed that program group membership was unrelated to the CIS score, the two factors making up the CIS score, and the seven items making up the factors. Program group membership was not significantly related to pretest measures of drug use (alcohol, cigarettes, marijuana, chewing tobacco; smallest p>.15), thus verifying that pretest equivalence was achieved. PMID:23722619

  12. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups.

    Directory of Open Access Journals (Sweden)

    Tazeen H Jafar

    Full Text Available Evidence on long term effectiveness of public health strategies for lowering blood pressure (BP is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA Trial, a 2 x 2 factorial, cluster randomized controlled trial, the combined home health education (HHE and trained general practitioner (GP intervention delivered over 2 years was more effective than no intervention (usual care in lowering systolic BP among adults with hypertension in urban Pakistan. However, it was not clear whether the effect would be sustained after the cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention period of COBRA trial participants to assess the effectiveness of the interventions on BP during extended follow-up.A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or greater, diastolic BP 90 mm Hg or greater, or already receiving treatment were followed by trained research staff masked to randomization status. BP was measured thrice with a calibrated automated device (Omron HEM-737 IntelliSense in the sitting position after 5 minutes of rest. BP measurements were repeated after two weeks. Generalized estimating equations (GEE were used to analyze the primary outcome of change in systolic BP from baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at baseline, sex, baseline systolic and diastolic BP, and presence of diabetes.After 7 years of follow-up, systolic BP levels among those randomised to combined HHE plus trained GP intervention were significantly lower (2.1 [4.1-0.1] mm Hg compared to those randomised to usual care, (P = 0.04. Participants receiving the combined intervention compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6] mg/dl.The benefit in systolic BP reduction observed in the original cohort assigned to the combined intervention was attenuated but still evident at 7- year follow-up. These

  13. A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer

    DEFF Research Database (Denmark)

    Nottelmann, Lise; Groenvold, Mogens; Vejlgaard, Tove Bahn

    2017-01-01

    is the primary outcome measure of the study. Secondary outcome measures include survival and economic consequences. DISCUSSION: To our knowledge the Pal-Rehab study is the first randomized, controlled, phase III trial to evaluate individually tailored, palliative rehabilitation in standard oncology care......BACKGROUND: The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation....... The patients are randomized to a specialized palliative rehabilitation intervention integrated in standard oncology care or to standard oncology care alone. The intervention consists of a multidisciplinary group program, individual consultations, or a combination of both. At baseline and after six and 12 weeks...

  14. Neck collar, "act-as-usual" or active mobilization for whiplash injury? A randomized parallel-group trial

    DEFF Research Database (Denmark)

    Kongsted, Alice; Montvilas, Erisela Qerama; Kasch, Helge

    2007-01-01

    practitioners within 10 days after a whiplash injury and randomized to: 1) immobilization of the cervical spine in a rigid collar followed by active mobilization, 2) advice to "act-as-usual," or 3) an active mobilization program (Mechanical Diagnosis and Therapy). Follow-up was carried out after 3, 6, and 12......-extension trauma to the cervical spine. It is unclear whether this, in some cases disabling, condition can be prevented by early intervention. Active interventions have been recommended but have not been compared with information only. Methods. Participants were recruited from emergency units and general......Study Design. Randomized, parallel-group trial. Objective. To compare the effect of 3 early intervention strategies following whiplash injury. Summary of Background Data. Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after a forced flexion...

  15. Analyzing indirect effects in cluster randomized trials. The effect of estimation method, number of groups and group sizes on accuracy and power.

    Directory of Open Access Journals (Sweden)

    Joop eHox

    2014-02-01

    Full Text Available Cluster randomized trials assess the effect of an intervention that is carried out at the group or cluster level. Ajzen’s theory of planned behaviour is often used to model the effect of the intervention as an indirect effect mediated in turn by attitude, norms and behavioural intention. Structural equation modelling (SEM is the technique of choice to estimate indirect effects and their significance. However, this is a large sample technique, and its application in a cluster randomized trial assumes a relatively large number of clusters. In practice, the number of clusters in these studies tends to be relatively small, e.g. much less than fifty. This study uses simulation methods to find the lowest number of clusters needed when multilevel SEM is used to estimate the indirect effect. Maximum likelihood estimation is compared to Bayesian analysis, with the central quality criteria being accuracy of the point estimate and the confidence interval. We also investigate the power of the test for the indirect effect. We conclude that Bayes estimation works well with much smaller cluster level sample sizes such as 20 cases than maximum likelihood estimation; although the bias is larger the coverage is much better. When only 5 to 10 clusters are available per treatment condition even with Bayesian estimation problems occur.

  16. Outcome of systemic and analytic group psychotherapy for adult women with history of intrafamilial childhood sexual abuse: a randomized controlled study

    DEFF Research Database (Denmark)

    Lau, M; Kristensen, Ellids

    2007-01-01

    Research suggests that group psychotherapy for adults with a history of child sexual abuse (CSA) is generally beneficial. Only few studies have included random assignment. This study compared the effects of analytic (A) and systemic group psychotherapy (S) on CSA.......Research suggests that group psychotherapy for adults with a history of child sexual abuse (CSA) is generally beneficial. Only few studies have included random assignment. This study compared the effects of analytic (A) and systemic group psychotherapy (S) on CSA....

  17. Infrared Spectroscopic Identification of Chosen Dental Materials and Natural Teeth

    Science.gov (United States)

    Hędzelek, W.; Marcinkowska, A.; Domka, L.; Wachowiak, R.

    2008-08-01

    Studies using solid phase infrared spectroscopy in the range of 400 to 4000 wave numbers were conducted in order to quickly identify solid tooth fragments and differentiate them from dental materials used in the dental practice. The frequently employed dental materials were evaluated. Natural chemical structure of permanent teeth obtained from donors of various ages provided the reference material. The infrared vibrations detected in infrared transmission spectra depended on the chemical structure of examined compound. Comparable distinctive peaks in infrared spectra of natural teeth and inorganic dental materials (porcelain) were exhibited. Analogous infrared spectra of dental materials consisting of organic matrix with inorganic fillers were found. In the case of acrylic materials specific organic groups were enhanced. The prepared database of infrared transmission spectra included 23 dental materials, facilitating their appropriate identification. Application of infrared spectroscopy allowed for a quick differential identification of typical dental materials produced from organic compounds for inorganic restorations (porcelain) and of tooth structure-resembling hydroxyapatite and its contaminate forms with fluoride and carbonate ions.

  18. Association of intervention outcomes with practice capacity for change: subgroup analysis from a group randomized trial.

    Science.gov (United States)

    Litaker, David; Ruhe, Mary; Weyer, Sharon; Stange, Kurt C

    2008-05-16

    The relationship between health care practices' capacity for change and the results and sustainability of interventions to improve health care delivery is unclear. In the setting of an intervention to increase preventive service delivery (PSD), we assessed practice capacity for change by rating motivation to change and instrumental ability to change on a one to four scale. After combining these ratings into a single score, random effects models tested its association with change in PSD rates from baseline to immediately after intervention completion and 12 months later. Our measure of practices' capacity for change varied widely at baseline (range 2-8; mean 4.8 +/- 1.6). Practices with greater capacity for change delivered preventive services to eligible patients at higher rates after completion of the intervention (2.7% per unit increase in the combined effort score, p sustain desired outcomes. Future work to refine measures of this practice characteristic may be useful in planning and implementing interventions that result in sustained, evidence-based improvements in health care delivery.

  19. Association of intervention outcomes with practice capacity for change: Subgroup analysis from a group randomized trial

    Directory of Open Access Journals (Sweden)

    Weyer Sharon

    2008-05-01

    Full Text Available Abstract Background The relationship between health care practices' capacity for change and the results and sustainability of interventions to improve health care delivery is unclear. Methods In the setting of an intervention to increase preventive service delivery (PSD, we assessed practice capacity for change by rating motivation to change and instrumental ability to change on a one to four scale. After combining these ratings into a single score, random effects models tested its association with change in PSD rates from baseline to immediately after intervention completion and 12 months later. Results Our measure of practices' capacity for change varied widely at baseline (range 2–8; mean 4.8 ± 1.6. Practices with greater capacity for change delivered preventive services to eligible patients at higher rates after completion of the intervention (2.7% per unit increase in the combined effort score, p Conclusion Greater capacity for change is associated with a higher probability that a practice will attain and sustain desired outcomes. Future work to refine measures of this practice characteristic may be useful in planning and implementing interventions that result in sustained, evidence-based improvements in health care delivery.

  20. Comparing physical exercise in groups to group cognitive behaviour therapy for the treatment of panic disorder in a randomized controlled trial.

    Science.gov (United States)

    Hovland, Anders; Nordhus, Inger Hilde; Sjøbø, Trond; Gjestad, Bente A; Birknes, Birthe; Martinsen, Egil W; Torsheim, Torbjørn; Pallesen, Ståle

    2013-07-01

    Previous studies have suggested that physical exercise can reduce symptoms for subjects suffering from panic disorder (PD). The efficacy of this intervention has so far not been compared to an established psychotherapy, such as cognitive behaviour therapy (CBT). Assessment of controlled long-term effects and the clinical significance of the treatment are also lacking. To compare physical exercise to CBT as treatment for PD, and assess controlled long-term and clinically significant effects. PD-patients were randomized to either three weekly sessions of physical exercise (n = 17), or one weekly session of CBT (n = 19). Both treatments ran for 12 weeks, were manualized and administered in groups. Patients were assessed twice before the start of treatment, at post-treatment and at 6 and 12 months thereafter. Primary outcome-measures consisted of the Mobility Inventory (MI), the Agoraphobia Cognitions Questionnaire (ACQ) and the Body Sensations Questionnaire (BSQ). A two-way repeated measures MANOVA of these measures demonstrated a significant effect of time, F(16, 544) = 7.28, p < .01, as well as a significant interaction effect, F(16, 544) = 1.71, p < .05, in favour of CBT. This finding was supported by the assessment of clinically significant changes of avoidant behaviour and of treatment-seeking one year later. Group CBT is more effective than group physical exercise as treatment of panic disorder, both immediately following treatment and at follow-up assessments.

  1. Subject-chosen activities in occupational therapy for the improvement of psychiatric symptoms of inpatients with chronic schizophrenia: a controlled trial.

    Science.gov (United States)

    Hoshii, Junko; Yotsumoto, Kayano; Tatsumi, Eri; Tanaka, Chito; Mori, Takashi; Hashimoto, Takeshi

    2013-07-01

    To compare the therapeutic effects of subject-chosen and therapist-chosen activities in occupational therapy for inpatients with chronic schizophrenia. Prospective comparative study. A psychiatric hospital in Japan. Fifty-nine patients with chronic schizophrenia who had been hospitalized for many years. The subjects received six-months occupational therapy, participating in either activities of their choice (subject-chosen activity group, n = 30) or activities chosen by occupational therapists based on treatment recommendations and patient consent (therapist-chosen activity group, n = 29). The Positive and Negative Syndrome Scale and the Global Assessment of Functioning (GAF) Scale were used to evaluate psychiatric symptoms and psychosocial function, respectively. After six-months occupational therapy, suspiciousness and hostility scores of the positive scale and preoccupation scores of the general psychopathology scale significantly improved in the subject-chosen activity group compared with the therapist-chosen activity group, with 2(2) (median (interquartile range)) and 3(1.25), 2(1) and 2.5(1), and 2(1) and 3(1), respectively. There were no significant differences in psychosocial functions between the two groups. In within-group comparisons before and after occupational therapy, suspiciousness scores of the positive scale, preoccupation scores of the general psychopathology scale, and psychosocial function significantly improved only in the subject-chosen activity group, with 3(1) to 2(2), 3(1) to 2(1), and 40(9) to 40(16) respectively, but not in the therapist-chosen activity group. The results suggested that the subject-chosen activities in occupational therapy could improve the psychiatric symptoms, suspiciousness, and preoccupation of the inpatients with chronic schizophrenia.

  2. Efficacy of aliskiren and valsartan in hypertensive patients with albuminuria: a randomized parallel-group study.

    Science.gov (United States)

    Spanos, Georgios; Kalaitzidis, Rigas; Karasavvidou, Despina; Pappas, Kosmas; Siamopoulos, Kostas C

    2013-12-01

    Blockade of the renin-angiotensin system (RAS) is a critical approach to the management of hypertension, especially in proteinuric patients. It is well proven that the direct renin inhibitor aliskiren shows comparable clinical efficacy to the angiotensin II receptor blocker valsartan on blood pressure control and albuminuria. However, there is only limited data on the hand-to-hand effectiveness of these two RAS blockers in improving arterial stiffness. We tested whether aliskiren or valsartan would improve arterial stiffness in hypertensive patients with albuminuria who are already on antihypertensive therapy. Thirty-four patients with hypertension and albuminuria Albuminuria was significantly reduced in both groups (56% for the aliskiren group, p < 0.05, and 38% for the valsartan group, p < 0.05). Only valsartan but not aliskiren significantly reduced carotid-femoral pulse wave velocity (-1.1 ± 0.8 m/s (p = 0.02) for valsartan and +0.1 ± 0.7 m/s (ns) for aliskiren). The results of our study showed that valsartan improves arterial stiffness to a significantly greater extent than aliskiren, despite a similar antihypertensive and antiproteinuric effect.

  3. Chosen quality parameters of pork sausage produced without curing mixture.

    Science.gov (United States)

    Kostecki, Adam; Bilska, Agnieszka; Danyluk, Bożena

    2015-01-01

    The aim of this study was to determine the influence of the dried celeriac juice addition, as a nitrogenous compounds sources, on the quality of the experimental pork sausage. In the sausages with vegetable preparation addition and in traditionally cured sausages amount of the sodium nitrate (III) and sodium nitrate (V) was determined (in the batter and 24 h after production). Moreover the total number of aerobic bacteria, number of coli forms, anaerobic survived bacteria, coagulase positive staphylococci, Listeria monocytogenes and occurrence of Salmonella in 25 g (according to Polish Standards) was determined during sausages storing (after 2, 14 and 21 days). Also sensory evaluation was carried out (after 2 and 14 days). After 2, 7, 14 and 21 days the amount of drip loss in the package was determined. Result. In the experimental sausage produced with the addition of vegetable preparation (E0), the content was 2.2 times higher of sodium nitrate (V) while sodium nitrate (III) three times lower, compared to traditionally cured sausages (K). In the E0 sausages faster aerobic microorganisms proliferation was observed. However, in these products, in comparison to the control group (K), no higher contamination with coliform bacteria, anaerobic sporulating bacteria, coagulase positive Staphylococci, Listeria monocytogenes or Salmonella was found. The sensory evaluation (colour in cross-section, flavour, taste, consistency) showed no statistically significant difference between the experimental sausages. Conclusions. In the sausages produced with dried celeriac juice addition there was above twice more sodium nitrate (V) and threefold less sodium nitrate (III) in comparison to traditionally cured sausages and faster growth of aerobic bacteria was demonstrated. Sensory quality of 'cold' and 'hot' sausages without curing salt was worse, but the score num. nd. The aim of this study was to determine the influence of the dried celeriac juice addition, as a nitrogenous

  4. The efficacy of lymphatic drainage and traditional massage in the prophylaxis of migraine: a randomized, controlled parallel group study.

    Science.gov (United States)

    Happe, Svenja; Peikert, Andreas; Siegert, Rudolf; Evers, Stefan

    2016-10-01

    This study aimed at examining the efficacy of lymphatic drainage (LD) and traditional massage (TM) in the prophylactic treatment of migraine using controlled prospective randomized clinical trial of 64 patients (57 women, 45 ± 10 years) with migraine with and without aura. Patients were randomized into three groups: LD (n = 21); TM (n = 21); waiting group (WG, n = 22). After a 4-week-baseline, a treatment period of 8 weeks was applied followed by a 4-week observation period. The patients filled in a headache diary continuously; every 4 weeks they filled in the German version of the CES-D and the German version of the Headache Disability Inventory. The main outcome measure was migraine frequency per month. At the end of the observation period, the number of migraine attacks and days decreased in the LD group by 1.8 and 3.1, respectively, in the TM group by 1.3 and 2.4, and in the WG by 0.4 and 0.2, respectively. The differences between LD and WG were significant (p = 0.006 and p = 0.015, respectively) as well as the differences between TM und WG (p = 0.042 and p = 0.016, respectively). There was a significant decrease in the amount of analgesic intake in the LD group compared to the two other groups (p = 0.004). TM and LD resulted in a reduction of migraine attack frequency. The analgesic intake only decreased significantly during LD intervention. Useful effects were identified for LD and TM as compared to WG for the prophylaxis of migraine. LD was more efficacious in some parameters than TM.

  5. Treatment of posttraumatic stress disorder in postwar Kosovar adolescents using mind-body skills groups: a randomized controlled trial.

    Science.gov (United States)

    Gordon, James S; Staples, Julie K; Blyta, Afrim; Bytyqi, Murat; Wilson, Amy T

    2008-09-01

    To determine whether participation in a mind-body skills group program based on psychological self-care, mind-body techniques, and self-expression decreases symptoms of posttraumatic stress disorder (PTSD). Eighty-two adolescents meeting criteria for PTSD according to the Harvard Trauma Questionnaire (which corresponds with 16 of the 17 diagnostic criteria for PTSD in DSM-IV) were randomly assigned to a 12-session mind-body group program or a wait-list control group. The program was conducted by high school teachers in consultation with psychiatrists and psychologists and included meditation, guided imagery, and breathing techniques; self-expression through words, drawings, and movement; autogenic training and biofeedback; and genograms. Changes in PTSD symptoms were measured using the Harvard Trauma Questionnaire. The study was conducted from September 2004 to May 2005 by The Center for Mind-Body Medicine at a high school in the Suhareka region of Kosovo. Students in the immediate intervention group had significantly lower PTSD symptom scores following the intervention than those in the wait-list control group (F = 29.8, df = 1,76; p < .001). Preintervention and postintervention scores (mean [SD]) for the intervention group were 2.5 (0.3) and 2.0 (0.3), respectively, and for the control group, 2.5 (0.3) and 2.4 (0.4), respectively. The decreased PTSD symptom scores were maintained in the initial intervention group at 3-month follow-up. After the wait-list control group received the intervention, there was a significant decrease (p < .001) in PTSD symptom scores compared to the preintervention scores. Mind-body skills groups can reduce PTSD symptoms in war-traumatized high school students and can be effectively led by trained and supervised schoolteachers. Copyright 2008 Physicians Postgraduate Press, Inc.

  6. Group cognitive behavioral therapy targeting intolerance of uncertainty: a randomized trial for older Chinese adults with generalized anxiety disorder.

    Science.gov (United States)

    Hui, Chen; Zhihui, Yang

    2017-12-01

    China has entered the aging society, but the social support systems for the elderly are underdeveloped, which may make the elderly feel anxiety about their health and life quality. Given the prevalence of generalized anxiety disorder (GAD) in the elderly, it is very important to pay more attention to the treatment for old adults. Although cognitive behavioral therapy targeting intolerance of uncertainty (CBT-IU) has been applied to different groups of patients with GAD, few studies have been performed to date. In addition, the effects of CBT-IU are not well understood, especially when applied to older adults with GAD. Sixty-three Chinese older adults with a principal diagnosis of GAD were enrolled. Of these, 32 were randomized to receive group CBT-IU (intervention group) and 31 were untreated (control group). GAD and related symptoms were assessed using the Penn State Worry Questionnaire, Intolerance of Uncertainty Scale-Chinese Version, Beck Anxiety Inventory, Beck Depression Inventory, Why Worry-II scale, Cognitive Avoidance Questionnaire, Generalized Anxiety Disorder Questionnaire-IV, and Generalized Anxiety Disorder Severity Scale across the intervention. The changes between pre and after the intervention were collected, as well as the six-month follow-up. F test and repeated-measures ANOVA were conducted to analyze the data. Compared to control group, the measures' scores of experimental group decreased significantly after the intervention and six-month follow-up. Besides the main effects for time and group were significant, the interaction effect for group × time was also significant. These results indicated the improvement of the CBT-IU group and the persistence of effect after six months. Group CBT-IU is effective in Chinese older adults with GAD. The effects of CBT-IU on GAD symptoms persist for at least six months after treatment.

  7. Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

    Science.gov (United States)

    Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

    2017-06-01

    The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

  8. Effectiveness of a group-based self-management program for people with chronic fatigue syndrome: a randomized controlled trial.

    Science.gov (United States)

    Pinxsterhuis, Irma; Sandvik, Leiv; Strand, Elin Bolle; Bautz-Holter, Erik; Sveen, Unni

    2017-01-01

    To evaluate the effectiveness of a group-based self-management program for people with chronic fatigue syndrome. A randomized controlled trial. Four mid-sized towns in southern Norway and two suburbs of Oslo. A total of 137 adults with chronic fatigue syndrome. A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care. Primary outcome measure: Medical Outcomes Study-Short Form-36 physical functioning subscale. Fatigue severity scale, self-efficacy scale, physical and mental component summary of the Short Form-36, and the illness cognition questionnaire (acceptance subscale). Assessments were performed at baseline, and at six-month and one-year follow-ups. At the six-month follow-up, a significant difference between the two groups was found concerning fatigue severity ( p = 0.039) in favor of the control group, and concerning self-efficacy in favor of the intervention group ( p = 0.039). These significant differences were not sustained at the one-year follow-up. No significant differences were found between the groups concerning physical functioning, acceptance, and health status at any of the measure points. The drop-out rate was 13.9% and the median number of sessions attended was seven (out of eight). The evaluated self-management program did not have any sustained effect, as compared with receiving usual care.

  9. Exercise intervention in childhood obesity: a randomized controlled trial comparing hospital-versus home-based groups.

    Science.gov (United States)

    Lisón, Juan Francisco; Real-Montes, José María; Torró, Isabel; Arguisuelas, María Dolores; Alvarez-Pitti, Julio; Martínez-Gramage, J; Aguilar, Francisco; Lurbe, Empar

    2012-01-01

    The aim of this study was to compare the effect of a hospital clinic group- versus home-based combined exercise-diet program for the treatment of childhood obesity. One hundred ten overweight/obese Spanish children and adolescents (6-16 years) in 2 intervention groups (hospital clinic group-based [n = 45] and home-based [n = 41]) and a sex-age-matched control group (n = 24) were randomly assigned to participate in a 6-month combined exercise (aerobic and resistance training) and Mediterranean diet program. Anthropometric values (including body weight, height, body mass index, BMI-Z score, and waist circumference) were measured pre- and postintervention for all the participants. Percentage body fat was also determined with a body fat analyzer (TANITA TBF-410 M). Our study showed a significant reduction in percentage body fat and body mass index Z-score among both intervention-group participants (4%, 0.16, hospital clinic group-based; 4.4%, 0.23, home-based; P exercise and Mediterranean diet program may be effective among overweight and obese children and adolescents, because it improves body composition, is feasible and can be adopted on a large scale without substantial expenses. Crown Copyright © 2012. Published by Elsevier Inc. All rights reserved.

  10. Adjuvant chemotherapy with sequential or concurrent anthracycline and docetaxel: Breast International Group 02-98 randomized trial

    DEFF Research Database (Denmark)

    Francis, P.; Crown, J.; Di, Leo A.

    2008-01-01

    BACKGROUND: Docetaxel is more effective than doxorubicin for patients with advanced breast cancer. The Breast International Group 02-98 randomized trial tested the effect of incorporating docetaxel into anthracycline-based adjuvant chemotherapy and compared sequential vs concurrent administration...... of doxorubicin at 50 mg/m2 plus docetaxel at 75 mg/m2, followed by three cycles of CMF). The primary comparison evaluated the efficacy of including docetaxel regardless of schedule and was planned after 1215 disease-free survival (DFS) events (ie, relapse, second primary cancer, or death from any cause...

  11. Habitual cocoa intake reduces arterial stiffness in postmenopausal women regardless of intake frequency: a randomized parallel-group study

    Directory of Open Access Journals (Sweden)

    Okamoto T

    2016-11-01

    Full Text Available Takanobu Okamoto,1 Ryota Kobayashi,1 Midori Natsume,2 Koichi Nakazato1 1Department of Exercise Physiology, Nippon Sport Science University, Tokyo, Japan; 2Food Sciences Research Laboratories, Meiji Co Ltd, Kanagawa, Japan Abstract: Arterial stiffness is substantially higher in postmenopausal than in premenopausal women. Daily cocoa intake has been shown to reduce central arterial stiffness in health adults, regardless of age; however, the effect of cocoa-intake frequency on arterial stiffness in postmenopausal women remains unclear. Therefore, the purpose of this study was to investigate the effects of cocoa-intake frequency on arterial stiffness in postmenopausal women. A total of 26 postmenopausal women (mean age ± standard deviation 64±12 years were randomly assigned to two groups with different cocoa-intake frequencies: one group ingested 17 g of cocoa once daily except on Sundays (every-day group, n=13, and the other ingested 17 g of cocoa twice daily every other day (every-other-day group, n=13. These intake regimens were maintained in both groups for 12 weeks. Carotid–femoral pulse-wave velocity and femoral–ankle pulse-wave velocity were measured in both groups at baseline and again at the end of the 12-week study period. Compared to baseline, both pulse-wave velocities had significantly decreased after the 12-week study period in both groups (P<0.05. However, no significant difference in degree of change was observed between the two groups. Although this study did not include a sedentary control group, these results suggest that regardless of frequency, habitual cocoa intake reduces central and peripheral arterial stiffness in postmenopausal women. Keywords: flavanol-enriched cocoa, pulse-wave velocity, intake frequency, endothelin 1

  12. A randomized controlled trial of a manual-based psychosocial group intervention for young people with epilepsy [PIE].

    Science.gov (United States)

    Dorris, Liam; Broome, Helen; Wilson, Margaret; Grant, Cathy; Young, David; Baker, Gus; Balloo, Selina; Bruce, Susan; Campbell, Jo; Concannon, Bernie; Conway, Nadia; Cook, Lisa; Davis, Cheryl; Downey, Bruce; Evans, Jon; Flower, Diane; Garlovsky, Jack; Kearney, Shauna; Lewis, Susan; Stephens, Victoria; Turton, Stuart; Wright, Ingram

    2017-07-01

    We conducted an exploratory RCT to examine feasibility and preliminary efficacy for a manual-based psychosocial group intervention aimed at improving epilepsy knowledge, self-management skills, and quality of life in young people with epilepsy. Eighty-three participants (33:50m/f; age range 12-17years) were randomized to either the treatment or control group in seven tertiary paediatric neuroscience centres in the UK, using a wait-list control design. Participants were excluded if they reported suicidal ideation and/or scored above the cut off on mental health screening measures, or if they had a learning disability or other neurological disorder. The intervention consisted of six weekly 2-hour sessions using guided discussion, group exercises and role-plays facilitated by an epilepsy nurse and a clinical psychologist. At three month follow up the treatment group (n=40) was compared with a wait-list control group (n=43) on a range of standardized measures. There was a significant increase in epilepsy knowledge in the treatment group (p=0.02). Participants receiving the intervention were also significantly more confident in speaking to others about their epilepsy (p=0.04). Quality of life measures did not show significant change. Participants reported the greatest value of attending the group was: Learning about their epilepsy (46%); Learning to cope with difficult feelings (29%); and Meeting others with epilepsy (22%). Caregiver and facilitator feedback was positive, and 92% of participants would recommend the group to others. This brief psychosocial group intervention was effective in increasing participants' knowledge of epilepsy and improved confidence in discussing their epilepsy with others. We discuss the qualitative feedback, feasibility, strengths and limitations of the PIE trial. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Schuengel Carlo

    2011-07-01

    Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed

  14. Group parent-child interaction therapy: A randomized control trial for the treatment of conduct problems in young children.

    Science.gov (United States)

    Niec, Larissa N; Barnett, Miya L; Prewett, Matthew S; Shanley Chatham, Jenelle R

    2016-08-01

    Although efficacious interventions exist for childhood conduct problems, a majority of families in need of services do not receive them. To address problems of treatment access and adherence, innovative adaptations of current interventions are needed. This randomized control trial investigated the relative efficacy of a novel format of parent-child interaction therapy (PCIT), a treatment for young children with conduct problems. Eighty-one families with 3- to 6-year-old children (71.6% boys, 85.2% White) with diagnoses of oppositional defiant or conduct disorder were randomized to individual PCIT (n = 42) or the novel format, Group PCIT. Parents completed standardized measures of children's conduct problems, parenting stress, and social support at intake, posttreatment, and 6-month follow-up. Therapist ratings, parent attendance, and homework completion provided measures of treatment adherence. Throughout treatment, parenting skills were assessed using the Dyadic Parent-Child Interaction Coding System. Parents in both group and individual PCIT reported significant improvements from intake to posttreatment and follow-up in their children's conduct problems and adaptive functioning, as well as significant decreases in parenting stress. Parents in both treatment conditions also showed significant improvements in their parenting skills. There were no interactions between time and treatment format. Contrary to expectation, parents in Group PCIT did not experience greater social support or treatment adherence. Group PCIT was not inferior to individual PCIT and may be a valuable format to reach more families in need of services. Future work should explore the efficiency and sustainability of Group PCIT in community settings. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  15. Effectiveness of a psycho-educational group program for major depression in primary care: a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Studies show the effectiveness of group psychoeducation in reducing symptoms in people with depression. However, few controlled studies that have included aspects of personal care and healthy lifestyle (diet, physical exercise, sleep) together with cognitive-behavioral techniques in psychoeducation are proven to be effective. The objective of this study is to assess the effectiveness of a psychoeducational program, which includes aspects of personal care and healthy lifestyle, in patients with mild/moderate depression symptoms in Primary Care (PC). Methods In a randomized, controlled trial, 246 participants over 20 years old with ICD-10 major depression were recruited through nurses/general practitioners at 12 urban Primary Care Centers (PCCs) in Barcelona. The intervention group (IG) (n=119) received a group psychoeducational program (12 weekly, 1.5 h sessions led by two nurses) and the control group (CG) (n=112) received usual care. Patients were assessed at baseline and at, 3, 6 and 9 months. The main outcome measures were the BDI, EQ-5D and remission based upon the BDI. Results 231 randomized patients were included, of whom 85 had mild depression and 146 moderate depression. The analyses showed significant differences between groups in relation to remission of symptoms, especially in the mild depression group with a high rate of 57% (p=0.009) at post-treatment and 65% (p=0.006) at 9 month follow up, and only showed significant differences on the BDI at post-treatment (p=0.016; effect size Cohen’s d’=.51) and at 6 and 9 month follow-up (p= 0.048; d’=.44). In the overall and moderate sample, the analyses only showed significant differences between groups on the BDI at post-treatment, p=0.02 (d’=.29) and p=0.010 (d’=.47), respectively. The psychoeducation group improved significantly on the EQ-5D at short and long-term. Conclusions This psychoeducational intervention is a short and long-term effective treatment for patients with mild

  16. DVD training for depression identification and treatment in older adults: a two-group, randomized, wait-list control study.

    Science.gov (United States)

    Lysack, Cathy; Leach, Carrie; Russo, Theresa; Paulson, Daniel; Lichtenberg, Peter A

    2013-01-01

    OBJECTIVE. To test the effectiveness of an educational intervention aimed at improving mental health knowledge and skills in occupational therapists working with older rehabilitation patients. METHOD. The DVD-format educational intervention was evaluated using a two-group randomized wait-list control design. Occupational therapists (n = 75) completed a 32-item knowledge questionnaire at three time points. Patient charts were reviewed (n = 960) at 3 months before and 3 and 6 months after DVD training to evaluate clinical practice change. RESULTS. A two-way analysis of variance showed knowledge scores increased significantly for both groups after DVD training. A significant Group × Time interaction and significant main effects for time and group were found. Chart review data also showed significant increases in desired clinical behaviors in both groups after training. The greatest single item of clinical practice change was use of a standardized depression screen. CONCLUSION. DVD-based training can significantly improve mental health practice. Copyright © 2013 by the American Occupational Therapy Association, Inc.

  17. What Makes Group MET Work? A Randomized Controlled Trial of College Student Drinkers in Mandated Alcohol Diversion

    Science.gov (United States)

    LaChance, Heather; Feldstein Ewing, Sarah W.; Bryan, Angela D.; Hutchison, Kent E.

    2009-01-01

    Nationally, college drinkers exhibit the highest rates of alcohol consumption and represent the largest percentage of problem drinkers. Group motivational enhancement therapy (GMET) has been found to catalyze problem drinking reductions among college student samples. While research supporting the use of single-session GMET in college samples (general and mandated) is emergent, no studies have evaluated a comprehensive model of the potential active ingredients of this group intervention. College students (N = 206; 88% Caucasian; 63% male; M age = 18.6) mandated to a university alcohol diversion program were randomly assigned to one of three conditions: the standard-of-care two-session ‘Focus on Alcohol Concerns’ education group (FAC), a single group motivational enhancement therapy (GMET), or a single Alcohol Information-only control group (AI) to evaluate the role of five putative mediators: readiness to change, self-efficacy, perceived risk, norm estimates, and positive drinking expectancies. At three and six month follow-ups, GMET students demonstrated greater reductions in problem drinking outcomes (drinks per drinking day, hazardous drinking symptoms, and alcohol-related problems). Of the five mediators proposed, only self-efficacy emerged as a significant mediator. PMID:20025366

  18. The effectiveness of group positive psychotherapy on depression and happiness in breast cancer patients: A randomized controlled trial

    Science.gov (United States)

    Dowlatabadi, Mohammad Mehdi; Ahmadi, Seyed Mojtaba; Sorbi, Mohammad Hossein; Beiki, Omid; Razavi, Tayebeh Khademeh; Bidaki, Reza

    2016-01-01

    Background Breast cancer is one of the most prevalent cancers in women in the world. It causes fear, despair, and takes a tremendous toll on psychological status. Objective To determine the effectiveness of group positive psychotherapy on the depression and happiness of breast cancer patients. Methods This randomized controlled trial was conducted with 42 breast cancer patients in The Oncology Center at Kermanshah, Iran in 2015. The Data were gathered before intervention and ten weeks afterwards. The data were collected using Beck’s Depression Inventory (BDI-II) and Oxford’s happiness Inventory (OHI). The data were analyzed by SPSS-16, Kolmogorov-Smirnov (K-S), chi-squared, and multivariate analysis of covariance (MANCOVA). Results The results showed a significant reduction in the depression of the group on positive psychotherapy compared with the control group. Also the positive psychotherapy group experienced a significant increase in the patients’ happiness, while there was no significant increase in the control group. Conclusion The results of this research showed the effectiveness of positive psychotherapy on the reduction of mental pressure and the improvement of the mental status of breast cancer patients. This economical therapy can be used to increase patients’ psychological health. Clinical Trial Registration The trial was registered at the Iranian Registry of Clinical Trials (IRST) with the identification number IRCT2013101410063N4. Funding The authors received financial support for the research from Kermanshah University of Medical Sciences. PMID:27123227

  19. Mindfulness-and body-psychotherapy-based group treatment of chronic tinnitus: a randomized controlled pilot study.

    Science.gov (United States)

    Kreuzer, Peter M; Goetz, Monika; Holl, Maria; Schecklmann, Martin; Landgrebe, Michael; Staudinger, Susanne; Langguth, Berthold

    2012-11-28

    Tinnitus, the perception of sound in absence of an external acoustic source, impairs the quality of life in 2% of the population. Since in most cases causal treatment is not possible, the majority of therapeutic attempts aim at developing and strengthening individual coping and habituation strategies. Therapeutic interventions that incorporate training in mindfulness meditation have become increasingly popular in the treatment of stress-related disorders. Here we conducted a randomized, controlled clinical study to investigate the efficacy of a specific mindfulness- and body-psychotherapy based program in patients suffering from chronic tinnitus. Thirty-six patients were enrolled in this pilot study. The treatment was specifically developed for tinnitus patients and is based on mindfulness and body psychotherapy. Treatment was performed as group therapy at two training weekends that were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22). Patients were randomized to receive treatment either immediately or after waiting time, which served as a control condition. The primary study outcome was the change in tinnitus complaints as measured by the German Version of the Tinnitus Questionnaire (TQ). ANOVA testing for the primary outcome showed a significant interaction effect time by group (F = 7.4; df = 1,33; p = 0.010). Post hoc t-tests indicated an amelioration of TQ scores from baseline to week 9 in both groups (intervention group: t = 6.2; df = 17; p < 0.001; control group: t = 2.5; df = 16; p = 0.023), but the intervention group improved more than the control group. Groups differed at week 7 and 9, but not at week 24 as far as the TQ score was concerned. Our results suggest that this mindfulness- and body-psychotherapy-based approach is feasible in the treatment of tinnitus and merits further evaluation in clinical studies with larger sample sizes.The study is

  20. A Comprehensive Lifestyle Peer Group-Based Intervention on Cardiovascular Risk Factors: The Randomized Controlled Fifty-Fifty Program.

    Science.gov (United States)

    Gómez-Pardo, Emilia; Fernández-Alvira, Juan Miguel; Vilanova, Marta; Haro, Domingo; Martínez, Ramona; Carvajal, Isabel; Carral, Vanesa; Rodríguez, Carla; de Miguel, Mercedes; Bodega, Patricia; Santos-Beneit, Gloria; Peñalvo, Jose Luis; Marina, Iñaki; Pérez-Farinós, Napoleón; Dal Re, Marian; Villar, Carmen; Robledo, Teresa; Vedanthan, Rajesh; Bansilal, Sameer; Fuster, Valentin

    2016-02-09

    Cardiovascular diseases stem from modifiable risk factors. Peer support is a proven strategy for many chronic illnesses. Randomized trials assessing the efficacy of this strategy for global cardiovascular risk factor modification are lacking. This study assessed the hypothesis that a peer group strategy would help improve healthy behaviors in individuals with cardiovascular risk factors. A total of 543 adults 25 to 50 years of age with at least 1 risk factor were recruited; risk factors included hypertension (20%), overweight (82%), smoking (31%), and physical inactivity (81%). Subjects were randomized 1:1 to a peer group-based intervention group (IG) or a self-management control group (CG) for 12 months. Peer-elected leaders moderated monthly meetings involving role-play, brainstorming, and activities to address emotions, diet, and exercise. The primary outcome was mean change in a composite score related to blood pressure, exercise, weight, alimentation, and tobacco (Fuster-BEWAT score, 0 to 15). Multilevel models with municipality as a cluster variable were applied to assess differences between groups. Participants' mean age was 42 ± 6 years, 71% were female, and they had a mean baseline Fuster-BEWAT score of 8.42 ± 2.35. After 1 year, the mean scores were significantly higher in the IG (n = 277) than in the CG (n = 266) (IG mean score: 8.84; 95% confidence interval (CI): 8.37 to 9.32; CG mean score: 8.17; 95% CI: 7.55 to 8.79; p = 0.02). The increase in the overall score was significantly larger in the IG compared with the CG (difference: 0.75; 95% CI: 0.32 to 1.18; p = 0.02). The mean improvement in the individual components was uniformly greater in the IG, with a significant difference for the tobacco component. The peer group intervention had beneficial effects on cardiovascular risk factors, with significant improvements in the overall score and specifically on tobacco cessation. A follow-up assessment will be performed 1 year after the final assessment

  1. Discrimination of the Bacillus cereus group members by pattern analysis of random amplified polymorphic DNA-PCR.

    Science.gov (United States)

    Kuwana, Ritsuko; Imamura, Daisuke; Takamatsu, Hiromu; Watabe, Kazuhito

    2012-06-01

    We tried to discriminate 16 strains of the Bacillus cereus group including B. cereus, B. thuringiensis, B. mycoides, B. pseudomycoides, and B. weihenstephanensis strains by the pattern analysis of Random Amplified Polymorphic DNA (RAPD) -PCR. Eight oligonucleotides primers were prepared and the polymorphic patterns of the DNA of each strain were compared with those of others. The primers E and F gave different patterns of RAPD-PCR products in all strains of the B. cereus group, so these primers are effective tools for the discrimination of closely related strains. All eight primers showed different polymorphic patterns of DNA for the four strains of B. cereus isolated from the kitchen of a private home, which verifies the advantage of the RAPD-PCR analysis for the discrimination of isolated strains of B. cereus from the environment.

  2. A group-delivered self-management program reduces spasticity in people with multiple sclerosis: A randomized, controlled pilot trial.

    Science.gov (United States)

    Hugos, Cinda L; Bourdette, Dennis; Chen, Yiyi; Chen, Zunqiu; Cameron, Michelle

    2017-01-01

    Spasticity affects more than 80% of people with multiple sclerosis (MS), affecting activity, participation, and quality of life. Based on an international guideline, an MS spasticity group education and stretching program, MS Spasticity: Take Control (STC), has been developed. The objective of this paper is to determine whether STC with home stretching is associated with greater changes in spasticity than usual care (UC), consisting of an illustrated stretching booklet and home stretching but without group instruction or support, in people with MS. Ambulatory MS patients with self-reported spasticity interfering with daily activities were randomized to STC or UC. Individuals completed questionnaires regarding MS, spasticity, walking, fatigue and mood, and physical measures of spasticity and walking. Thirty-eight of 40 participants completed both assessments. Mean total score and scores on two subscales of the MS Spasticity Scale-88 improved more with STC than with UC (p spasticity more than UC and provided encouraging improvements in other measures.

  3. Effect of Facilitation of Local Maternal-and-Newborn Stakeholder Groups on Neonatal Mortality: Cluster-Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Lars Åke Persson

    Full Text Available BACKGROUND: Facilitation of local women's groups may reportedly reduce neonatal mortality. It is not known whether facilitation of groups composed of local health care staff and politicians can improve perinatal outcomes. We hypothesised that facilitation of local stakeholder groups would reduce neonatal mortality (primary outcome and improve maternal, delivery, and newborn care indicators (secondary outcomes in Quang Ninh province, Vietnam. METHODS AND FINDINGS: In a cluster-randomized design 44 communes were allocated to intervention and 46 to control. Laywomen facilitated monthly meetings during 3 years in groups composed of health care staff and key persons in the communes. A problem-solving approach was employed. Births and neonatal deaths were monitored, and interviews were performed in households of neonatal deaths and of randomly selected surviving infants. A latent period before effect is expected in this type of intervention, but this timeframe was not pre-specified. Neonatal mortality rate (NMR from July 2008 to June 2011 was 16.5/1,000 (195 deaths per 11,818 live births in the intervention communes and 18.4/1,000 (194 per 10,559 live births in control communes (adjusted odds ratio [OR] 0.96 [95% CI 0.73-1.25]. There was a significant downward time trend of NMR in intervention communes (p = 0.003 but not in control communes (p = 0.184. No significant difference in NMR was observed during the first two years (July 2008 to June 2010 while the third year (July 2010 to June 2011 had significantly lower NMR in intervention arm: adjusted OR 0.51 (95% CI 0.30-0.89. Women in intervention communes more frequently attended antenatal care (adjusted OR 2.27 [95% CI 1.07-4.8]. CONCLUSIONS: A randomized facilitation intervention with local stakeholder groups composed of primary care staff and local politicians working for three years with a perinatal problem-solving approach resulted in increased attendance to antenatal care and reduced

  4. Mindfulness-and body-psychotherapy-based group treatment of chronic tinnitus: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Kreuzer Peter M

    2012-11-01

    Full Text Available Abstract Background Tinnitus, the perception of sound in absence of an external acoustic source, impairs the quality of life in 2% of the population. Since in most cases causal treatment is not possible, the majority of therapeutic attempts aim at developing and strengthening individual coping and habituation strategies. Therapeutic interventions that incorporate training in mindfulness meditation have become increasingly popular in the treatment of stress-related disorders. Here we conducted a randomized, controlled clinical study to investigate the efficacy of a specific mindfulness- and body-psychotherapy based program in patients suffering from chronic tinnitus. Methods Thirty-six patients were enrolled in this pilot study. The treatment was specifically developed for tinnitus patients and is based on mindfulness and body psychotherapy. Treatment was performed as group therapy at two training weekends that were separated by an interval of 7 weeks (eleven hours/weekend and in four further two-hour sessions (week 2, 9, 18 and 22. Patients were randomized to receive treatment either immediately or after waiting time, which served as a control condition. The primary study outcome was the change in tinnitus complaints as measured by the German Version of the Tinnitus Questionnaire (TQ. Results ANOVA testing for the primary outcome showed a significant interaction effect time by group (F = 7.4; df = 1,33; p = 0.010. Post hoc t-tests indicated an amelioration of TQ scores from baseline to week 9 in both groups (intervention group: t = 6.2; df = 17; p  Conclusions Our results suggest that this mindfulness- and body-psychotherapy-based approach is feasible in the treatment of tinnitus and merits further evaluation in clinical studies with larger sample sizes. The study is registered with clinicaltrials.gov (NCT01540357.

  5. Future oriented group training for suicidal patients: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Kerkhof Ad

    2009-10-01

    Full Text Available Abstract Background In routine psychiatric treatment most clinicians inquire about indicators of suicide risk, but once the risk is assessed not many clinicians systematically focus on suicidal thoughts. This may reflect a commonly held opinion that once the depressive or anxious symptoms are effectively treated the suicidal symptoms will wane. Consequently, many clients with suicidal thoughts do not receive systematic treatment of their suicidal thinking. There are many indications that specific attention to suicidal thinking is necessary to effectively decrease the intensity and recurrence of suicidal thinking. We therefore developed a group training for patients with suicidal thoughts that is easy to apply in clinical settings as an addition to regular treatment and that explicitly focuses on suicidal thinking. We hypothesize that such an additional training will decrease the frequency and intensity of suicidal thinking. We based the training on cognitive behavioural approaches of hopelessness, worrying, and future perspectives, given the theories of Beck, McLeod and others, concerning the lack of positive expectations characteristic for many suicidal patients. In collaboration with each participant in the training individual positive future possibilities and goals were challenged. Methods/Design We evaluate the effects of our program on suicide ideation (primary outcome measure. The study is conducted in a regular treatment setting with regular inpatients and outpatients representative for Dutch psychiatric treatment settings. The design is a RCT with two arms: TAU (Treatment as Usual versus TAU plus the training. Follow up measurements are taken 12 months after the first assessment. Discussion There is a need for research on the effectiveness of interventions in suicidology, especially RCT's. In our treatment program we combine aspects and interventions that have been proven to be useful in the treatment of suicidal thinking and behavior

  6. Group schema therapy versus group cognitive behavioral therapy for social anxiety disorder with comorbid avoidant personality disorder: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Baljé, Astrid; Greeven, Anja; van Giezen, Anne; Korrelboom, Kees; Arntz, Arnoud; Spinhoven, Philip

    2016-10-08

    Social anxiety disorder (SAD) with comorbid avoidant personality disorder (APD) has a high prevalence and is associated with serious psychosocial problems and high societal costs. When patients suffer from both SAD and APD, the Dutch multidisciplinary guidelines for personality disorders advise offering prolonged cognitive behavioral therapy (CBT). Recently there is increasing evidence for the effectiveness of schema therapy (ST) for personality disorders such as borderline personality disorder and cluster C personality disorders. Since ST addresses underlying personality characteristics and maladaptive coping strategies developed in childhood, this treatment might be particularly effective for patients with SAD and comorbid APD. To our knowledge, there are no studies comparing CBT with ST in this particular group of patients. This superiority trial aims at comparing the effectiveness of these treatments. As an additional goal, predictors and underlying mechanisms of change will be explored. The design of the study is a multicentre two-group randomized controlled trial (RCT) in which the treatment effect of group cognitive behavioral therapy (GCBT) will be compared to that of group schema therapy (GST) in a semi-open group format. A total of 128 patients aged 18-65 years old will be enrolled. Patients will receive 30 sessions of GCBT or GST during a period of approximately 9 months. Primary outcome measures are the Liebowitz Social Anxiety Scale Self-Report (LSAS-SR) for social anxiety disorder and the newly developed Avoidant Personality Disorder Severity Index (AVPDSI) for avoidant personality disorder. Secondary outcome measures are the MINI section SAD, the SCID-II section APD, the Schema Mode Inventory (SMI-2), the Inventory of Depressive Symptomatology Self-Report (IDS-SR), the World Health Organization Quality of Life-BREF (WHOQOL-BREF), the Difficulties in Emotion Regulation Scale (DERS), the Rosenberg Self-Esteem Scale (RSES) and the Acceptance and Action

  7. The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study

    Science.gov (United States)

    Hosomi, Naohisa; Nagai, Yoji; Kohriyama, Tatsuo; Ohtsuki, Toshiho; Aoki, Shiro; Nezu, Tomohisa; Maruyama, Hirofumi; Sunami, Norio; Yokota, Chiaki; Kitagawa, Kazuo; Terayama, Yasuo; Takagi, Makoto; Ibayashi, Setsuro; Nakamura, Masakazu; Origasa, Hideki; Fukushima, Masanori; Mori, Etsuro; Minematsu, Kazuo; Uchiyama, Shinichiro; Shinohara, Yukito; Yamaguchi, Takenori; Matsumoto, Masayasu

    2015-01-01

    Background Although statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients. Methods This is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints. Finding Although 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events. Interpretation Although whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis. Funding This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and

  8. Can a Back Pain E-mail Discussion Group improve health status and lower health care costs?: A randomized study.

    Science.gov (United States)

    Lorig, Kate R; Laurent, Diana D; Deyo, Richard A; Marnell, Margaret E; Minor, Marian A; Ritter, Philip L

    2002-04-08

    Given the high health care utilization, limited evidence for the effectiveness of back pain interventions, and the proliferation of e-mail health discussion groups, this study seeks to determine if the Internet can be used to improve health status and health care utilization for people with chronic back pain. Randomized controlled trial. Participants included 580 people from 49 states with chronic back pain having at least 1 outpatient visit in the past year, no "red-flag" symptoms, and access to e-mail. Major exclusion criteria included continuous back pain for more than 90 days causing major activity intolerance and/or receiving disability payments. Closed, moderated, e-mail discussion group. Participants also received a book and videotape about back pain. Controls received a subscription to a non-health-related magazine of their choice. Pain, disability, role function, health distress, and health care utilization. At 1-year treatment, subjects compared with controls demonstrated improvements in pain (P =.045), disability (P =.02), role function (P =.007), and health distress (P =.001). Physician visits for the past 6 months declined by 1.5 visits for the treatment group and by 0.65 visits for the control group (P =.07). Mean hospital days declined nearly 0.20 days for the treated group vs and increased 0.04 days for the control group (P =.24). An e-mail discussion group can positively affect health status and possibly health care utilization. It may have a place in the treatment of chronic recurrent back pain.

  9. GrOup based physical Activity for oLder adults (GOAL) randomized controlled trial: study protocol.

    Science.gov (United States)

    Beauchamp, Mark R; Harden, Samantha M; Wolf, Svenja A; Rhodes, Ryan E; Liu, Yan; Dunlop, William L; Schmader, Toni; Sheel, Andrew W; Zumbo, Bruno D; Estabrooks, Paul A

    2015-06-27

    Physical activity has health benefits across the lifespan, yet only 13 % of Canadian older adults are sufficiently active. Results from a number of observational studies indicate that adults display positive preferences for exercising with others of a similar age and same gender, and that intra-group age- and gender-similarity are associated with elevated exercise adherence. However, research has yet to experimentally examine the extent to which intra-group age- and gender-related similarity affect exercise adherence behaviors. The GrOup-based physical Activity for oLder adults (GOAL) trial is a three-arm randomized control trial that will examine the efficacy of two different group-based exercise programs for older adults (informed by the tenets of self-categorization theory) in relation to a standard group-based exercise program. Within this manuscript we outline the design and proposed evaluation of the GOAL trial. The first arm is comprised of exercise groups made up of participants of a similar-age and of the same gender; the second arm consists of groups with similar-aged mixed gender participants; the control arm is comprised of mixed-aged mixed gender participants. We aim to compare the adherence rates of participants across conditions, as well as potential moderation effects and mediating mechanisms. Results from this trial will inform intervention designs to improve the exercise adherence behaviors of older adult. At a systems-level, should support be derived for the efficacy of the interventions tested in this trial, changing group composition (i.e., age, gender) represents a feasible program adaptation for physical activity centers. ClinicalTrials.gov # NCT02023632 . Registered December 13, 2013.

  10. CBT4BN: A Randomized Controlled Trial of Online Chat and Face-to-Face Group Therapy for Bulimia Nervosa

    Science.gov (United States)

    Zerwas, Stephanie C.; Watson, Hunna J.; Hofmeier, Sara M.; Levine, Michele D.; Hamer, Robert M.; Crosby, Ross D.; Runfola, Cristin D.; Peat, Christine M.; Shapiro, Jennifer R.; Zimmer, Benjamin; Moessner, Markus; Kordy, Hans; Marcus, Marsha D.; Bulik, Cynthia M.

    2016-01-01

    Objective Although cognitive-behavioral therapy (CBT) represents the first-line evidence-based psychotherapy for bulimia nervosa (BN), most individuals seeking treatment do not have access to this specialized intervention. We compared an Internet-based manualized version of CBT group therapy for BN conducted via a therapeutic chat group (CBT4BN) to the same treatment conducted via a traditional face-to-face group therapy (CBTF2F). Method In a two-site, randomized, controlled non-inferiority trial, we tested the hypothesis that CBT4BN would not be inferior to CBTF2F. One hundred forty-nine adult patients with BN (2.6% males) received up to 16 sessions of group CBT over 20 weeks in either CBT4BN or CBTF2F and outcomes were compared at the end of treatment and 12-month follow-up. Results At the end of treatment, CBT4BN was inferior to CBTF2F in producing abstinence from binge eating and purging and in leading to reductions in the frequency of binge eating and purging. However, by 12-month follow-up, CBT4BN was mostly not inferior to CBTF2F. Participants in the CBT4BN condition, but not CBTF2F, continued to reduce their binge-eating and purging frequency from end of treatment to 12-month follow-up. Conclusions CBT delivered online in a group chat format appears to be an efficacious treatment for BN although the trajectory of recovery may be slower than face-to-face group therapy. Online chat groups may increase accessibility of treatment and represent a cost-effective approach to service delivery. However, barriers in service delivery such as state-specific license and ethical guidelines for online therapists need to be addressed. PMID:27883997

  11. Personality disorder moderates outcome in short- and long-term group analytic psychotherapy: A randomized clinical trial.

    Science.gov (United States)

    Lorentzen, Steinar; Ruud, Torleif; Fjeldstad, Anette; Høglend, Per A

    2015-06-01

    In a randomized clinical trial, short- and long-term psychodynamic group psychotherapy (STG and LTG, respectively) schedules were equally effective for the 'typical' patient during a 3-year study period. Although several studies have reported good effects for patients with personality disorders (PD) in diverse forms of psychotherapy, the significance of treatment duration is unclear. Therefore, we tested the hypothesis that PD patients would improve more during and after LTG than STG. A randomized, longitudinal, prospective study contrasting the outcomes during and after short- and long-term dynamic group psychotherapies. One hundred and sixty-seven outpatients with mood disorders, anxiety disorders, or PD were randomized to STG or LTG (respectively, 20 or 80 weekly sessions of 90 min each). Outcome measures are as follows: symptoms (SCL-90-R), interpersonal problems (IIP-C), and psychosocial functioning (GAF split version: GAF-Symptom and GAF-Function). PD pathology (number of PD criteria items) was selected a priori as a putative moderator of treatment effects. Change during the 3-year study period was assessed using linear mixed models. The study was registered at ClinicalTrials.gov as NCT 00021417. Our hypothesis was supported, as patients with PD improved significantly more regarding all outcome variables in LTG than STG. For patients without PD, the rate of change was similar across 3 years; however, the rate of change in symptoms and interpersonal problems was higher in STG during the first 6 months. The effectiveness of LTG is higher for patients with co-morbid PD. Patients without PD do not appear to experience additional gain from LTG. Clinical implications: LTG demonstrates better effectiveness than STG for patients with personality disorder co-morbidity (PD). Patients without PD do not appear to experience additional gain from attending LTG. Correct initial allocation to treatment duration may prevent disruptive breaks in relationships and lead to both

  12. The influence of magnesium supplementation on concentrations of chosen bioelements and toxic metals in adult human hair. Magnesium and chosen bioelements in hair.

    Science.gov (United States)

    Kozielec, Tadeusz; Sałacka, Anna; Karakiewicz, Beata

    2004-09-01

    The basic functions of bioelements in biological systems is widely known. Depletion of bioelements and excess of toxic elements lead to impairment of metabolism in the living organism. The existence of magnesium deficiencies in the adult and pediatric populations may cause increased accumulation of toxic metals including lead and cadmium. Prevention of adverse effects of toxic metals may include supplementation with some bioelements and vitamins. The aim of this study was to evaluate the influence of magnesium supplementation on concentrations of chosen bioelements and toxic metals in hair in the adult human population. The research was performed on 124 individuals (53 males and 71 females aged 19-72 years), inhabitants of the city of Szczecin. The concentrations of magnesium, zinc, copper, lead and cadmium were studied in hair. Measurements were performed using the inversion volt-amperometry method with application of an EDD-Tribo PC ETP volt-amperometer. Finally, the supplementation study enrolled 65 individuals with an increased concentration of lead. The studied individuals were divided into two groups: one treated group that enrolled 50 patients who were supplemented with magnesium and the control group that enrolled 15 persons receiving placebo. Finally, supplementation was completed by 32 individuals from the treated group and 10 individuals from the control group. Supplementation was performed using Slow-Mag-B6 preparation at the total daily dose of five tablets divided into 2-3 doses. One tablet contains 535 mg of magnesium chloride i.e. 64 mg of magnesium ions (5.26 mEgMg2) and 5 mg of vitamin B6. Supplementation was performed for a period of 3 months. The remaining individuals did not complete the supplementation due to various reasons; however, none of them resulted from the poor tolerance of the preparation or its adverse events. The results achieved underwent statistical analysis. The results of the study revealed a positive influence of

  13. Headache: the placebo effects in the control groups in randomized clinical trials; an analysis of systematic reviews.

    Science.gov (United States)

    de Groot, Femke M; Voogt-Bode, Annieke; Passchier, Jan; Berger, Marjolein Y; Koes, Bart W; Verhagen, Arianne P

    2011-06-01

    The purpose of this study is to describe the effects in the placebo and "no treatment" arms in trials with headache patients. This is a secondary analysis of randomized controlled trials from 8 systematic reviews and selected trials with a "no treatment" or placebo control group. The different types of "no treatment" and placebo interventions were assessed and classified into 6 subgroups. The analyses were carried out according to type of outcome variable. In total, 119 studies were included (7119 participants). The mean recovery rate in all control groups was 35.7%. Significantly more participants recovered in control groups of pharmacological studies than in nonpharmacological studies: 38.5% vs 15.0%, respectively. Adults were more likely to recover in nonpharmacological studies and children in pharmacological studies. The mean recovery rate in the control groups was 36%. The recovery rate varied substantially between type of intervention and patients. Copyright © 2011 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  14. Group versus Internet-based cognitive-behavioral therapy for procrastination: Study protocol for a randomized controlled trial

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    Alexander Rozental

    2014-04-01

    Full Text Available Procrastination is defined as a voluntarily delay of an intended course of action despite expecting to be worse-off for the delay, and is considered a persistent behavior pattern that can result in major psychological suffering. About one-fifth of the adult population and half of the student population are presumed having substantial difficulties due to recurrent procrastination in their everyday lives. However, chronic and severe procrastinators seldom receive adequate care due to preconceptions and the lack of understanding regarding procrastination and the treatment interventions that are assumed beneficial. Cognitive-behavioral therapy is often deemed a treatment of choice, although the evidence supporting its use is scarce, and only one randomized controlled trial has been performed. The primary aim of the proposed study is therefore to test the efficacy of cognitive-behavioral therapy delivered as either a group intervention or via the Internet. Participants will consist of students recruited through the Student Health Centre at Karolinska Institutet. A randomized controlled trial with a sample size of 100 participants divided into blocks of thirty will be used, comparing an eight-week Internet-based cognitive-behavioral therapy intervention, and an eight-week group cognitive-behavioral therapy based intervention. It is believed that the proposed study will result in two important findings. First, different treatment interventions in cognitive-behavioral therapy are assumed to be helpful for people suffering from problems caused by procrastination. Second, both an Internet-based cognitive-behavioral therapy intervention and a group intervention are presumed suitable for administering treatment for procrastination, which is considered important as the availability of adequate care is limited, particularly among students. The proposed study will increase the knowledge regarding the efficacy of different treatments of procrastination, as well

  15. Group medical visits in the follow-up of women with a BRCA mutation: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hoogerbrugge Nicoline

    2011-08-01

    Full Text Available Abstract Background BRCA mutation carriers have a 40-80% life-time risk of developing breast cancer. They may opt for yearly breast cancer surveillance or for prophylactic mastectomy. Both options show increased survival rates. It is a complex choice to be made between these two options. As a result most women experience high levels of distress and high needs for information. To fulfill the needs for psychosocial support and information we have introduced group medical consultations (GMCs. A GMC provides individual medical visits conducted within a group. This 90 minute group-visit with 8-12 patients gives patients the opportunity to spend more time with their clinician and a behavioral health professional and learn from other patients experiencing similar topics. However, it should be noted that group sessions may increase fear in some patients or influence their decision making. Methods/design In this randomized controlled trial, 160 BRCA mutation carriers diagnosed maximally 2 years ago are recruited from the Radboud University Nijmegen Medical Centre. Participants are randomized in a 1:1 ratio to either the GMC intervention group (onetime participation in a GMC instead of a standard individual visit or to a usual care control group. Primary outcome measures are empowerment and psychological distress (SCL 90. Secondary outcome measures are fear of cancer, information needs before the consultation and the received information, self-examination of the breasts, patient satisfaction, quality of life and cost-effectiveness. Data are collected via self-reported questionnaires 1 week before the visit, and at 1 week and at 3 months follow-up. A pilot study was conducted to test all procedures and questionnaires. Discussion The possibility for interaction with other BRCA mutation carriers within a medical visit is unique. This study will assess the effectiveness of GMCs for BRCA mutation carriers to improve empowerment and decrease distress compared

  16. Internet-vs. group-delivered cognitive behavior therapy for insomnia: A randomized controlled non-inferiority trial.

    Science.gov (United States)

    Blom, Kerstin; Tarkian Tillgren, Hanna; Wiklund, Tobias; Danlycke, Ewa; Forssén, Mattias; Söderström, Alexandra; Johansson, Robert; Hesser, Hugo; Jernelöv, Susanna; Lindefors, Nils; Andersson, Gerhard; Kaldo, Viktor

    2015-07-01

    The aim of this study was to compare guided Internet-delivered to group-delivered cognitive behavioral therapy (CBT) for insomnia. We conducted an 8-week randomized controlled non-inferiority trial with 6-months follow-up. Participants were forty-eight adults with insomnia, recruited via media. Interventions were guided Internet-delivered CBT (ICBT) and group-delivered CBT (GCBT) for insomnia. Primary outcome measure was the Insomnia Severity Index (ISI), secondary outcome measures were sleep diary data, depressive symptoms, response- and remission rates. Both treatment groups showed significant improvements and large effect sizes for ISI (Within Cohen's d: ICBT post = 1.8, 6-months follow-up = 2.1; GCBT post = 2.1, 6-months follow-up = 2.2). Confidence interval of the difference between groups post-treatment and at FU6 indicated non-inferiority of ICBT compared to GCBT. At post-treatment, two thirds of patients in both groups were considered responders (ISI-reduction > 7p). Using diagnostic criteria, 63% (ICBT) and 75% (GCBT) were in remission. Sleep diary data showed moderate to large effect sizes. We conclude that both guided Internet-CBT and group-CBT in this study were efficacious with regard to insomnia severity, sleep parameters and depressive symptoms. The results are in line with previous research, and strengthen the evidence for guided Internet-CBT for insomnia. The study protocol was approved by, and registered with, the regional ethics review board in Linköping, Sweden, registration number 2010/385-31. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  17. Children with autism spectrum disorder and social skills groups at school: a randomized trial comparing intervention approach and peer composition.

    Science.gov (United States)

    Kasari, Connie; Dean, Michelle; Kretzmann, Mark; Shih, Wendy; Orlich, Felice; Whitney, Rondalyn; Landa, Rebecca; Lord, Catherine; King, Bryan

    2016-02-01

    Peer relationships improve for children with autism spectrum disorder (ASD) in clinic-based social skills groups but rarely generalize to real world contexts. This study compares child outcomes of two social skills interventions conducted in schools with children in Kindergarten through fifth grade. Children with ASD were randomized to one of two interventions that varied on group composition (mixed typical and ASD vs. all ASD or social difficulties) and intervention approach (didactic SKILLS based vs. activity-based ENGAGE groups). Interventions were implemented at school for 8 weeks (16 sessions) with an 8-week follow-up. Innovative measures of peer nomination and playground peer engagement, as well as teacher reports of child behavior problems and teacher-child relationship were analyzed for 137 children with ASD across four sites. On the primary outcome of social network connections from the peer nomination measure, there was no main effect of treatment, but there were moderator effects. Children with low teacher-child closeness or high conflict improved more in their social connections if they received the SKILLS intervention, whereas children with higher teacher-child closeness improved more if they received the ENGAGE intervention. Only two secondary outcome measures yielded significant effects of treatment. Children in the SKILLS groups increased peer engagement and decreased isolation during recess. Child behavior problems and teacher-child closeness moderated peer engagement such that children with higher behavior problems and lower closeness benefitted more from SKILLS groups. These findings suggest that social skills groups conducted at school can affect both peer engagement during recess as well as peer acceptability. Child characteristics and teacher-child relationship prior to intervention yield important information on who might benefit from a specific social skills intervention. © 2015 Association for Child and Adolescent Mental Health.

  18. The effectiveness of a Housing First adaptation for ethnic minority groups: findings of a pragmatic randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Vicky Stergiopoulos

    2016-10-01

    Full Text Available Abstract Background Little is known about the effectiveness of Housing First (HF among ethnic minority groups, despite its growing popularity for homeless adults experiencing mental illness. This randomized controlled trial tests the effectiveness of a HF program using rent supplements and intensive case management, enhanced by anti-racism and anti-oppression practices for homeless adults with mental illness from diverse ethnic minority backgrounds. Methods This unblinded pragmatic field trial was carried out in community settings in Toronto, Canada. Participants were 237 adults from ethnic minority groups experiencing mental illness and homelessness, who met study criteria for moderate needs for mental health services. Participants were randomized to either adapted HF (n = 135 or usual care (n = 102 and followed every 3 months for 24 months. The primary study outcome was housing stability; secondary outcomes included physical and mental health, social functioning, quality of life, arrests and health service use. Intention to treat statistical analyses examined the effectiveness of the intervention compared to usual care. Results During the 24-month study period, HF participants were stably housed a significantly greater proportion of time compared to usual care participants, 75 % (95 % CI 70 to 81 vs. 41 % (95 % CI 35 to 48, respectively, for a difference of 34 %, 95 % CI 25 to 43. HF also led to improvements in community integration over the course of the study: the change in the mean difference between treatment groups from baseline to 24-months was significantly greater among HF participants compared to those in usual care (change in mean difference = 2.2, 95 % CI 0.06 to 4.3. Baseline diagnosis of psychosis was associated with reduced likelihood of being housed ≥ 50 % of the study period (OR = 0.37, 95 % CI 0.18 to 0.72. Conclusion Housing First enhanced with anti-racism and anti-oppression practices can

  19. Design and rationale of the medical students learning weight management counseling skills (MSWeight) group randomized controlled trial.

    Science.gov (United States)

    Ockene, Judith K; Ashe, Karen M; Hayes, Rashelle B; Churchill, Linda C; Crawford, Sybil L; Geller, Alan C; Jolicoeur, Denise; Olendzki, Barbara C; Basco, Maria Theresa; Pendharkar, Jyothi A; Ferguson, Kristi J; Guck, Thomas P; Margo, Katherine L; Okuliar, Catherine A; Shaw, Monica A; Soleymani, Taraneh; Stadler, Diane D; Warrier, Sarita S; Pbert, Lori

    2018-01-01

    Physicians have an important role addressing the obesity epidemic. Lack of adequate teaching to provide weight management counseling (WMC) is cited as a reason for limited treatment. National guidelines have not been translated into an evidence-supported, competency-based curriculum in medical schools. Weight Management Counseling in Medical Schools: A Randomized Controlled Trial (MSWeight) is designed to determine if a multi-modal theoretically-guided WMC educational intervention improves observed counseling skills and secondarily improve perceived skills and self-efficacy among medical students compared to traditional education (TE). Eight U.S. medical schools were pair-matched and randomized in a group randomized controlled trial to evaluate whether a multi-modal education (MME) intervention compared to traditional education (TE) improves observed WMC skills. The MME intervention includes innovative components in years 1-3: a structured web-course; a role play exercise, WebPatientEncounter, and an enhanced outpatient internal medicine or family medicine clerkship. This evidence-supported curriculum uses the 5As framework to guide treatment and incorporates patient-centered counseling to engage the patient. The primary outcome is a comparison of scores on an Objective Structured Clinical Examination (OSCE) WMC case among third year medical students. The secondary outcome compares changes in scores of medical students from their first to third year on an assessment of perceived WMC skills and self-efficacy. MSWeight is the first RCT in medical schools to evaluate whether interventions integrated into the curriculum improve medical students' WMC skills. If this educational approach for teaching WMC is effective, feasible and acceptable it can affect how medical schools integrate WMC teaching into their curriculum. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Cost-Effectiveness of Group and Internet Cognitive Behavioral Therapy for Insomnia in Adolescents: Results from a Randomized Controlled Trial.

    Science.gov (United States)

    De Bruin, Eduard J; van Steensel, Francisca J A; Meijer, Anne Marie

    2016-08-01

    To investigate cost-effectiveness of adolescent cognitive behavioral therapy for insomnia (CBTI) in group- and Internet-delivered formats, from a societal perspective with a time horizon of 1 y. Costs and effects data up to 1-y follow-up were obtained from a randomized controlled trial (RCT) comparing Internet CBTI to face-to-face group CBTI. The study was conducted at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam, and the academic youth mental health care center UvAMinds in Amsterdam. Sixty-two participants meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for insomnia were randomized to face-to-face group CBTI (GT; n = 31, age = 15.6 y ± 1.8, 71.0% girls) or individual Internet CBTI (IT; n = 31, age = 15.4 y ± 1.5, 83.9% girls). The intervention consisted of six weekly sessions and a 2-mo follow up booster-session of CBTI, consisting of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT sessions were held in groups of six to eight adolescents guided by two trained sleep therapists. IT consisted of individual Internet therapy with preprogrammed content similar to GT, and guided by trained sleep therapists. Outcome measures were subjective sleep efficiency (SE) ≥ 85%, and quality-adjusted life-years (QALY). Analyses were conducted from a societal perspective. Incremental cost-effectiveness ratios (ICERs) were calculated using bootstrap sampling, and presented in cost-effectiveness planes. Primary analysis showed costs over 1 y were higher for GT but effects were similar for IT and GT. Bootstrapped ICERs demonstrated there is a high probability of IT being cost-effective compared to GT. Secondary analyses confirmed robustness of results. Internet CBTI is a cost-effective treatment compared to group CBTI for adolescents, although effects were largely similar for both formats

  1. Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Trial.

    Science.gov (United States)

    Espí-López, Gemma V; Serra-Añó, Pilar; Vicent-Ferrando, Juan; Sánchez-Moreno-Giner, Miguel; Arias-Buría, Jose L; Cleland, Joshua; Fernández-de-Las-Peñas, César

    2017-06-01

    Study Design Randomized controlled trial. Background Evidence suggests that multimodal interventions that include exercise therapy may be effective for patellofemoral pain (PFP); however, no study has investigated the effects of trigger point (TrP) dry needling (DN) in people with PFP. Objectives To compare the effects of adding TrP DN to a manual therapy and exercise program on pain, function, and disability in individuals with PFP. Methods Individuals with PFP (n = 60) recruited from a public hospital in Valencia, Spain were randomly allocated to manual therapy and exercises (n = 30) or manual therapy and exercise plus TrP DN (n = 30). Both groups received the same manual therapy and strengthening exercise program for 3 sessions (once a week for 3 weeks), and 1 group also received TrP DN to active TrPs within the vastus medialis and vastus lateralis muscles. The pain subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS; 0-100 scale) was used as the primary outcome. Secondary outcomes included other subscales of the KOOS, the Knee Society Score, the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC), and the numeric pain-rating scale. Patients were assessed at baseline and at 15-day (posttreatment) and 3-month follow-ups. Analysis was conducted with mixed analyses of covariance, adjusted for baseline scores. Results At 3 months, 58 subjects (97%) completed the follow-up. No significant between-group differences (all, P>.391) were observed for any outcome: KOOS pain subscale mean difference, -2.1 (95% confidence interval [CI]: -4.6, 0.4); IKDC mean difference, 2.3 (95% CI: -0.1, 4.7); knee pain intensity mean difference, 0.3 (95% CI: -0.2, 0.8). Both groups experienced similar moderate-to-large within-group improvements in all outcomes (standardized mean differences of 0.6 to 1.1); however, only the KOOS function in sport and recreation subscale surpassed the prespecified minimum important change. Conclusion The current

  2. The Effectiveness of a Group Triple P with Chinese Parents Who Have a Child with Developmental Disabilities: A Randomized Controlled Trial

    Science.gov (United States)

    Leung, Cynthia; Fan, Angel; Sanders, Matthew R.

    2013-01-01

    The study examined the effectiveness of Group Triple P, a Level 4 variant of the Triple P multilevel system of parenting support, with Chinese parents who had a preschool aged child with a developmental disability, using randomized controlled trial design. Participants (Intervention group: 42; Waitlist Control group: 39) completed measures on…

  3. Randomized Trial of Group Music Therapy With Chinese Prisoners: Impact on Anxiety, Depression, and Self-Esteem.

    Science.gov (United States)

    Chen, Xi-Jing; Hannibal, Niels; Gold, Christian

    2016-07-01

    This study investigated the effects of group music therapy on improving anxiety, depression, and self-esteem in Chinese prisoners. Two-hundred male prisoners were randomly assigned to music therapy (n = 100) or standard care (n = 100). The music therapy had 20 sessions of group therapy compared with standard care. Anxiety (State and Trait Anxiety Inventory [STAI]), depression (Beck Depression Inventory [BDI]), and self-esteem (Texas Social Behavior Inventory [TSBI], Rosenberg Self-Esteem Inventory [RSI]) were measured by standardized scales at baseline, mid-program, and post-program. Data were analyzed based on the intention to treat principle. Compared with standard care, anxiety and depression in the music therapy condition decreased significantly at mid-test and post-test; self-esteem improved significantly at mid-test (TSBI) and at post-test (TSBI, RSI). Improvements were greater in younger participants (STAI-Trait, RSI) and/or in those with a lower level of education (STAI-State, STAI-Trait). Group music therapy seems to be effective in improving anxiety, depression, and self-esteem and was shown to be most beneficial for prisoners of younger age or with lower education level. © The Author(s) 2015.

  4. Intranasal Midazolam versus Rectal Diazepam for the Management of Canine Status Epilepticus: A Multicenter Randomized Parallel-Group Clinical Trial.

    Science.gov (United States)

    Charalambous, M; Bhatti, S F M; Van Ham, L; Platt, S; Jeffery, N D; Tipold, A; Siedenburg, J; Volk, H A; Hasegawa, D; Gallucci, A; Gandini, G; Musteata, M; Ives, E; Vanhaesebrouck, A E

    2017-07-01

    Intranasal administration of benzodiazepines has shown superiority over rectal administration for terminating emergency epileptic seizures in human trials. No such clinical trials have been performed in dogs. To evaluate the clinical efficacy of intranasal midazolam (IN-MDZ), via a mucosal atomization device, as a first-line management option for canine status epilepticus and compare it to rectal administration of diazepam (R-DZP) for controlling status epilepticus before intravenous access is available. Client-owned dogs with idiopathic or structural epilepsy manifesting status epilepticus within a hospital environment were used. Dogs were randomly allocated to treatment with IN-MDZ (n = 20) or R-DZP (n = 15). Randomized parallel-group clinical trial. Seizure cessation time and adverse effects were recorded. For each dog, treatment was considered successful if the seizure ceased within 5 minutes and did not recur within 10 minutes after administration. The 95% confidence interval was used to detect the true population of dogs that were successfully treated. The Fisher's 2-tailed exact test was used to compare the 2 groups, and the results were considered statistically significant if P < .05. IN-MDZ and R-DZP terminated status epilepticus in 70% (14/20) and 20% (3/15) of cases, respectively (P = .0059). All dogs showed sedation and ataxia. IN-MDZ is a quick, safe and effective first-line medication for controlling status epilepticus in dogs and appears superior to R-DZP. IN-MDZ might be a valuable treatment option when intravenous access is not available and for treatment of status epilepticus in dogs at home. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  5. Comparison of efficacy, safety, and cost-effectiveness of rupatadine and olopatadine in patients of allergic rhinitis: A prospective, randomized, double-blind, parallel group study

    OpenAIRE

    Ganesh Dakhale; Yogesh Tathod; Seema Patel; Sonali Pimpalkhute; Latesh Raghute; Ajita Khamkar

    2016-01-01

    Objective: To compare the efficacy, safety, and cost-effectiveness of rupatadine and olopatadine in patients of allergic rhinitis (AR). Materials and Methods: A 2-week, single-centered, randomized, double-blind, parallel group comparative clinical study was conducted on patients with AR. Following inclusion and exclusion criteria, 67 patients were recruited and randomized to two treatment groups and received the respective drugs for 2 weeks. At follow-up, parameters assessed were total nasal ...

  6. Effect of mental imagery on performance elite athletes’ in youth and adult age groups: a randomized trial

    Directory of Open Access Journals (Sweden)

    Tohid Seif-Barghi

    2013-06-01

    Full Text Available Background: Athletes are usually skilled in physical aspects of sports; they are widely involved in physical conditioning, technical and tactical training. However they usually ignore the psychological and cognitive skills linked to their performance. Sport imagery is a well known fundamental skill that has a critical role in how a player performs and shows his/her competency during a real world game. On the other hand football as a complex team sport includes several skills linked to physical and psychological properties. We aimed to study the effect of cognitive imagery on elite football players through league competitions in two separate studies.Methods: Twenty two youth players and Twenty two adult players randomly assigned to imagery and control groups. Players in intervention group received 12 weeks training program for specific cognitive imagery and general cognitive imagery. Imagery training program focused on an important component of football performance as “successful passing”. Players in control group were assigned to a waiting list with no intervention. In order to evaluate outcome variable we assessed successful passing in real compete-tions as player performance in both pre and post test occasions.Results: Findings of study in youth participants showed that young players in interven-tion group improved the performance of passing compared to control players (OR=1.41, P0.05, CI 95%: 0.82, 1.4(.Conclusion: These results showed that cognitive imagery intervention can affect elite soccer players’ performance. This effect is more prominent in youth age football players.

  7. Effectiveness and cost-effectiveness of meaning-centered group psychotherapy in cancer survivors: protocol of a randomized controlled trial.

    Science.gov (United States)

    van der Spek, Nadia; Vos, Joël; van Uden-Kraan, Cornelia F; Breitbart, William; Cuijpers, Pim; Knipscheer-Kuipers, Kitty; Willemsen, Vincent; Tollenaar, Rob A E M; van Asperen, Christi J; Verdonck-de Leeuw, Irma M

    2014-01-28

    Meaning-focused coping may be at the core of adequate adjustment to life after cancer. Cancer survivors who experience their life as meaningful are better adjusted, have better quality of life and psychological functioning. Meaning-Centered Group Psychotherapy for Cancer Survivors (MCGP-CS) was designed to help patients to sustain or enhance a sense of meaning and purpose in their lives. The aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of MCGP-CS. Survivors diagnosed with cancer in the last 5 years and treated with curative intent, are recruited via several hospitals in the Netherlands. After screening, 168 survivors are randomly assigned to one of the three study arms: 1. Meaning-Centered Group Psychotherapy (MCGP-CS) 2. Supportive group psychotherapy (SGP) 3. Care as usual (CAU). Baseline assessment takes place before randomisation, with follow up assessments post-intervention and at 3, 6 and 12 months follow-up. Primary outcome is meaning making (PMP, PTGI, SPWB). Secondary outcome measures address quality of life (EORTC-30), anxiety and depression (HADS), hopelessness (BHS), optimism (LOT-R), adjustment to cancer (MAC), and costs (TIC-P, EQ-5D, PRODISQ). Meaning-focused coping is key to adjustment to life after cancer, however, there is a lack of evidence based psychological interventions in this area. Many cancer survivors experience feelings of loneliness and alienation, and have a need for peer support, therefore a group method in particular, can be beneficial for sustaining or enhancing a sense of meaning. If this MCGP-CS is effective for cancer survivors, it can be implemented in the practice of psycho-oncology care. Netherlands Trial Register, NTR3571.

  8. Four-year follow-up of a randomized controlled trial of triple p group for parent and child outcomes.

    Science.gov (United States)

    Heinrichs, Nina; Kliem, Sören; Hahlweg, Kurt

    2014-04-01

    Approximately 15-20% of children experience behavioral and/or emotional difficulties. Evidence-based treatment will likely not be sufficient to reduce the prevalence of these difficulties in children and adolescents. Effective prevention programs are therefore also needed to enable families access to support at multiple points across the lifecourse. The aim of the current investigation was to evaluate the 4-year efficacy of the group-based Triple P (Positive Parenting Program) as a prevention program administered universally. Seventeen preschools were randomly assigned to Triple P (n = 11 preschools, 186 families) or a no parenting intervention control group (n = 6 preschools, 94 families). Long-term efficacy was analyzed with hierarchical linear models using maternal and paternal self-report measures. Mothers and fathers from the intervention preschool group reported significant reductions in dysfunctional parenting behavior (d = 0.24 and 0.19, respectively). Mothers also reported a less steep decline from pre- to post-intervention in positive parenting behavior, which was maintained 4 years later (d = 0.38). Fathers from intervention preschools reported a delayed less steep decline in positive parenting during the follow-up (d = 0.33). In addition, mothers from intervention preschools reported immediate improvement in child behavior problems during the program while mothers from control preschools did not report this immediate change. However, with mothers from intervention preschools reporting more child behavior problems at baseline, the effect disappeared by the fourth year (d = 0.19). The results support the long-term efficacy of the Triple P-group program as a universal prevention intervention for changing parenting behavior while there was little evidence for maintenance of change in behavior problems.

  9. Breastfeeding preterm infants - a randomized controlled trial of the effectiveness of an Internet-based peer-support group.

    Science.gov (United States)

    Niela-Vilén, Hannakaisa; Axelin, Anna; Melender, Hanna-Leena; Löyttyniemi, Eliisa; Salanterä, Sanna

    2016-10-01

    The aim of this study was to examine whether an Internet-based peer-support intervention has an effect on the duration of breastfeeding or breast milk expression or maternal breastfeeding attitude compared with routine care in the mothers of preterm infants. In addition, the feasibility of the intervention was examined. A few peer-support interventions conducted face-to-face or by telephone have given promising results in promoting breastfeeding in preterm infants. A randomized controlled trial with a 1-year follow-up was conducted in one hospital in Finland in 2011-2015. Altogether 124 mothers of preterm (group. The intervention was a closed peer-support group in social media. Data were collected by structured questionnaires. Neonatal and breastfeeding data were collected from patient records. The duration of overall breastfeeding was on average 3·0 and 4·3 months, in the experimental and control groups respectively. The intervention had no effect on breastfeeding or expressing the breast milk or maternal breastfeeding attitude. A breastfeeding-favourable attitude and at least two previous children predicted longer duration of breastfeeding. Attitude-score decreased during the follow-up. The mothers in the experimental group enjoyed peer support, but only a few reported it as having some impact on breastfeeding. Although the Internet-based peer-support intervention had no effect, the importance of breastfeeding attitude for the duration of breastfeeding in mothers of preterm infants was shown. In future, interventions in social media should be studied more and attitude-focused interventions be developed. © 2016 John Wiley & Sons Ltd.

  10. Methods chosen by parents of preschoolers to prevent vitamin D deficiency

    Directory of Open Access Journals (Sweden)

    Lucyna Sochocka

    2015-06-01

    Full Text Available Introduction. Results of the epidemiologic studies conducted over recent years indicate vitamin D deficiency, especially among children and young people. The following factors affecting occurrence of vitamin D deficiency growth should be mentioned: improper lifestyle, using UV filters and inadequate vitamin D intake. The aim of the research was an attempt to evaluate action carried out as part of preschoolers' vitamin d deficiency prophylaxis taken by their parents. Material and the methods. The research was conducted in 2014. The group contained 118 parents of children aged 4–6. The method of the diagnostic survey was utilized in the research with poll used as a technique and author's survey questionnaire provided as a tool. The obtained results of the research underwent statistical analysis. In order to define the existence of the differences or correlations between analyzed immeasurable parameters, chi–square test was used. Results. Most of the interviewed parents supply their children with fish; 14.4% (n=17 do this 2–3 a week;8.5% (n=10 would never serve their children fish. Whole milk, cheese and eggs were most frequently chosen among products containing vitamin D. Children of 93.2% (n=110 of the interviewed parents spend at least two hours a day outdoors from April to September. However, less than 89.8% (n=106 of the parents state that that children’s skin is protected with UV sunscreen at the time. 14.4% (n=17 of the interviewed parents provide their kids with vitamin D on a daily basis, all year around. Cod liver oil is the most common preparation chosen by parents who declared vitamin D supplementation. Conclusions. On-going education of parents concerning nutrition principles of children seems necessary as they are responsible for cultivating good eating habits among the young.

  11. A group-delivered self-management program reduces spasticity in people with multiple sclerosis: A randomized, controlled pilot trial

    Science.gov (United States)

    Bourdette, Dennis; Chen, Yiyi; Chen, Zunqiu; Cameron, Michelle

    2017-01-01

    Background Spasticity affects more than 80% of people with multiple sclerosis (MS), affecting activity, participation, and quality of life. Based on an international guideline, an MS spasticity group education and stretching program, MS Spasticity: Take Control (STC), has been developed. Objective The objective of this paper is to determine whether STC with home stretching is associated with greater changes in spasticity than usual care (UC), consisting of an illustrated stretching booklet and home stretching but without group instruction or support, in people with MS. Methods Ambulatory MS patients with self-reported spasticity interfering with daily activities were randomized to STC or UC. Individuals completed questionnaires regarding MS, spasticity, walking, fatigue and mood, and physical measures of spasticity and walking. Results Thirty-eight of 40 participants completed both assessments. Mean total score and scores on two subscales of the MS Spasticity Scale-88 improved more with STC than with UC (p spasticity more than UC and provided encouraging improvements in other measures. PMID:28607753

  12. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

    DEFF Research Database (Denmark)

    Kruse, A Y; Kjaergard, L L; Krogsgaard, K

    2000-01-01

    To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... the total attitude score (4.8 points) and the randomized clinical trials attitude subscale score (1.8 points). In conclusion, written information significantly improved outpatients' knowledge about and attitude toward randomized clinical trials. Detailed rather than brief information was more effective...

  13. HealthWorks: results of a multi-component group-randomized worksite environmental intervention trial for weight gain prevention

    Directory of Open Access Journals (Sweden)

    Linde Jennifer A

    2012-02-01

    Full Text Available Abstract Background U.S. adults are at unprecedented risk of becoming overweight or obese, and most scientists believe the primary cause is an obesogenic environment. Worksites provide an opportunity to shape the environments of adults to reduce obesity risk. The goal of this group-randomized trial was to implement a four-component environmental intervention at the worksite level to positively influence weight gain among employees over a two-year period. Environmental components focused on food availability and price, physical activity promotion, scale access, and media enhancements. Methods Six worksites in a U.S. metropolitan area were recruited and randomized in pairs at the worksite level to either a two-year intervention or a no-contact control. Evaluations at baseline and two years included: 1 measured height and weight; 2 online surveys of individual dietary intake and physical activity behaviors; and 3 detailed worksite environment assessment. Results Mean participant age was 42.9 years (range 18-75, 62.6% were women, 68.5% were married or cohabiting, 88.6% were white, 2.1% Hispanic. Mean baseline BMI was 28.5 kg/m2 (range 16.9-61.2 kg/m2. A majority of intervention components were successfully implemented. However, there were no differences between sites in the key outcome of weight change over the two-year study period (p = .36. Conclusions Body mass was not significantly affected by environmental changes implemented for the trial. Results raise questions about whether environmental change at worksites is sufficient for population weight gain prevention. Trial Registration ClinicalTrials.gov: NCT00708461

  14. Chosen risk factors for osteoporosis and the level of knowledge about the disease in peri- and postmenopausal women

    OpenAIRE

    Mariola Janiszewska; Teresa Kulik; Małgorzata A. Dziedzic; Dorota Żołnierczuk-Kieliszek

    2015-01-01

    Introduction : Osteoporosis as a chronic disease, affecting especially women in postmenopausal age, is an important, social and economic health problem especially of women of today’s world. The aim of the study was to assess the level of knowledge of women in the peri- and postmenopausal period about the prevention of osteoporosis and show the influence of chosen risk factors on the level of this knowledge. Material and methods : A group of 300 women aged 45-65, being patients of healthc...

  15. Recycling and reuse of chosen kinds of waste materials in a building industry

    Science.gov (United States)

    Ferek, B.; Harasymiuk, J.; Tyburski, J.

    2016-08-01

    The article describes the current state of knowledge and practice in Poland concerning recycling as a method of reuse of chosen groups of waste materials in building industry. The recycling of building scraps is imposed by environmental, economic and technological premises. The issue of usage of sewage residues is becoming a problem of ever -growing gravity as the presence of the increasing number of pernicious contaminants makes their utilization for agricultural purposes more and more limited. The strategies of using waste materials on Polish building sites were analyzed. The analysis of predispositions to salvage for a group of traditional materials, such as: timber, steel, building debris, insulation materials, plastics, and on the example of new materials, such as: artificial light aggregates made by appropriate mixing of siliceous aggregates, glass refuses and sewage residues in order to obtain a commodity which is apt for economic usage also was made in the article. The issue of recycling of waste materials originating from building operations will be presented in the context of the binding home and EU legal regulations. It was proved that the level of recycling of building wastes in Poland is considerably different from one which is achieved in the solid market economies, both in quantity and in assortment. The method of neutralization of building refuses in connection with special waste materials, which are sewage sludge that is presented in the article may be one of the alternative solutions to the problem of recycling of these wastes not only on the Polish scale.

  16. A group randomized controlled trial integrating obesity prevention and control for postpartum adolescents in a home visiting program.

    Science.gov (United States)

    Haire-Joshu, Debra L; Schwarz, Cynthia D; Peskoe, Sarah B; Budd, Elizabeth L; Brownson, Ross C; Joshu, Corinne E

    2015-06-26

    Adolescence represents a critical period for the development of overweight that tracks into adulthood. This risk is significantly heightened for adolescents that become pregnant, many of whom experience postpartum weight retention. The aim of this study was to evaluate Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multicomponent obesity prevention intervention targeting postpartum adolescents participating in a national home visiting child development-parent education program. A group randomized, nested cohort design was used with 1325 adolescents, 694 intervention and 490 control, (mean age = 17.8 years, 52 % underrepresented minorities) located across 30 states. Participatory methods were used to integrate lifestyle behavior change strategies within standard parent education practice. Content targeted replacement of high-risk obesogenic patterns (e.g. sweetened drink and high fat snack consumption, sedentary activity) with positive behaviors (e.g. water intake, fruit and vegetables, increased walking). Parent educators delivered BALANCE through home visits, school based classroom-group meetings, and website activities. Control adolescents received standard child development information. Phase I included baseline to posttest (12 months); Phase II included baseline to follow-up (24 months). When compared to the control group, BALANCE adolescents who were ≥12 weeks postpartum were 89 % more likely (p = 0.02) to maintain a normal BMI or improve an overweight/obese BMI by 12 months; this change was not sustained at 24 months. When compared to the control group, BALANCE adolescents significantly improved fruit and vegetable intake (p = .03). In stratified analyses, water intake improved among younger BALANCE teens (p = .001) and overweight/obese BALANCE teens (p = .05) when compared to control counterparts. There were no significant differences between groups in sweetened drink and snack consumption

  17. Peer support and additional information in group medical consultations (GMCs) for BRCA1/2 mutation carriers: A randomized controlled trial

    NARCIS (Netherlands)

    Visser, Annemiek; van Laarhoven, Hanneke W. M.; Woldringh, Gwendolyn H.; Hoogerbrugge, Nicoline; Prins, Judith B.

    2016-01-01

    Group medical consultations (GMCs) provide individual medical visits in the presence of ≤ 7 peer- patients. This study evaluated the efficacy of GMCs in the yearly breast cancer surveillance of BRCA mutation carriers. This randomized controlled trial compared GMCs (intervention group, n = 63) with

  18. Group and Individual Treatment of Obsessive-Compulsive Disorder Using Cognitive Therapy and Exposure Plus Response Prevention: A 2-Year Follow-Up of Two Randomized Trials

    Science.gov (United States)

    Whittal, Maureen L.; Robichaud, Melisa; Thordarson, Dana S.; McLean, Peter D.

    2008-01-01

    Relatively little is known about the long-term durability of group treatments for obsessive-compulsive disorder (OCD) and contemporary cognitive treatments. The current study investigated the 2-year follow-up results for participants who completed randomized trials of group or individual treatment and received either cognitive therapy (CT) or…

  19. Feedback versus no feedback to improve patient outcome in group psychotherapy for eating disorders (F-EAT): A randomized clinical trial

    DEFF Research Database (Denmark)

    Davidsen, Annika Helgadóttir; Waaddegaard, Mette; Poulsen, Stig Bernt

    Background: A high rate of dropout in the treatment of eating disorders calls for ways to improve treatment attendance. Research indicates that continuous feedback on patient improvement and the therapeutic alliance reduces the number of dropouts and increases patient outcome. There are, however......, only three published randomized trials on the effect of feedback on the treatment of eating disorders showing inconclusive results, and there are no randomized trials on the effect of feedback in group therapy. Objective: The current randomized clinical trial aims to investigate the impact......: Standard treatment (systemic and narrative group psychotherapy) with feedback intervention using the Outcome Rating Scale (ORS) and Group Session Rating Scale (GSRS), or the control group: Standard treatment only. The primary outcome is rate of attendance. Secondary outcome is severity of eating disorder...

  20. The Family Startup Program: study protocol for a randomized controlled trial of a universal group-based parenting support program.

    Science.gov (United States)

    Trillingsgaard, Tea; Maimburg, Rikke Damkjær; Simonsen, Marianne

    2015-04-21

    Inadequate parenting is an important public health problem with possible severe and long-term consequences related to child development. We have solid theoretical and political arguments in favor of efforts enhancing the quality of the early family environment in the population at large. However, little is known about effect of universal approaches to parenting support during the transition to parenthood. This protocol describes an experimental evaluation of group based parenting support, the Family Startup Program (FSP), currently implemented large scale in Denmark. Participants will be approximately 2500 pregnant women and partners. Inclusion criteria are parental age above 18 and the mother expecting first child. Families are recruited when attending routine pregnancy scans provided as a part of the publicly available prenatal care program at Aarhus University Hospital, Skejby. Families are randomized within four geographically defined strata to one of two conditions a) participation in FSP or b) Treatment As Usual (TAU). FSP aims to prepare new families for their roles as parents and enhance parental access to informal sources of support, i.e. social network and community resources. The program consists of twelve group sessions, with nine families in each group, continuing from pregnancy until the child is 15 months old. TAU is the publicly available pre- and postnatal care available to families in both conditions. Analyses will employ survey data, administrative data from health visitors, and administrative register based data from Statistics Denmark. All data sources will be linked via the unique Danish Civil Registration Register (CPR) identifier. Data will be obtained at four time points, during pregnancy, when the child is nine months, 18 months and seven years. The primary study outcome is measured by the Parenting Sense of Competence scale (PSOC) J Clin Child Psychol 18:167-75, 1989. Other outcomes include parenting and couple relationship quality

  1. Addressing behavioral impacts of childhood leukemia: A feasibility pilot randomized controlled trial of a group videoconferencing parenting intervention.

    Science.gov (United States)

    Williams, Lauren K; McCarthy, Maria C; Burke, Kylie; Anderson, Vicki; Rinehart, Nicole

    2016-10-01

    Child emotional and behavioral problems constitute significant sequelae of acute lymphoblastic leukemia (ALL) treatment. The aims of this study were to a) examine the feasibility, acceptability and satisfaction of a parenting intervention amongst parents of children with ALL and b) explore whether participation in a parenting intervention shows promise for improvements in child behavior. 12 parents with a child aged between 2 and 8 years receiving maintenance phase treatment for ALL participated in a phase 2 randomized controlled trial comparing eight weeks of group online participation in Triple P: Positive Parenting Program with no intervention. The number of eligible parents who completed the intervention was low (31.6%). Main reasons for non-consent or dropout were program time commitment too high or content not relevant. For parents who completed the intervention, satisfaction and acceptability was high. Parents reported the intervention as highly relevant and topical, feasible, helpful and a positive experience. Results indicated a non-significant trend towards improved total child behavioral and emotional difficulties following the intervention. Qualitative results indicated that intervention group parents reported improvements in parenting skills and competence, and decreased child behavioral problems. These pilot data highlight the difficulties of engaging and retaining parents in an 8-week parenting intervention in this context. For parents who completed the intervention, results indicated high feasibility, acceptability and satisfaction. Suggestions for further research and intervention modifications are provided to enhance uptake and strengthen efforts to assist parents in addressing child behavioral and emotional challenges during ALL treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study).

    Science.gov (United States)

    Luciano, Juan V; Guallar, José A; Aguado, Jaume; López-Del-Hoyo, Yolanda; Olivan, Bárbara; Magallón, Rosa; Alda, Marta; Serrano-Blanco, Antoni; Gili, Margalida; Garcia-Campayo, Javier

    2014-04-01

    In the last decade, there has been burgeoning interest in the effectiveness of third-generation psychological therapies for managing fibromyalgia (FM) symptoms. The present study examined the effectiveness of acceptance and commitment therapy (ACT) on functional status as well as the role of pain acceptance as a mediator of treatment outcomes in FM patients. A total of 156 patients with FM were enrolled at primary health care centers in Zaragoza, Spain. The patients were randomly assigned to a group-based form of ACT (GACT), recommended pharmacological treatment (RPT; pregabalin + duloxetine), or wait list (WL). The primary end point was functional status (measured with the Fibromyalgia Impact Questionnaire, FIQ). Secondary end points included pain catastrophizing, pain acceptance, pain, anxiety, depression, and health-related quality of life. The differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. Overall, GACT was statistically superior to both RPT and WL immediately after treatment, and improvements were maintained at 6months with medium effect sizes in most cases. Immediately after treatment, the number needed to treat for 20% improvement compared to RPT was 2 (95% confidence interval 1.2-2.0), for 50% improvement 46, and for achieving a status of no worse than mild impaired function (FIQ total score acceptance only mediated the relationship between study condition and health-related quality of life. These findings are discussed in relation to previous psychological research on FM treatment. Copyright © 2013 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  3. The effects of teachers' homework follow-up practices on students' EFL performance: a randomized-group design.

    Science.gov (United States)

    Rosário, Pedro; Núñez, José C; Vallejo, Guillermo; Cunha, Jennifer; Nunes, Tânia; Suárez, Natalia; Fuentes, Sonia; Moreira, Tânia

    2015-01-01

    This study analyzed the effects of five types of homework follow-up practices (i.e., checking homework completion; answering questions about homework; checking homework orally; checking homework on the board; and collecting and grading homework) used in class by 26 teachers of English as a Foreign Language (EFL) using a randomized-group design. Once a week, for 6 weeks, the EFL teachers used a particular type of homework follow-up practice they had previously been assigned to. At the end of the 6 weeks students completed an EFL exam as an outcome measure. The results showed that three types of homework follow-up practices (i.e., checking homework orally; checking homework on the board; and collecting and grading homework) had a positive impact on students' performance, thus highlighting the role of EFL teachers in the homework process. The effect of EFL teachers' homework follow-up practices on students' performance was affected by students' prior knowledge, but not by the number of homework follow-up sessions.

  4. Culturally appropriate health education for Type 2 diabetes in ethnic minority groups: an updated Cochrane Review of randomized controlled trials.

    Science.gov (United States)

    Creamer, J; Attridge, M; Ramsden, M; Cannings-John, R; Hawthorne, K

    2016-02-01

    To give an updated perspective of interventions from additional data collected since our first review, conducted in 2008. This updated Cochrane Review incorporates new information from recent randomized controlled trials on culturally appropriate diabetes health education interventions. An electronic literature search of six databases was repeated, with databases of ongoing trials checked and three journals hand-searched. Meta-analysis was carried out for sufficiently homogeneous outcomes, and common themes among trials were highlighted. A total of 22 new trials were added to the original 11. Meta-analysis of 28 trials containing suitable data showed significant improvements in glycaemic control (HbA1c ) and diabetes knowledge over a period of 24 months, after the delivery of culturally appropriate education to participants, compared with those receiving 'conventional' care. There were no consistent benefits over the control group in other selected outcome measures, and lack of data continued to make analysis of several outcome measures difficult. Research activity in this field has increased considerably over the past 6 years, with culturally appropriate diabetes education showing consistent benefits over conventional care in terms of glycaemic control and diabetes knowledge, sustained in the short- to mid-term. Further research is needed to determine the clinical significance of these improvements and their cost-effectiveness. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

  5. Improving Nutrition and Physical Activity Policies in Afterschool Programs: Results from a Group-Randomized Controlled Trial

    Science.gov (United States)

    Kenney, Erica L.; Giles, Catherine M.; deBlois, Madeleine E.; Gortmaker, Steven L.; Chinfatt, Sherene; Cradock, Angie L.

    2017-01-01

    OBJECTIVE Afterschool programs can be health-promoting environments for children. Written policies positively influence nutrition and physical activity (PA) environments, but effective strategies for building staff capacity to write such policies have not been evaluated. This study measures the comprehensiveness of written nutrition, PA, and screen time policies in afterschool programs and assesses impact of the Out of School Nutrition and Physical Activity (OSNAP) intervention on key policies. METHODS Twenty afterschool programs in Boston, MA participated in a group-randomized, controlled trial from September 2010 to June 2011. Intervention program staff attended learning collaboratives focused on practice and policy change. The Out-of-School Time (OST) Policy Assessment Index evaluated written policies. Inter-rater reliability and construct validity of the measure and impact of the intervention on written policies were assessed. RESULTS The measure demonstrated moderate to excellent inter-rater reliability (Spearman’s r=0.53 to 0.97) and construct validity. OSNAP was associated with significant increases in standards-based policy statements surrounding snacks (+2.6, p=0.003), beverages (+2.3, p=0.008), screen time (+0.8, p=0.046), family communication (+2.2, p=0.002), and a summary index of OSNAP goals (+3.3, p=0.02). CONCLUSIONS OSNAP demonstrated success in building staff capacity to write health-promoting policy statements. Future research should focus on determining policy change impact on practices. PMID:24941286

  6. The Effect of Group Discussion-based Education on Self-management of Adults with Type 2 Diabetes Mellitus Compared with Usual Care: A Randomized Control Trial.

    Science.gov (United States)

    Habibzadeh, Hosein; Sofiani, Akbar; Alilu, Leyla; Gillespie, Mark

    2017-11-01

    We sought to determine the effect of group discussion-based education on the self-management capability of patients with type 2 diabetes in Iran. This randomized control trial was conducted on 90 patients with type 2 diabetes. Participants were allocated randomly into one of two groups; intervention and control. The intervention group received the group discussion-based education while the control group received routine care only. The Lin's self-management questionnaire was completed at baseline and three months post-intervention. Statistical analysis, including the use of independent t-test, identified that in comparison to the control group, significant increases were observed in the scores of self-organization (t =11.24, p self-adjustment (t = 7.53, p self-monitoring (t = 6.42, p self-management (t = 10.82, p self-manage diabetes.

  7. Thesis The effect of flavoinoids and chosen chelators on the oxidation of natural substances

    OpenAIRE

    Malá, Marie

    2014-01-01

    Mgr. Marie Malá, Thesis The effect of flavoinoids and chosen chelators on the oxidation of natural substances, Charles University in Prague, Faculty of Pharmacy in Hradec Králové, 2014, 67 pages. Thesis "The effect of flavonoids and chosen chelators on the oxidation of natural substances" deals with Fenton's reaction. For the needs of this work it means the effect of chosen flavonoids and chelators on oxidation of salicylic acid in presence of peroxide and ferrous ions. Chelators were efficie...

  8. Chosen Aspects of Non‑Profit Sector and Volunteering in Slovakia

    Directory of Open Access Journals (Sweden)

    Beata Gavurova

    2017-01-01

    Full Text Available The significance of voluntary activities in Slovakia constantly increases as it is one of the fundamental areas, which is of particular interest to chosen communities as well as the general public, with the scope of these activities exceeding religious or social groups and national character. The current situation of voluntary activities is not satisfactory and there is an absence of primary research studies that would provide a relevant and complex overview of the volunteering system. Further worsening the situation is the fact that volunteering actions were not even defined in the legal system until 2011. Evaluation of the existing situation and development of voluntary activities realized in Slovakia is carried out using a questionnaire survey, identifying the fundamental barriers of its development and evaluating the potential for implementing new challenges and trends. The most problematic issue is area of financing, closely related to non‑governmental sector financing issues. A lack of understanding by the donors concerning the process of investing in volunteers, even in high quality programs, is also an important problem, along with the lack of legislation and mistrust. Organization and volunteer motivation was also investigated.

  9. Blood gas analysis, blood saturation and chosen parameters of spirometric examination in NSCLC patients undergoing chemotherapy and pulmonary rehabilitation.

    Science.gov (United States)

    Tokarski, Sławomir; Tokarska, Kamila; Schwarz, Ewa; Obrebska, Agnieszka; Mejer, Anna; Kowalski, Jan

    2014-04-01

    In industrialized countries lung cancer is associated with highest mortality among carcinoma. Progression of the disease is associated with diminished tolerance for physical activities, aggravated dyspnea and lowering of life quality. The aim of study was the evaluation of blood gas, blood saturation and chosen parameters of spirometric examination in NSCLC patients undergoing chemotherapy and pulmonary rehabilitation. Analysis of capillary blood was done using RapidPoint 405 Siemens device. Spirometric examination was done using PNEUMO abcMED device. Forty-nine patients with inoperable NSCLC were subjected to the examination. This included 38 men and 11 women aged between 46-75 years (mean age 63 +/- 7.5 years) who were separated into two groups: group I--25 patients undergoing standard chemotherapy (group C); group II--24 patients undergoing standard chemotherapy and pulmonary rehabilitation (group CK). All patients were subjected to blood gas analysis, blood saturation analysis and spirometric examination twice, before and after first-line chemotherapy Increase of pO2 and SaO2 in blood, and FEV1 and FVC in spirometric examination was significantly higher in patients undergoing pulmonary rehabilitation and chemotherapy (group II) (p blood gas, blood saturation analysis and chosen parameters of spirometric analysis. Pulmonary rehabilitation in patients with lung cancer seems to be an important form of supplementary treatment.

  10. Influence of Motivation on the Effectiveness of Work in a chosen Firm

    OpenAIRE

    Hrutkaiová, Gabriela

    2011-01-01

    This bachelor thesis is concerned with motivation of employees, describes factors, which can directly or indirectly influence workers and instigate them to efficient work. Theory engages with the definition of motivation term, and its importance, motivation progression and also describes concrete tools, which stimulate increase in employee's motivation. The practical part evaluates system of motivation and its effect in chosen company and also decides whether chosen methods succeeded.

  11. Effects of gradient and speed on freely chosen cadence: the key role of crank inertial load.

    Science.gov (United States)

    Sassi, Aldo; Rampinini, Ermano; Martin, David T; Morelli, Andrea

    2009-01-19

    The purpose of this study was to describe the relationship between road gradient (RG) and freely chosen cadence (FCC) in a group of professional cyclists during their normal training. In addition, a calculation of crank inertial load (CIL) was estimated in order to establish the relationship between FCC and CIL. Ten professional cyclists were monitored during training using commercially available power meters (Shoberer Rad Messtechnik (SRM), professional version). For each cyclist, recorded training sessions were reviewed to identify the hardest 6-8 training sessions (approximately 18 h of training). RG was estimated based on the relationship between power output, total mass and speed. The analysis was performed using 2113+/-317 samples of 30 s average data, collected on terrain ranging from -4%RG to 12%RG. The individual relationship between FCC and RG could be described by a linear regression model. There was a moderate correlation between FCC and CIL (group's r=0.42), and a multiple regression including the measured power output (WPO) increased the variance explained (R2=0.24). The correlation was very large between CIL and v (r=0.91), and was not strengthened by adding WPO as an independent variable (r=0.91). In conclusion, this investigation documents that in professional cyclists engaged in training, there is a linear decrease in FCC as RG increases (-4%RG and 12%RG). This decrease in FCC appears to be due to the reduction in v as slope increases. It is surmised that CIL plays a key role in the modulation of FCC.

  12. The effect of order of dwells on the first dwell gaze bias for eventually chosen items.

    Science.gov (United States)

    Onuma, Takuya; Penwannakul, Yuwadee; Fuchimoto, Jun; Sakai, Nobuyuki

    2017-01-01

    The relationship between choice and eye movement has gained marked interest. The gaze bias effect, i.e., the tendency to look longer at items that are eventually chosen, has been shown to occur in the first dwell (initial cohesion of fixations for an item). In the two-alternative forced-choice (2AFC) paradigm, participants would look at one of the items first (defined as first look; FL), and they would then move and look at another item (second look; SL). This study investigated how the order in which the chosen items were looked at modulates the first dwell gaze bias effect. Participants were asked to assert their preferences and perceptual 2AFC decisions about human faces (Experiment 1) and daily consumer products (Experiment 2), while their eye movements were recorded. The results showed that the first dwell gaze bias was found only when the eventually chosen item was looked at after another one; the chosen item was looked at for longer as compared to the not-chosen item in the SL, but not in the FL. These results indicate that participants actively allocate more time to looking at a subsequently chosen item only after they perceive both items in the SL. Therefore, the selective encoding seems to occur in the early comparison stage of visual decision making, and not in the initial encoding stage. These findings provide insight into the relationship between choice and eye movement.

  13. n-th Roots in finite polyhedral and centro-polyhedral groups

    Indian Academy of Sciences (India)

    The probability that a randomly chosen element in a non-abelian finite group has a square root, has been investigated by certain authors in recent years. In this paper, this probability will be generalized for the -th roots when ≥ 2 and it will be computed for every finite polyhedral group and all of the finite ...

  14. Quality of life and standard of living in a randomly selected group of psychiatrically disabled people in Sweden 2 years after a psychiatry reform.

    Science.gov (United States)

    Carlsson, I; Frederiksen, S-O; Gottfries, C-G

    2002-07-01

    In Sweden, a psychiatry reform, aimed at improving the living conditions of the psychiatrically disabled, came into force in 1995. The aim of the present study was to evaluate the impact of the reform by investigating quality of life and standard of living 2 years later in a randomly selected group of people with longstanding psychiatric disability. Self-ratings and interviews were conducted in a study group and a control group. The study group consisted of 19 women and 18 men (mean age 46.1 years) diagnosed with neurosis, schizophrenia or affective disorder. The control group consisted of 19 women and 17 men (mean age 48.7 years). Self-rated quality of life was significantly poorer in the study group (P standard of living in either group but a significant negative correlation in the control group (P standard of living.

  15. The prevalence and classification of chronic kidney disease in cats randomly selected within four age groups and in cats recruited for degenerative joint disease studies

    Science.gov (United States)

    Marino, Christina L; Lascelles, B Duncan X; Vaden, Shelly L; Gruen, Margaret E; Marks, Steven L

    2015-01-01

    Chronic kidney disease (CKD) and degenerative joint disease are both considered common in older cats. Information on the co-prevalence of these two diseases is lacking. This retrospective study was designed to determine the prevalence of CKD in two cohorts of cats: cats randomly selected from four evenly distributed age groups (RS group) and cats recruited for degenerative joint disease studies (DJD group), and to evaluate the concurrence of CKD and DJD in these cohorts. The RS group was randomly selected from four age groups from 6 months to 20 years, and the DJD group comprised cats recruited to four previous DJD studies, with the DJD group excluding cats with a blood urea nitrogen and/or serum creatinine concentration >20% (the upper end of normal) for two studies and cats with CKD stages 3 and 4 for the other two studies. The prevalence of CKD in the RS and DJD groups was higher than expected at 50% and 68.8%, respectively. CKD was common in cats between 1 and 15 years of age, with a similar prevalence of CKD stages 1 and 2 across age groups in both the RS and DJD cats, respectively. We found significant concurrence between CKD and DJD in cats of all ages, indicating the need for increased screening for CKD when selecting DJD treatments. Additionally, this study offers the idea of a relationship and causal commonality between CKD and DJD owing to the striking concurrence across age groups and life stages. PMID:24217707

  16. Prevalence and classification of chronic kidney disease in cats randomly selected from four age groups and in cats recruited for degenerative joint disease studies.

    Science.gov (United States)

    Marino, Christina L; Lascelles, B Duncan X; Vaden, Shelly L; Gruen, Margaret E; Marks, Steven L

    2014-06-01

    Chronic kidney disease (CKD) and degenerative joint disease are both considered common in older cats. Information on the co-prevalence of these two diseases is lacking. This retrospective study was designed to determine the prevalence of CKD in two cohorts of cats: cats randomly selected from four evenly distributed age groups (RS group) and cats recruited for degenerative joint disease studies (DJD group), and to evaluate the concurrence of CKD and DJD in these cohorts. The RS group was randomly selected from four age groups from 6 months to 20 years, and the DJD group comprised cats recruited to four previous DJD studies, with the DJD group excluding cats with a blood urea nitrogen and/or serum creatinine concentration >20% (the upper end of normal) for two studies and cats with CKD stages 3 and 4 for the other two studies. The prevalence of CKD in the RS and DJD groups was higher than expected at 50% and 68.8%, respectively. CKD was common in cats between 1 and 15 years of age, with a similar prevalence of CKD stages 1 and 2 across age groups in both the RS and DJD cats, respectively. We found significant concurrence between CKD and DJD in cats of all ages, indicating the need for increased screening for CKD when selecting DJD treatments. Additionally, this study offers the idea of a relationship and causal commonality between CKD and DJD owing to the striking concurrence across age groups and life stages. © ISFM and AAFP 2013.

  17. Effects of a Topical Saffron (Crocus sativus L) Gel on Erectile Dysfunction in Diabetics: A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Mohammadzadeh-Moghadam, Hossein; Nazari, Seyed Mohammad; Shamsa, Ali; Kamalinejad, Mohammad; Esmaeeli, Habibollah; Asadpour, Amir Abbas; Khajavi, Abdoljavad

    2015-10-01

    Erectile dysfunction is a man's persistent or recurrent inability to achieve and maintain erection for a satisfactory sexual relationship. As diabetes is a major risk factor for erectile dysfunction, the prevalence of erectile dysfunction among diabetic men has been reported as 35% to 90%. This randomized, parallel-group, double-blind, placebo-controlled trial investigated the effects of a topical saffron (Crocus sativus L) gel on erectile dysfunction in diabetic men. Patients were randomly allocated to 2 equal groups (with 25 patients each). The intervention group was treated with topical saffron, and the control received a similar treatment with placebo. The 2 groups were assessed using the International Index of Erectile Function Questionnaire before the intervention and 1 month after the intervention. Compared to placebo, the prepared saffron gel could significantly improve erectile dysfunction in diabetic patients (P saffron can be considered as a treatment option for diabetic men with erectile dysfunction. © The Author(s) 2015.

  18. Comparison of efficacy, safety, and cost-effectiveness of rupatadine and olopatadine in patients of allergic rhinitis: A prospective, randomized, double-blind, parallel group study.

    Science.gov (United States)

    Dakhale, Ganesh; Tathod, Yogesh; Patel, Seema; Pimpalkhute, Sonali; Raghute, Latesh; Khamkar, Ajita

    2016-01-01

    To compare the efficacy, safety, and cost-effectiveness of rupatadine and olopatadine in patients of allergic rhinitis (AR). A 2-week, single-centered, randomized, double-blind, parallel group comparative clinical study was conducted on patients with AR. Following inclusion and exclusion criteria, 67 patients were recruited and randomized to two treatment groups and received the respective drugs for 2 weeks. At follow-up, parameters assessed were total nasal symptom score (TNSS), change in total and differential count of eosinophil. In olopatadine group, there was a significantly higher reduction in TNSS (P rupatadine. Both the drugs significantly reduced the absolute eosinophil count, but olopatadine (P rupatadine group. Olopatadine is a better choice in AR in comparison to rupatadine due to its better efficacy and safety profile.

  19. From Planning to Implementation: An Examination of Changes in the Research Design, Sample Size, and Precision of Group Randomized Trials Launched by the Institute of Education Sciences

    Science.gov (United States)

    Spybrook, Jessaca; Puente, Anne Cullen; Lininger, Monica

    2013-01-01

    This article examines changes in the research design, sample size, and precision between the planning phase and implementation phase of group randomized trials (GRTs) funded by the Institute of Education Sciences. Thirty-eight GRTs funded between 2002 and 2006 were examined. Three studies revealed changes in the experimental design. Ten studies…

  20. The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study--a randomized controlled trial

    DEFF Research Database (Denmark)

    Toft, Ulla; Kristoffersen, Lis; Ladelund, Steen

    2008-01-01

    Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits....

  1. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    NARCIS (Netherlands)

    Pradhan, M.; Brinkman, S.A.; Beatty, A.; Maika, A.; Satriawan, E.; de Ree, J.; Hasan, A.

    2013-01-01

    Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program

  2. Efficacy of Cognitive Behavioral Therapy for insomnia in adolescents: A randomized controlled trial with internet therapy, group therapy and a waiting list condition

    NARCIS (Netherlands)

    de Bruin, E.J.; Bögels, S.M.; Oort, F.J.; Meijer, A.M.

    2015-01-01

    Study Objectives: To investigate the efficacy of cognitive behavioral therapy for insomnia (CBTI) in adolescents. Design: A randomized controlled trial of CBTI in group therapy (GT), guided internet therapy (IT), and a waiting list (WL), with assessments at baseline, directly after treatment

  3. Characterization of geometrical random uncertainty distribution for a group of patients in radiotherapy; Caracterizacion de la distribucion de incertidumbres geometricas aleatorias para un grupo de pacientes en radioterapia

    Energy Technology Data Exchange (ETDEWEB)

    Munoz Montplet, C.; Jurado Bruggeman, D.

    2010-07-01

    Geometrical random uncertainty in radiotherapy is usually characterized by a unique value in each group of patients. We propose a novel approach based on a statistically accurate characterization of the uncertainty distribution, thus reducing the risk of obtaining potentially unsafe results in CT V-Pt margins or in the selection of correction protocols.

  4. The effects of adding group-based lifestyle counselling to individual counselling on changes in plasma glucose levels in a randomized controlled trial: The Inter99 study

    DEFF Research Database (Denmark)

    Lau, C.; Vistisen, D.; Toft, U.

    2011-01-01

    participants, 4053 were determined to be at high risk based on a risk estimate of ischaemic heart disease or the presence of risk factors (smoking, hypertension, hypercholesterolaemia, obesity, impaired glucose tolerance). Of these subjects, 90% were randomized to high-intensity intervention (group A) and 10...

  5. Chosen aspects of quality of life in patients with venous leg ulcers

    Directory of Open Access Journals (Sweden)

    Michaela Miertová

    2016-12-01

    Full Text Available Aim: The aim of the paper was to describe chosen aspects of quality of life in patients with venous leg ulcers treated at home in the Turiec region, and to find differences in assessing quality of life in relation to degree of adherence to external compression therapy. Design: A quantitative cross-sectional study. Methods: There were 61 patients with venous leg ulcers at 68.59 ± 9.49 years of age, with an average length of wound treatment of 6.34 ± 5.51 years. The adapted self-assessment questionnaire, the Freiburg Life Quality Assessment wound module (FLQA-w, was used to gain empirical data. Results: The findings revealed that the worst score was achieved in the category of everyday life (3.61 ± 0.93. Statistically significant differences were found between the group of respondents who apply bandages on a daily basis and those who did not use them at all. Regular bandage application is closely connected with positive assessment of wound therapy (p = 0.043, psychosocial life (p = 0.023, verbalisation of well-being in various categories (p = 0.001, assessment of state of the wound (p = 0.032, assessment of health condition (p = 0.019, and overall quality of life (p = 0.014. Length of wound treatment is related to assessments of quality of life. Conclusion: Non-healing wounds, the associated therapy and financial means required to treat them, and the pain resulting from them, are connected with physical difficulty, experience of negative emotions, and, thus, the worsening of patientsʼ quality of life. The results of the study could form the basis for further studies on similar issues.

  6. The Effect of Participation in Support Groups on Depression, Anxiety and Stress in Family Caregivers of People with Alzheimers: Randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Fahimeh Taati

    2016-07-01

    Full Text Available This study sought to determine the effect of participation in support groups on the depression, anxiety and stress level of caregivers of patients with Alzheimer. This study was a single blind randomized clinical controlled trial (RCT with 80 family caregivers of people with Alzheimer’s (per group=40. The intervention group participated in eight sessions 1.5- 2 hours in support groups. The tool used in this study was the DASS-21 questionnaire for measuring depression, anxiety and stress level of the caregivers, analysis of parametric data, using SPSS version 21. Findings showed, participation in support groups showed no significant difference on depression, anxiety and stress in family caregivers of Alzheimer patients in the control group and the intervention group. Given that caring for these patients by their family members are very sensitive and costly issues for policy makers and health service providers, community and families of these patients.

  7. Group cognitive behavior therapy or social skills training for individuals with a recent onset of psychosis? Results of a randomized controlled trial.

    Science.gov (United States)

    Lecomte, Tania; Leclerc, Claude; Corbière, Marc; Wykes, Til; Wallace, Charles J; Spidel, Alicia

    2008-12-01

    This study aimed at determining the effectiveness of group cognitive behavior therapy (CBT) for recent onset psychosis in comparison with a recognized intervention for individuals with severe mental illness-social skills training. One hundred twenty-nine participants took part in a single-blind randomized controlled trial with repeated measures (baseline, 3 months, and 9 months). Participants were randomized to 1 of 3 conditions: group CBT, group social skills training for symptom management, or a wait-list control group. Both interventions were delivered by mental health staff with minimal training. Both treatments resulted in improvements on positive and negative symptoms compared with the wait-list control group, with the CBT group having significant effects over time on overall symptoms, and post-treatment effects on self-esteem, and active coping skills compared with the wait-list control group and lower drop-out rates than the skills training group. Therapist fidelity was adequate for both treatment conditions. Group CBT for psychosis is a promising intervention for individuals with recent onset of psychosis and their mental health professionals.

  8. The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study – a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Smith Lisa

    2008-11-01

    Full Text Available Abstract Background Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits. Methods The study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301, two random sample were drawn (group A, n = 11,708; group B, n = 1,308. Subjects were invited for a health screening program. Participation rate was 52.5%. All participants received individual life-style counselling. Individuals at high risk of ischemic heart disease in group A were furthermore offered group-based life-style counselling. The intervention was repeated for high-risk individuals after one and three years. At five-year follow-up all participants were invited for a health examination. High risk individuals were included in this study (n = 2 356 and changes in dietary intake were analyzed using multilevel linear regression analyses. Results At one-year follow-up group A had significantly increased the unsaturated/saturated fat ratio compared to group B and in men a significantly greater decrease in saturated fat intake was found in group A compared to group B (net change: -1.13 E%; P = 0.003. No differences were found between group A and B at three-year follow-up. At five-year follow-up group A had significantly increased the unsaturated/saturated fat ratio (net change: 0.09; P = 0.01 and the fish intake compared to group B (net change: 5.4 g/day; P = 0.05. Further, in men a non-significant tendency of a greater decrease was found at five year follow-up in group A compared to group B (net change: -0.68 E%; P = 0.10. The intake of fibre and vegetables increased in both groups, however, no significant difference was found between the groups. No differences between groups were found for saturated fat

  9. The Effect of Group Discussion-based Education on Self-management of Adults with Type 2 Diabetes Mellitus Compared with Usual Care: A Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Hosein Habibzadeh

    2017-11-01

    Full Text Available Objectives: We sought to determine the effect of group discussion-based education on the self-management capability of patients with type 2 diabetes in Iran. Methods: This randomized control trial was conducted on 90 patients with type 2 diabetes. Participants were allocated randomly into one of two groups; intervention and control. The intervention group received the group discussion-based education while the control group received routine care only. The Lin’s self-management questionnaire was completed at baseline and three months post-intervention. Results: Statistical analysis, including the use of independent t-test, identified that in comparison to the control group, significant increases were observed in the scores of self-organization (t =11.24, p < 0.001, self-adjustment (t = 7.53, p < 0.001, interaction with health experts (t = 7.31, p < 0.001, blood sugar self-monitoring (t = 6.42, p < 0.001, adherence to the proposed diet (t = 5.22, p < 0.001, and total self-management (t = 10.82, p < 0.001 in the intervention group. Conclusions: Sharing experiences through group discussions and receiving instructive feedback can improve the ability to self-manage diabetes.

  10. Single- versus two-visit pulpectomy treatment in primary teeth with apical periodontitis: A double-blind, parallel group, randomized controlled trial.

    Science.gov (United States)

    Bharuka, Sneha Bharatkumar; Mandroli, Praveenkumar S

    2016-01-01

    Reduction of the bacterial populations to levels compatible with periradicular tissue healing is the primary microbiological goal of the endodontic treatment of teeth with apical periodontitis. The number of visits required to treat teeth with apical periodontitis represents one of the most debatable issues in endodontics. The objective of this study was to compare and evaluate the clinical and radiographic outcome of single- versus two-visit pulpectomy treatment in primary teeth with apical periodontitis at the end of 6-month healing period. A parallel group, double-blind, randomized controlled trial was carried out in 64 children aged 4-8 years. Nonvital primary teeth with apical periodontitis with enough coronal structure were selected. Sixty-four children were assigned randomly into two groups (32 children each) by block randomization, and allocation concealment was done with closed envelop method. Group I underwent single-visit pulpectomy followed by obturation with zinc oxide eugenol (ZOE). Group II underwent conventional two-visit pulpectomy with intracanal calcium hydroxide, followed by obturation with ZOE. Postoperative clinical and radiographic evaluation was carried out at 1, 3, and 6 months after the end of the treatment. The data were analyzed by Wilcoxon's signed rank test, Mann-Whitney U-test, and Friedman test. There was no statistically significant difference in clinical and radiographic outcomes in both the groups at the end of 6-month healing period. Single-visit pulpectomy can be considered as a viable option for the treatment of primary teeth with apical periodontitis.

  11. A randomized, controlled clinical trial of standard, group and brief cognitive-behavioral therapy for panic disorder with agoraphobia: a two-year follow-up.

    Science.gov (United States)

    Marchand, André; Roberge, Pasquale; Primiano, Sandra; Germain, Vanessa

    2009-12-01

    A randomized controlled clinical trial with a wait-list control group was conducted to examine the effectiveness of three modalities (brief, group, and standard) of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants meeting DSM-IV criteria were randomly assigned to each treatment condition: a 14-session standard CBT (n=33), a 14-session group CBT (n=35) and a 7-session brief CBT (n=32). Participants received a self-study manual and were assigned weekly readings and exercises. The results indicate that regardless of the treatment condition, CBT for moderate to severe PDA is beneficial in medium and long term. To this effect, all three-treatment conditions significantly reduced the intensity of symptoms, increased participants' quality of life, offered high effect sizes, superior maintenance of gains over time, and lower rates of relapse, compared to the wait-list control.

  12. Individual and Group Cognitive-Behavioral Treatment for Work-Related Stress Complaints and Sickness Absence: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Vente, W.de; Kamphuis, J.H.; Emmelkamp, P.M.G.; Blonk, R.W.B.

    2008-01-01

    Work-related stress is widespread and can lead to long-term absenteeism and work disability. Cognitive-behavioral treatment (CBT) has demonstrated effectiveness in treating psychopathology but has only rarely been tested in clinical samples with work-related stress. A randomized controlled trial was

  13. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial.

    NARCIS (Netherlands)

    Hartgrink, H.H.; Velde, C.J. van de; Putter, H.; Bonenkamp, J.J.; Meershoek-Klein Kranenbarg, E.; Songun, I.; Welvaart, K.; Krieken, J.H.J.M. van; Meijer, S.; Plukker, J.T.; Elk, P.J. van; Obertop, H.; Gouma, D.J.; Lanschot, J.J.B. van; Taat, C.W.; Graaf, P.W. de; Meyenfeldt, M.F. von; Tilanus, H.W.; Sasako, M.

    2004-01-01

    PURPOSE: The extent of lymph node dissection appropriate for gastric cancer is still under debate. We have conducted a randomized trial to compare the results of a limited (D1) and extended (D2) lymph node dissection in terms of morbidity, mortality, long-term survival and cumulative risk of

  14. Extended lymph node dissection for gastric cancer : Who may benefit? Final results of the randomized Dutch Gastric Cancer Group Trial

    NARCIS (Netherlands)

    Hartgrink, HH; van de Velde, CJH; Putter, H; Bonenkamp, JJ; Kranenbarg, EK; Songun, [No Value; Welvaart, K; van Krieken, JHJM; Meijer, S; Plukker, JTM; van Elk, PJ; Obertop, H; Gouma, DJ; van Lanschot, JJB; Taat, CW; de Graaf, PW; von Meyenfeldt, MF; Tilanus, H; Sasako, M

    2004-01-01

    Purpose. The extent of lymph node dissection appropriate for gastric cancer is still under debate. We have conducted a randomized trial to compare the results of a limited (D1) and extended (D2) lymph node dissection in terms of morbidity, mortality, long-term survival and cumulative risk of

  15. Desensitization to a whole egg by rush oral immunotherapy improves the quality of life of guardians: A multicenter, randomized, parallel-group, delayed-start design study.

    Science.gov (United States)

    Itoh-Nagato, Naoka; Inoue, Yuzaburo; Nagao, Mizuho; Fujisawa, Takao; Shimojo, Naoki; Iwata, Tsutomu

    2017-08-01

    Patients with food allergies and their families have a significantly reduced health-related quality of life (QOL). We performed a multicenter, randomized, parallel-group, delayed-start design study to clarify the efficacy and safety of rush oral immunotherapy (rOIT) and its impact on the participants' daily life and their guardians (UMIN000003943). Forty-five participants were randomly divided into an early-start group and a late-start group. The early-start group received rOIT for 3 months, while the late-start group continued the egg elimination diet (control). In the next stage, both groups received OIT until all participants had finished 12 months of maintenance OIT. The ratio of the participants in whom an increase of the TD was achieved in the first stage was significantly higher in the early-start group (87.0%), than in the late-start group (22.7%). The QOL of the guardians in the early-start group significantly improved after the first stage (65.2%), in comparison to the late-start group (31.8%). During 12 months of rOIT, the serum ovomucoid-specific IgE levels, the percentage of CD203c + basophils upon stimulation with egg white, and the wheal size to egg white were decreased, while the serum ovomucoid-specific IgG4 levels were increased. However, approximately 80% of the participants in the early-start group showed an allergic reaction during the first stage of the study, whereas none of the patients in the late-start group experienced an allergic reaction. rOIT induced desensitization to egg and thus improved the QOL of guardians; however, the participants experienced frequent allergic reactions due to the treatment. Copyright © 2017 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

  16. Comparison of efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic spontaneous urticaria: A randomized, double-blind, comparative, parallel group trial

    Directory of Open Access Journals (Sweden)

    Ganesh N Dakhale

    2016-01-01

    Full Text Available Objective: To compare efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic spontaneous urticaria. Materials and Methods: A 6-week, single-centered, randomized, double blind, parallel group comparative clinical study was conducted on patients with chronic spontaneous urticaria. Following inclusion and exclusion criteria, 60 patients were recruited and were randomized to two treatment groups and received the respective drugs for 6 weeks. At follow-up, parameters assessed were mean total symptom score (MTSS calculated by adding the mean number of wheals (MNW and the mean pruritus score (MPS, number of wheals, size of wheal, scale for interference of wheals with sleep (SIWS. Results: Both the drugs significantly reduced the MTSS, number of wheals, size of wheal, scale for interference of wheals with sleep, but olopatadine was found to be superior. In olopatadine group, there was significantly higher reduction in MTSS (p = 0.01, Number of wheals (P < 0.05, Size of wheals (p < 0.05, Scale for intensity of erythema (p < 0.05 and change in eosinopils count (p = 0.015 than that of rupatadine. Incidence of adverse effects was found to be less in olopatadine group when compared with rupatadine group. Cost effectiveness ratio was less in olopatadine group as compared to rupatadine group throughout the treatment. Conclusions: Olopatadine is a better choice in chronic spontaneous urticaria in comparison to rupatadine due to its better efficacy, safety and cost effectiveness profile.

  17. Comparison of Efficacy, Safety and Cost-effectiveness of Rupatadine and Olopatadine in Patients of Chronic Spontaneous Urticaria: A Randomized, Double-blind, Comparative, Parallel Group Trial.

    Science.gov (United States)

    Dakhale, Ganesh N; Wankhede, Sumit S; Mahatme, Mohini S; Hiware, Sachin K; Mishra, Dharmendra B; Dudhgaonkar, Sujata S

    2016-01-01

    To compare efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic spontaneous urticaria. A 6-week, single-centered, randomized, double blind, parallel group comparative clinical study was conducted on patients with chronic spontaneous urticaria. Following inclusion and exclusion criteria, 60 patients were recruited and were randomized to two treatment groups and received the respective drugs for 6 weeks. At follow-up, parameters assessed were mean total symptom score (MTSS) calculated by adding the mean number of wheals (MNW) and the mean pruritus score (MPS), number of wheals, size of wheal, scale for interference of wheals with sleep (SIWS). Both the drugs significantly reduced the MTSS, number of wheals, size of wheal, scale for interference of wheals with sleep, but olopatadine was found to be superior. In olopatadine group, there was significantly higher reduction in MTSS (p = 0.01), Number of wheals (P rupatadine. Incidence of adverse effects was found to be less in olopatadine group when compared with rupatadine group. Cost effectiveness ratio was less in olopatadine group as compared to rupatadine group throughout the treatment. Olopatadine is a better choice in chronic spontaneous urticaria in comparison to rupatadine due to its better efficacy, safety and cost effectiveness profile.

  18. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients’ Depression: A Randomized, Single-Blinded, Controlled Study

    Directory of Open Access Journals (Sweden)

    Kai-Jo Chiang

    2015-01-01

    Full Text Available The aim of the study was to investigate the long-term (one year effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT or control group (usual outpatient psychiatric care group and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II and Hamilton Rating Scale for Depression (HRSD. The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ. Both groups were evaluated at the pretest (before 2 weeks, posttest (after 12 therapy sessions, and short- (3 months, medium- (6 months, and long-term (12 months follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P<0.001. Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P<0.001. We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up.

  19. Palm theory for random time changes

    Directory of Open Access Journals (Sweden)

    Masakiyo Miyazawa

    2001-01-01

    Full Text Available Palm distributions are basic tools when studying stationarity in the context of point processes, queueing systems, fluid queues or random measures. The framework varies with the random phenomenon of interest, but usually a one-dimensional group of measure-preserving shifts is the starting point. In the present paper, by alternatively using a framework involving random time changes (RTCs and a two-dimensional family of shifts, we are able to characterize all of the above systems in a single framework. Moreover, this leads to what we call the detailed Palm distribution (DPD which is stationary with respect to a certain group of shifts. The DPD has a very natural interpretation as the distribution seen at a randomly chosen position on the extended graph of the RTC, and satisfies a general duality criterion: the DPD of the DPD gives the underlying probability P in return.

  20. The effect of peer-group size on the delivery of feedback in basic life support refresher training: a cluster randomized controlled trial.

    Science.gov (United States)

    Cho, Youngsuk; Je, Sangmo; Yoon, Yoo Sang; Roh, Hye Rin; Chang, Chulho; Kang, Hyunggoo; Lim, Taeho

    2016-07-04

    Students are largely providing feedback to one another when instructor facilitates peer feedback rather than teaching in group training. The number of students in a group affect the learning of students in the group training. We aimed to investigate whether a larger group size increases students' test scores on a post-training test with peer feedback facilitated by instructor after video-guided basic life support (BLS) refresher training. Students' one-rescuer adult BLS skills were assessed by a 2-min checklist-based test 1 year after the initial training. A cluster randomized controlled trial was conducted to evaluate the effect of student number in a group on BLS refresher training. Participants included 115 final-year medical students undergoing their emergency medicine clerkship. The median number of students was 8 in the large groups and 4 in the standard group. The primary outcome was to examine group differences in post-training test scores after video-guided BLS training. Secondary outcomes included the feedback time, number of feedback topics, and results of end-of-training evaluation questionnaires. Scores on the post-training test increased over three consecutive tests with instructor-led peer feedback, but not differ between large and standard groups. The feedback time was longer and number of feedback topics generated by students were higher in standard groups compared to large groups on the first and second tests. The end-of-training questionnaire revealed that the students in large groups preferred the smaller group size compared to their actual group size. In this BLS refresher training, the instructor-led group feedback increased the test score after tutorial video-guided BLS learning, irrespective of the group size. A smaller group size allowed more participations in peer feedback.

  1. Student Self-Efficacy in a Chosen Business Career Path: The Influence of Cognitive Style

    Science.gov (United States)

    Harder, Joseph T.; Czyzewski, Alan; Sherwood, Arthur L.

    2015-01-01

    An important dimension of university students' academic success is retention in their chosen major. When students do switch majors or interrupt their education, it is largely due to their lack of confidence about doing well academically, as well as perceived chances of success in the career area related to university major. A term often used for…

  2. Short Chosen-Prefix Collisions for MD5 and the Creation of a Rogue CA Certificate

    NARCIS (Netherlands)

    M.M.J. Stevens (Marc); A. Sotirov (Alexander); J. Appelbaum; A.K. Lenstra (Arjen); D. Molnar; D.A. Osvik; B. de Weger (Benne)

    2009-01-01

    textabstractWe present a refined chosen-prefix collision construction for MD5 that allowed creation of a rogue Certification Authority (CA) certificate, based on a collision with a regular end-user website certificate provided by a commercial CA. Compared to the previous construction from Eurocrypt

  3. Group Parent-Child Interaction Therapy: A Randomized Control Trial for the Treatment of Conduct Problems in Young Children

    OpenAIRE

    Niec, LN; Barnett, ML; Prewett, MS; Chatham, JRS

    2016-01-01

    Although efficacious interventions exist for childhood conduct problems, a majority of families in need of services do not receive them. To address problems of treatment access and adherence, innovative adaptations of current interventions are needed. This randomized control trial investigated the relative efficacy of a novel format of parent-child interaction therapy (PCIT), a treatment for young children with conduct problems.Eighty-one families with 3- to 6-year-old children (71.6% boys, 8...

  4. What's on Your Mind? Conversation Topics Chosen by People With Degenerative Cognitive-Linguistic Disorders for Communication Boards.

    Science.gov (United States)

    Fried-Oken, Melanie; Daniels, Darlene; Ettinger, Olivia; Mooney, Aimee; Noethe, Glory; Rowland, Charity

    2015-05-01

    Conversational topics chosen by a group of adults with degenerative cognitive-linguistic disorders for personalized communication board development were examined. The patient-generated themes commonly selected are presented to guide treatment planning and communication board development. Communication boards were created for 109 adults as part of a larger research project. One autobiographical topic that each participant would enjoy discussing multiple times was represented on each communication board with 16 pictures and word labels. For this review, topics were collapsed into general themes through a consensus process and examined by gender and age. Sixty unique conversational topics were identified from 109 participants and collapsed into 9 general themes: Hobbies, Family, Travel, Work, Home/Places I've Lived, Sports/Fitness, Religion, Animals, and World War II. Age and gender produced variations in themes chosen, though no significance in rank orders was found across groups. Topics selected by adults with degenerative cognitive-linguistic disorders for communication boards resemble common conversational adult themes and do not center around basic needs or medical issues. Differences in gender and age for topic selection tend to be based on traditional roles. These general themes should be used when creating personalized communication boards for those who benefit from conversational aids.

  5. Effects of online group exercises for older adults on physical, psychological and social wellbeing: a randomized pilot trial.

    Science.gov (United States)

    Baez, Marcos; Khaghani Far, Iman; Ibarra, Francisco; Ferron, Michela; Didino, Daniele; Casati, Fabio

    2017-01-01

    Intervention programs to promote physical activity in older adults, either in group or home settings, have shown equivalent health outcomes but different results when considering adherence. Group-based interventions seem to achieve higher participation in the long-term. However, there are many factors that can make of group exercises a challenging setting for older adults. A major one, due to the heterogeneity of this particular population, is the difference in the level of skills. In this paper we report on the physical, psychological and social wellbeing outcomes of a technology-based intervention that enable online group exercises in older adults with different levels of skills. A total of 37 older adults between 65 and 87 years old followed a personalized exercise program based on the OTAGO program for fall prevention, for a period of eight weeks. Participants could join online group exercises using a tablet-based application. Participants were assigned either to the Control group, representing the traditional individual home-based training program, or the Social group, representing the online group exercising. Pre- and post- measurements were taken to analyze the physical, psychological and social wellbeing outcomes. After the eight-weeks training program there were improvements in both the Social and Control groups in terms of physical outcomes, given the high level of adherence of both groups. Considering the baseline measures, however, the results suggest that while in the Control group fitter individuals tended to adhere more to the training, this was not the case for the Social group, where the initial level had no effect on adherence. For psychological outcomes there were improvements on both groups, regardless of the application used. There was no significant difference between groups in social wellbeing outcomes, both groups seeing a decrease in loneliness despite the presence of social features in the Social group. However, online social interactions

  6. Effects of online group exercises for older adults on physical, psychological and social wellbeing: a randomized pilot trial

    Directory of Open Access Journals (Sweden)

    Marcos Baez

    2017-04-01

    Full Text Available Background Intervention programs to promote physical activity in older adults, either in group or home settings, have shown equivalent health outcomes but different results when considering adherence. Group-based interventions seem to achieve higher participation in the long-term. However, there are many factors that can make of group exercises a challenging setting for older adults. A major one, due to the heterogeneity of this particular population, is the difference in the level of skills. In this paper we report on the physical, psychological and social wellbeing outcomes of a technology-based intervention that enable online group exercises in older adults with different levels of skills. Methods A total of 37 older adults between 65 and 87 years old followed a personalized exercise program based on the OTAGO program for fall prevention, for a period of eight weeks. Participants could join online group exercises using a tablet-based application. Participants were assigned either to the Control group, representing the traditional individual home-based training program, or the Social group, representing the online group exercising. Pre- and post- measurements were taken to analyze the physical, psychological and social wellbeing outcomes. Results After the eight-weeks training program there were improvements in both the Social and Control groups in terms of physical outcomes, given the high level of adherence of both groups. Considering the baseline measures, however, the results suggest that while in the Control group fitter individuals tended to adhere more to the training, this was not the case for the Social group, where the initial level had no effect on adherence. For psychological outcomes there were improvements on both groups, regardless of the application used. There was no significant difference between groups in social wellbeing outcomes, both groups seeing a decrease in loneliness despite the presence of social features in the

  7. [Factors influenced vitamin or mineral supplements use in a chosen group of children aged 6-12].

    Science.gov (United States)

    Bylinowska, Justyna; Januszko, Olga; Rolf, Katarzyna; Sicińska, Ewa; Kałuza, Joanna; Pietruszka, Barbara

    2012-01-01

    Due to growing popularity of food supplements the producers of such products introduce food supplements developed especially for children. This, as a consequence, may lead to a risk of exceeded intake of some nutrients. The aim of this study was to identify determinants of vitamin/mineral supplements intake in 6-12-year-old children. The study was conducted by questionnaire method among parents of 743 children attending primary schools. Dietary supplements during the year preceding the survey received 40% of children, while 16.7% on the tested day. It was found that women with secondary and higher education level more frequently reported use of such preparations by their children (43% and 40% respectively). Supplements received more children with moderate or slight deficient body weight (54.2%) compared to children with severe deficiency (29.7%) or obese (25.8%); children with chronic diseases (56%) compared to healthy (37%), participating in extracurricular sport activities (49%) compared to non-participating (35%) and children with more correct dietary habits. Simultaneously supplements and fortified products were used by 34% of children. . The decision of supplements use parents often undertook alone (67% of preparation), while only 31% of them after medical consultation. There is a need to educate children and their parents about the use of supplements and the risks associated with it.

  8. Feedback versus no feedback in improving patient outcome in group psychotherapy for eating disorders (F-EAT): protocol for a randomized clinical trial

    Science.gov (United States)

    2014-01-01

    Background Continuous feedback on patient improvement and the therapeutic alliance may reduce the number of dropouts and increase patient outcome. There are, however, only three published randomized trials on the effect of feedback on the treatment of eating disorders, showing inconclusive results, and there are no randomized trials on the effect of feedback in group therapy. Accordingly the current randomized clinical trial, initiated in September 2012 at the outpatient clinic for eating disorders at Stolpegaard Psychotherapy Centre, aims to investigate the impact of continuous feedback on attendance and outcome in group psychotherapy. Methods/design The hypothesis is that continuous feedback to both patient and therapist on treatment progress and alliance will increase attendance and treatment outcome. The trial is set up using a randomized design with a minimum of 128 patients allocated to either an experimental or control group at a ratio of 1:1. The experimental group will receive standard treatment (systemic and narrative group psychotherapy) with feedback intervention, whereas the control group will receive standard treatment only. The participants are diagnosed with bulimia nervosa, binge eating disorder, or an eating disorder not otherwise specified, according to the DSM-IV. In the experimental group feedback to the participants, based on the Outcome Rating Scale (ORS) and the Group Session Rating Scale (GSRS), is actively added to standard treatment. The ORS assesses areas of life functioning known to change as a result of therapeutic intervention. The GSRS assesses key dimensions of effective therapeutic relationships. In the control group, the patients fill out the Outcome Rating Scale only, and feedback is not provided. The primary outcome is the rate of attendance to treatment sessions. The secondary outcome is the severity of eating disorder symptoms. Exploratory outcomes are the level of psychological and social functioning, and suicide or self

  9. Feedback versus no feedback in improving patient outcome in group psychotherapy for eating disorders (F-EAT): protocol for a randomized clinical trial.

    Science.gov (United States)

    Davidsen, Annika Helgadóttir; Poulsen, Stig; Waaddegaard, Mette; Lindschou, Jane; Lau, Marianne

    2014-04-23

    Continuous feedback on patient improvement and the therapeutic alliance may reduce the number of dropouts and increase patient outcome. There are, however, only three published randomized trials on the effect of feedback on the treatment of eating disorders, showing inconclusive results, and there are no randomized trials on the effect of feedback in group therapy. Accordingly the current randomized clinical trial, initiated in September 2012 at the outpatient clinic for eating disorders at Stolpegaard Psychotherapy Centre, aims to investigate the impact of continuous feedback on attendance and outcome in group psychotherapy. The hypothesis is that continuous feedback to both patient and therapist on treatment progress and alliance will increase attendance and treatment outcome. The trial is set up using a randomized design with a minimum of 128 patients allocated to either an experimental or control group at a ratio of 1:1. The experimental group will receive standard treatment (systemic and narrative group psychotherapy) with feedback intervention, whereas the control group will receive standard treatment only. The participants are diagnosed with bulimia nervosa, binge eating disorder, or an eating disorder not otherwise specified, according to the DSM-IV. In the experimental group feedback to the participants, based on the Outcome Rating Scale (ORS) and the Group Session Rating Scale (GSRS), is actively added to standard treatment. The ORS assesses areas of life functioning known to change as a result of therapeutic intervention. The GSRS assesses key dimensions of effective therapeutic relationships. In the control group, the patients fill out the Outcome Rating Scale only, and feedback is not provided.The primary outcome is the rate of attendance to treatment sessions. The secondary outcome is the severity of eating disorder symptoms. Exploratory outcomes are the level of psychological and social functioning, and suicide or self-harm. This is measured with the

  10. A cluster randomized controlled trial for child and parent weight management: children and parents randomized to the intervention group have correlated changes in adiposity.

    Science.gov (United States)

    Berry, Diane C; McMurray, Robert G; Schwartz, Todd A; Hall, Emily G; Neal, Madeline N; Adatorwover, Reuben

    2017-01-01

    Studies have suggested that obesity is linked within families and that successful interventions involve both the parent and child with obesity. However little information exists regarding similarities in adiposity and weight loss between the parent and child, especially in low socio-economic ethnically diverse households. The purpose of this study was to examine the relationships between the changes from baseline over time in adiposity, weight, health behaviors, and self-efficacy in children (n = 184) and parents (n = 184) participating in an 18-month weight loss program. Within the intervention group only and for each post-baseline time point, Pearson correlation coefficients were computed for children's changes (from baseline) in adiposity, weight, health behaviors, and self-efficacy, with their parents' corresponding changes from baseline, to determine how strongly the dyads were correlated. At the completion of 18 months, the intervention group parents demonstrated strong positive correlations between parent and child change in waist circumference (r = 0.409, p parents and their children with obesity are strongly correlated. NCT01378806 Retrospectively Registered on June 22, 2011.

  11. A JASTRO study group report. A randomized phase III trial of hyperthermia in combination with radiotherapy for superficial tumors

    Energy Technology Data Exchange (ETDEWEB)

    Hiraoka, Masahiro; Nishimura, Yasumasa; Mitsumori, Michihide [Kyoto Univ. (Japan). Faculty of Medicine] [and others

    1998-06-01

    Result of study about local effect of hyperthermia in combination with radiotherapy for superficial tumors was reported. The irradiation was more than 90% isodose for lesion, and total dose was 60 Gy in cases with anamnesis and 40-50 Gy and without anamnesis at a rate of five times a week and 2 Gy at one time. Hyperthermia was carried out four times; once a week, at 42.5 degrees on tumor side edge, and for 40 minutes. Total 53 cases (neck lymph node metastasis 30 cases, relapse breast cancer 11, advanced breast cancer 1, other superficial tumor 11) were divided into 2 groups. Radiotherapy without hyperthermia (group R) was 27 cases, radiotherapy with hyperthermia (group H) was 26 cases. CR and CR+PR within 2 months after treatment were as follows: Group R: 50%, 85%, Group H: 64%, 100%. The CR+PR was superior in group H (p=0.0497). The CR at maximum effect after treatment was 65% of group R and 86% of group H (p=0.17). The local control rate after CR was not different in both groups. (K.H.)

  12. Comparing Acceptance and Commitment Group Therapy and 12-Steps Narcotics Anonymous in Addict’s Rehabilitation Process: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Manoochehr Azkhosh

    2016-12-01

    Full Text Available Objective: Substance abuse is a socio-psychological disorder. The aim of this study was to compare the effectiveness of acceptance and commitment therapy with 12-steps Narcotics Anonymous on psychological well-being of opiate dependent individuals in addiction treatment centers in Shiraz, Iran.Method: This was a randomized controlled trial. Data were collected at entry into the study and at post-test and follow-up visits. The participants were selected from opiate addicted individuals who referred to addiction treatment centers in Shiraz. Sixty individuals were evaluated according to inclusion/ exclusion criteria and were divided into three equal groups randomly (20 participants per group. One group received acceptance and commitment group therapy (Twelve 90-minute sessions and the other group was provided with the 12-steps Narcotics Anonymous program and the control group received the usual methadone maintenance treatment. During the treatment process, seven participants dropped out. Data were collected using the psychological well-being questionnaire and AAQ questionnaire in the three groups at pre-test, post-test and follow-up visits. Data were analyzed using repeated measure analysis of variance.Results: Repeated measure analysis of variance revealed that the mean difference between the three groups was significant (P<0.05 and that acceptance and commitment therapy group showed improvement relative to the NA and control groups on psychological well-being and psychological flexibility.Conclusion: The results of this study revealed that acceptance and commitment therapy can be helpful in enhancing positive emotions and increasing psychological well-being of addicts who seek treatment.

  13. Comparing Acceptance and Commitment Group Therapy and 12-Steps Narcotics Anonymous in Addict’s Rehabilitation Process: A Randomized Controlled Trial

    Science.gov (United States)

    Azkhosh, Manoochehr; Farhoudianm, Ali; Saadati, Hemn; Shoaee, Fateme; Lashani, Leila

    2016-01-01

    Objective: Substance abuse is a socio-psychological disorder. The aim of this study was to compare the effectiveness of acceptance and commitment therapy with 12-steps Narcotics Anonymous on psychological well-being of opiate dependent individuals in addiction treatment centers in Shiraz, Iran. Method: This was a randomized controlled trial. Data were collected at entry into the study and at post-test and follow-up visits. The participants were selected from opiate addicted individuals who referred to addiction treatment centers in Shiraz. Sixty individuals were evaluated according to inclusion/ exclusion criteria and were divided into three equal groups randomly (20 participants per group). One group received acceptance and commitment group therapy (Twelve 90-minute sessions) and the other group was provided with the 12-steps Narcotics Anonymous program and the control group received the usual methadone maintenance treatment. During the treatment process, seven participants dropped out. Data were collected using the psychological well-being questionnaire and AAQ questionnaire in the three groups at pre-test, post-test and follow-up visits. Data were analyzed using repeated measure analysis of variance. Results: Repeated measure analysis of variance revealed that the mean difference between the three groups was significant (Pacceptance and commitment therapy group showed improvement relative to the NA and control groups on psychological well-being and psychological flexibility. Conclusion: The results of this study revealed that acceptance and commitment therapy can be helpful in enhancing positive emotions and increasing psychological well-being of addicts who seek treatment. PMID:28050185

  14. Group Contingencies, Randomization of Reinforcers, and Criteria for Reinforcement, Self-Monitoring, and Peer Feedback on Reducing Inappropriate Classroom Behavior

    Science.gov (United States)

    Coogan, Brenda Anne; Kehle, Thomas J.; Bray, Melissa A.; Chafouleas, Sandra M.

    2007-01-01

    Considerable research has demonstrated the effectiveness of interdependent and unknown dependent group contingencies on reducing inappropriate classroom behavior. Several investigators have focused on the addition of self-monitoring and peer feedback to these interdependent and unknown dependent group contingencies in order to further improve…

  15. A group randomized trial using an appointment system to improve adherence to ART at reproductive and child health clinics implementing Option B+ in Tanzania.

    OpenAIRE

    Ross-Degnan, Dennis; Chalker, John; Liana, Jafary; Kajoka, Mwikemo Deborah; Valimba, Richard; Kimatta, Suleiman; Dillip, Angel; Vialle-Valentin, Catherine; Embrey, Martha; Lieber, Rachel; Johnson, Keith

    2017-01-01

    Introduction: In October 2013, Tanzania adopted Option B+ under which HIV-positive pregnant women are initiated on antiretroviral therapy in reproductive and child health clinics at diagnosis. Studies have shown that adherence and retention to antiretroviral treatment can be problematic. Methods: We implemented a group randomized controlled trial in 24 reproductive and child health clinics in eight districts in Mbeya region. The trial tested the impact of implementing paper-based appointment ...

  16. Efficacy and safety of bilastine in Japanese patients with perennial allergic rhinitis: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III study

    OpenAIRE

    Okubo, Kimihiro; Gotoh, Minoru; Asako, Mikiya; Nomura, Yasuyuki; Togawa, Michinori; Saito, Akihiro; Honda, Takayuki; Ohashi, Yoshihiro

    2016-01-01

    Background: Bilastine, a novel non-sedating second-generation H1 antihistamine, has been approved in most European countries since 2010. This study aimed to evaluate the superiority of bilastine over placebo in Japanese patients with perennial allergic rhinitis (PAR). Methods: This randomized, double-blind, placebo-controlled, parallel-group, phase III study (trial registration number JapicCTI-142600) evaluated the effect of a 2-week treatment period with bilastine (20 mg once daily), fexo...

  17. A failure to confirm the effectiveness of a brief group psychoeducational program for mothers of children with high-functioning pervasive developmental disorders: a randomized controlled pilot trial

    Science.gov (United States)

    Suzuki, Masako; Yamada, Atsurou; Watanabe, Norio; Akechi, Tatsuo; Katsuki, Fujika; Nishiyama, Takeshi; Imaeda, Masayuki; Miyachi, Taishi; Otaki, Kazuo; Mitsuda, Yumiko; Ota, Akino; Furukawa, Toshi A

    2014-01-01

    Objective The purpose of this study was to examine the effectiveness of group psychoeducation to relieve the psychological distress of mothers of children with high-functioning pervasive developmental disorders (HFPDD) and to improve the behaviors of the children. Methods Seventy-two mothers of preschool outpatients with HFPDD were randomly assigned to a four-session brief group psychoeducational program (GP). The sessions were held every second week in addition to the usual treatment (GP + treatment as usual [TAU] group), or to a TAU-alone group. The primary outcome was self-reported symptoms of maternal mental health as assessed using the 28-item General Health Questionnaire (GHQ-28) at 21 weeks post-randomization (week 21). The GHQ-28 at the end of the intervention (week 7), Aberrant Behavior Checklist (ABC) for the behavior of the children, the Zarit Burden Interview (ZBI), and the Medical Outcomes Study 36-item Short Form Health Survey (SF-36) were carried out at weeks 7 and 21. We tested the group effects with the interaction between the intervention and the evaluation points. Results The GHQ-28 score at week 21 was significantly higher in the GP + TAU group as compared to that in the TAU-alone group, indicating a greater improvement in the TAU-alone group. There was no evidence that GP + TAU led to a greater improvement of maternal mental health than TAU-alone at week 7. Similarly, no evidence was obtained to indicate that GP + TAU led to a reduction in the ABC or ZBI scores by week 7 or 21. The adjusted scores for the RF (role emotional) and MH (mental health) subscales of the SF-36 at week 21 were also significantly lower in the GP + TAU group, indicating a similar tendency to that of the change of the GHQ-28 score at week 21. Conclusion The psychoeducational program did not alleviate maternal distress, aberrant behaviors of the children, or caregiver burden. PMID:25061301

  18. HPV self-sampling or the Pap-smear: a randomized study among cervical screening nonattenders from lower socioeconomic groups in France.

    Science.gov (United States)

    Sancho-Garnier, H; Tamalet, C; Halfon, P; Leandri, F X; Le Retraite, L; Djoufelkit, K; Heid, P; Davies, P; Piana, L

    2013-12-01

    Today in France, low attendance to cervical screening by Papanicolaou cytology (Pap-smear) is a major contributor to the 3,000 new cervical cancer cases and 1,000 deaths that occur from this disease every year. Nonattenders are mostly from lower socioeconomic groups and testing of self-obtained samples for high-risk Human Papilloma virus (HPV) types has been proposed as a method to increase screening participation in these groups. In 2011, we conducted a randomized study of women aged 35-69 from very low-income populations around Marseille who had not responded to an initial invitation for a free Pap-smear. After randomization, one group received a second invitation for a free Pap-smear and the other group was offered a free self-sampling kit for HPV testing. Participation rates were significantly different between the two groups with only 2.0% of women attending for a Pap-smear while 18.3% of women returned a self-sample for HPV testing (p ≤ 0.001). The detection rate of high-grade lesions (≥CIN2) was 0.2‰ in the Pap-smear group and 1.25‰ in the self-sampling group (p = 0.01). Offering self-sampling increased participation rates while the use of HPV testing increased the detection of cervical lesions (≥CIN2) in comparison to the group of women receiving a second invitation for a Pap-smear. However, low compliance to follow-up in the self-sampling group reduces the effectiveness of this screening approach in nonattenders women and must be carefully managed. Copyright © 2013 UICC.

  19. The Effect of Spiritual and Religious Group Psychotherapy on Suicidal Ideation in Depressed Patients: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Hossein Ebrahimi

    2014-06-01

    Full Text Available Introduction: Suicide is a great economical, social and public health problem. It is prevalent worldwide and has a lot of negative effects on individuals, families and society. Depression is often prelude to Suicide. An important part of the treatment of the mentally ill patients is spiritual-religious psychotherapy which should be done after physical treatment. The aim of this study was to determine the effect of spiritual and religious group psychotherapy on suicidal ideation in depressed patients. Methods: 51 depressed patients with suicidal ideation from Razi hospital (Tabriz, Iran participated in this clinical trial. To collect Data questionnaire was used which included demographic and Beck Suicide Scale Ideation. Experimental group participated in 10 sessions of group psychotherapy. Each section lasted 1 hour. Two weeks after the last section post test was done. Statistical software SPSS ver 13 was used for data analysis. Results: Results of independent t-test revealed no difference between two groups in terms of suicidal ideation before intervention but after study there is a statistical difference. Also the results of ANCOVA test showed a significant relationship between spiritual group therapy and decrease in suicidal ideation, so that this intervention can make 57% of variance in suicidal ideation of experimental group.Conclusion: Regarding positive effect of spiritual and religious group psychotherapy on decreasing suicidal ideation of depressed patients, we suggest this intervention to be held in Psychiatric Wards and also more study on depression and other psychiatric patients with greater sample size would be helpful.

  20. High prevalence of multidrug resistance and random distribution of mobile genetic elements among uropathogenic Escherichia coli (UPEC) of the four major phylogenetic groups.

    Science.gov (United States)

    Rijavec, Matija; Starcic Erjavec, Marjanca; Ambrozic Avgustin, Jerneja; Reissbrodt, Rolf; Fruth, Angelika; Krizan-Hergouth, Veronika; Zgur-Bertok, Darja

    2006-08-01

    One hundred and ten UTI Escherichia coli strains, from Ljubljana, Slovenia, were analyzed for antibiotic resistances, mobile DNA elements, serotype, and phylogenetic origin. A high prevalence of drug resistance and multidrug resistance was found. Twenty-six percent of the isolates harbored a class 1 integron, while a majority of the strains (56%) harbored rep sequences characteristic of F-like plasmids. int as well as rep sequences were found to be distributed in a random manner among strains of the four major phylogenetic groups indicating that all groups have a similar tendency to acquire and maintain mobile genetic elements frequently associated with resistance determinants.

  1. A comparison of bibliotherapy and face-to-face group therapy for children with anxiety disorders: Results of a randomized controlled trial

    DEFF Research Database (Denmark)

    Arendt, Kristian Bech; Thastum, Mikael

    (James, James, Cowdrey, Soler & Choke, 2015), more studies of less intensive treatment formats are still warranted. Bibliotherapy is a low cost therapy with minimal therapist assistance, which in a few studies have been shown to result in favorable outcomes compared to waitlist and outcomes comparable...... to face-to-face treatment (e.g. Lyneham & Rapee, 2006, Cobham, 2012). The aim of the current study was to examine the efficacy of therapist supported group bibliotherapy compared to face-to-face group treatment using a randomized controlled design....

  2. Effects of music therapy on drug avoidance self-efficacy in patients on a detoxification unit: a three-group randomized effectiveness study.

    Science.gov (United States)

    Silverman, Michael J

    2014-01-01

    Self-efficacy is a component of Bandura's social cognitive theory and can lead to abstinence and a reduction of relapse potential for people who have substance abuse disorders. To date, no music therapy researcher has utilized this theoretical model to address abstinence and reduce the likelihood of relapse in people who have addictions. The purpose of this study was to determine the effects of music therapy on drug avoidance self-efficacy in a randomized three-group wait-list control design with patients on a detoxification unit. Participants (N = 131) were cluster randomized to one of three single-session conditions: music therapy, verbal therapy, or wait-list control. Music therapy participants received a group lyric analysis intervention, verbal therapy participants received a group talk therapy session, and wait-list control participants eventually received a group recreational music therapy intervention. Although there was no significant between-group difference in drug avoidance self-efficacy, participants in the music therapy condition tended to have the highest mean drug avoidance self-efficacy scores. Posttest written comments supported the use of both music therapy and verbal therapy sessions. Two music therapy participants specifically noted that their initial skepticism had dissipated after receiving music therapy. Despite a lack of significant differences, the theoretical support of self-efficacy for substance abuse rehabilitation suggests that this may be an area of continued clinical focus and empirical investigation. Clinical anecdotes, limitations of the study, and suggestions for future research are provided.

  3. Effects of supportive-expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors: a randomized control trial.

    Science.gov (United States)

    Tabrizi, Fatemeh Moghaddam; Radfar, Moloud; Taei, Zeynab

    2016-09-01

    Evaluation of the effect of supportive expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors. A randomized control trial including breast cancer patients who had completed chemotherapy and randomly allocated into two groups: intervention (n = 41) and control (n = 40). The intervention consisted of twelve weekly 90-min sessions for groups of six to eight breast cancer survivors. Data were obtained pre-to -post the intervention and at 8-week follow-up. The data were analyzed using a repeated-measures analysis of variance (ANOVA). The findings revealed a significant reduction in loneliness scores (F = 69.85, p group, while scores of control participants did not show this pattern during the study. The strongest effects were found for global quality of life (effect size) = 0.59), for future perspectives (effect size = 0.51), emotional functioning (effect size = 0.35) and social functioning (effect size = 0.31). The intervention was effective on loneliness, hope and quality of life in the intervention group. The intervention needs further evaluation in a larger study and with other cancer types. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  4. Group Therapy for Repeated Deliberate Self-Harm in Adolescents: Failure of Replication of a Randomized Trial

    Science.gov (United States)

    Hazell, Philip L.; Martin, Graham; McGill, Katherine; Kay, Tracey; Wood, Alison; Trainor, Gemma; Harrington, Richard

    2009-01-01

    A study revealing the superiority of group therapy to routine care in preventing the recurrence of self-harming behavior among adolescents is unsuccessfully replicated. The study's findings contradicted those of the original study.

  5. Efficacy of the Group Music and Imagery method (GrpMI) for women suffering from fibromyalgia: A randomized controlled trial

    DEFF Research Database (Denmark)

    Pedersen, Inge Nygaard

    2018-01-01

    Abstract Background: Fibromyalgia (FM) affects about 2-4% of the world population. Patients, mostly women, experience chronic widespread pain, fatigue, stiffness, sleep disturbances, and psychological disorders, especially depression and anxiety. Objective: The aim of this study was to assess...... the efficacy of Group Music and Imagery (GrpMI), including relaxation, music listening and spontaneous imagery, for subjective psychological wellbeing, functional capacity and health, pain perception, anxiety and depression in women with FM. Methods: Fifty-six women aged 35 to 65 (M = 51.3) diagnosed with FM...... groups found a significant increase in psychological wellbeing and a reduction in the rest of the variables, whereas the control groups only showed decreases in trait anxiety and trait depression. No significant differences were observed in the control groups at the follow-up, while the experimental...

  6. Randomized controlled trial of two forms of self-management group education in Japanese people with impaired glucose tolerance.

    Science.gov (United States)

    Imai, Saeko; Kozai, Hana; Naruse, Yuko; Watanabe, Kanji; Fukui, Michiaki; Hasegawa, Goji; Obayashi, Hiroshi; Nakamura, Naoto; Naito, Yuji; Yoshikawa, Toshikazu; Kajiyama, Shizuo

    2008-09-01

    The aim of this study was to determine the effectiveness of education on diabetes prevention in subjects with impaired glucose tolerance. A total of 100 subjects of impaired glucose tolerance with hemoglobin A1c (HbA1c) levels >/=5.5 to education in 8 sessions over a 6-month period. The support group consisted of 10 members collaborating with a dietitian or a nurse who learned coping skills by employing a participant-centered approach. Participants in the support group were required to keep a diary that monitored weight, food intake and blood glucose levels, while the control group attended several lectures. Subjects assigned to the support group had a reduction in mean HbA1c levels from 5.77 +/- 0.36% at baseline to 5.39 +/- 0.24% at the endpoint (peducation can be effective for improving glycemic control in participants when carried out in collaboration with educators and other team members.

  7. CUSTOMERS' EXPECTATIONS AND EXPERIENCES WITHIN CHOSEN ASPECTS OF LOGISTIC CUSTOMER SERVICE QUALITY

    Directory of Open Access Journals (Sweden)

    Marta Kadłubek

    2015-06-01

    Full Text Available The article presents chosen aspects of logistic customer service quality. In the first part of the paper, the authors describe theoretical issues of logistics service quality and Servqual method. The reference of chosen theoretical aspects of logistic service quality in relation to Servqual method and their presentation and analysis afterwards on practical example is the main aim of the article. Customers' expectations and experiences towards the logistics customer service were examined as two fundamental areas which allow for recognizing the quality aspects of the customer service in commercial cargo motor transport enterprises. Evaluation of the level of customers' expectations and perception toward particular elements of logistic customer service offered to 294 customers by 147 Polish commercial cargo motor transport enterprises was realized.

  8. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

    DEFF Research Database (Denmark)

    Krogh, Jesper; Saltin, Bengt; Gluud, Christian

    2009-01-01

    OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners...... or psychiatrists and were eligible if they fulfilled the International Classification of Diseases, Tenth Revision, criteria for unipolar depression and were aged between 18 and 55 years. Patients (N = 165) were allocated to supervised strength, aerobic, or relaxation training during a 4-month period. The primary...... repetition maximum for chest press increased by a mean (95% CI) of 4.0 kg (0.8 to 7.2; p = .014) in the strength training group versus the relaxation group, and maximal oxygen uptake increased by 2.7 mL/kg/min (1.2 to 4.3; p = .001) in the aerobic group versus the relaxation group. At 4 months, the mean...

  9. The effect of group counseling based on self-awareness skill on sexual risk-taking among girl students in Gorgan, Iran: a randomized trial.

    Science.gov (United States)

    Kabiri, Golnoosh; Ziaei, Tayebe; Aval, Masumeh Rezaei; Vakili, Mohammad Ali

    2017-09-15

    Background Sexual puberty in adolescents occurs before their mental and emotional maturity and exposes them to high-risk sexual behaviors. Because sexual risk-taking occurs before adolescents become involved in a sexual relationship, this study was conducted to identify the effect of group counseling based on self-awareness skill on sexual risk-taking among female high school students in Gorgan in order to suggest some preventative measures. Methods The present parallel study is a randomized field trial conducted on 96 girl students who were studying in grades 10, 11 and 12 of high school with an age range of 14-18 years old. Sampling was done based on a multi-stage process. In the first stage, through the randomized clustering approach, four centers among six health centers were selected. In the second stage, 96 samples were collected through consecutive sampling. Finally, the samples were divided into two intervention and control groups (each one having 48 subjects) through the simple randomized approach. It has to be noted that no blinding was done in the present study. The data were collected using a demographic specifications form and the Iranian Adolescents Risk-Taking Scale (IARS). The consultation sessions based on self-awareness skill were explained to an intervention group through 60-min sessions over 7 weeks. The pretest was conducted for both groups and the posttest was completed 1 week and 1 month after the intervention by the intervention and control groups. Finally, after the loss of follow-up/drop out, a total of 80 subjects remained in the study; 42 subjects in the intervention group and 38 subjects in the control group. Data analyses were done using SPSS v.16 along with the Freidman non-parametric test and the Mann-Whitney and Wilcoxon tests. Results The results showed that the sexual risk-taking mean scores in the intervention group (10.54 ± 15.64) were reduced by applying 1-week (8.03 ± 12.82) and 1-month (4.91 ± 10.10) follow-ups after the

  10. Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development.

    Science.gov (United States)

    Brookes, Sara T; Macefield, Rhiannon C; Williamson, Paula R; McNair, Angus G; Potter, Shelley; Blencowe, Natalie S; Strong, Sean; Blazeby, Jane M

    2016-08-17

    Methods for developing a core outcome or information set require involvement of key stakeholders to prioritise many items and achieve agreement as to the core set. The Delphi technique requires participants to rate the importance of items in sequential questionnaires (or rounds) with feedback provided in each subsequent round such that participants are able to consider the views of others. This study examines the impact of receiving feedback from different stakeholder groups, on the subsequent rating of items and the level of agreement between stakeholders. Randomized controlled trials were nested within the development of three core sets each including a Delphi process with two rounds of questionnaires, completed by patients and health professionals. Participants rated items from 1 (not essential) to 9 (absolutely essential). For round 2, participants were randomized to receive feedback from their peer stakeholder group only (peer) or both stakeholder groups separately (multiple). Decisions as to which items to retain following each round were determined by pre-specified criteria. Whilst type of feedback did not impact on the percentage of items for which a participant subsequently changed their rating, or the magnitude of change, it did impact on items retained at the end of round 2. Each core set contained discordant items retained by one feedback group but not the other (3-22 % discordant items). Consensus between patients and professionals in items to retain was greater amongst those receiving multiple group feedback in each core set (65-82 % agreement for peer-only feedback versus 74-94 % for multiple feedback). In addition, differences in round 2 scores were smaller between stakeholder groups receiving multiple feedback than between those receiving peer group feedback only. Variability in item scores across stakeholders was reduced following any feedback but this reduction was consistently greater amongst the multiple feedback group. In the development of

  11. Direct versus indirect and individual versus group modes of language therapy for children with primary language impairment: principal outcomes from a randomized controlled trial and economic evaluation.

    Science.gov (United States)

    Boyle, James M; McCartney, Elspeth; O'Hare, Anne; Forbes, John

    2009-01-01

    Many school-age children with language impairments are enrolled in mainstream schools and receive indirect language therapy, but there have been, to the authors' knowledge, no previous controlled studies comparing the outcomes and costs of direct and indirect intervention delivered by qualified therapists and therapy assistants, and each delivery mode offered to children individually or in groups. To investigate the relative effectiveness of indirect and direct intervention therapy modes delivered individually or in groups for children with primary language impairment. A multi-centre randomized controlled trial investigated 161 children with primary language impairment aged 6-11 years randomized to a usual-therapy control group or to direct individual, indirect individual, direct group or indirect group therapy modes. Intervention was delivered three times a week for 30-40-min sessions in mainstream schools over 15 weeks. Language performance was assessed at baseline, post-therapy and at 12 months. Cost analysis was based on salary and travel costs for intervention modes and usual therapy. Compared with controls, children receiving project therapy made short-term improvements in expressive (p = 0.031), but not receptive, language immediately following intervention. Children with specific expressive language delay were more likely to show improvement than those with mixed receptive-expressive difficulties. The four project therapy modes did not differ on primary language outcomes (all p-values>0.392) and there were no further improvements evident at follow-up. Indirect group therapy was the least costly mode, with direct individual therapy the most costly. Intervention in this age group can be effective for expressive language and can be delivered equally effectively though speech and language therapy assistants and to children in groups.

  12. Group music therapy for patients with persistent post-traumatic stress disorder--an exploratory randomized controlled trial with mixed methods evaluation.

    Science.gov (United States)

    Carr, Catherine; d'Ardenne, Patricia; Sloboda, Ann; Scott, Carleen; Wang, Duolao; Priebe, Stefan

    2012-06-01

    Not all patients with post-traumatic stress disorder (PTSD) respond to cognitive behavioural therapy (CBT). Literature suggests group music therapy might be beneficial in treating PTSD. However, feasibility and effectiveness have not been assessed. The study objectives were to assess whether group music therapy was feasible for patients who did not respond to CBT, and whether it has an effect on PTSD symptoms and depression. The study employed mixed methods comprising of an exploratory randomized controlled trial, qualitative content analysis of therapy, and patient interviews. Patients with significant PTSD symptoms (n = 17) following completion of CBT were randomly assigned to treatment (n = 9) or control groups (n = 8). The treatment group received 10 weeks of group music therapy after which exit interviews were conducted. Control group patients were offered the intervention at the end of the study. Symptoms were assessed on the Impact of Events Scale-Revised and Beck Depression Inventory II at the beginning and end of treatment. Treatment-group patients experienced a significant reduction in severity of PTSD symptoms (-20.18; 95% confidence interval [CI]: [-31.23, -9.12]) and a marginally significant reduction in depression (-11.92; 95%CI: [-24.05, 0.21]) at 10 weeks from baseline compared to the control. Patients viewed music therapy as helpful and reported experiences concur with current literature. Group music therapy appears feasible and effective for PTSD patients who have not sufficiently responded to CBT. Limitations include the small sample size and lack of blinding. Further research should address these limitations, test sustainability, and identify specific factors that address symptoms in treatment. ©2011 The British Psychological Society.

  13. Video-games used in a group setting is feasible and effective to improve indicators of physical activity in individuals with chronic stroke: a randomized controlled trial.

    Science.gov (United States)

    Givon, Noa; Zeilig, Gabi; Weingarden, Harold; Rand, Debbie

    2016-04-01

    To investigate the feasibility of using video-games in a group setting and to compare the effectiveness of video-games as a group intervention to a traditional group intervention for improving physical activity in individuals with chronic stroke. A single-blind randomized controlled trial with evaluations pre and post a 3-month intervention, and at 3-month follow-up. Compliance (session attendance), satisfaction and adverse effects were feasibility measures. Grip strength and gait speed were measures of physical activity. Hip accelerometers quantified steps/day and the Action Research Arm Test assessed the functional ability of the upper extremity. Forty-seven community-dwelling individuals with chronic stroke (29-78 years) were randomly allocated to receive video-game (N=24) or traditional therapy (N=23) in a group setting. There was high treatment compliance for both interventions (video-games-78%, traditional therapy-66%), but satisfaction was rated higher for the video-game (93%) than the traditional therapy (71%) (χ(2)=4.98, P=0.026). Adverse effects were not reported in either group. Significant improvements were demonstrated in both groups for gait speed (F=3.9, P=0.02), grip strength of the weaker (F=6.67, P=0.002) and stronger hands (F=7.5, P=0.001). Daily steps and functional ability of the weaker hand did not increase in either group. Using video-games in a small group setting is feasible, safe and satisfying. Video-games improve indicators of physical activity of individuals with chronic stroke. © The Author(s) 2015.

  14. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial.

    Science.gov (United States)

    Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

    2015-01-01

    Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

  15. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nuria eRuffini

    2015-08-01

    Full Text Available Context: Heart Rate Variability (HRV indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT on ANS activity through changes of High Frequency, a heart rate variability index indicating the parasympathetic activity, in healthy subjects, compared with sham therapy and control group.Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults, both smokers and non-smokers and not on medications. At enrollment subjects were randomized in 3 groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920.Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 minutes.Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency rate (p<0.001, and decrease of sympathetic activity, as revealed by Low Frequency rate (p<0.01; results also showed a reduction of Low Frequency/High Frequency ratio (p<0.001 and Detrended fluctuation scaling exponent (p<0.05. Conclusions: Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

  16. Adsorption capacity of chosen sandy ground with respect to contaminants relocating with groundwater

    Directory of Open Access Journals (Sweden)

    Aniszewski Andrzej

    2017-03-01

    Full Text Available One of the most important problems concerning contaminant transport in the ground is the problem related to the definition of parameters characterizing the adsorption capacity of ground for the chosen contaminants relocating with groundwater. In this paper, for chloride and sulfate indicators relocating in sandy ground, the numerical values of retardation factors (Ra (treated as average values and pore groundwater velocities with adsorption (ux/Ra (in micro-pore ground spaces are taken into consideration. Based on 2D transport equation the maximal dimensionless concentration values (C*max c in the chosen ground cross-sections were calculated. All the presented numerical calculations are related to the unpublished measurement series which was marked in this paper as: October 1982. For this measurement series the calculated concentration values are compared to the measured concentration ones (C*max m given recently to the author of this paper. In final part of this paper the parameters characterizing adsorption capacity (Ra, ux/Ra are also compared to the same parameters calculated for the two earlier measurement series. Such comparison also allowed for the estimation of a gradual in time depletion of adsorption capacity for the chosen sandy ground.

  17. Given and chosen: youth-led research on family-supported conversations about sexuality.

    Science.gov (United States)

    Zaleski, Nikki; Martin, Paula; Messinger, Joy

    2015-01-01

    The Youth Leadership Council supported by the Illinois Caucus for Adolescent Health completed a Community-Based Participatory Research study to assess the perceived barriers and benefits to conversations about sex and sexuality between youth and their given and chosen families. This mixed-methods research project defines given families as the family youths are born into or live at home with, and chosen families as those youths choose to surround themselves with such as friends or mentors. The Youth Leadership Council found that youths discuss sex and sexuality with both given and chosen families, but a majority felt that they received only "somewhat accurate" information. This project builds on current and past research by allowing youths to disclose their gender identity and sexual orientation, which showed a clear need for more education around asexual identities especially within given family settings. As a Community Based Participatory Research study, pragmatic next steps based on the finding are included for practitioners and researchers who work in the area of adolescent sexual and reproductive health.

  18. Transdermal Buprenorphine Relieves Neuropathic Pain: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial in Diabetic Peripheral Neuropathic Pain.

    Science.gov (United States)

    Simpson, Richard W; Wlodarczyk, John H

    2016-09-01

    To evaluate the efficacy and safety of transdermal buprenorphine in patients with diabetic peripheral neuropathic pain (DPNP). This multicenter, randomized, double-blind, placebo-controlled, parallel-group trial enrolled patients with type 1 or type 2 diabetes and stable glycemic control who had been experiencing moderate to severe DPNP for at least 6 months on maximal tolerated conventional therapy. Patients were randomly assigned to receive buprenorphine (5 μg/h) or placebo patches. The dose was titrated to effect to a maximum of 40 μg/h. Paracetamol was available as rescue analgesia. The severity of pain and other symptoms of DPNP were assessed daily in a patient diary and at clinic visits. One hundred eight-six patients were enrolled, with 93 randomized to either buprenorphine or placebo. A high proportion of patients did not complete the study (buprenorphine 37 of 93, placebo 24 of 93). The main reason for premature withdrawal in the buprenorphine group was adverse events commonly due to untreated nausea and/or vomiting. Among the per-protocol population, more patients in the buprenorphine group (86.3%) experienced a 30% reduction in average versus baseline pain at week 12 than those in the placebo group (56.6%, P buprenorphine group within the intention-to-treat analysis of the same end point (51.7% vs. 41.3%, P = 0.175). Transdermal buprenorphine, when tolerated, is an effective therapy for DPNP and provides another option to manage this challenging painful condition. Nausea and constipation need to be managed proactively to optimize treatment outcomes. © 2016 by the American Diabetes Association.

  19. Radiation Therapy Did Not Induce Long-Term Changes in Rectal Mucosa: Results From the Randomized Scandinavian Prostate Cancer Group 7 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Slagsvold, Jens Erik, E-mail: Jens.Erik.Slagsvold@stolav.no [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Viset, Trond [Department of Pathology, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Wibe, Arne [Institute of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim (Norway); Department of Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Kaasa, Stein [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); European Palliative Care Research Center, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim (Norway); Widmark, Anders [Department of Radiation Sciences, Cancercentrum, Umeå (Sweden); Lund, Jo-Åsmund [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); European Palliative Care Research Center, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim (Norway)

    2016-07-15

    Purpose: To investigate long-term changes in the rectal mucosa after curative external beam radiation therapy in the treatment of prostate cancer. Methods and Materials: In the Scandinavian Prostate Cancer Group 7 trial, 880 men with locally advanced prostate cancer were randomized to hormonal therapy alone versus hormonal therapy plus radiation therapy to 70 Gy. A subcohort from this trial being randomized at our center (n=178) was invited to a study on late anorectal side effects during 2003-2005, approximately 5 years after treatment, including measuring health-reported quality of life and physician-assessed toxicity score by the Late Effects Normal Tissue Task Force/Subjective, Objective, Management, Analytic (LENT/SOMA) and European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group score. Sixty-seven patients had a rectal mucosa biopsy. Sixty-four biopsies were included in the final analysis, of which 33 patients were randomized to hormonal treatment and 31 to hormonal treatment plus radiation therapy. The presence of fibrosis, number of capillaries, and lymphocyte infiltration was then evaluated by light microscopy. Results: The group receiving radiation therapy had significantly higher LENT/SOMA and function/bother scale scores than the group that only received hormonal treatment, but there was no significant difference in the presence of fibrosis, ectasia, number of capillaries in the lamina propria, or lymphocyte infiltration between the groups. Conclusion: Radiation therapy to 70 Gy to the prostate does not induce long-term microscopic mucosal changes in the rectum 5 years after treatment. This is in contrast to the general assumption that structural changes, including fibrosis, seen after radiation therapy include the mucosa. We speculate that the main late effects of radiation therapy on the structure of the rectum are located in the deeper layers of the rectal wall than the mucosa.

  20. Single- versus two-visit pulpectomy treatment in primary teeth with apical periodontitis: A double-blind, parallel group, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sneha Bharatkumar Bharuka

    2016-01-01

    Full Text Available Context: Reduction of the bacterial populations to levels compatible with periradicular tissue healing is the primary microbiological goal of the endodontic treatment of teeth with apical periodontitis. The number of visits required to treat teeth with apical periodontitis represents one of the most debatable issues in endodontics. Objectives: The objective of this study was to compare and evaluate the clinical and radiographic outcome of single- versus two-visit pulpectomy treatment in primary teeth with apical periodontitis at the end of 6-month healing period. Settings and Design: A parallel group, double-blind, randomized controlled trial was carried out in 64 children aged 4-8 years. Nonvital primary teeth with apical periodontitis with enough coronal structure were selected. Sixty-four children were assigned randomly into two groups (32 children each by block randomization, and allocation concealment was done with closed envelop method. Methods and Materials: Group I underwent single-visit pulpectomy followed by obturation with zinc oxide eugenol (ZOE. Group II underwent conventional two-visit pulpectomy with intracanal calcium hydroxide, followed by obturation with ZOE. Postoperative clinical and radiographic evaluation was carried out at 1, 3, and 6 months after the end of the treatment. Statistical Analysis Used: The data were analyzed by Wilcoxon′s signed rank test, Mann-Whitney U-test, and Friedman test. Results: There was no statistically significant difference in clinical and radiographic outcomes in both the groups at the end of 6-month healing period. Conclusion: Single-visit pulpectomy can be considered as a viable option for the treatment of primary teeth with apical periodontitis.

  1. Maximal-entropy random walk unifies centrality measures

    Science.gov (United States)

    Ochab, J. K.

    2012-12-01

    This paper compares a number of centrality measures and several (dis-)similarity matrices with which they can be defined. These matrices, which are used among others in community detection methods, represent quantities connected to enumeration of paths on a graph and to random walks. Relationships between some of these matrices are derived in the paper. These relationships are inherited by the centrality measures. They include measures based on the principal eigenvector of the adjacency matrix, path enumeration, as well as on the stationary state, stochastic matrix, or mean first-passage times of a random walk. As the random walk defining the centrality measure can be arbitrarily chosen, we pay particular attention to the maximal-entropy random walk, which serves as a very distinct alternative to the ordinary (diffusive) random walk used in network analysis. The various importance measures, defined both with the use of ordinary random walk and the maximal-entropy random walk, are compared numerically on a set of benchmark graphs with varying mixing parameter and are grouped with the use of the agglomerative clustering technique. It is shown that centrality measures defined with the two different random walks cluster into two separate groups. In particular, the group of centrality measures defined by the maximal-entropy random walk does not cluster with any other measures on change of graphs’ parameters, and members of this group produce mutually closer results than members of the group defined by the ordinary random walk.

  2. Maximal-entropy random walk unifies centrality measures.

    Science.gov (United States)

    Ochab, J K

    2012-12-01

    This paper compares a number of centrality measures and several (dis-)similarity matrices with which they can be defined. These matrices, which are used among others in community detection methods, represent quantities connected to enumeration of paths on a graph and to random walks. Relationships between some of these matrices are derived in the paper. These relationships are inherited by the centrality measures. They include measures based on the principal eigenvector of the adjacency matrix, path enumeration, as well as on the stationary state, stochastic matrix, or mean first-passage times of a random walk. As the random walk defining the centrality measure can be arbitrarily chosen, we pay particular attention to the maximal-entropy random walk, which serves as a very distinct alternative to the ordinary (diffusive) random walk used in network analysis. The various importance measures, defined both with the use of ordinary random walk and the maximal-entropy random walk, are compared numerically on a set of benchmark graphs with varying mixing parameter and are grouped with the use of the agglomerative clustering technique. It is shown that centrality measures defined with the two different random walks cluster into two separate groups. In particular, the group of centrality measures defined by the maximal-entropy random walk does not cluster with any other measures on change of graphs' parameters, and members of this group produce mutually closer results than members of the group defined by the ordinary random walk.

  3. A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer

    DEFF Research Database (Denmark)

    Nottelmann, Lise; Groenvold, Mogens; Vejlgaard, Tove Bahn

    2017-01-01

    in a 12-week individually tailored, palliative rehabilitation program initiated shortly after a diagnosis of advanced cancer. METHODS: This single center, randomized, controlled trial will include 300 patients with newly diagnosed advanced cancer recruited from the Department of Oncology, Vejle Hospital...... initiated shortly after an advanced cancer diagnosis. The study will contribute with evidence on the effectiveness of implementing early palliative care in standard oncology treatment and hopefully offer new knowledge and future directions as to the content of palliative rehabilitation programs. TRIAL......BACKGROUND: The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation...

  4. Access to a simulator is not enough: the benefits of virtual reality training based on peer-group-derived benchmarks--a randomized controlled trial.

    Science.gov (United States)

    von Websky, Martin W; Raptis, Dimitri A; Vitz, Martina; Rosenthal, Rachel; Clavien, P A; Hahnloser, Dieter

    2013-11-01

    Virtual reality (VR) simulators are widely used to familiarize surgical novices with laparoscopy, but VR training methods differ in efficacy. In the present trial, self-controlled basic VR training (SC-training) was tested against training based on peer-group-derived benchmarks (PGD-training). First, novice laparoscopic residents were randomized into a SC group (n = 34), and a group using PGD-benchmarks (n = 34) for basic laparoscopic training. After completing basic training, both groups performed 60 VR laparoscopic cholecystectomies for performance analysis. Primary endpoints were simulator metrics; secondary endpoints were program adherence, trainee motivation, and training efficacy. Altogether, 66 residents completed basic training, and 3,837 of 3,960 (96.8 %) cholecystectomies were available for analysis. Course adherence was good, with only two dropouts, both in the SC-group. The PGD-group spent more time and repetitions in basic training until the benchmarks were reached and subsequently showed better performance in the readout cholecystectomies: Median time (gallbladder extraction) showed significant differences of 520 s (IQR 354-738 s) in SC-training versus 390 s (IQR 278-536 s) in the PGD-group (p group being more efficient. Basic VR laparoscopic training based on PGD benchmarks with external assessment is superior to SC training, resulting in higher trainee motivation and better performance in simulated laparoscopic cholecystectomies. We recommend such a basic course based on PGD benchmarks before advancing to more elaborate VR training.

  5. Effectiveness and safety of 0.15% ganciclovir in situ ophthalmic gel for herpes simplex keratitis - a multicenter, randomized, investigator-masked, parallel group study in Chinese patients.

    Science.gov (United States)

    Lin, Tong; Gong, Lan; Sun, Xing-Huai; Zhao, Nai-Qing; Chen, Wei; Yuan, Hui-Ping; Shao, Yan; Gao, Ming-Hong; Tang, Hai

    2013-01-01

    Parallel comparison with 0.15% ganciclovir (GCV) ophthalmic gel to evaluate the effectiveness and safety of 0.15% GCV in situ ophthalmic gel for the treatment of herpes simplex keratitis (HSK). This was a multicenter, randomized, investigator-masked, parallel group study. HSK patients were randomly divided into two groups, with the corresponding treatment of 0.15% GCV ophthalmic gel or 0.15% GCV in situ ophthalmic gel. Symptoms and signs were observed before administration, and 3 (±1), 7 (±1), 14 (±2), and 21 (±3) days after the administration. The clinical effective rate was considered as the primary outcome. The safety profile was evaluated by AEs, visual acuity, and ocular tolerance. The clinical effective rate in the per-protocol (PP) dataset for the treatment group and the control group were 95.10% and 93.00%, respectively (P = 0.5282). The noninferiority test showed significant differences (P = 0.000305, P < 0.025), indicating that the tested drug was noninferior to the control. Patients in the PP dataset of both groups experienced decreases in the total scores of clinical indicators. Ocular AEs were few but similar between the two groups. There were no significant differences between patients' visions between the two groups before and after administration in the safety analysis set. In terms of drug tolerance, the rates of patients without transient blurred vision during all the visits in the treatment group were higher than those for the control group (P < 0.05). During the third and fourth visits, the rates of patients with eye itching were 4.08% and 1.22% in the treatment group, and 13.59% and 8.14% in the control group, respectively (P < 0.05). During the second visit, the rates of patients with eye irritation were 14.42% in the treatment group and 25.71% in the control group (P < 0.05). The 0.15% GCV in situ ophthalmic gel was effective and safe for the treatment of HSK, and was not inferior to 0.15% GCV ophthalmic gel. The 0.15% GCV in situ

  6. Group psychotherapy for eating disorders: A randomized clinical trial and a pre-treatment moderator and mediator analyses

    DEFF Research Database (Denmark)

    Davidsen, Annika Helgadóttir

    English summary The aim of this thesis was twofold. First, I wanted to examine the effect of client feedback on treatment attendance and outcome in group psychotherapy for eating disorders. Second, I wanted to contribute to the relatively scarce body of research on the consequences of an eating...... disorder on functionality. Group psychotherapy of various types is widely used to treat individuals with eating disorders. Dropout is, however, an important problem in the treatment of these patients, and it is therefore important to find ways to increase attendance. One of the means to address...... the Outcome Rating Scale and the Group Session Rating Scale. The primary outcome was rate of attendance at treatment sessions; the secondary outcome was the severity of eating disorder symptoms measured with the Eating Disorder Examination interview. Exploratory outcomes were psychological distress measured...

  7. Effects of music therapy on self- and experienced stigma in patients on an acute care psychiatric unit: a randomized three group effectiveness study.

    Science.gov (United States)

    Silverman, Michael J

    2013-10-01

    Stigma is a major social barrier that can restrict access to and willingness to seek psychiatric care. Psychiatric consumers may use secrecy and withdrawal in an attempt to cope with stigma. The purpose of this study was to determine the effects of music therapy on self- and experienced stigma in acute care psychiatric inpatients using a randomized design with wait-list control. Participants (N=83) were randomly assigned by cluster to one of three single-session group-based conditions: music therapy, education, or wait-list control. Participants in the music therapy and education conditions completed only posttests while participants in the wait-list control condition completed only pretests. The music therapy condition was a group songwriting intervention wherein participants composed lyrics for "the stigma blues." Results indicated significant differences in measures of discrimination (experienced stigma), disclosure (self-stigma), and total stigma between participants in the music therapy condition and participants in the wait-list control condition. From the results of this randomized controlled investigation, music therapy may be an engaging and effective psychosocial technique to treat stigma. Limitations, suggestions for future research, and implications for clinical practice and psychiatric music therapy research are provided. © 2013.

  8. The effectiveness of a psycho-educational group after early-stage breast cancer treatment: results of a randomized French study.

    Science.gov (United States)

    Dolbeault, S; Cayrou, S; Brédart, A; Viala, A L; Desclaux, B; Saltel, P; Gauvain-Piquard, A; Hardy, P; Dickes, P

    2009-06-01

    Many women with breast cancer need psychological help to cope more effectively after treatment. Cognitive and behavioural techniques are not yet well established in France. A multi-site randomized study was conducted to evaluate the effects of a psycho-educational group intervention in this population. Two hundred and three patients, recruited after primary treatment, were randomly assigned either to a treatment group (psycho-educational intervention) or to a waiting-list control group. The 8-week programme of 2 h sessions comprised of thematic discussions, information and training in stress management techniques. Evaluation at baseline, after 8 sessions, and 1 month after programme completion, included evaluations using the STAI, POMS, MAC, EORTC QLQ-C30 and EORTC QLQ-BR23 breast module scales. We observed a significant reduction in anxiety (STAI, POMS) among group participants, a reduction in anger, depression and fatigue (POMS), a significant improvement in vigor and interpersonal relationships (POMS), in emotional and role functioning, in health status and fatigue level (EORTC QLQ-C30). In contrast, coping strategies (MAC) were not significantly different between groups. No group-related negative effects were observed and the global satisfaction levels were very high. This study demonstrates the feasibility and effectiveness of a psycho-educational intervention, which can accelerate the reduction of those negative affects which are present at the end of treatment. It represents an excellent complement or an alternative to individual psycho-oncologic therapeutic support, widely proposed in France, and should now be tested in groups with other types of cancer and at other disease phases.

  9. Teaching medical students exposure therapy for phobia/panic - randomized, controlled comparison of face-to-face tutorial in small groups vs. solo computer instruction.

    Science.gov (United States)

    McDonough, Michael; Marks, Isaac M

    2002-05-01

    To compare the teaching value of one session of computer-guided solo instruction in exposure therapy for phobias with that of one face-to-face small-group tutorial. Non-blind, randomized, controlled study. King's College Hospital Medical School, London. Thirty-seven third-year medical students and 11 behaviour therapists. Seventy-five true/false multiple choice questions relating to (b) below answered at pre- and post-teaching by students and just once by behaviour therapists to obtain 'expert' scores; pre- and post-teaching ratings of interest in behaviour therapy and post-teaching ratings of educational and enjoyment value. EDUCATIONAL INTERVENTIONS: (a) All students had a 20-minute group lecture on basic concepts and historical aspects just before randomization to: (b) 90 min of either solo computer or group face-to-face tutorial teaching. Computer instruction used a short version of 'FearFighter'- a self-help computer system for people suffering from phobias. Solo computer instruction taught exposure therapy principles effectively but improved multiple choice question scores marginally less than did small-group tutorial teaching. Tutorial teaching required 5 times more teacher time but led to knowledge scores that did not differ significantly from those of behaviour therapists. Students clearly rated face-to-face small-group tutorial teaching as more enjoyable. The knowledge gain from a solo computer session resembled that from a small-group face-to-face tutorial, and required far less teacher time, but was less enjoyable. Enjoyment might rise if the computer session was group-oriented and aimed at students rather than patients. In general computer teaching might be best used to complement rather than replace conventional teaching.

  10. A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems.

    Science.gov (United States)

    Stocks, Jennifer Dugan; Taneja, Baldeo K; Baroldi, Paolo; Findling, Robert L

    2012-04-01

    To evaluate safety and tolerability of four doses of immediate-release molindone hydrochloride in children with attention-deficit/hyperactivity disorder (ADHD) and serious conduct problems. This open-label, parallel-group, dose-ranging, multicenter trial randomized children, aged 6-12 years, with ADHD and persistent, serious conduct problems to receive oral molindone thrice daily for 9-12 weeks in four treatment groups: Group 1-10 mg (5 mg if weight children with ADHD and serious conduct problems. Secondary outcome measures included change in Nisonger Child Behavior Rating Form-Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem subscale scores, change in Clinical Global Impressions-Severity (CGI-S) and -Improvement (CGI-I) subscale scores from baseline to end point, and Swanson, Nolan, and Pelham rating scale-revised (SNAP-IV) ADHD-related subscale scores. The study randomized 78 children; 55 completed the study. Treatment with molindone was generally well tolerated, with no clinically meaningful changes in laboratory or physical examination findings. The most common treatment-related adverse events (AEs) included somnolence (n=9), weight increase (n=8), akathisia (n=4), sedation (n=4), and abdominal pain (n=4). Mean weight increased by 0.54 kg, and mean body mass index by 0.24 kg/m(2). The incidence of AEs and treatment-related AEs increased with increasing dose. NCBRF-TIQ subscale scores improved in all four treatment groups, with 34%, 34%, 32%, and 55% decreases from baseline in groups 1, 2, 3, and 4, respectively. CGI-S and SNAP-IV scores improved over time in all treatment groups, and CGI-I scores improved to the greatest degree in group 4. Molindone at doses of 5-20 mg/day (children weighing blind, placebo-controlled trials are needed to further investigate molindone in this pediatric population.

  11. Effectiveness and cost-effectiveness of meaning-centered group psychotherapy in cancer survivors: protocol of a randomized controlled trial.

    NARCIS (Netherlands)

    van der Spek, N.; Vos, J.; van Uden-Kraan, C.F.; Breitbart, W.; Cuijpers, P.; Knipscheer-Kuipers, K.; Willemsen, V.W.B.; Tollenaar, R.A.; van Asperen, C.J.; de Leeuw, I.M.

    2014-01-01

    Background: Meaning-focused coping may be at the core of adequate adjustment to life after cancer. Cancer survivors who experience their life as meaningful are better adjusted, have better quality of life and psychological functioning. Meaning-Centered Group Psychotherapy for Cancer Survivors

  12. Developing Singing Confidence in Early Childhood Teachers Using Acceptance and Commitment Therapy and Group Singing: A Randomized Trial

    Science.gov (United States)

    Swain, Nicola; Bodkin-Allen, Sally

    2017-01-01

    Early childhood teachers are often required to sing, which requires confidence. The purpose of the present study was to treat early childhood teachers who self-identified as uncertain singers using either a group singing (GS) approach, or a talking approach, based on Acceptance and Commitment Therapy (ACT). The aim of the study was to increase…

  13. Evaluation of a Group Cognitive-Behavioral Depression Prevention Program for Young Adolescents: A Randomized Effectiveness Trial

    Science.gov (United States)

    Gillham, Jane E.; Reivich, Karen J.; Brunwasser, Steven M.; Freres, Derek R.; Chajon, Norma D.; Kash-MacDonald, V. Megan; Chaplin, Tara M.; Abenavoli, Rachel M.; Matlin, Samantha L.; Gallop, Robert J.; Seligman, Martin E. P.

    2012-01-01

    Depression is a common psychological problem in adolescence. Recent research suggests that group cognitive-behavioral interventions can reduce and prevent symptoms of depression in youth. Few studies have tested the effectiveness of such interventions when delivered by school teachers and counselors (as opposed to research team staff). We…

  14. Children with Autism Spectrum Disorder and Social Skills Groups at School: A Randomized Trial Comparing Intervention Approach and Peer Composition

    Science.gov (United States)

    Kasari, Connie; Dean, Michelle; Kretzmann, Mark; Shih, Wendy; Orlich, Felice; Whitney, Rondalyn; Landa, Rebecca; Lord, Catherine; King, Bryan

    2016-01-01

    Background: Peer relationships improve for children with autism spectrum disorder (ASD) in clinic-based social skills groups but rarely generalize to real world contexts. This study compares child outcomes of two social skills interventions conducted in schools with children in Kindergarten through fifth grade. Method: Children with ASD were…

  15. Internet-Delivered Targeted Group Intervention for Body Dissatisfaction and Disordered Eating in Adolescent Girls: A Randomized Controlled Trial

    Science.gov (United States)

    Heinicke, Brooke E.; Paxton, Susan J.; McLean, Sian A.; Wertheim, Eleanor H.

    2007-01-01

    This study evaluated a targeted intervention designed to alleviate body image and eating problems in adolescent girls that was delivered over the internet so as to increase access to the program. The program consisted of six, 90-minute weekly small group, synchronous on-line sessions and was facilitated by a therapist and manual. Participants were…

  16. Randomized, parallel-group, double-blind, controlled study to evaluate the efficacy and safety of carbohydrate-derived fulvic acid in topical treatment of eczema.

    Science.gov (United States)

    Gandy, Justin J; Snyman, Jacques R; van Rensburg, Constance Ej

    2011-01-01

    The purpose of this study was to evaluate the efficacy and safety of carbohydratederived fulvic acid (CHD-FA) in the treatment of eczema in patients two years and older. In this single-center, double-blind, placebo-controlled, parallel-group comparative study, 36 volunteers with predetermined eczema were randomly assigned to receive either the study drug or placebo twice daily for four weeks. All safety parameters remained within normal limits, with no significant differences in either group. Significant differences were observed for both severity and erythema in the placebo and CHD-FA treated groups, and a significant difference was observed for scaling in the placebo-treated group. With regard to the investigator assessment of global response to treatment, a significant improvement was observed in the CHD-FA group when compared with the placebo group. A statistically significant decrease in visual analog scale score was observed in both groups, when comparing the baseline with the final results. CHD-FA was well tolerated, with no difference in reported side effects other than a short-lived burning sensation on application. CHD-FA significantly improved some aspects of eczema. Investigator assessment of global response to treatment with CHD-FA was significantly better than that with emollient therapy alone. The results of this small exploratory study suggest that CHD-FA warrants further investigation in the treatment of eczema.

  17. Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial.

    Science.gov (United States)

    Andersson, Gerhard; Carlbring, Per; Holmström, Annelie; Sparthan, Elisabeth; Furmark, Tomas; Nilsson-Ihrfelt, Elisabeth; Buhrman, Monica; Ekselius, Lisa

    2006-08-01

    Sixty-four individuals with social phobia (social anxiety disorder) were assigned to a multimodal cognitive-behavioral treatment package or to a waiting list control group. Treatment consisted of a 9-week, Internet-delivered, self-help program that was combined with 2 group exposure sessions in real life and minimal therapist contact via e-mail. Results were analyzed on an intention-to-treat basis, including all randomized participants. From pre- to posttest, treated participants in contrast to controls showed significant improvement on most measured dimensions (social anxiety scales, general anxiety and depression levels, quality of life). The overall within- and between-groups effect sizes were Cohen's d = 0.87 and 0.70, respectively. Treatment gains were maintained at 1-year follow-up. The results from this study support the continued use and development of Internet-distributed, self-help programs for people diagnosed with social phobia.

  18. A Web-Based, Social Networking Beginners' Running Intervention for Adults Aged 18 to 50 Years Delivered via a Facebook Group: Randomized Controlled Trial.

    Science.gov (United States)

    Looyestyn, Jemma; Kernot, Jocelyn; Boshoff, Kobie; Maher, Carol

    2018-02-26

    Online social networks continue to grow in popularity, with 1.7 billion users worldwide accessing Facebook each month. The use of social networking sites such as Facebook for the delivery of health behavior programs is relatively new. The primary aim of this study was to determine the effectiveness of a Web-based beginners' running program for adults aged 18 to 50 years, delivered via a Facebook group, in increasing physical activity (PA) and cardiorespiratory fitness. A total of 89 adults with a mean age of 35.2 years (SD 10.9) were recruited online and via print media. Participants were randomly allocated to receive the UniSA Run Free program, an 8-week Web-based beginners' running intervention, delivered via a closed Facebook group (n=41) that included daily interactive posts (information with links, motivational quotes, opinion polls, or questions) and details of the running sessions; or to the control group who received a hard copy of the running program (n=48). Assessments were completed online at baseline, 2 months, and 5 months. The primary outcome measures were self-reported weekly moderate to vigorous physical activity (MVPA) and objectively measured cardiorespiratory fitness. Secondary outcomes were social support, exercise attitudes, and self-efficacy. Analyses were undertaken using random effects mixed modeling. Compliance with the running program and engagement with the Facebook group were analyzed descriptively. Both groups significantly increased MVPA across the study period (P=.004); however, this was significantly higher in the Facebook group (P=.04). The Facebook group increased their MVPA from baseline by 140 min/week versus 91 min for the control at 2 months. MVPA remained elevated for the Facebook group (from baseline) by 129 min/week versus a 50 min/week decrease for the control at 5 months. Both groups had significant increases in social support scores at 2 months (P=.02); however, there were no group by time differences (P=.16). There were

  19. A group-delivered self-management program reduces spasticity in people with multiple sclerosis: A randomized, controlled pilot trial

    OpenAIRE

    Hugos, Cinda L; Bourdette, Dennis; Chen, Yiyi; Chen, Zunqiu; Cameron, Michelle

    2017-01-01

    Background Spasticity affects more than 80% of people with multiple sclerosis (MS), affecting activity, participation, and quality of life. Based on an international guideline, an MS spasticity group education and stretching program, MS Spasticity: Take Control (STC), has been developed. Objective The objective of this paper is to determine whether STC with home stretching is associated with greater changes in spasticity than usual care (UC), consisting of an illustrated stretching booklet an...

  20. Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial.

    Science.gov (United States)

    Faurholt-Jepsen, M; Frost, M; Ritz, C; Christensen, E M; Jacoby, A S; Mikkelsen, R L; Knorr, U; Bardram, J E; Vinberg, M; Kessing, L V

    2015-10-01

    The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder. A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups. Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval -0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group. These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.

  1. Reducing substance involvement in college students: a three-arm parallel-group randomized controlled trial of a computer-based intervention.

    Science.gov (United States)

    Christoff, Adriana de Oliveira; Boerngen-Lacerda, Roseli

    2015-06-01

    The prevalence of alcohol and other drug use is high among college students. Reducing their consumption will likely be beneficial for society as a whole. Computer and web-based interventions are promising for providing behaviorally based information. The present study compared the efficacy of three interventions (computerized screening and motivational intervention [ASSIST/MBIc], non-computerized screening and motivational intervention [ASSIST/MBIi], and screening only [control]) in college students in Curitiba, Brazil. A convenience sample of 458 students scored moderate and high risk on the ASSIST. They were then randomized into the three arms of the randomized controlled trial (ASSIST/MBIc, ASSIST/MBIi [interview], and assessment-only [control]) and assessed at baseline and 3 months later. The ASSIST involvement scores decreased at follow-up compared with baseline in the three groups, suggesting that any intervention is better than no intervention. For alcohol, the specific involvement scores decreased to a low level of risk in the three groups and the MBIc group showed a positive outcome compared with control, and the scores for each question were reduced in the two intervention groups compared to baseline. For tobacco, involvement scores decreased in the three groups, but they maintained moderate risk. For marijuana, a small positive effect was observed in the ASSIST/MBIi and control groups. The ASSIST/MBIc may be a good alternative to interview interventions because it is easy to administer, students frequently use such computer-based technologies, and individually tailored content can be delivered in the absence of a counselor. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. The effects of Nordic Walking training on selected upper-body muscle groups in female-office workers: A randomized trial.

    Science.gov (United States)

    Kocur, Piotr; Pospieszna, Barbara; Choszczewski, Daniel; Michalowski, Lukasz; Wiernicka, Marzena; Lewandowski, Jacek

    2017-01-01

    Regular Nordic Walking training could improve fitness and reduce tenderness in selected muscle groups in office workers. An assessment of the effects of a 12-week Nordic Walking training program on the perceived pain threshold (PPT) and the flexibility of selected upper-body muscle groups in postmenopausal female office workers. 39 office workers were selected at random for the treatment group (NWg, n = 20) and the control group (Cg, n = 19). The persons from the NW group completed a 12-week Nordic Walking training program (3 times a week/1 hour). PPTs measurements in selected muscles and functional tests evaluating upper-body flexibility (Back Scratch - BS) were carried out twice in every participant of the study: before and after the training program. A significant increase in PPT (kg/cm2) was observed in the following muscles in the NW group only: upper trapezius (from 1,32 kg/cm2 to 1,99 kg/cm2), mid trapezius (from 2,92 kg/cm2 to 3,30 kg/cm2), latissimus dorsi (from 1,66 kg/cm2 to 2,21 kg/cm2) and infraspinatus (from 1,63 kg/cm2 to 2,93 kg/cm2). Moreover, a significant improvement in the BS test was noted in the NW group compared with the control group (from -1,16±5,7 cm to 2,18±5,1 cm in the NW group vs from -2,52±6,1 to -2,92±6,2 in the control group). A 12-week Nordic Walking training routine improves shoulder mobility and reduces tenderness in the following muscles: trapezius pars descendens and middle trapezius, infraspinatus and latissimus dorsi, in female office workers.

  3. Fluvial sediments characterization of Hornád river in its chosen parts (preliminary study

    Directory of Open Access Journals (Sweden)

    Stela Hanigovská

    2008-12-01

    Full Text Available Knowledge of main river sedimentary characteristics is very important source of information for next study or potentialcommercial usage of fluvial sediments. In paper is shown characterization of sediment distribution in chosen part of the river Hornád.Three main facial types were studied and described – gravel, sand and clay. Model created in this study shows that Hornád is a riverwith predominant gravel transport. This model also shows a sufficient amount of gravel for commercial use in some parts of the river.

  4. Informed consent in rhinoplasty: prospective randomized study of risk recall in patients who are given written disclosure of risks versus traditional oral discussion groups.

    Science.gov (United States)

    Hong, Paul; Makdessian, Ara Samuel; Ellis, David A F; Taylor, S Mark

    2009-06-01

    To determine the effectiveness of providing written information in enhancing patient understanding and retention. A multicentre prospective randomized study was conducted in university-affiliated ambulatory surgical centres. One hundred consecutive patients seen for rhinoplasty consultation were included. Patients were randomly assigned to (1) those receiving traditional oral dialogue of the surgical risks or (2) those receiving an oral discussion and a written pamphlet outlining the risks of the procedure. Fourteen to 18 days after the consultation, each patient was contacted for an assessment of risk recall. Overall risk recall was higher in the group that received written information (2.3 vs 1.3 of 5 risks; p group that received a pamphlet, patients with university and postgraduate levels of education had a better rate of recall (p groups reported higher risk recall (p < .01). Patient risk recall of rhinoplasty is improved with the addition of written information during the informed consent process. As the process of informed consent plays a very decisive role in facial plastic surgery, enhanced postoperative satisfaction may result from the use of supplemental educational materials.

  5. Manage at work: a randomized, controlled trial of a self-management group intervention to overcome workplace challenges associated with chronic physical health conditions.

    Science.gov (United States)

    Shaw, William S; Besen, Elyssa; Pransky, Glenn; Boot, Cécile R L; Nicholas, Michael K; McLellan, Robert K; Tveito, Torill H

    2014-05-28

    The percentage of older and chronically ill workers is increasing rapidly in the US and in many other countries, but few interventions are available to help employees overcome the workplace challenges of chronic pain and other physical health conditions. While most workers are eligible for job accommodation and disability compensation benefits, other workplace strategies might improve individual-level coping and problem solving to prevent work disability. In this study, we hypothesize that an employer-sponsored group intervention program employing self-management principles may improve worker engagement and reduce functional limitation associated with chronic disorders. In a randomized controlled trial (RCT), workers participating in an employer-sponsored self-management group intervention will be compared with a no-treatment (wait list) control condition. Volunteer employees (n = 300) will be recruited from five participating employers and randomly assigned to intervention or control. Participants in the intervention arm will attend facilitated group workshop sessions at work (10 hours total) to explore methods for improving comfort, adjusting work habits, communicating needs effectively, applying systematic problem solving, and dealing with negative thoughts and emotions about work. Work engagement and work limitation are the principal outcomes. Secondary outcomes include fatigue, job satisfaction, self-efficacy, turnover intention, sickness absence, and health care utilization. Measurements will be taken at baseline, 6-, and 12-month follow-up. A process evaluation will be performed alongside the randomized trial. This study will be most relevant for organizations and occupational settings where some degree of job flexibility, leeway, and decision-making autonomy can be afforded to affected workers. The study design will provide initial assessment of a novel workplace approach and to understand factors affecting its feasibility and effectiveness

  6. Peer support and additional information in group medical consultations (GMCs) for BRCA1/2 mutation carriers: A randomized controlled trial.

    Science.gov (United States)

    Visser, Annemiek; van Laarhoven, Hanneke W M; Woldringh, Gwendolyn H; Hoogerbrugge, Nicoline; Prins, Judith B

    2016-01-01

    Group medical consultations (GMCs) provide individual medical visits in the presence of ≤ 7 peer- patients. This study evaluated the efficacy of GMCs in the yearly breast cancer surveillance of BRCA mutation carriers. This randomized controlled trial compared GMCs (intervention group, n = 63) with individual medical visits (control group, n = 59). Between-group differences on the primary outcomes distress and empowerment, were analyzed one week and three months after the visit. Feasibility is evaluated in terms of demand, acceptability and practicability. No between-group differences were found on primary outcomes. More themes were discussed in GMCs. Seventy-five percent of GMC-participants experienced peer support. Carriers reported significantly higher satisfaction with individual visits. GMCs were less time-efficient. This is the first GMC study which reports results in favor of individual visits. The hereditary nature of the condition differentiates our study population from earlier studied GMC groups. Even though most participants experienced peer support and received more information, the lower patient satisfaction may be explained by the lack of individual time with the clinician and disruption of normal surveillance routines. As the need for peer support and additional information is present in a substantial part of carriers, future research should study the process of peer support.

  7. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design

    DEFF Research Database (Denmark)

    Nielsen, Niklas; Wetterslev, Jørn; al-Subaie, Nawaf

    2012-01-01

    Experimental animal studies and previous randomized trials suggest an improvement in mortality and neurologic function with induced hypothermia after cardiac arrest. International guidelines advocate the use of a target temperature management of 32°C to 34°C for 12 to 24 hours after resuscitation...... from out-of-hospital cardiac arrest. A systematic review indicates that the evidence for recommending this intervention is inconclusive, and the GRADE level of evidence is low. Previous trials were small, with high risk of bias, evaluated select populations, and did not treat hyperthermia...... in the control groups. The optimal target temperature management strategy is not known....

  8. Tapentadol immediate-release for acute postbunionectomy pain: a phase 3, randomized, double-blind, placebo-controlled, parallel-group study in Taiwan.

    Science.gov (United States)

    Chen, Yeung-Jen; Chiang, Chao-Ching; Huang, Peng-Ju; Huang, Jason; Karcher, Keith; Li, Honglan

    2015-11-01

    To evaluate the efficacy and safety of tapentadol immediate-release (IR) for treating acute pain following orthopedic bunionectomy surgery in a Taiwanese population. This was a phase 3, randomized, double-blind, placebo-controlled, parallel-group bridging study in which Taiwanese patients (N = 60) with moderate-to-severe pain following bunionectomy were randomized (1:1:1) to receive tapentadol IR 50 or 75 mg or placebo orally every 4-6 hours over a 72 hour period. The primary endpoint was the sum of pain intensity difference over 48 hours (SPID48), analyzed using analysis of variance. Out of 60 patients randomized (mainly women [96.7%]; median age 44 years), 41 (68.3%) completed the treatment. Mean SPID48 values were significantly higher for tapentadol IR (p ≤ 0.006: 50 mg, p ≤ 0.004: 75 mg) compared with placebo. Between-group differences in LS means of SPID48 (vs. placebo) were tapentadol IR 50 mg: 105.6 (95% CI: 32.0; 179.2); tapentadol IR 75 mg: 126.6 (95% CI: 49.5; 203.7). Secondary endpoints including SPID at 12, 24, and 72 hours, time to first use of rescue medication, cumulative distribution of responder rates, total pain relief and sum of total pain relief and sum of pain intensity difference at 12, 24, 48, and 72 hours, and patient global impression of change showed numerically better results supporting that tapentadol IR (50 and 75 mg) was more efficacious than placebo in relieving acute pain. The most frequent treatment emergent adverse events reported in ≥ 10% patients in either group were dizziness, nausea, and vomiting. A limitation of this study may possibly include more controlled patient monitoring through 4-6 hour dosing intervals, which reflects optimal conditions and thus may not approximate real-world clinical practice. However, all treatment groups would be equally affected by such bias of frequent monitoring, if any, since it was a randomized and double-blind study. Tapentadol IR treatment significantly relieved acute postoperative

  9. A randomized, open, parallel group, multicenter trial to investigate analgesic efficacy and safety of a new transdermal fentanyl patch compared to standard opioid treatment in cancer pain

    DEFF Research Database (Denmark)

    Kress, Hans G; Von der Laage, Dorothea; Hoerauf, Klaus H

    2008-01-01

    to be pharmacokinetically bioequivalent to the marketed fentanyl patch. To determine noninferiority in efficacy in cancer patients and to compare safety, a clinical trial comparing the new fentanyl patch with standard oral or transdermal opioid treatment was planned. The design was an open, parallel group, multicenter...... trial, in which 220 patients were randomized to receive either the fentanyl patch or standard opioid treatment for 30 days. The primary efficacy variable, pain intensity (PI) on a 0-10-point numerical rating scale, was recorded once daily. The primary endpoint was the relative area under the curve of PI...

  10. Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomized phase III trial.

    Science.gov (United States)

    Breugom, A J; van Gijn, W; Muller, E W; Berglund, Å; van den Broek, C B M; Fokstuen, T; Gelderblom, H; Kapiteijn, E; Leer, J W H; Marijnen, C A M; Martijn, H; Meershoek-Klein Kranenbarg, E; Nagtegaal, I D; Påhlman, L; Punt, C J A; Putter, H; Roodvoets, A G H; Rutten, H J T; Steup, W H; Glimelius, B; van de Velde, C J H

    2015-04-01

    The discussion on the role of adjuvant chemotherapy for rectal cancer patients treated according to current guidelines is still ongoing. A multicentre, randomized phase III trial, PROCTOR-SCRIPT, was conducted to compare adjuvant chemotherapy with observation for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision (TME). The PROCTOR-SCRIPT trial recruited patients from 52 hospitals. Patients with histologically proven stage II or III rectal adenocarcinoma were randomly assigned (1:1) to observation or adjuvant chemotherapy after preoperative (chemo)radiotherapy and TME. Radiotherapy consisted of 5 × 5 Gy. Chemoradiotherapy consisted of 25 × 1.8-2 Gy combined with 5-FU-based chemotherapy. Adjuvant chemotherapy consisted of 5-FU/LV (PROCTOR) or eight courses capecitabine (SCRIPT). Randomization was based on permuted blocks of six, stratified according to centre, residual tumour, time between last irradiation and surgery, and preoperative treatment. The primary end point was overall survival. Of 470 enrolled patients, 437 were eligible. The trial closed prematurely because of slow patient accrual. Patients were randomly assigned to observation (n = 221) or adjuvant chemotherapy (n = 216). After a median follow-up of 5.0 years, 5-year overall survival was 79.2% in the observation group and 80.4% in the chemotherapy group [hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.62-1.39; P = 0.73]. The HR for disease-free survival was 0.80 (95% CI 0.60-1.07; P = 0.13). Five-year cumulative incidence for locoregional recurrences was 7.8% in both groups. Five-year cumulative incidence for distant recurrences was 38.5% and 34.7%, respectively (P = 0.39). The PROCTOR-SCRIPT trial could not demonstrate a significant benefit of adjuvant chemotherapy with fluoropyrimidine monotherapy after preoperative (chemo)radiotherapy and TME on overall survival, disease-free survival, and recurrence rate. However, this trial did not complete

  11. Theses\\' subjects chosen from public needs: Experience of Yazd Health Study (YaHS

    Directory of Open Access Journals (Sweden)

    AA Dehghanitaftiti

    2014-12-01

    Full Text Available Yazd Health Study (YaHS is an endeavor to involve students in design, implementation and analysis of a large study. Over 150 graduate and post graduate students from various disciplines have been invited to participate in a large longitudinal study with 10000 samples. Participants were selected randomly from Yazd population, over 1000000 as December 2014. Four hundred variables grouped in the following sections were asked 1 demographics, 2 physical activity, 3sleep quality and quantity, 4 mental health, 5 history y of chronic illnesses, 6 history of surgical operations, 7 dental health, 8 history of accidents, 9 dietetic habits, 10 occupation and communication history, 11 traditional medicine, 12 history of smoking and addiction and 13 women’s health. The interview follows by anthropometric measurements including weight, height, BMI, waist circumference, hip circumference, neck circumference and WHR. Per cent body fat, % body muscle, visceral fat, resting metabolism have been measured followed by pulse and blood pressure. Students were trained to participate in design, piloting and the main phase of data collection. Students evaluated the experience useful and constructive. In return of their collaboration in interviewing 50-100 study participants, they will receive data for their theses' proposal. This will help them to access a large and high quality set of data and disseminate the results in high quality peer reviewed journals as well as national and international conferences. The students mandated to write an executive summary of their thesis and disseminate it to health managers and inter-sectoral decision makers. They will gain bonus score if they can publish their main findings in public media. Acknowledgments: Thanks to students who participated in the study and A. Professor Masoud Mirzaei, the principal investigator of Yazd Health Study (YAHS for providing information on the design and the progress of the study.

  12. Effect of cognitive behavioral group therapy for recovery of self-esteem on community-living individuals with mental illness: Non-randomized controlled trial.

    Science.gov (United States)

    Kunikata, Hiroko; Yoshinaga, Naoki; Nakajima, Kazuo

    2016-10-01

    The aim of this study was to examine over a 12-month post-intervention period whether the participation of community-living individuals with mental illness in cognitive behavioral group therapy for recovery of self-esteem (CBGTRS) resulted in improved outcomes. This was a non-randomized controlled trial. The participants were persons with mental illness who resided in communities in the Chugoku region of Japan. In total, 41 were assigned to an experimental group (CBGTRS intervention, 12 group sessions), and 21 to a control group. Outcome indices (self-esteem, moods, cognition, subjective well-being, psychiatric symptoms) were measured for the experimental group prior to intervention (T0), immediately post-intervention (T1), and at 3 (T2) and 12 (T3) months post-intervention. The control group was measured at the same intervals. For the experimental group, self-esteem scores at T1, T2, and T3 were significantly higher than at T0. Moods and cognition scores remained significantly low until T2. Scores for Inadequate Mental Mastery in the subjective well-being index had not decreased by T3. Confidence in Coping remained significantly high until T2. Psychiatric symptoms scores at T0, T1, T2, and T3 were significantly lower than at T0. The means and standard errors for self-esteem and Inadequate Mental Mastery increased until T3, and those for Tension-Anxiety, Depression-Dejection, and Confusion decreased until T2. From within-group trends and between-group differences in self-esteem, we conclude that CBGTRS may have a relatively long-term effect on self-esteem recovery. T2 is the turning point for moods and cognition; thus, follow-up is needed 3 months following the initial program. © 2016 The Authors. Psychiatry and Clinical Neurosciences © 2016 Japanese Society of Psychiatry and Neurology.

  13. Crestal Bone Loss under Delayed Loading of Full Thickness Versus Flapless Surgically Placed Dental Implants in Controlled Type 2 Diabetic Patients: A Parallel Group Randomized Clinical Trial.

    Science.gov (United States)

    Yadav, Rohit; Agrawal, Kaushal Kishor; Rao, Jitendra; Anwar, Mohd; Alvi, Habib Ahmed; Singh, Kalpana; Himanshu, D

    2016-10-12

    To compare crestal bone loss around dental implants using a delayed loading protocol. Bone loss was compared in patients following conventional full thickness flap and flapless surgery in controlled type 2 diabetic patients. Eighty-eight type 2 diabetic patients satisfying predetermined inclusion and exclusion criteria were selected for this single center, parallel group study after obtaining institutional review board approval and informed consent. These patients were randomly divided into two groups. Group I consisted of patients undergoing full thickness flap surgery for implant placement, and group II consisted of patients undergoing flapless surgery for implant placement. The mean age, duration of diabetes, glycosylated hemoglobin levels, and male-to-female ratio in both groups were matched and compared statistically. Dental implants were placed followed by delayed loading (4 months) in both groups. Crestal bone loss was assessed with intraoral periapical radiographs with the help of computer software (DBSWIN viewer). Actual implant length acted as the radiographic index, and implant-abutment junctions were used as a reference point for all measurements. Mesial and distal bone levels at baseline, 6, and 12 months post implant placement of the two groups were determined. Mesial and distal crestal bone loss from baseline to 6 and 12 months were calculated and compared with Tukey test using SPSS v15.0 statistical analysis software. Tukey test revealed similar (not statistically different) mean mesial crestal bone loss between the two groups after 6 months (0.47 ± 0.08 mm vs. 0.36 ± 0.13 mm, p = 0.576) and after 12 months (1.56 ± 0.25 mm vs. 1.50 ± 0.22 mm, p = 0.891). The mean distal bone loss resulting between the two groups was not statistically different at 6 months (0.44 ± 0.08 mm vs. 0.35 ± 0.12 mm, p = 0.687) and at 12 months (1.57 ± 0.23 mm vs. 1.61 ± 0.22 mm, p = 0.947). The results of this clinical randomized control trial indicated that in

  14. The effectiveness of standardized skin care regimens on skin dryness in nursing home residents: A randomized controlled parallel-group pragmatic trial.

    Science.gov (United States)

    Hahnel, Elisabeth; Blume-Peytavi, Ulrike; Trojahn, Carina; Dobos, Gabor; Stroux, Andrea; Garcia Bartels, Natalie; Jahnke, Irina; Lichterfeld-Kottner, Andrea; Neels-Herzmann, Heike; Klasen, Anja; Kottner, Jan

    2017-05-01

    Aged residents of institutional long-term care facilities are at high risk for developing skin and tissue diseases. Besides various common skin problems, dry skin (xerosis cutis) is one of the most frequent skin conditions in this setting. To investigate the effectiveness of two structured skin care regimens in comparison to routine skin care on xerosis cutis in nursing home residents. A multi-center, pragmatic, randomized, controlled, investigator blinded study with three parallel groups. The study was conducted in a random sample of ten out of 291 institutional long-term care facilities of the federal state of Berlin, Germany. Long-term care residents being 65+ years affected by dry skin were included. The residents were allocated into one of three study groups. Two interventional groups used standardized skin care regimens, consisting of a body wash and twice daily applications of leave-on products for eight weeks. The third control group performed skin care as usual. All participating residents were examined at baseline and after 4 and 8 weeks. Xerosis cutis was measured with the Overall Dry Skin score. Instrumental skin barrier measurements were performed at baseline and after 8 weeks. Diaries were used to document washing and skin care frequencies. In total, 133 residents were included and allocated to one of the three groups. Mean age was 83.8 (SD 8.3) years, 65.4% were female and most residents had care levels I (42.9%) or II (42.9%) according to the German Social Code Book XI. Mean Barthel score was 46.8 (SD 24.2) and mean Braden score was 17.6 (SD 3.7). Leg skin areas were drier compared to arms and trunk areas. At the end of the study the Overall Dry Skin scores in the intervention groups were lower compared to the control group. There were statistically significant improvements of skin dryness in both intervention groups compared to the control group over time. The results of this pragmatic trial indicate that structured skin care regimens are effective

  15. Face-to-face individual counseling and online group motivational interviewing in improving oral health: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Gao, Xiaoli; Lo, Edward Chin-Man; McGrath, Colman; Ho, Samuel Mun-Yin

    2015-09-18

    Motivational interviewing (MI) has great potential in changing health-related behaviors. In addition to delivery in face-to-face individual counseling, MI can be delivered through online groups, a method that is particularly appealing to adolescents and may offer several benefits. This randomized controlled trial compares the effectiveness of prevailing health education (HE), face-to-face individual MI and online group MI in improving adolescents' oral health behaviors (diet and toothbrushing) and in preventing dental caries and periodontal diseases. In each of Hong Kong's main districts (Hong Kong Island, Kowloon and the New Territories), three secondary schools will be recruited and randomly assigned to three groups (HE, face-to-face individual MI, and online group MI). A total of 495 adolescents (aged 12 to 13 years) with unfavorable oral health behaviors ("snacking twice or more a day" and/or "brushing teeth less than twice a day") will be recruited: 165 in each group. Two dental hygienists will be trained to deliver the interventions. HE will be provided through an oral health talk. Participants in the "face-to-face individual MI" group will join a one-on-one counseling session. For "online group MI," participants will form groups of 6 to 8 and join a synchronous text-based online counseling session. At baseline and after 6, 12 and 24 months, clinical outcomes (caries increment and gingival health) and oral health self-efficacy and behaviors (toothbrushing and snacking) will be recorded through an oral examination and a questionnaire, respectively. Effectiveness of the interventions will be evaluated and compared. The primary outcomes will be the "number of new carious surfaces" and "gingival bleeding score" (% of surfaces with gingival bleeding). The secondary outcomes will be changes in oral health self-efficacy and behaviors (toothbrushing and snacking frequencies). A preliminary economic evaluation and a process evaluation will be included to analyze the

  16. The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fottrell Edward F

    2011-09-01

    Full Text Available Abstract Background Progress on neonatal survival has been slow in most countries. While there is evidence on what works to reduce newborn mortality, there is limited knowledge on how to deliver interventions effectively when health systems are weak. Cluster randomized trials have shown strong reductions in neonatal mortality using community mobilisation with women's groups in rural Nepal and India. A similar trial in Bangladesh showed no impact. A main hypothesis is that this negative finding is due to the much lower coverage of women's groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if women's group coverage is a main determinant of their impact. The study aims to test the effect on newborn and maternal health outcomes of a participatory women's group intervention with a high population coverage of women's groups. Methods A cluster randomised trial of a participatory women's group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a women's group intervention with high population coverage, the same 9 intervention and 9 control unions will be used as in the 2005-2007 trial. These had been randomly allocated using the districts as strata. To increase coverage, 648 new groups were formed in addition to the 162 existing groups that were part of the previous trial. An open cohort of women who are permanent residents in the union in which their delivery or death was identified, is enrolled. Women and their newborns are included after birth, or, if a woman dies during pregnancy, after her death. Excluded are women who are temporary residents in the union in which their birth or death was identified. The primary outcome is neonatal mortality in the last 24 months of the study. A low cost surveillance system will be used to record all birth outcomes and deaths to women of reproductive age in the study population. Data on home

  17. A hybrid effectiveness-implementation cluster randomized trial of group CBT for anxiety in urban schools: rationale, design, and methods.

    Science.gov (United States)

    Eiraldi, Ricardo; Khanna, Muniya S; Jawad, Abbas F; Fishman, Jessica; Glick, Henry A; Schwartz, Billie S; Cacia, Jaclyn; Wandersman, Abraham; Beidas, Rinad

    2016-07-12

    Schools present a context with great potential for the implementation of psychosocial evidence-based practices. Cognitive behavioral therapy (CBT) is an evidence-based practice that has been found to be very effective in treating anxiety in various community settings, including schools. Friends for Life (FRIENDS) is an efficacious group CBT protocol for anxiety. Unfortunately, evidence-based practices for anxiety are seldom employed in under-resourced urban schools, because many treatment protocols are not a good fit for the urban school context or the population, existing behavioral health staff do not receive adequate training or support to allow them to implement the treatment with fidelity, or school districts do not have the resources to contract with external consultants. In our prior work, we adapted FRIENDS to create a more culturally sensitive, focused, and feasible CBT protocol for anxiety disorders (CBT for Anxiety Treatment in Schools (CATS)). The aim of this 5-year study is to evaluate both the effectiveness of CATS for urban public schools compared to the original FRIENDS as well as compare the implementation strategies (train-the-trainer vs. train-the-trainer + ongoing consultation) by conducting a three-arm, parallel group, type 2 hybrid effectiveness-implementation trial in 18 K-8 urban public schools. We will also assess the cost-effectiveness and the mediators and moderators of fidelity. Ninety therapists, 18 agency supervisors, and 360 children will participate. The interactive systems framework for dissemination and implementation guides the training and support procedures for therapists and supervisors. This study has the potential to demonstrate that agency therapists and supervisors who have had little to no prior exposure to evidence-based practices (EBPs) can implement an anxiety disorder EBP with fidelity. Comparisons of the implementation strategies would provide large urban mental health systems with data to make decisions about the

  18. Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Cheung, Yee Tak Derek; Chan, Ching Han Helen; Lai, Chi-Keung Jonah; Chan, Wai Fung Vivian; Wang, Man Ping; Li, Ho Cheung William; Chan, Sophia Siu Chee; Lam, Tai-Hing

    2015-10-22

    Quit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence. Our aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently. This was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days. Fewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators' posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants' posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant. The intervention via the WhatsApp social group was effective in reducing relapse probably because of enhanced discussion and

  19. Effects of a psychoeducational versus a support group intervention in patients with early-stage breast cancer: results of a randomized controlled trial.

    Science.gov (United States)

    Schou Bredal, Inger; Kåresen, Rolf; Smeby, Nina Aarhus; Espe, Randi; Sørensen, Elin Myklebust; Amundsen, Mette; Aas, Hans; Ekeberg, Øivind

    2014-01-01

    Limited documentation exists on the effectiveness of psychoeducational group (PEG) versus support group (SG) interventions among breast cancer patients during primary care. Support group is a component of the hospitals' routine breast cancer care. The aim of this study was to investigate which of these approaches provides the greatest benefits to participants, particularly to women with low optimism (pessimists). The primary outcomes investigated here were anxiety, depression, and mental adjustment to cancer. A total of 367 women with early-stage breast cancer were randomized to the PEG or SG intervention starting 1 to 8 weeks after surgery. The PEG intervention included health education, enhancement of problem-solving skills, stress management, and psychological support. Participants in both groups showed improvement over time; however, no significant differences in emotional distress were found. The PEG participants exhibited more positive attitude at 2 and 6 months (P < .001) and less helplessness/hopelessness (P = .01) at 2 months compared with the SG participants. However, no significant differences were found between the groups at 12 months. Pessimists did not benefit more from attending the PEG than they did from attending the SG. Both groups showed improvement in emotional distress and coping over time. Although the results were limited, the PEG intervention seems to enhance short-term, but not long-term, adaptive coping. Psychoeducational group intervention yields benefits during the difficult period when patients receive adjuvant chemotherapy or radiotherapy. Thus, the hospital's standard group interventions have been changed to include more health education and stress management, but within the same time frame as the original SG.

  20. Radiofrequency catheter selection based on cavotricuspid angiography compared with a control group with an externally cooled-tip catheter: a randomized pilot study.

    Science.gov (United States)

    Da Costa, Antoine; Romeyer-Bouchard, Cécile; Jamon, Yann; Bisch, Laurence; Isaaz, Karl

    2009-05-01

    Radiofrequency ablation (RFA) of cavotricuspid isthmus (CTI)-dependent atrial flutter (AFL) can be performed using either externally cooled-tip RFA catheters or large-tip (8 mm) catheters. However, experimental and clinical studies suggest that the efficacy of both catheters may vary with CTI anatomy and catheters orientation. The aim of this prospective study was to evaluate: a RFA catheter selection based on CTI angiography compared with a control group with an externally cooled-tip catheter together with the risk of an expensive crossover catheter in both groups. Over a period of 16 months, 119 patients were included and randomized. When comparing the angiographic group (n = 56) and the externally cooled-tip RFA catheter group (n = 63), the duration of application time with a median of 7 min (interquartile range 4.5-11) versus a median of 10 min (interquartile range 6-20; P = 0.008) and the duration of X-ray exposure with a median of 7 min (interquartile range 4-10) versus a median of 10 min (interquartile range 5-15; P = 0.025) were significantly lower in the angiographic group versus externally cooled-tip catheter group. Furthermore, the number of catheters crossover was significantly higher in the angiographic group versus externally cooled-tip catheter group I (27% vs 7%; P = 0.007). This study shows that a strategy with a catheter selection based on a CTI angiographic evaluation is superior to an empirical use of an externally cooled-tip catheter during CTI RFA. Thus, angiographic isthmus evaluation predicts the effectiveness of a RFA catheter and the risk of an expensive catheter crossover.

  1. The Use of Self-Directed Relapse Prevention Booklets to Assist in Maintaining Abstinence After a 6-Week Group Smoking Cessation Treatment Program: A Randomized Controlled Trial.

    Science.gov (United States)

    Veldheer, Susan; Hrabovsky, Shari; Yingst, Jessica; Sciamanna, Chris; Berg, Arthur; Foulds, Jonathan

    2017-06-01

    Identifying effective relapse prevention interventions is a vital step to help smokers maintain abstinence for the long term. The purpose of this study is to determine if providing recently quit smokers with self-directed relapse prevention booklets is effective at maintaining abstinence after intensive group smoking cessation treatment. Two hundred and twenty-five participants were randomized to receive Forever Free (FF) relapse prevention booklets or a control booklet (Surgeon General's report, SG) at the end of a 6-week group treatment program. Participants were then contacted by phone to assess whether they had read the materials. Smoking status was assessed 6 months after their target quit date. Primary analyses focused on the 115 participants who quit at the end of treatment. There was no difference in the 6-month quit rate between groups (40.7% quit FF vs. 44.6% quit SG, p = .67). The FF group read a significantly smaller proportion of the materials versus the control booklet (20.0% read most or all of FF vs. 72.0% of SG, p self-directed relapse prevention booklets did not reduce relapse or enhance cessation over general tobacco and health information when added to intensive group smoking cessation treatment. However, this study lacked power to detect a small but clinically meaningful positive effect.

  2. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

    Science.gov (United States)

    Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

    2015-01-01

    Context: Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05). Conclusions: Findings suggested that OMT can influence ANS activity increasing

  3. AIDE-Acute Illness and Depression in Elderly Patients. Cognitive Behavioral Group Psychotherapy in Geriatric Patients With Comorbid Depression: A Randomized, Controlled Trial.

    Science.gov (United States)

    Hummel, Jana; Weisbrod, Cecilia; Boesch, Leila; Himpler, Katharina; Hauer, Klaus; Hautzinger, Martin; Gaebel, Andrea; Zieschang, Tania; Fickelscherer, Andrea; Diener, Slawomira; Dutzi, Ilona; Krumm, Bertram; Oster, Peter; Kopf, Daniel

    2017-04-01

    Comorbid depression is highly prevalent in geriatric patients and associated with functional loss, frequent hospital re-admissions, and a higher mortality rate. Cognitive behavioral psychotherapy (CBT) has shown to be effective in older depressive patients living in the community. To date, CBT has not been applied to older patients with acute physical illness and comorbid depression. To evaluate the effectiveness of CBT in depressed geriatric patients, hospitalized for acute somatic illness. Randomized controlled trial with waiting list control group. Postdischarge intervention in a geriatric day clinic; follow-up evaluations at the patients' homes. A total of 155 randomized patients, hospitalized for acute somatic illness, aged 82 ± 6 years and suffering from depression [Hospital Anxiety and Depression Scale (HADS) scores >7]. Exclusion criteria were dementia, delirium, and terminal state of medical illness. Fifteen, weekly group sessions based on a CBT manual. Commencement of psychotherapy immediately after discharge in the intervention group and a 4-month waiting list interval with usual care in the control group. HADS depression total score after 4 months. Secondary endpoints were functional, cognitive, psychosocial and physical status, resource utilization, caregiver burden, and amount of contact with physician. The intervention group improved significantly in depression scores (HADS baseline 18.8; after 4 months 11.4), whereas the control group deteriorated (HADS baseline 18.1; after 4 months 21.6). Significant improvement in the intervention group, but not in the control group, was observed for most secondary outcome parameters such as the Barthel and Karnofsky indexes. Intervention effects were less pronounced in patients with cognitive impairment or acute fractures. CBT is feasible and highly effective in geriatric patients. The benefits extend beyond effective recovery and include improvement in physical and functional parameters. Early diagnosis

  4. [Efficacy of esomeprazole compared with omeprazole in reflux esophagitis patients -a phase III, multicenter, randomized, double-blind, parallel-group trial-].

    Science.gov (United States)

    Kinoshita, Yoshikazu; Miwa, Hiroto; Kasugai, Kunio

    2013-02-01

    Efficacy of esomeprazole 40mg/day (E40) and 20mg/day (E20) as initial treatment for reflux esophagitis (RE) was compared with omeprazole 20mg/day (O20) in this multicenter, prospective, randomized, double-blind study. Healing rates at week 8 (primary endpoint) were 90.0% (171/190), 87.3% (165/189), and 87.4% (166/190) for the E40, E20, and O20 groups, respectively, confirming the non-inferiority of E40 and E20 to O20. Drug-related adverse events were reported in 4.2%, 7.9%, and 8.4% of patients in the E40, E20 and O20 groups, respectively, but none of these events were serious. Initial treatment of esomeprazole for RE was generally well tolerated, confirming the non-inferiority effect with omeprazole.

  5. Dose-response efficacy of a new estradiol transdermal matrix patch for 7-day application: a randomized, double-blind, placebo-controlled study. Italian Menopause Research Group.

    Science.gov (United States)

    Rovati, L C; Setnikar, I; Genazzani, A R

    2000-08-01

    New estradiol (E2) transdermal matrix patches developed for once-a-week application, releasing 25 micrograms E2 (7D-25) or 50 micrograms E2 (7D-50) daily, were investigated in comparison with a placebo patch and the twice-weekly parent patch releasing 50 micrograms E2 (Derm-50) daily. Three hundred and eleven postmenopausal patients suffering at least seven hot flushes daily were randomly assigned to the four parallel groups and treated continuously for 12 weeks without progestin opposition. The daily number of hot flushes significantly decreased in all groups. At the 12th week the decrease from a base-line average of eight to nine episodes per day was 78% with 7D-25, 93% and 97% respectively with 7D-50 and Derm-50, and significantly (p fashion and all were well tolerated.

  6. A Multicenter, Randomized, Open-Labeled, Parallel Group Trial of Sildenafil in Alcohol-Associated Erectile Dysfunction: The Impact on Psychosocial Outcomes

    Directory of Open Access Journals (Sweden)

    Alexander Grinshpoon

    2009-09-01

    Full Text Available To examine the effect of sildenafil on erectile dysfunction (ED and psychosocial outcomes in alcohol-dependent (AD men, 108 men with these diagnoses were randomly assigned to either take sildenafil (50 mg as add-on to standard treatment for AD, or the same treatment without sildenafil, for 12 weeks. Only 50 patients in sildenafil group and 51 in control group twice completed the International Index of Erectile Function (IIEF and a battery of self-report questionnaires. IIEF scores and psychosocial functioning, self-esteem and support from friends improved only for sildenafil-treated patients (P < 0.001. The high effect sizes suggest that the observed benefits are unlikely to be a placebo effect, although their unspecific nature could not be ruled out. In men with ED associated with AD, sildenafil improves both ED and psychosocial outcomes. Further placebo-controlled clinical trial is warranted.

  7. Randomized clinical trial of therapeutic music video intervention for resilience outcomes in adolescents/young adults undergoing hematopoietic stem cell transplant: a report from the Children's Oncology Group.

    Science.gov (United States)

    Robb, Sheri L; Burns, Debra S; Stegenga, Kristin A; Haut, Paul R; Monahan, Patrick O; Meza, Jane; Stump, Timothy E; Cherven, Brooke O; Docherty, Sharron L; Hendricks-Ferguson, Verna L; Kintner, Eileen K; Haight, Ann E; Wall, Donna A; Haase, Joan E

    2014-03-15

    To reduce the risk of adjustment problems associated with hematopoietic stem cell transplant (HSCT) for adolescents/young adults (AYAs), we examined efficacy of a therapeutic music video (TMV) intervention delivered during the acute phase of HSCT to: 1) increase protective factors of spiritual perspective, social integration, family environment, courageous coping, and hope-derived meaning; 2) decrease risk factors of illness-related distress and defensive coping; and 3) increase outcomes of self-transcendence and resilience. This was a multisite randomized, controlled trial (COG-ANUR0631) conducted at 8 Children's Oncology Group sites involving 113 AYAs aged 11-24 years undergoing myeloablative HSCT. Participants, randomized to the TMV or low-dose control (audiobooks) group, completed 6 sessions over 3 weeks with a board-certified music therapist. Variables were based on Haase's Resilience in Illness Model (RIM). Participants completed measures related to latent variables of illness-related distress, social integration, spiritual perspective, family environment, coping, hope-derived meaning, and resilience at baseline (T1), postintervention (T2), and 100 days posttransplant (T3). At T2, the TMV group reported significantly better courageous coping (Effect Size [ES], 0.505; P = .030). At T3, the TMV group reported significantly better social integration (ES, 0.543; P = .028) and family environment (ES, 0.663; P = .008), as well as moderate nonsignificant effect sizes for spiritual perspective (ES, 0.450; P = .071) and self-transcendence (ES, 0.424; P = .088). The TMV intervention improves positive health outcomes of courageous coping, social integration, and family environment during a high-risk cancer treatment. We recommend the TMV be examined in a broader population of AYAs with high-risk cancers. © 2013 American Cancer Society.

  8. Pilot randomized controlled trial of a mindfulness-based group intervention in adolescent girls at risk for type 2 diabetes with depressive symptoms.

    Science.gov (United States)

    Shomaker, Lauren B; Bruggink, Stephanie; Pivarunas, Bernadette; Skoranski, Amanda; Foss, Jillian; Chaffin, Ella; Dalager, Stephanie; Annameier, Shelly; Quaglia, Jordan; Brown, Kirk Warren; Broderick, Patricia; Bell, Christopher

    2017-06-01

    (1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance. Parallel-group, randomized controlled pilot trial conducted at a university. Thirty-three girls 12-17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n=17) or cognitive-behavioral program (n=16). Both interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation. Adolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition. Most adolescents attended ≥80% sessions (mindfulness: 92% versus cognitive-behavioral: 87%, p=1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (psmindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (psmindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive symptoms and better insulin resistance. ClinicalTrials.gov identifier: NCT02218138

  9. AN OPEN-LABEL, RANDOMIZED, PARALLEL-GROUP, PROSPECTIVE CLINICAL TRIAL FOR EVALUATION OF EFFICACY AND SAFETY OF AGOMELATINE IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER

    Directory of Open Access Journals (Sweden)

    Manish N

    2015-12-01

    Full Text Available AIM Agomelatine is one of the newer antidepressant drugs with potent melatonergic properties which tend to resynchronize the circadian rhythm. This study attempts to compare the efficacy of Agomelatine with Fluoxetine in patients with Major Depressive Disorder. METHODS This is a prospective, interventional, open-label, randomized, comparative, parallel-group study conducted at a private psychiatry clinic in Central India as a part of multi-centre clinical trial. A total of 23 patients with Major Depressive Disorder (having a total score of >20 in HDRS-17 scale and a score of at least 4 in CGI-S were screened at our site and out of them 21 patients were randomized to either Agomelatine or fluoxetine (11 on Agomelatine and 10 on fluoxetine treatment. These patients were followed up prospectively on Day 15th, Day 29th, Day 43rd and Day 57th after randomization and HDRS 17 scale along with CGI-S scale were applied at these visits. Tolerability to the study drugs were assessed by evaluation of adverse events reported voluntarily, observed on physical and systemic examination, or found on laboratory investigations during the study period. RESULTS It was found that patients from both the treatment groups (Agomelatine and Fluoxetine showed statistically significant (p<0.001 improvement in major depression symptoms in terms of reduction in HDRS-17 score and CGI-S score. Also, in terms of safety, there was no reported serious adverse event with Agomelatine. CONCLUSION Agomelatine can be an important effective therapeutic option in the treatment of major depressive disorder. However, considering the small sample size from this center, it is suggested that the data/results presented in this report should be read in conjunction with the data from other centers.

  10. Efficacy and safety of pioglitazone added to alogliptin in Japanese patients with type 2 diabetes mellitus: a multicentre, randomized, double-blind, parallel-group, comparative study.

    Science.gov (United States)

    Kaku, K; Katou, M; Igeta, M; Ohira, T; Sano, H

    2015-12-01

    A phase IV, multicentre, randomized, double-blind, parallel-group, comparative study was conducted in Japanese subjects with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control, despite treatment with alogliptin in addition to diet and/or exercise therapy. Subjects with glycated haemoglobin (HbA1c) concentrations of 6.9-10.5% were randomized to receive 16 weeks' double-blind treatment with pioglitazone 15 mg, 30 mg once daily or placebo added to alogliptin 25 mg once daily. The primary endpoint was the change in HbA1c from baseline at the end of treatment period (week 16). Both pioglitazone 15 and 30 mg combination therapy resulted in a significantly greater reduction in HbA1c than alogliptin monotherapy [-0.80 and -0.90% vs 0.00% (the least squares mean using analysis of covariance model); p < 0.0001, respectively]. The overall incidence rates of treatment-emergent adverse events were similar among the treatment groups. Pioglitazone/alogliptin combination therapy was effective and generally well tolerated in Japanese subjects with T2DM and is considered to be useful in clinical settings. © 2015 John Wiley & Sons Ltd.

  11. A group intervention to reduce intimate partner violence among female drug users. Results from a randomized controlled pilot trial in a community substance-abuse center.

    Science.gov (United States)

    Tirado-Muñoz, Judit; Gilchrist, Gail; Lligoña, Eva; Gilbert, Louisa; Torrens, Marta

    2015-09-15

    A greater proportion of drug dependent women are victims of intimate partner violence (IPV) than women in the general population; however, few interventions have been developed to reduce IPV among drug dependent women. An adapted version of the Women's Wellness Treatment, to address IPV and depressive symptoms, was piloted in a randomized controlled trial conducted in outpatient treatment program in Barcelona, Spain among 14 women receiving outpatient treatment for a drug use disorder who screened positive for IPV in the previous month. Participants were randomly assigned to receive the 10 session cognitive behavioral therapy (IPaViT-CBT) group intervention or treatment as usual. The frequency of IPV, depressive symptoms, substance use, quality of life and health status were assessed at baseline and 1, 3 and 12 months post intervention. Intention to treat analysis was performed. Moderate effects for the intervention were found in reducing psychological maltreatment, increasing assertiveness of IPV and reducing aggressiveness in the partner relationship, and in reducing the frequency of drinking up to 3 months post intervention. The intervention did not significantly reduce the likelihood of any IPV, depressive symptoms, quality of life or self-reported health status, up to 12-months post intervention. This pilot trial suggests some initial support for the 10-session CBT group intervention among IPV victims who received treatment for drug use. Study findings indicate that it is feasible to deliver the intervention in a community substance abuse center. An adequately powered trial is required to replicate these results.

  12. Randomized Controlled Trial of Group Cognitive Behavioural Therapy for Post-Traumatic Stress Disorder in Children and Adolescents Exposed to Tsunami in Thailand.

    Science.gov (United States)

    Pityaratstian, Nuttorn; Piyasil, Vinadda; Ketumarn, Panom; Sitdhiraksa, Nanthawat; Ularntinon, Sirirat; Pariwatcharakul, Pornjira

    2015-09-01

    Post-traumatic stress disorder (PTSD) is a common and debilitating consequence of natural disaster in children and adolescents. Accumulating data show that cognitive behavioural therapy (CBT) is an effective treatment for PTSD. However, application of CBT in a large-scale disaster in a setting with limited resources, such as when the tsunami hit several Asian countries in 2004, poses a major problem. This randomized controlled trial aimed to test for the efficacy of the modified version of CBT for children and adolescents with PSTD. Thirty-six children (aged 10-15 years) who had been diagnosed with PSTD 4 years after the tsunami were randomly allocated to either CBT or wait list. CBT was delivered in 3-day, 2-hour-daily, group format followed by 1-month posttreatment self-monitoring and daily homework. Compared to the wait list, participants who received CBT demonstrated significantly greater improvement in symptoms of PTSD at 1-month follow-up, although no significant improvement was observed when the measures were done immediately posttreatment. Brief, group CBT is an effective treatment for PTSD in children and adolescents when delivered in conjunction with posttreatment self-monitoring and daily homework.

  13. Manipulative therapy and rehabilitation for recurrent ankle sprain with functional instability: a short-term, assessor-blind, parallel-group randomized trial.

    Science.gov (United States)

    Lubbe, Danella; Lakhani, Ekta; Brantingham, James W; Parkin-Smith, Gregory F; Cassa, Tammy K; Globe, Gary A; Korporaal, Charmaine

    2015-01-01

    The purpose of this study was to compare manipulative therapy (MT) plus rehabilitation to rehabilitation alone for recurrent ankle sprain with functional instability (RASFI) to determine short-term outcomes. This was an assessor-blind, parallel-group randomized comparative trial. Thirty-three eligible participants with RASFI were randomly allocated to receive rehabilitation alone or chiropractic MT plus rehabilitation. All participants undertook a daily rehabilitation program over the course of the 4-week treatment period. The participants receiving MT had 6 treatments over the same treatment period. The primary outcome measures were the Foot and Ankle Disability Index and the visual analogue pain scale, with the secondary outcome measure being joint motion palpation. Data were collected at baseline and during week 5. Missing scores were replaced using a multiple imputation method. Statistical analysis of the data composed of repeated-measures analysis of variance. Between-group analysis demonstrated a difference in scores at the final consultation for the visual analogue scale and frequency of joint motion restrictions (P ≤ .006) but not for the Foot and Ankle Disability Index (P = .26). This study showed that the patients with RASFI who received chiropractic MT plus rehabilitation showed significant short-term reduction in pain and the number of joint restrictions in the short-term but not disability when compared with rehabilitation alone. Copyright © 2015 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

  14. A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale

    Directory of Open Access Journals (Sweden)

    Thackeray Anne

    2010-04-01

    Full Text Available Abstract Background Patients with signs of nerve root irritation represent a sub-group of those with low back pain who are at increased risk of persistent symptoms and progression to costly and invasive management strategies including surgery. A period of non-surgical management is recommended for most patients, but there is little evidence to guide non-surgical decision-making. We conducted a preliminary study examining the effectiveness of a treatment protocol of mechanical traction with extension-oriented activities for patients with low back pain and signs of nerve root irritation. The results suggested this approach may be effective, particularly in a more specific sub-group of patients. The aim of this study will be to examine the effectiveness of treatment that includes traction for patients with low back pain and signs of nerve root irritation, and within the pre-defined sub-group. Methods/Design The study will recruit 120 patients with low back pain and signs of nerve root irritation. Patients will be randomized to receive an extension-oriented treatment approach, with or without the addition of mechanical traction. Randomization will be stratified based on the presence of the pre-defined sub-grouping criteria. All patients will receive 12 physical therapy treatment sessions over 6 weeks. Follow-up assessments will occur after 6 weeks, 6 months, and 1 year. The primary outcome will be disability measured with a modified Oswestry questionnaire. Secondary outcomes will include self-reports of low back and leg pain intensity, quality of life, global rating of improvement, additional healthcare utilization, and work absence. Statistical analysis will be based on intention to treat principles and will use linear mixed model analysis to compare treatment groups, and examine the interaction between treatment and sub-grouping status. Discussion This trial will provide a methodologically rigorous evaluation of the effectiveness of using traction

  15. Individuals with lumbar spinal stenosis seek education and care focused on self-management - results of focus groups among participants enrolled in a randomized controlled trial.

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    Lynch, Andrew D; Bove, Allyn M; Ammendolia, Carlo; Schneider, Michael

    2017-12-12

    The effectiveness of treatments for chronic, degenerative conditions of the lumbar spine can be influenced by patient perceptions and expectations regarding treatment. The primary purpose of this study was to understand the factors that are important to individuals with lumbar spinal stenosis (LSS) regarding different non-surgical treatments. These factors were considered within the context of each treatment received as a part of the parent randomized controlled trial (RCT). Focus Group study of RCT participants PATIENT SAMPLE: Convenience sample of 50 individuals with LSS (28 female, average age 73 ± 7.7 years) from an RCT participated in one of six focus groups. Focus groups consisted of patients previously randomized to one of three non-surgical treatments: 1) medical care; 2) community-based group exercise; and 3) clinic-based manual therapy and individualized exercise. Experiences, opinions, and preferences of individuals with LSS who participated in an RCT. Inter-coder agreement for qualitative analysis was conducted with kappa statistics. Participants discussed their experiences and perceptions regarding study treatment and their general experience with LSS using open-ended questions provided by a facilitator. Transcripts were coded according to modified grounded theory in an open approach, using codes that addressed the primary focus group discussion topics (primary coding) and codes for emerging topics (secondary coding). Secondary coding sought to identify themes concerning living with LSS and seeking treatment that were emergent from the focus groups. This study was funded by the Patient Centered Research Outcomes Institute. The authors report no conflicts of interest. Three themes related to medical treatment and symptom management arose from analyses - (1) an emotional response to LSS; (2) a desire for education about LSS and motivation to pursue education from any available source; and (3) a desire for individualized care based on self

  16. Comparing the effect of auditory-only and auditory-visual modes in two groups of Persian children using cochlear implants: a randomized clinical trial.

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    Oryadi Zanjani, Mohammad Majid; Hasanzadeh, Saeid; Rahgozar, Mehdi; Shemshadi, Hashem; Purdy, Suzanne C; Mahmudi Bakhtiari, Behrooz; Vahab, Maryam

    2013-09-01

    Since the introduction of cochlear implantation, researchers have considered children's communication and educational success before and after implantation. Therefore, the present study aimed to compare auditory, speech, and language development scores following one-sided cochlear implantation between two groups of prelingual deaf children educated through either auditory-only (unisensory) or auditory-visual (bisensory) modes. A randomized controlled trial with a single-factor experimental design was used. The study was conducted in the Instruction and Rehabilitation Private Centre of Hearing Impaired Children and their Family, called Soroosh in Shiraz, Iran. We assessed 30 Persian deaf children for eligibility and 22 children qualified to enter the study. They were aged between 27 and 66 months old and had been implanted between the ages of 15 and 63 months. The sample of 22 children was randomly assigned to two groups: auditory-only mode and auditory-visual mode; 11 participants in each group were analyzed. In both groups, the development of auditory perception, receptive language, expressive language, speech, and speech intelligibility was assessed pre- and post-intervention by means of instruments which were validated and standardized in the Persian population. No significant differences were found between the two groups. The children with cochlear implants who had been instructed using either the auditory-only or auditory-visual modes acquired auditory, receptive language, expressive language, and speech skills at the same rate. Overall, spoken language significantly developed in both the unisensory group and the bisensory group. Thus, both the auditory-only mode and the auditory-visual mode were effective. Therefore, it is not essential to limit access to the visual modality and to rely solely on the auditory modality when instructing hearing, language, and speech in children with cochlear implants who are exposed to spoken language both at home and at school

  17. Early home-based group education to support informed decision-making among patients with end-stage renal disease: a multi-centre randomized controlled trial.

    Science.gov (United States)

    Massey, Emma K; Gregoor, Peter J H Smak; Nette, Robert W; van den Dorpel, Marinus A; van Kooij, Anthony; Zietse, Robert; Zuidema, Willij C; Timman, Reinier; Busschbach, Jan J; Weimar, Willem

    2016-05-01

    The aim was to test the effectiveness of early home-based group education on knowledge and communication about renal replacement therapy (RRT). We conducted a randomized controlled trial using a cross-over design among 80 end-stage renal disease (ESRD) patients. Between T0 and T1 (weeks 1-4) Group 1 received the intervention and Group 2 received standard care. Between T1 and T2 (weeks 5-8) Group 1 received standard care and Group 2 received the intervention. The intervention was a group education session on RRT options held in the patient's home given by social workers. Patients invited members from their social network to attend. Self-report questionnaires were used at T0, T1 and T2 to measure patients' knowledge and communication, and concepts from the Theory of Planned Behaviour such as attitude. Comparable questionnaires were completed pre-post intervention by 229 attendees. Primary RRT was registered up to 2 years post-intervention. Multilevel linear modelling was used to analyse patient data and paired t-tests for attendee data. Statistically significant increases in the primary targets knowledge and communication were found among patients and attendees after receiving the intervention. The intervention also had a significant effect in increasing positive attitude toward living donation and haemodialysis. Of the 80 participants, 49 underwent RRT during follow-up. Of these, 34 underwent a living donor kidney transplant, of which 22 were pre-emptive. Early home-based group education supports informed decision-making regarding primary RRT for ESRD patients and their social networks and may remove barriers to pre-emptive transplantation. © The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

  18. Randomized, parallel-group, double-blind, controlled study to evaluate the efficacy and safety of carbohydrate-derived fulvic acid in topical treatment of eczema

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    Gandy JJ

    2011-09-01

    Full Text Available Justin J Gandy, Jacques R Snyman, Constance EJ van RensburgDepartment of Pharmacology, Faculty of Health Sciences, University of Pretoria, Pretoria, South AfricaBackground: The purpose of this study was to evaluate the efficacy and safety of carbohydrate-derived fulvic acid (CHD-FA in the treatment of eczema in patients two years and older.Methods: In this single-center, double-blind, placebo-controlled, parallel-group comparative study, 36 volunteers with predetermined eczema were randomly assigned to receive either the study drug or placebo twice daily for four weeks.Results: All safety parameters remained within normal limits, with no significant differences in either group. Significant differences were observed for both severity and erythema in the placebo and CHD-FA treated groups, and a significant difference was observed for scaling in the placebo-treated group. With regard to the investigator assessment of global response to treatment, a significant improvement was observed in the CHD-FA group when compared with the placebo group. A statistically significant decrease in visual analog scale score was observed in both groups, when comparing the baseline with the final results.Conclusion: CHD-FA was well tolerated, with no difference in reported side effects other than a short-lived burning sensation on application. CHD-FA significantly improved some aspects of eczema. Investigator assessment of global response to treatment with CHD-FA was significantly better than that with emollient therapy alone. The results of this small exploratory study suggest that CHD-FA warrants further investigation in the treatment of eczema.Keywords: fulvic acid, eczema, anti-inflammatory, efficacy, safety

  19. Use of participant focus groups to identify barriers and facilitators to worksite exercise therapy adherence in randomized controlled trials involving firefighters

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    Mayer JM

    2013-03-01

    Full Text Available John M Mayer,1 James L Nuzzo,1 Simon Dagenais2 1School of Physical Therapy and Rehabilitation Sciences, College of Medicine, University of South Florida, Tampa, FL, 2Palladian Health, West Seneca, NY, USA Background: Firefighters are at increased risk for back injuries, which may be mitigated through exercise therapy to increase trunk muscle endurance. However, long-term adherence to exercise therapy is generally poor, limiting its potential benefits. Focus groups can be used to identify key barriers and facilitators to exercise adherence among study participants. Objective: To explore barriers and facilitators to worksite exercise therapy adherence among firefighters to inform future randomized controlled trials (RCTs. Methods: Participants enrolled in a previous RCT requiring twice-weekly worksite exercise therapy for 24 weeks were asked to take part in moderated focus group discussions centered on eight open-ended questions related to exercise adherence. Responses were analyzed qualitatively using a social ecological framework to identify key intrapersonal, interpersonal, and institutional barriers and potential facilitators to exercise adherence. Results: A total of 27 participants were included in the four focus group discussions, representing 50% of those assigned to a worksite exercise therapy group in the previous RCT, in which only 67% of scheduled exercise therapy sessions were completed. Lack of self-motivation was cited as the key intrapersonal barrier to adherence, while lack of peer support was the key interpersonal barrier reported, and lack of time to exercise during work shifts was the key institutional barrier identified. Conclusion: Focus group discussions identified both key barriers and potential facilitators to increase worksite exercise therapy adherence among firefighters. Future studies should consider educating and reminding participants about the benefits of exercise, providing individual and group incentives based on

  20. Collapsing a perfect superposition to a chosen quantum state without measurement.

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    Ahmed Younes

    Full Text Available Given a perfect superposition of [Formula: see text] states on a quantum system of [Formula: see text] qubits. We propose a fast quantum algorithm for collapsing the perfect superposition to a chosen quantum state [Formula: see text] without applying any measurements. The basic idea is to use a phase destruction mechanism. Two operators are used, the first operator applies a phase shift and a temporary entanglement to mark [Formula: see text] in the superposition, and the second operator applies selective phase shifts on the states in the superposition according to their Hamming distance with [Formula: see text]. The generated state can be used as an excellent input state for testing quantum memories and linear optics quantum computers. We make no assumptions about the used operators and applied quantum gates, but our result implies that for this purpose the number of qubits in the quantum register offers no advantage, in principle, over the obvious measurement-based feedback protocol.

  1. Comparative analysis of chosen transforms in the context of de-noising harmonic signals

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    Artur Zacniewski

    2015-09-01

    Full Text Available In the article, comparison of popular transforms used i.a. in denoising harmonical signals was presented. The division of signals submitted to mathematical analysis was shown and chosen transforms such as Short Time Fourier Transform, Wigner-Ville Distribution, Wavelet Transform and Discrete Cosine Transform were presented. Harmonic signal with white noise added was submitted for research. During research, the parameters of noise were changed to analyze the effects of using particular transform on noised signal. The importance of right choice for transform and its parameters (different for particular kind of transform was shown. Small changes in parameters or different functions used in transform can lead to considerably different results.[b]Keywords[/b]: denoising of harmonical signals, wavelet transform, discrete cosine transform, DCT

  2. COMPARISON OF THE CHOSEN ENVIRONMENTAL FEATURES OF THE ARABLE LAND AND FALLOW

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    Stanisław Włodek

    2014-10-01

    Full Text Available The results and analysis of the chosen physico-chemical soil properties of the fallow, which was not cultivated for 7 years and of the arable land, situated close to it, are presented in this work. Soil moisture content was higher and the weed infestation rate was bigger on the arable land in comparison to fallow. Significant increase of C.org. as well as P, K and Mg availability for plant was noticed on the fallow. On the arable land segetal species were common, whereas on the fallow ruderal species occurred as well. In spite of the close neighborhood of fallow with Solidago gigantea and Solidago canadensis species domination, this species was not reported on the arable land.

  3. Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder: Study protocol for a pragmatic, multicenter non-inferiority randomized controlled trial.

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    Arnfred, Sidse M; Aharoni, Ruth; Hvenegaard, Morten; Poulsen, Stig; Bach, Bo; Arendt, Mikkel; Rosenberg, Nicole K; Reinholt, Nina

    2017-01-23

    Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT. The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression, Social Anxiety Disorder and Agoraphobia/Panic Disorder. In total, 248 patients are recruited from three regional MHS centers across Denmark and included in two intervention arms. The primary outcome is patient-ratings of well-being (WHO Well-being Index, WHO-5), secondary outcomes include level of depressive and anxious symptoms, personality variables, emotion regulation, reflective functioning, and social adjustment. Assessments are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence. The current study will be the first RCT investigating the dissemination of the UP in a MHS setting, the UP delivered in groups, and with depressive patients included. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in

  4. Arousal and attention: self-chosen stimulation optimizes cortical excitability and minimizes compensatory effort.

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    Fischer, Thomas; Langner, Robert; Birbaumer, Niels; Brocke, Burkhard

    2008-08-01

    Cortical excitability is assumed to depend on cortical arousal level in an inverted U-shaped fashion: Largest (optimal) excitability is usually associated with medium levels of arousal. It has been proposed that under conditions of low arousal, compensatory effort is exerted if attentional demands persist. People tend to avoid this resource-consuming top-down compensation by creating or selecting environmental conditions that provide sufficient bottom-up stimulation. These assumptions were tested in an attention-demanding dual-task situation: We combined a simulated driving task to induce three different arousal levels by varying stimulation (high vs. low vs. self-chosen) with a visual two-stimulus paradigm to assess cortical excitability by the initial contingent negative variation (iCNV) component of the event-related potential. Additionally, we analyzed the oscillatory power of the beta2 band of the electroencephalogram at anterior frontal sites, which is assumed to reflect low-arousal compensatory activity. The iCNV amplitude differed in all three arousal conditions as expected: It was highest in the condition of self-chosen stimulation and lowest in the low- and high-arousal conditions. Additionally, in the low-arousal condition, anterior frontal beta2 power was found to be significantly higher than in the other two conditions and correlated positively with subjective strain. This pattern of results suggests that subjects select medium levels of stimulation which optimize cortical excitability under attentional demand conditions. The elevated fronto-central beta2 power in the low-stimulation condition may indicate the involvement of the anterior cingulate cortex in compensating for reduced arousal by top-down stimulation of the noradrenergic arousal system.

  5. Analysis of chosen urban bioclimatic conditions in Upper Silesian Industrial Region, Poland

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    Zimnol, Jan

    2013-04-01

    Due to the increasing urbanization, people spend more and more time in cities. Because of that fact during the last century the human bioclimatological approach had an important influence on the applied urban bioclimatology. The aim of the study was to analyze chosen thermal bioclimatic conditions in urban area of Upper Silesian Industrial Region in connection with the atmospheric circulation and air masses. The study was focused on the thermal conditions that are important for the bioclimatological research on human thermal comfort. They were the basis for making study on how to show the influence of the air masses and circulations types on frequency and variability of the chosen bioclimate indexes. That research was based on data (2004 - 2008) acquired by the Silesian University (Faculty of Earth Sciences) meteorological station located in the city of Sosnowiec (50°17'N, 19°08'E, h=263 m a.s.l.). The temperature measurements were made automatically every 10 minutes on the 2 meters above the ground level. Previous research showed that the station is a good representation of the local urban climate conditions in Upper Silesian Industrial Region. In the study the following air temperatures were taken into consideration: average day temperature, maximum day temperature, minimum day temperature and the average air temperature at 12 UTC. They were associated with atmospheric circulation types and masses typical for the region. Using the data mentioned above I conducted a classification to divide days into following objective categories: cool, cold, comfortable, hot, warm and very hot in the seasonal depiction. The final stage of the work was to find the answer to the following question: "When and how do the strong air masses and air circulations types modify bioclimatic conditions in the study area?" Answer to that question together with further results of the research will be presented on my poster.

  6. Post-discharge management following hip fracture - get you back to B4: A parallel group, randomized controlled trial study protocol

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    Brown Roy A

    2011-06-01

    Full Text Available Abstract Background Fall-related hip fractures result in significant personal and societal consequences; importantly, up to half of older adults with hip fracture never regain their previous level of mobility. Strategies of follow-up care for older adults after fracture have improved investigation for osteoporosis; but managing bone health alone is not enough. Prevention of fractures requires management of both bone health and falls risk factors (including the contributing role of cognition, balance and continence to improve outcomes. Methods/Design This is a parallel group, pragmatic randomized controlled trial to test the effectiveness of a post-fracture clinic compared with usual care on mobility for older adults following their hospitalization for hip fracture. Participants randomized to the intervention will attend a fracture follow-up clinic where a geriatrician and physiotherapist will assess and manage their mobility and other health issues. Depending on needs identified at the clinical assessment, participants may receive individualized and group-based outpatient physiotherapy, and a home exercise program. Our primary objective is to assess the effectiveness of a novel post-discharge fracture management strategy on the mobility of older adults after hip fracture. We will enrol 130 older adults (65 years+ who have sustained a hip fracture in the previous three months, and were admitted to hospital from home and are expected to be discharged home. We will exclude older adults who prior to the fracture were: unable to walk 10 meters; diagnosed with dementia and/or significant comorbidities that would preclude their participation in the clinical service. Eligible participants will be randomly assigned to the Intervention or Usual Care groups by remote allocation. Treatment allocation will be concealed; investigators, measurement team and primary data analysts will be blinded to group allocation. Our primary outcome is mobility

  7. Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial.

    Science.gov (United States)

    Philipsen, Alexandra; Jans, Thomas; Graf, Erika; Matthies, Swantje; Borel, Patricia; Colla, Michael; Gentschow, Laura; Langner, Daina; Jacob, Christian; Groß-Lesch, Silke; Sobanski, Esther; Alm, Barbara; Schumacher-Stien, Martina; Roesler, Michael; Retz, Wolfgang; Retz-Junginger, Petra; Kis, Bernhard; Abdel-Hamid, Mona; Heinrich, Viola; Huss, Michael; Kornmann, Catherine; Bürger, Arne; Perlov, Evgeniy; Ihorst, Gabriele; Schlander, Michael; Berger, Mathias; Tebartz van Elst, Ludger

    2015-12-01

    Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder with high prevalence in adulthood. There is a recognized need to assess the efficacy of psychotherapy in adult ADHD. To evaluate the efficacy of cognitive behavioral group psychotherapy (GPT) compared with individual clinical management (CM) and that of methylphenidate hydrochloride compared with placebo. Prospective, multicenter, randomized clinical trial of 18- to 58-year-old outpatients with ADHD from 7 German study centers. Patients were recruited between January 2007 and August 2010, treatment was finalized in August 2011, and final follow-up assessments occurred in March 2013. Sessions of GPT and CM were held weekly for the first 12 weeks and monthly thereafter (9 months). Patients received either methylphenidate or placebo for 1 year. The primary outcome was the change in the ADHD Index of the Conners Adult ADHD Rating Scale from baseline to the end of the 3-month intensive treatment (blinded observer ratings). Secondary outcomes included ADHD ratings after 1 year, blinded observer ratings using the Clinical Global Impression Scale, and self-ratings of depression. Among 1480 prescreened patients, 518 were assessed for eligibility, 433 were centrally randomized, and 419 were analyzed as randomized. After 3 months, the ADHD Index all-group baseline mean of 20.6 improved to adjusted means of 17.6 for GPT and 16.5 for CM, with no significant difference between groups. Methylphenidate (adjusted mean, 16.2) was superior to placebo (adjusted mean, 17.9) (difference, -1.7; 97.5% CI, -3.0 to -0.4; P = .003). After 1 year, treatment effects remained essentially stable. Descriptive analyses showed that methylphenidate was superior to placebo in patients assigned to GPT (difference, -1.7; 95% CI, -3.2 to -0.1; P = .04) or CM (difference, -1.7; 95% CI, -3.3 to -0.2; P = .03). Regarding depression, no significant differences were found. In contrast, GPT was superior to CM for all

  8. Metformin Treatment in Type 2 Diabetes in Pregnancy: An Active Controlled, Parallel-Group, Randomized, Open Label Study in Patients with Type 2 Diabetes in Pregnancy

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    Jahan Ara Ainuddin

    2015-01-01

    Full Text Available Aims. To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability. Methods. In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma. Results. Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain (P24 hours in metformin group (P<0.01. Significant reduction in cost of treatment was found in metformin group. Conclusion. Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763.

  9. CHILE: Outcomes of a group randomized controlled trial of an intervention to prevent obesity in preschool Hispanic and American Indian children.

    Science.gov (United States)

    Davis, Sally M; Myers, Orrin B; Cruz, Theresa H; Morshed, Alexandra B; Canaca, Glenda F; Keane, Patricia C; O'Donald, Elena R

    2016-08-01

    We examined the outcomes of the Child Health Initiative for Lifelong Eating and Exercise (CHILE) study, a group randomized controlled trial to design, implement, and test the efficacy of a trans-community intervention to prevent obesity in children enrolled in Head Start centers in rural American Indian and Hispanic communities in New Mexico. CHILE was a 5-year evidence-based intervention that used a socioecological approach to improving dietary intake and increasing physical activity of 1898 children. The intervention included a classroom curriculum, teacher and food service training, family engagement, grocery store participation, and healthcare provider support. Height and weight measurements were obtained four times (fall of 2008, spring and fall of 2009, and spring of 2010), and body mass index (BMI) z-scores in the intervention and comparison groups were compared. At baseline, demographic characteristics in the comparison and intervention groups were similar, and 33% of all the children assessed were obese or overweight. At the end of the intervention, there was no significant difference between the two groups in BMI z-scores. Obesity prevention research among Hispanic and AI preschool children in rural communities is challenging and complex. Although the CHILE intervention was implemented successfully, changes in overweight and obesity may take longer than 2years to achieve. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. A randomized controlled trial of an enhanced interdisciplinary community based group program for people with Parkinson's disease: study rationale and protocol

    Science.gov (United States)

    Peters, Catherine; Currin, Michelle; Tyson, Sara; Rogers, Anthea; Healy, Susan; McPhail, Steven; Brauer, Sandra G.; Heathcote, Katharine; Comans, Tracy

    2012-01-01

    Parkinson's disease (PD) is a progressive, chronic neurodegenerative disorder for which there is no known cure. Physical exercise programs may be used to assist with the physical management of PD. Several studies have demonstrated that community based physical therapy programs are effective in reducing physical aspects of disability among people with PD. While multidisciplinary therapy interventions may have the potential to reduce disability and improve the quality of life of people with PD, there is very limited clinical trial evidence to support or refute the use of a community based multidisciplinary or interdisciplinary programs for people with PD. A two group randomized trial is being undertaken within a community rehabilitation service in Brisbane, Australia. Community dwelling adults with a diagnosis of Idiopathic Parkinson's disease are being recruited. Eligible participants are randomly allocated to a standard exercise rehabilitation group program or an intervention group which incorporates physical, cognitive and speech activities in a multi-tasking framework. Outcomes will be measured at 6-week intervals for a period of six months. Primary outcome measures are the Montreal Cognitive Assessment (MoCA) and the Timed Up and Go (TUG) cognitive test. Secondary outcomes include changes in health related quality of life, communication, social participation, mobility, strength and balance, and carer burden measures. This study will determine the immediate and long-term effectiveness of a unique multifocal, interdisciplinary, dual-tasking approach to the management of PD as compared to an exercise only program. We anticipate that the results of this study will have implications for the development of cost effective evidence based best practice for the treatment of people with PD living in the community. PMID:22593807

  11. Tretinoin Nanogel 0.025% Versus Conventional Gel 0.025% in Patients with Acne Vulgaris: A Randomized, Active Controlled, Multicentre, Parallel Group, Phase IV Clinical Trial.

    Science.gov (United States)

    Chandrashekhar, B S; Anitha, M; Ruparelia, Mukesh; Vaidya, Pradyumna; Aamir, Riyaz; Shah, Sunil; Thilak, S; Aurangabadkar, Sanjeev; Pal, Sandeep; Saraswat, Abir; Sanmukhani, Jayesh J

    2015-01-01

    Conventional topical tretinoin formulation is often associated with local adverse events. Nanogel formulation of tretinoin has good physical stability and enables good penetration of tretinoin into the pilo-sebaceous glands. The present study was conducted to assess the efficacy and safety of a nanogel formulation of tretinoin as compared to its conventional gel formulation in the treatment of acne vulgaris of the face. This randomized, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by the two gel formulations locally applied once daily at night for 12 wk. Acne lesion counts (inflammatory, non-inflammatory & total) and severity grading were carried out on the monthly scheduled visits along with the tolerability assessments. A total of 207 patients were randomized in the study. Reductions in the total (72.9% vs. 65.0%; p = 0.03) and inflammatory (78.1% vs. 66.9%; p = 0.02) acne lesions were reported to be significantly greater with the nanogel formulation as compared to the conventional gel formulation. Local adverse events were significantly less (p = 0.04) in the nanogel group (13.3%) as compared to the conventional gel group (24.7%). Dryness was the most common adverse event reported in both the treatment groups while peeling of skin, burning sensation and photosensitivity were reported in patients using the conventional gel only. In the treatment of acne vulgaris of the face, tretinoin nanogel formulation appears to be more effective and better tolerated than the conventional gel formulation.

  12. A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment.

    Science.gov (United States)

    Serpell, M; Ratcliffe, S; Hovorka, J; Schofield, M; Taylor, L; Lauder, H; Ehler, E

    2014-08-01

    Peripheral neuropathic pain (PNP) associated with allodynia poses a significant clinical challenge. The efficacy of Δ(9) -tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray, a novel cannabinoid formulation, was investigated in this 15-week randomized, double-blind, placebo-controlled parallel group study. In total, 303 patients with PNP associated with allodynia were screened; 128 were randomized to THC/CBD spray and 118 to placebo, in addition to their current analgesic therapy. The co-primary efficacy endpoints were the 30% responder rate in PNP 0-10 numerical rating scale (NRS) score and the mean change from baseline to the end of treatment in this score. Various key secondary measures of pain and functioning were also investigated. At the 30% responder level, there were statistically significant treatment differences in favour of THC/CBD spray in the full analysis (intention-to-treat) dataset [p = 0.034; 95% confidence interval (CI): 1.05-3.70]. There was also a reduction in mean PNP 0-10 NRS scores in both treatment groups that was numerically higher in the THC/CBD spray group, but which failed to reach statistical significance. Secondary measures of sleep quality 0-10 NRS score (p = 0.0072) and Subject Global Impression of Change (SGIC) (p = 0.023) also demonstrated statistically significant treatment differences in favour of THC/CBD spray treatment. These findings demonstrate that, in a meaningful proportion of otherwise treatment-resistant patients, clinically important improvements in pain, sleep quality and SGIC of the severity of their condition are obtained with THC/CBD spray. THC/CBD spray was well tolerated and no new safety concerns were identified. © 2014 European Pain Federation - EFIC®

  13. Efficacy and safety of eslicarbazepine acetate versus controlled-release carbamazepine monotherapy in newly diagnosed epilepsy: A phase III double-blind, randomized, parallel-group, multicenter study.

    Science.gov (United States)

    Trinka, Eugen; Ben-Menachem, Elinor; Kowacs, Pedro A; Elger, Christian; Keller, Birgit; Löffler, Kurt; Rocha, José Francisco; Soares-da-Silva, Patrício

    2018-01-25

    We assessed the efficacy and safety of once-daily eslicarbazepine acetate in comparison with twice-daily (BID) controlled-release carbamazepine (carbamazepine-CR) monotherapy in newly diagnosed focal epilepsy patients. This randomized, double-blind, noninferiority trial (NCT01162460) utilized a stepwise design with 3 dose levels. Patients who remained seizure-free for the 26-week evaluation period (level A: eslicarbazepine acetate 800 mg/carbamazepine-CR 200 mg BID) entered a 6-month maintenance period. If a seizure occurred during the evaluation period, patients were titrated to the next target level (level B: eslicarbazepine acetate 1200 mg/carbamazepine-CR 400 mg BID, level C: eslicarbazepine acetate 1600 mg/carbamazepine-CR 600 mg BID) and the evaluation period began again. The primary endpoint was the proportion of seizure-free patients for 6 months after stabilization in the per protocol set. The predefined noninferiority criteria were -12% absolute and -20% relative difference between treatment groups. Eight hundred fifteen patients were randomly assigned; 785 (388 in the eslicarbazepine acetate group and 397 in the carbamazepine-CR group) were included in the per protocol set, and 813 (401 in the eslicarbazepine acetate group and 412 in the carbamazepine-CR group) were included in the full analysis set for the primary analysis. Overall, 71.1% of eslicarbazepine acetate-treated patients and 75.6% of carbamazepine-CR-treated patients were seizure-free for ≥6 months at the last evaluated dose (average risk difference = -4.28%, 95% confidence interval [CI] = -10.30 to 1.74; relative risk difference = -5.87%, 95% CI = -13.50 to 2.44) in the per protocol set. Rates of treatment-emergent adverse events were similar between groups for patients in the safety set. Noninferiority was also demonstrated in the full analysis set, as 70.8% of patients with eslicarbazepine acetate and 74.0% with carbamazepine-CR were seizure-free at the last evaluated dose

  14. Internet-based individually versus group guided self-help treatment for social anxiety disorder: protocol of a randomized controlled trial.

    Science.gov (United States)

    Schulz, Ava; Stolz, Timo; Berger, Thomas

    2014-04-15

    Social anxiety disorder (SAD) is one of the most common mental disorders and causes subjective suffering and economic burden worldwide. Although effective treatments are available, a lot of cases go untreated. Internet-based self-help is a low-threshold and flexible treatment alternative for SAD. Various studies have already shown that internet-based self-help can be effective to reduce social phobic symptoms significantly. Most of the interventions tested include therapist support, whereas the role of peer support within internet-based self-help has not yet been fully understood. There is evidence suggesting that patients' mutual exchange via integrated discussion forums can increase the efficacy of internet-based treatments. This study aims at investigating the added value of therapist-guided group support on the treatment outcome of internet-based self-help for SAD. The study is conducted as a randomized controlled trial. A total of 150 adults with a diagnosis of SAD are randomly assigned to either a waiting-list control group or one of the active conditions. The participants in the two active conditions use the same internet-based self-help program, either with individual support by a psychologist or therapist-guided group support. In the group guided condition, participants can communicate with each other via an integrated, protected discussion forum. Subjects are recruited via topic related websites and links; diagnostic status will be assessed with a telephone interview. The primary outcome variables are symptoms of SAD and diagnostic status after the intervention. Secondary endpoints are general symptomology, depression, quality of life, as well as the primary outcome variables 6 months later. Furthermore, process variables such as group processes, the change in symptoms and working alliance will be studied. The results of this study should indicate whether group-guided support could enhance the efficacy of an internet-based self-help treatment for SAD

  15. A randomized, controlled trial of group cognitive-behavioral therapy for compulsive buying disorder: posttreatment and 6-month follow-up results.

    Science.gov (United States)

    Mueller, Astrid; Mueller, Ulrike; Silbermann, Andrea; Reinecker, Hans; Bleich, Stefan; Mitchell, James E; de Zwaan, Martina

    2008-07-01

    The purpose of this study was to conduct a randomized trial comparing the efficacy of a group cognitive-behavioral therapy (CBT) intervention designed for the treatment of compulsive buying disorder to a waiting list control (WLC) group. Thirty-one patients with compulsive buying problems according to the criteria developed by McElroy et al. were assigned to receive active treatment (12 weekly sessions and 6-month follow-up) and 29 to the WLC group. The treatment was specifically aimed at interrupting and controlling the problematic buying behavior, establishing healthy purchasing patterns, restructuring maladaptive thoughts and negative feelings associated with shopping and buying, and developing healthy coping skills. Primary outcome measures were the Compulsive Buying Scale (CBS), the Yale-Brown Obsessive Compulsive Scale-Shopping Version (YBOCS-SV), and the German Compulsive Buying Scale (G-CBS). Secondary outcome measures were the Symptom Checklist-90-Revised (SCL-90-R), the Barratt Impulsiveness Scale (BIS-11), and the Saving Inventory-Revised (SI-R). The study was completed between November 2003 and May 2007 at the University Hospital of Erlangen, Bavaria, Germany. Multivariate analysis revealed significant differences between the CBT and the WLC groups on the primary outcome variables (outcome-by-time-by-group effect, Pillai's trace, F = 6.960, df = 1, p = .002). The improvement was maintained during the 6-month follow-up. The treatment did not affect other psychopathology, e.g., compulsive hoarding, impulsivity, or SCL-90-R scores. We found that lower numbers of visited group therapy sessions and higher pretreatment hoarding traits as measured with the SI-R total score were significant predictors for nonresponse. The results suggest that a disorder-specific cognitive-behavioral intervention can significantly impact compulsive buying behavior.

  16. Effect on arm function and cost of robot-assisted group therapy in subacute patients with stroke and a moderately to severely affected arm: a randomized controlled trial.

    Science.gov (United States)

    Hesse, Stefan; Heß, Anke; Werner C, Cordula; Kabbert, Nadine; Buschfort, Rüdiger

    2014-07-01

    To evaluate the effectiveness and efficiency of robot-assisted arm group therapy (RAGT) versus individual arm therapy (IAT) to restore motor function in the moderately to severely affected patient after stroke. Single blind randomized controlled trial. Two in-patient neurological rehabilitation centers. Fifty first time subacute patients with stroke and a non-functional hand. The patients practiced either 30 minutes of RAGT + 30 minutes of IAT (group A) or 2x30 minutes of IAT (group B), per workday for four weeks. The RAGT consisted of six workstations enabling repetitive practice of finger, wrist, forearm and shoulder movements. Patients practiced according to their impairment level on at least two workstations per session. The IAT followed the Motor Relearning Programme, enriched by elements of the impairment-oriented training. Changes of the Fugl Meyer Score (FM, 0-66) between baseline and after 4 weeks, incremental cost effectiveness. Patients were homogeneous at study onset. All patients improved their upper limb motor function over time, but there were no between group differences. The initial (terminal) FM scores were 14.6±9.4 (25.7±16.5) in group A and 16.5±9.8 (31.1±19.1) in group B. The treatment of a single patient with RAGT cost 4.15 €, compared to 10.00 € for a patient to receive IAT. RAGT in combination with IAT was equally effective as a double session of IAT regarding the restoration of upper limb motor functions in moderate to severely affected subacute patients with stroke. The treatment costs for RAGT were less. © The Author(s) 2014.

  17. A Randomized Single Blind Parallel Group Study Comparing Monoherbal Formulation Containing Holarrhena antidysenterica Extract with Mesalamine in Chronic Ulcerative Colitis Patients

    Directory of Open Access Journals (Sweden)

    Sarika Johari

    2016-01-01

    Full Text Available Background: Incidences of side effects and relapses are very common in chronic ulcerative colitis patients after termination of the treatment. Aims and Objectives: This study aims to compare the treatment with monoherbal formulation of Holarrhena antidysenterica with Mesalamine in chronic ulcerative colitis patients with special emphasis to side effects and relapse. Settings and Design: Patients were enrolled from an Ayurveda Hospital and a private Hospital, Gujarat. The study was randomized, parallel group and single blind design. Materials and Methods: The protocol was approved by Institutional Human Research Ethics Committee of Anand Pharmacy College on 23rd Jan 2013. Three groups (n = 10 were treated with drug Mesalamine (Group I, monoherbal tablet (Group II and combination of both (Group III respectively. Baseline characteristics, factors affecting quality of life, chronicity of disease, signs and symptoms, body weight and laboratory investigations were recorded. Side effects and complications developed, if any were recorded during and after the study. Statistical Analysis Used: Results were expressed as mean ± SEM. Data was statistically evaluated using t-test, Wilcoxon test, Mann Whitney U test, Kruskal Wallis test and ANOVA, wherever applicable, using GraphPad Prism 6. Results: All the groups responded positively to the treatments. All the patients were positive for occult blood in stool which reversed significantly after treatment along with rise in hemoglobin. Patients treated with herbal tablets alone showed maximal reduction in abdominal pain, diarrhea, and bowel frequency and stool consistency scores than Mesalamine treated patients. Treatment with herbal tablet alone and in combination with Mesalamine significantly reduced the stool infection. Patients treated with herbal drug alone and in combination did not report any side effects, relapse or complications while 50% patients treated with Mesalamine exhibited the relapse with

  18. A randomized, double-blind, placebo-controlled, parallel-group study of SLI381 (Adderall XR) in children with attention-deficit/hyperactivity disorder.

    Science.gov (United States)

    Biederman, Joseph; Lopez, Frank A; Boellner, Samuel W; Chandler, Mark C

    2002-08-01

    SLI381 (Adderall XR) is a 2-component extended-release capsule formulation of Adderall designed to produce a therapeutic effect that lasts throughout the day with 1 morning dose. The primary objective of this study was to assess the efficacy and safety of SLI381 compared with placebo in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children in a naturalistic school and home setting. A secondary objective was to assess the diurnal variation in responses based on morning and afternoon assessments. A multicenter, randomized, double-blind, parallel-group, placebo-controlled trial was conducted at 47 sites. After a 1-week washout of any previous stimulant medication, patients were randomized to receive single-daily morning doses of placebo or SLI381 10 mg, 20 mg, or 30 mg for 3 weeks. Participants aged 6 to 12 years inclusive who satisfied Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria diagnosis of ADHD were included. The primary efficacy parameter was the Conners Global Index Scale for Teachers. Secondary efficacy parameters included the Conners Global Index Scale for Parents, the Clinical Global Impressions Scale for improvement, and the Parent Global Assessment for improvement. Safety was assessed by recording adverse events, laboratory tests, and vital signs at each visit during the study. Physical examinations and electrocardiograms were performed at the screening and the end of the study. Five hundred eighty-four children were randomized, 563 were included in the intent-to-treat population, and 509 completed the entire study. Intention-to-treat analysis of Conners Global Index Scale for Teachers and Conners Global Index Scale for Parents scores revealed significant improvement in morning, afternoon, and late afternoon behavior for all active treatment groups versus placebo. All active treatment groups showed significant dose-related improvement in behavior from baseline. Both the Clinical Global Impressions

  19. Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition.

    Science.gov (United States)

    de Bruin, Eduard J; Bögels, Susan M; Oort, Frans J; Meijer, Anne Marie

    2015-12-01

    To investigate the efficacy of cognitive behavioral therapy for insomnia (CBTI) in adolescents. A randomized controlled trial of CBTI in group therapy (GT), guided internet therapy (IT), and a waiting list (WL), with assessments at baseline, directly after treatment (post-test), and at 2 months follow-up. Diagnostic interviews were held at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam. Treatment for GT occurred at the mental health care center UvAMinds in Amsterdam, the Netherlands. One hundred sixteen adolescents (mean age = 15.6 y, SD = 1.6 y, 25% males) meeting DSM-IV criteria for insomnia, were randomized to IT, GT, or WL. CBTI of 6 weekly sessions, consisted of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT was conducted in groups of 6 to 8 adolescents, guided by 2 trained sleep therapists. IT was applied through an online guided self-help website with programmed instructions and written feedback from a trained sleep therapist. Sleep was measured with actigraphy and sleep logs for 7 consecutive days. Symptoms of insomnia and chronic sleep reduction were measured with questionnaires. Results showed that adolescents in both IT and GT, compared to WL, improved significantly on sleep efficiency, sleep onset latency, wake after sleep onset, and total sleep time at post-test, and improvements were maintained at follow-up. Most of these improvements were found in both objective and subjective measures. Furthermore, insomnia complaints and symptoms of chronic sleep reduction also decreased significantly in both treatment conditions compared to WL. Effect sizes for improvements ranged from medium to large. A greater proportion of participants from the treatment conditions showed high end-state functioning and clinically significant improvement after treatment and at follow-up compared to WL. This study is the first randomized

  20. Effect of ice compression on pain after mandibular third molar surgery: a single-blind, randomized controlled trial

    NARCIS (Netherlands)

    Forouzanfar, T.; Sabelis, A.; Ausems, S.; Baart, J.A.; van der Waal, I.

    2008-01-01

    This study was designed to investigate the effect of compression with ice and compression alone on pain and quality of life after surgical removal of mandibular third molars. A prospective, single-blind, randomized controlled study design was chosen. Participants in group A applied 45 min of

  1. A randomized trial comparing concurrent chemoradiotherapy with single-agent cisplatin versus cisplatin plus gemcitabine in patients with advanced cervical cancer: An Asian Gynecologic Oncology Group study.

    Science.gov (United States)

    Wang, Chun-Chieh; Chou, Hung-Hsueh; Yang, Lan-Yan; Lin, Hao; Liou, Wen-Shiung; Tseng, Chih-Wen; Liu, Feng-Yuan; Liou, Jui-Der; Huang, Kuan-Gen; Huang, Huei-Jean; Huang, Eng-Yen; Chen, Chien-Hsun; Chang, Ting-Chang; Chang, Chee-Jen; Hong, Ji-Hong; Lai, Chyong-Huey

    2015-06-01

    A recent randomized trial demonstrated that concurrent chemoradiotherapy (CCRT) with weekly cisplatin and gemcitabine, followed by two adjuvant cycles of cisplatin and gemcitabine improved survival for advanced cervical cancer patients. An Asian Gynecologic Oncology Group (AGOG) study was designed to determine whether only adding gemcitabine in the chemoradiation phase without adjuvant chemotherapy could improve survival. Between March 2009 and March 2013, 74 eligible patients with International Federation of Obstetrics and Gynecology stage III/IVA cervical cancer or stage I/II with positive pelvic/para-aortic nodal metastasis were enrolled. Thirty-seven patients were randomized to arm C (weekly cisplatin 40mg/m(2)) and 37 patients were randomized to arm CG (weekly cisplatin 40mg/m(2) and gemcitabine 125mg/m(2)), for six cycles. Six eligible patients were excluded before the beginning of treatment. An interim analysis showed superimposable progression-free (PFS) and overall survival (OS), a decision of closing accrual was made. A 3-year PFS was similar in both arms (arm C 65.1% vs. arm CG 71.0%, p=0.71), and a 3-year OS was 74.1% in arm C vs. 85.9% in arm CG (p=0.89), but crossed over at 5years. Grade 2-4 hematological toxicities, including neutropenia (p=0.028) and thrombocytopenia (p=0.001), were more frequent in arm CG than arm C. Despite limitation in power, it suggests that only adding gemcitabine at the CCRT phase does not provide substantially superior results, but treatment toxicities could increase. Further studies are required to determine the role of post-CCRT adjuvant chemotherapy in advanced cervical cancer. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Teaching tobacco dependence treatment and counseling skills during medical school: rationale and design of the Medical Students helping patients Quit tobacco (MSQuit) group randomized controlled trial.

    Science.gov (United States)

    Hayes, Rashelle B; Geller, Alan; Churchill, Linda; Jolicoeur, Denise; Murray, David M; Shoben, Abigail; David, Sean P; Adams, Michael; Okuyemi, Kola; Fauver, Randy; Gross, Robin; Leone, Frank; Xiao, Rui; Waugh, Jonathan; Crawford, Sybil; Ockene, Judith K

    2014-03-01

    Physician-delivered tobacco treatment using the 5As is clinically recommended, yet its use has been limited. Lack of adequate training and confidence to provide tobacco treatment is cited as leading reasons for limited 5A use. Tobacco dependence treatment training while in medical school is recommended, but is minimally provided. The MSQuit trial (Medical Students helping patients Quit tobacco) aims to determine if a multi-modal and theoretically-guided tobacco educational intervention will improve tobacco dependence treatment skills (i.e. 5As) among medical students. 10 U.S. medical schools were pair-matched and randomized in a group-randomized controlled trial to evaluate whether a multi-modal educational (MME) intervention compared to traditional education (TE) will improve observed tobacco treatment skills. MME is primarily composed of TE approaches (i.e. didactics) plus a 1st year web-based course and preceptor-facilitated training during a 3rd year clerkship rotation. The primary outcome measure is an objective score on an Objective Structured Clinical Examination (OSCE) tobacco-counseling smoking case among 3rd year medical students from schools who implemented the MME or TE. MSQuit is the first randomized to evaluate whether a tobacco treatment educational intervention implemented during medical school will improve medical students' tobacco treatment skills. We hypothesize that the MME intervention will better prepare students in tobacco dependence treatment as measured by the OSCE. If a comprehensive tobacco treatment educational learning approach is effective, while also feasible and acceptable to implement, then medical schools may substantially influence skill development and use of the 5As among future physicians. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

  3. A randomized trial of individual versus group-format exercise and self-management in individuals with Parkinson’s disease and comorbid depression

    Directory of Open Access Journals (Sweden)

    Sajatovic M

    2017-05-01

    Full Text Available Martha Sajatovic,1,2 Angela L Ridgel,3 Ellen M Walter,1,4 Curtis M Tatsuoka,1,2 Kari Colón-Zimmermann,2 Riane K Ramsey,2 Elisabeth Welter,2 Steven A Gunzler,1,4 Christina M Whitney,1,4 Benjamin L Walter1,4 1Department of Neurology, Case Western Reserve University School of Medicine, 2Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, Cleveland, 3Department of Exercise Physiology, Kent State University, Kent, 4Movement Disorders Center, University Hospitals Cleveland Medical Center, Cleveland, OH, USA Background: Depression is common in people with Parkinson’s disease (PD, and exercise is known to improve depression and PD. However, lack of motivation and low self-efficacy can make exercise difficult for people with PD and comorbid depression (PD-Dep. A combined group exercise and chronic disease self-management (CDSM program may improve the likelihood that individuals will engage in exercise and will show a reduction in depression symptoms. The purpose of this study was to compare changes in depression in PD-Dep between individual versus group exercise plus CDSM and to examine participant adherence and perception of the interventions.Methods: Participants (N=30 were randomized to either Enhanced EXerCisE thErapy for PD (EXCEED; group CDSM and exercise or self-guided CDSM plus exercise. Outcomes were change in depression assessed with the Montgomery–Asberg Depression Rating Scale (MADRS, cognition, apathy, anxiety, sleep, quality of life, motor function, self-efficacy, and patient satisfaction.Results: Both groups showed significant improvement in MADRS (P<0.001 with no significant group difference. Individuals in EXCEED group enjoyed the group dynamics but noted difficulty with the fixed-time sessions.Conclusion: Both group CDSM plus exercise and self-guided CDSM plus exercise can improve depression in PD-Dep. These findings suggest that development of a remotely delivered group-based CDSM format

  4. The Effects of Waiting for Treatment: A Meta-Analysis of Waitlist Control Groups in Randomized Controlled Trials for Social Anxiety Disorder.

    Science.gov (United States)

    Steinert, Christiane; Stadter, Katja; Stark, Rudolf; Leichsenring, Falk

    2017-05-01

    Social anxiety disorder (SAD) is a highly prevalent mental disorder. However, little is known about how SAD changes in subjects who do not receive treatment. Waitlist control groups (WLCGs) are frequently included in randomized controlled trials (RCTs) on the treatment of mental disorders. Data from WLCGs are of value as they provide information on the untreated short-term course of a disorder and may serve as disorder-specific norms of change (benchmarks) against which treatment outcomes of SAD can be compared. Thus, we performed a meta-analysis focusing on the effects occurring in WLCGs of RCTs for SAD. Our study was conducted along the PRISMA guidelines. Thirty RCTs (total n = 2460) comprising 30 WLCGs and 47 treatment groups were included. Mean waiting time was 10.6 weeks. The pooled effect of waiting on SAD measures was g = 0.128 (95% CI: 0.057-0.199). Effects regarding other forms of anxiety, depression and functioning were of similarly small size. In contrast, change in the treatment groups was large, both within (g = 0.887) and between groups (g = 0.860). Our results show that for SAD, changes occurring in WLCGs of RCTs are small. The findings may serve as benchmarks in pilot studies of a new treatment or as an additional comparison in studies comparing two active treatments. For psychotherapy research in general, the small effect sizes found in WLCGs confirm that testing a treatment against a waiting list is not a very strict test. Further research on WLCGs in specific mental disorders is required, for example examining the expectancies of patients randomized to waiting. Copyright © 2016 John Wiley & Sons, Ltd. In clinical practice, patients suffering from a mental disorder often have to wait for treatment. By analyzing data from waitlist control groups we can gain estimates of symptom change that occur during waiting. It could be seen that waiting for treatment only results in a negligible effect. Thus, in the short-term (i.e., 10.6

  5. The influence of review pathology on study outcome of a randomized multicentre superficial bladder cancer trial. Members of the Dutch South East Cooperative Urological Group.

    Science.gov (United States)

    Witjes, J A; Kiemeney, L A; Schaafsma, H E; Debruyn, F M

    1994-02-01

    To determine whether differences between local and review pathology in a multicentre study influence the results of treatment and results from prognostic factor analysis. A randomized multicentre study in superficial bladder cancer is reported, in which the influence of local and review pathology on the study outcome was investigated. The conformity between local and review pathology of the pT category was 79.3%, of the grade 70.2%, and the combination of both 59.7%. In local pathology, undergrading was more frequent than overgrading and overstaging more frequent than understaging. However, the risks of recurrent disease in the separate stage and grade groups remained the same after correcting the pathology result. A prognostic factor analysis with regard to the risk of recurrent disease was carried out. The Cox hazard ratios of tumour localization, multiplicity, patient age (significant factors), tumour grade, size, history and gender (not significant) remained almost the same after correction for review pathology. Only the prognostic relevance of tumour stage increased after pathology correction. We conclude that, although review pathology caused considerable changes in the pathology results, this did not change the results of treatment, and hardly altered the results of a prognostic factor analysis in this randomized study.

  6. Cost-effectiveness of Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: results from a randomized controlled trial.

    Science.gov (United States)

    Hedman, Erik; Andersson, Erik; Ljótsson, Brjánn; Andersson, Gerhard; Rück, Christian; Lindefors, Nils

    2011-11-01

    Social anxiety disorder (SAD) is highly prevalent and associated with a substantial societal economic burden, primarily due to high costs of productivity loss. Cognitive behavior group therapy (CBGT) is an effective treatment for SAD and the most established in clinical practice. Internet-based cognitive behavior therapy (ICBT) has demonstrated efficacy in several trials in recent years. No study has however investigated the cost-effectiveness of ICBT compared to CBGT from a societal perspective, i.e. an analysis where both direct and indirect costs are included. The aim of the present study was to investigate the cost-effectiveness of ICBT compared to CBGT from a societal perspective using a prospective design. We conducted a randomized controlled trial where participants with SAD were randomized to ICBT (n=64) or CBGT (n=62). Economic data were assessed at pre-treatment, immediately following treatment and six months after treatment. Results showed that the gross total costs were significantly reduced at six-month follow-up, compared to pre-treatment in both treatment conditions. As both treatments were equivalent in reducing social anxiety and gross total costs, ICBT was more cost-effective due to lower intervention costs. We conclude that ICBT can be more cost-effective than CBGT in the treatment of SAD and that both treatments reduce societal costs for SAD. Copyright © 2011 Elsevier Ltd. All rights reserved.

  7. School-based mindfulness intervention for stress reduction in adolescents: Design and methodology of an open-label, parallel group, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jeanette M. Johnstone

    2016-12-01

    Full Text Available Adolescents are in a high-risk period developmentally, in terms of susceptibility to stress. A mindfulness intervention represents a potentially useful strategy for developing cognitive and emotion regulation skills associated with successful stress coping. Mindfulness strategies have been used successfully for emotional coping in adults, but are not as well studied in youth. This article details a novel proposal for the design of an 8-week randomized study to evaluate a high school-based mindfulness curriculum delivered as part of a two semester health class. A wellness education intervention is proposed as an active control, along with a waitlist control condition. All students enrolled in a sophomore (10th grade health class at a private suburban high school will be invited to participate (n = 300. Pre-test assessments will be obtained by youth report, parent ratings, and on-site behavioral testing. The assessments will evaluate baseline stress, mood, emotional coping, controlled attention, and working memory. Participants, divided into 13 classrooms, will be randomized into one of three conditions, by classroom: A mindfulness intervention, an active control (wellness education, and a passive control (waitlist. Waitlisted participants will receive one of the interventions in the following term. Intervention groups will meet weekly for 8 weeks during regularly scheduled health classes. Immediate post-tests will be conducted, followed by a 60-day post-test. It is hypothesized that the mindfulness intervention will outperform the other conditions with regard to the adolescents' mood, attention and response to stress.

  8. The effect of a core exercise program on Cobb angle and back muscle activity in male students with functional scoliosis: a prospective, randomized, parallel-group, comparative study.

    Science.gov (United States)

    Park, Yun Hee; Park, Young Sook; Lee, Yong Taek; Shin, Hee Suk; Oh, Min-Kyun; Hong, Jiyeon; Lee, Kyoung Yul

    2016-06-01

    To assess the effect of core strengthening exercises on Cobb angle and muscle activity in male college students with functional scoliosis. Static and dynamic back muscle activity were evaluated via surface electromyography (sEMG). A core exercise protocol comprising 18 exercises was performed three times/week for 10 weeks. Patients were randomly allocated to either a home- or community-based exercise programme. Cervical thoracolumbar scans and sEMG were performed after 10 weeks. A total of 87 students underwent cervical thoracolumbar scans. Of these, 53 were abnormal and were randomised between the home-based (n = 25) or community-based (n = 28) groups. After the 10-week exercise programme, Cobb angles were significantly lower and back muscle strength was significantly improved than baseline in both groups, but there were no statistically significant between group differences. A 10-week core strengthening exercise programme decreases Cobb angle and improves back muscle strength in patients with functional scoliosis. © The Author(s) 2016.

  9. Immediate versus delayed loading of strategic mini dental implants for the stabilization of partial removable dental prostheses: a patient cluster randomized, parallel-group 3-year trial.

    Science.gov (United States)

    Mundt, Torsten; Al Jaghsi, Ahmad; Schwahn, Bernd; Hilgert, Janina; Lucas, Christian; Biffar, Reiner; Schwahn, Christian; Heinemann, Friedhelm

    2016-07-30

    Acceptable short-term survival rates (>90 %) of mini-implants (diameter implants as strategic abutments for a better retention of partial removable dental prosthesis (PRDP) are not available. The purpose of this study is to test the hypothesis that immediately loaded mini-implants show more bone loss and less success than strategic mini-implants with delayed loading. In this four-center (one university hospital, three dental practices in Germany), parallel-group, controlled clinical trial, which is cluster randomized on patient level, a total of 80 partially edentulous patients with unfavourable number and distribution of remaining abutment teeth in at least one jaw will receive supplementary min-implants to stabilize their PRDP. The mini-implant are either immediately loaded after implant placement (test group) or delayed after four months (control group). Follow-up of the patients will be performed for 36 months. The primary outcome is the radiographic bone level changes at implants. The secondary outcome is the implant success as a composite variable. Tertiary outcomes include clinical, subjective (quality of life, satisfaction, chewing ability) and dental or technical complications. Strategic implants under an existing PRDP are only documented for standard-diameter implants. Mini-implants could be a minimal invasive and low cost solution for this treatment modality. The trial is registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00007589 ( www.germanctr.de ) on January 13(th), 2015.

  10. Infliximab versus intravenous immunoglobulin for refractory Kawasaki disease: a phase 3, randomized, open-label, active-controlled, parallel-group, multicenter trial.

    Science.gov (United States)

    Mori, Masaaki; Hara, Takuma; Kikuchi, Masako; Shimizu, Hiroyuki; Miyamoto, Tomoyuki; Iwashima, Satoru; Oonishi, Tatsuya; Hashimoto, Kunio; Kobayashi, Norimoto; Waki, Kenji; Suzuki, Yasuo; Otsubo, Yoshikazu; Yamada, Hiroshi; Ishikawa, Chikao; Kato, Taichi; Fuse, Shigeto

    2018-01-31

    We compared the efficacy and safety of infliximab with intravenous immunoglobulin (IVIG), a standard therapy, in a phase 3 trial (NCT01596335) for Japanese patients with Kawasaki disease (KD) showing persistent fever after initial IVIG. Patients with initial IVIG-refractory KD, aged 1-10 years, received a single dose of IV infliximab 5 mg/kg or IV polyethylene glycol-treated human immunoglobulin (VGIH) 2 g/kg on day 0. Primary outcome was defervescence rate within 48 h after the start of treatment. Safety was evaluated through day 56. Overall, 31 patients were randomized (infliximab, n = 16; VGIH, n = 15); 31.3% and 60.0% patients discontinued due to worsening KD. Defervescence rate within 48 h was greater with infliximab (76.7%) than VGIH (37.0%) (p = 0.023), and defervescence was achieved earlier with infliximab (p = 0.0072). Coronary artery lesions occurred in 1 (6.3%) and 3 (20.0%) patients receiving infliximab and VGIH, respectively, up to day 21. Adverse events occurred in 15 (93.8%) and 15 (100.0%) patients in the infliximab and VGIH groups, respectively. No serious adverse events in the infliximab group and one in the VGIH group were observed. Infliximab improved the defervescence rate within 48 h and time to defervescence versus standard therapy, and was well tolerated in patients with IVIG-refractory KD.

  11. Effects of the "Circle of Life" HIV-prevention program on marijuana use among American Indian middle school youths: a group randomized trial in a Northern Plains tribe.

    Science.gov (United States)

    Asdigian, Nancy L; Whitesell, Nancy Rumbaugh; Keane, Ellen M; Mousseau, Alicia C; Kaufman, Carol E

    2016-12-29

    Early substance use threatens many American Indian/Alaska Native (AI/AN) communities, as it is a risk factor for maladaptive use and adverse health outcomes. Marijuana is among the first substances used by AI/AN youth, and its use becomes widespread during adolescence. Interventions that delay or reduce marijuana use hold the promise of curbing substance disorders and other health risk disparities in AI/AN populations. We evaluated the effectiveness of the Circle of Life (COL) program in reducing marijuana use among young AI adolescents. COL is a culturally tailored, theory-based human immunodeficiency virus (HIV) and sexually transmitted disease (STD) intervention shown to delay sexual initiation among AI youths. We conducted secondary analyses of data from a school-based group randomized trial conducted between 2006 and 2007 in all 13 middle schools on a rural, Northern Plains reservation (N = 635, 47% female). We used discrete-time survival analysis (DTSA) to assess COL effectiveness on risk of marijuana initiation among AI youths and latent growth curve modeling (LGCM) to evaluate effects on frequency of marijuana use over time. DTSA models showed that the overall risk of marijuana initiation was 17.3% lower in the COL group compared to the control group. No intervention effect on frequency of marijuana use emerged in LGCM analyses. COL is a multifaceted, culturally tailored, skills-based program effective in preventing marijuana uptake among AI youth.

  12. Patient-reported outcomes of bimatoprost for eyelash growth: results from a randomized, double-masked, vehicle-controlled, parallel-group study.

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    Fagien, Steven; Walt, John G; Carruthers, Jean; Cox, Sue Ellen; Wirta, David; Weng, Emily; Beddingfield, Frederick C

    2013-08-01

    Hypotrichosis of the eyelashes may negatively influence an individual's self-perception and appearance. Assessing the impact of treatment from a patient's perspective may be particularly relevant in trials of aesthetic agents. Once-daily dermal (topically applied) administration of bimatoprost ophthalmic solution 0.03% has been associated with increased eyelash prominence (ie, length, thickness, darkness). The authors assess patient-reported outcomes (PRO) after treatment with bimatoprost for hypotrichosis of the eyelashes. In this multicenter, double-masked, randomized, vehicle-controlled, parallel clinical trial, 4 PRO questionnaires were distributed to 278 patients (bimatoprost [n = 137] and vehicle [n = 141]). The primary PRO questionnaire was the 23-item Eyelash Satisfaction Questionnaire (ESQ), which measured satisfaction in 3 domains: length, fullness, and overall satisfaction (LFOS); confidence, attractiveness, and professionalism (CAP); and impact on daily routine (DR). By week 16, the bimatoprost group reported significantly greater improvements from baseline on all ESQ items (P ≤ .0433). These improvements were sustained through the 4-week posttreatment study visit. Patient satisfaction was significantly greater in the bimatoprost group than in the vehicle group for all 3 domains: LFOS (weeks 8-20; P ≤ .0052), CAP (weeks 12-20; P < .0001), and DR (weeks 16 and 20; P ≤ .01). The bimatoprost group reported significantly greater levels of positive patient outcomes and satisfaction than the vehicle group across all 23 questions and all 3 domains of the primary PRO questionnaire. These results support the effectiveness, as measured by objective measures and PRO, of once-daily bimatoprost ophthalmic solution 0.03% at producing more prominent eyelashes in adults.

  13. Short-term and long-term effects of a psycho-educational group intervention for family caregivers in palliative home care - results from a randomized control trial.

    Science.gov (United States)

    Holm, Maja; Årestedt, Kristofer; Carlander, Ida; Fürst, Carl-Johan; Wengström, Yvonne; Öhlen, Joakim; Alvariza, Anette

    2016-07-01

    Family caregivers in cancer and palliative care often face heavy responsibilities and feel insufficiently prepared for the situation as caregivers. This study evaluates short-term and long-term effects of a psycho-educational group intervention aiming to increase preparedness for family caregiving in specialized palliative home care. The study design was a randomized control trial where family caregivers were allocated either to an intervention or control group. The intervention was delivered as a program including three sessions by health professionals (physician, nurse, and social worker/priest). Family caregivers from 10 specialized palliative home care settings were included. Questionnaires with validated instruments at baseline, upon completion, and 2 months following the intervention were used to measure effects of the intervention. The primary outcome was preparedness for caregiving in family caregivers. In total, 21 intervention programs were delivered, and 119 family caregivers completed all three measurements. The intervention group had significantly increased their preparedness for caregiving in both the short-term and long-term follow-up compared with the control group. The intervention group also reported significantly increased competence for caregiving in short-term but not long. No effects of the intervention were found on rewards for caregiving, caregiver burden, health, anxiety, or depression. The psycho-educational intervention has the potential to be used by health professionals to improve preparedness for caregiving among family caregivers in palliative care both in short and long terms. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  14. A Randomized Controlled Trial to Decrease Job Burnout in First-Year Internal Medicine Residents Using a Facilitated Discussion Group Intervention.

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    Ripp, Jonathan A; Fallar, Robert; Korenstein, Deborah

    2016-05-01

    Background Burnout is common in internal medicine (IM) trainees and is associated with depression and suboptimal patient care. Facilitated group discussion reduces burnout among practicing clinicians. Objective We hypothesized that this type of intervention would reduce incident burnout among first-year IM residents. Methods Between June 2013 and May 2014, participants from a convenience sample of 51 incoming IM residents were randomly assigned (in groups of 3) to the intervention or a control. Twice-monthly theme-based discussion sessions (18 total) led by expert facilitators were held for intervention groups. Surveys were administered at study onset and completion. Demographic and personal characteristics were collected. Burnout and burnout domains were the primary outcomes. Following convention, we defined burnout as a high emotional exhaustion or depersonalization score on the Maslach Burnout Inventory. Results All 51 eligible residents participated; 39 (76%) completed both surveys. Initial burnout prevalence (10 of 21 [48%] versus 7 of 17 [41%], P = .69), incidence of burnout at year end (9 of 11 [82%] versus 5 of 10 [50%], P = .18), and secondary outcomes were similar in intervention and control arms. More residents in the intervention group had high year-end depersonalization scores (18 of 21 [86%] versus 9 of 17 [53%], P = .04). Many intervention residents revealed that sessions did not truly free them from clinical or educational responsibilities. Conclusions A facilitated group discussion intervention did not decrease burnout in resident physicians. Future discussion-based interventions for reducing resident burnout should be voluntary and effectively free participants from clinical duties.

  15. Efficacy of Trunk Regimes on Balance, Mobility, Physical Function, and Community Reintegration in Chronic Stroke: A Parallel-Group Randomized Trial.

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    Karthikbabu, Suruliraj; Chakrapani, Mahabala; Ganesan, Sailakshmi; Ellajosyula, Ratnavalli; Solomon, John M

    2018-01-17

    The study objective was to examine the efficacy of plinth and Swiss ball-based trunk exercise regimes on balance, mobility, physical function, and community reintegration compared with standard physiotherapy in chronic stroke. This observer-blinded parallel-group randomized trial was conducted in outpatient stroke units. People with chronic stroke aged between 30 and 75 years, first onset of unilateral cortical lesion, poor trunk performance, 10 m independent walking ability with or without walking aids, and absence of pusher syndrome were included. Trunk Impairment Scale 2.0, Brunel Balance Assessment, Tinetti scale, gait speed, Stroke Impact Scale-16, and Reintegration to Normal Living Index were the measures. Experimental interventions involved the practice of selective upper and lower trunk movements using either plinth or Swiss ball. Control group received standard physiotherapy. All the patients practiced 1 hour exercise session, 3 sessions a week over a duration of 6 weeks and followed up after 3 and 12 months. Of 108 patients allocated into 3 groups, baseline characteristics were similar. Postintervention compared with control group, the plinth, and Swiss ball groups showed significant mean changes in the outcome measures: trunk impairment scale 2.0 (3.6;4.1 points), Brunel Balance Assessment (1-level), Tinetti scale (5;5.2 points), gait speed (.06;.08 m/s), Stroke Impact Scale-16 (8.7;7.2 points), and community reintegration (7.6;8.8 points). These improvements were retained during 3-12 months' follow-up. Statistical significant was set at P reintegration in chronic stroke as against standard physiotherapy. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  16. The South Australian couples sildenafil study: double-blind, parallel-group randomized controlled study to examine the psychological and relationship consequences of sildenafil use in couples.

    Science.gov (United States)

    Hundertmark, James; Esterman, Adrian; Ben-Tovim, David; Austin, Mary-Anne; Dougherty, Melissa

    2007-07-01

    The South Australian Couples Sildenafil (SACS) study sought to look more closely at the role of sexual functioning in couples by exploring the impact of treatment for erectile dysfunction (ED) with sildenafil. The SACS study investigated the individual and dyadic impact of the drug sildenafil (Viagra) on couples over a 6-month period. A range of outcome measures were utilized including the Dyadic Adjustment Scale (DAS), the International Index of Erectile Function (IIEF), and the Erectile Dysfunction Inventory of Treatment Satisfaction. Couples were recruited through the use of local media and general practitioners. Couples were randomly allocated to placebo or active drug with the option of using up to one study tablet per day for 6 months. Couples were reviewed at 2 weeks, 4 weeks, 8 weeks, 3 months, and 6 months. There were 108 couples who were eligible for the study with the eventual analysis including 49 couples in the active treatment group and 47 in the placebo group with similar demographic and background profiles found in both groups. A large number of psychosocial, quality-of-life, and sexual measures were recorded at the end of the trial for both male subjects and their female partners. Predictably, the erectile response in the active treatment group showed a significant improvement as measured by the IIEF although no change was found between the active and placebo groups in relationship functioning as measured by the DAS scores. The SACS study found no difference between treatment arms with regard to relationship functioning after the use of sildenafil for ED. Potential contributing factors to a "no change" result are discussed. The SACS study adds to the available literature on psychological and interpersonal factors in the treatment of ED which have not been sufficiently investigated until recently.

  17. Cognitive Therapy and Task Concentration Training Applied as Intensified Group Therapies for Social Anxiety Disorder with Fear of Blushing-A Randomized Controlled Trial.

    Science.gov (United States)

    Härtling, Samia; Klotsche, Jens; Heinrich, Anke; Hoyer, Jürgen

    2016-11-01

    The current study examines the efficacy of intensified group therapy for social anxiety disorder with fear of blushing. Task concentration training (TCT) and cognitive therapy (CT) were applied during one weekend and compared with a waiting list condition in a randomized controlled trial including 82 patients. On a second weekend, another intervention was added (resulting in TCT-CT and CT-TCT sequences) to examine order effects. Task concentration training and CT were both superior to the waiting list and equally effective after the first therapy weekend. Also, no differences were found between the sequences TCT-CT and CT-TCT at post-assessment. At 6- and 12-month follow-up, effects remained stable or further improved. At the 6-month follow-up, remission rates in completers, established by diagnostic status, were between 69% and 73%. Intensified group therapy is highly effective in treating social anxiety disorder with fear of blushing. Group formats for patients sharing a common primary concern may contribute to the dissemination of cognitive-behavioural therapy. Copyright © 2015 John Wiley & Sons, Ltd. Key Practitioner Message: This study focuses on blushing from fearful individuals within the SAD spectrum to improve evidence for treatment efficacy in those whose social fears are centred around observable bodily sensations. This study integrates task concentration training into the SAD model of Clark and Wells to combine two evidence-based treatments for SAD under one treatment model. This study uses an innovative format of brief, intensified group therapy, conducted on two full-day weekend group sessions delivered over two weekends, with strong observed effect sizes. Copyright © 2015 John Wiley & Sons, Ltd.

  18. A randomized controlled trial to evaluate the effectiveness of a cognitive behavioural group approach to improve patient adherence to peritoneal dialysis fluid restrictions: a pilot study.

    Science.gov (United States)

    Hare, Jennifer; Clark-Carter, David; Forshaw, Mark

    2014-03-01

    Peritoneal dialysis (PD) requires patients to take an active role in their adherence to fluid restrictions. Although fluid non-adherence had been identified among this patient group, no specific interventions have been researched or published with in the PD population. The current study sought to investigate whether an applied cognitive behavioural therapy (CBT-based intervention) used among haemodialysis patients would improve fluid adherence among PD patients; utilizing clinical indicators used in practice. Fifteen PD patients identified as fluid non-adherent were randomly assigned to an intervention group (IG) or a deferred-entry control group (CG). The study ran for a total of 21 weeks, with five data collection points; at baseline, post-intervention and at three follow-up points; providing a RCT phase and a combined longitudinal analysis phase. The content of the group intervention encompassed educational, cognitive and behavioural components, aimed to assist patients' self-management of fluid. No significant differences in weight (kg) reduction were found in either phase and undesirable changes in blood pressure (BP) were observed. However, in the longitudinal phase, a statistically significant difference in oedematous status was observed at 6-week follow-up; which may be indicative of fluid adherence. Positive and significant differences were observed in the desired direction for measures of psychological well-being, quality of life and health beliefs; areas correlated with enhanced fluid adherence in other research. This study reveals encouraging and significant changes in predictors of fluid adherence. Although there were no significant changes in weight as a crude clinical measure of fluid intake, significant reductions in oedematous status were observed as a consequence of this CBT-based group intervention.

  19. Vildagliptin vs liraglutide as a second-line therapy switched from sitagliptin-based regimens in patients with type 2 diabetes: A randomized, parallel-group study

    Science.gov (United States)

    Takeshita, Yumie; Takamura, Toshinari; Kita, Yuki; Otoda, Toshiki; Kato, Ken-ichiro; Wakakuri, Hitomi; Yamada, Masayuki; Misu, Hirofumi; Matsushima, Yukiko; Kaneko, Shuichi

    2015-01-01

    Introduction A step-up strategy for dipeptidyl peptidase (DPP)-4 inhibitor-based regimens has not yet been established. In addition, similarities and differences between DPP-4 inhibitors and glucagon-like peptide (GLP)-1 receptor agonists remain to be elucidated in humans. We investigated the pleiotropic effects of vildagliptin vs liraglutide in patients with type 2 diabetes on sitagliptin-based regimens in an open-label, randomized, clinical trial. Materials and Methods A total of 122 patients with type 2 diabetes that was inadequately controlled by sitagliptin-based regimens were randomly assigned to either vildagliptin (50 mg, twice daily) or liraglutide treatment (0.9 mg, once daily) for 12 weeks. The primary outcomes were glycated hemoglobin and body mass index. Results Both vildagliptin and liraglutide significantly lowered glycated hemoglobin within 12 weeks after switching from sitagliptin, but liraglutide produced a greater reduction (−0.67 ± 0.12% vs −0.36 ± 0.53%). Liraglutide lowered body mass index, whereas vildagliptin did not affect body mass index. Vildagliptin lowered fasting C-peptide immunoreactivity, but liraglutide did not. Vildagliptin increased serum levels of adiponectin, arachidonic acid, eicosapentaenoic acid and docosahexaenoic acid, whereas liraglutide had no effect on these levels. Quality of life, assessed using the diabetes treatment satisfaction questionnaire, was not impaired in either group. The most common adverse events were gastrointestinal symptoms, which occurred with similar frequencies in both groups. Conclusions Vildagliptin-mediated improvements in glycemic control did not correlate with indices for insulin secretion and insulin sensitivity. Switching from sitagliptin to liraglutide is useful in managing hyperglycemia and weight. Each agent exerts unique pleiotropic effects. This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (no. 000004953). PMID

  20. Effects of the Quest to Lava Mountain Computer Game on Dietary and Physical Activity Behaviors of Elementary School Children: A Pilot Group-Randomized Controlled Trial.

    Science.gov (United States)

    Sharma, Shreela V; Shegog, Ross; Chow, Joanne; Finley, Carrie; Pomeroy, Mike; Smith, Carolyn; Hoelscher, Deanna M

    2015-08-01

    Computer-based educational games present an opportunity for health education in school; however, their feasibility in school settings and effectiveness in changing behavior are poorly understood. To evaluate the feasibility, acceptability, and effects of the Quest to Lava Mountain (QTLM) computer game on dietary behaviors, physical activity behaviors, and psychosocial factors among ethnically diverse children in Texas. Quasi-experimental group-randomized controlled trial conducted during the 2012-2013 school year. A total of 107 children in fourth and fifth grade consented. There was an attrition rate of 8.8% with a final sample size of 44 children in three intervention schools, and a sample of 50 children in three comparison schools. Dietary intake was measured using two random 24-hour recalls, whereas child self-report surveys measured diet, physical activity, and psychosocial factors before and after the intervention. Process data on QTLM usability and back-end server data on QTLM exposure and progress achieved were collected. QTLM was implemented as part of the in-school or afterschool program. Recommended game exposure duration was 90 min/wk for 6 weeks. Analysis of covariance or logistic regression models evaluated effects of QTLM on diet, physical activity, and psychosocial factors. Post hoc exploratory analysis examined the changes before and after the intervention in outcome variables among children in the intervention group. Significance was set at Pphysical activity attitudes (P=0.041) pre- to postintervention. There were no significant effects of QTLM on physical activity. However, post hoc analysis showed that higher QTLM exposure and gaming progress was associated with increased frequency of physical activity (Pphysical activity behaviors among children in elementary school. Copyright © 2015 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  1. Can supervised group exercises including ergonomic advice reduce the prevalence and severity of low back pain and pelvic girdle pain in pregnancy? A randomized controlled trial.

    Science.gov (United States)

    Eggen, Marit Horst; Stuge, Britt; Mowinckel, Petter; Jensen, Kjersti Smee; Hagen, Kåre Birger

    2012-06-01

    Many women have low back pain (LBP) or pelvic girdle pain (PGP) during pregnancy, but there is limited evidence of effective primary and secondary preventive strategies. The purpose of this study was to investigate whether a group-based exercise program can reduce the prevalence and severity of LBP and PGP in pregnant women. An observer-blinded randomized controlled trial with equal assignments to a training group and a control group was conducted. The study was conducted in primary care maternity units in 2 suburban municipalities in the southeastern part of Norway. The participants were 257 pregnant women who were healthy and between 18 and 40 years of age before gestation week 20. The training group received supervised exercises in groups once a week, and the control group received standard care. The main outcome measures were self-reported LBP and self-reported PGP. Secondary outcome measures were pain intensity in the morning and evening, disability, and 8-Item Short-Form Health Survey (SF-8) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Follow-up measurements were performed at gestation weeks 24, 28, 32, and 36. Overall, there was no effect of the program on the prevalence of PGP (odds ratio = 1.03, 95% confidence interval [CI] = 0.66 to 1.59) or LBP (odds ratio = 0.77, 95% CI = 0.50 to 1.19). For the secondary outcomes, the estimated mean differences between the groups were -0.4 (95% CI = -0.8 to 0.1) for pain intensity in the morning, -0.4 (95% CI = -1.0 to 0.2) for pain intensity in the evening, -1.0 (95% CI = -2.2 to 0.0) for disability, 1.8 (95% CI = 0.0 to 3.7) for the SF-8 PCS, and -0.6 (95% CI = -2.2 to 1.4) for the SF-8 MCS. Due to low statistical power, the estimates for the primary outcomes are imprecise. Supervised group exercise did not reduce the prevalence of LBP or PGP in pregnancy.

  2. A failure to confirm the effectiveness of a brief group psychoeducational program for mothers of children with high-functioning pervasive developmental disorders: a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Suzuki M

    2014-06-01

    Full Text Available Masako Suzuki,1 Atsurou Yamada,1 Norio Watanabe,1 Tatsuo Akechi,1 Fujika Katsuki,2 Takeshi Nishiyama,3 Masayuki Imaeda,4 Taishi Miyachi,4 Kazuo Otaki,5 Yumiko Mitsuda,6 Akino Ota,6 Toshi A Furukawa7 1Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 2Department of Psychiatric and Mental Health Nursing, Nagoya City University School of Nursing, Nagoya, Japan; 3Clinical Trial Management Center, Nagoya City University Hospital, Nagoya, Japan; 4Department of Neonatology and Pediatrics, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 5Kazuo Mental Clinic, Toyohashi, Japan; 6Toyokawa Sakura Hospital, Toyokawa Japan; 7Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan Objective: The purpose of this study was to examine the effectiveness of group psychoeducation to relieve the psychological distress of mothers of children with high-functioning pervasive developmental disorders (HFPDD and to improve the behaviors of the children. Methods: Seventy-two mothers of preschool outpatients with HFPDD were randomly assigned to a four-session brief group psychoeducational program (GP. The sessions were held every second week in addition to the usual treatment (GP + treatment as usual [TAU] group, or to a TAU-alone group. The primary outcome was self-reported symptoms of maternal mental health as assessed using the 28-item General Health Questionnaire (GHQ-28 at 21 weeks post-randomization (week 21. The GHQ-28 at the end of the intervention (week 7, Aberrant Behavior Checklist (ABC for the behavior of the children, the Zarit Burden Interview (ZBI, and the Medical Outcomes Study 36-item Short Form Health Survey (SF-36 were carried out at weeks 7 and 21. We tested the group effects with the interaction between the intervention and the evaluation points. Results: The GHQ-28

  3. Value stability and change during self-chosen life transitions: self-selection versus socialization effects.

    Science.gov (United States)

    Bardi, Anat; Buchanan, Kathryn E; Goodwin, Robin; Slabu, Letitia; Robinson, Mark

    2014-01-01

    Three longitudinal studies examine a fundamental question regarding adjustment of personal values to self-chosen life transitions: Do values fit the new life setting already at its onset, implying value-based self-selection? Or do values change to better fit the appropriate and desirable values in the setting, implying value socialization? As people are likely to choose a life transition partly based on their values, their values may fit the new life situation already at its onset, leaving little need for value socialization. However, we propose that this may vary as a function of the extent of change the life transition entails, with greater change requiring more value socialization. To enable generalization, we used 3 longitudinal studies spanning 3 different life transitions and different extents of life changes: vocational training (of new police recruits), education (psychology vs. business students), and migration (from Poland to Britain). Although each life transition involved different key values and different populations, across all 3 studies we found value fit to the life situation already early in the transition. Value socialization became more evident the more aspects of life changed as part of the transition, that is, in the migration transition. The discussion focuses on the implications of these findings for research on values and personality change, as well as limitations and future directions for research.

  4. Assessment of economic efficiency of conventional and organic agricultural enterprises in a chosen region

    Directory of Open Access Journals (Sweden)

    Ivana Brožová

    2013-01-01

    Full Text Available The present paper is aimed at assessing the economic efficiency of organically farming agricultural enterprises in a chosen region of the Czech Republic. The results recorded in the organic farming sector were confronted both with conventional agriculture and FADN (Farm Accountancy Data Network enterprises in the respective region. Economic efficiency has been evaluated firstly by means of a production base (equity, assets, and liabilities. Secondly, profit indicators (operating profit, accounting profit have been employed while monitoring the share of profitable and loss-making farms. Different profitability ratios were calculated per one hectare of farmland in order to provide a thorough comparison with conventional farming. Last but not least, the research strived to assess the overall economic and financial situation of agricultural enterprises by means of the following ratios: profitability, liquidity, indebtedness, interest coverage and total assets turnover. Following the research findings, several suggestions related to the database improvement and subsequent profitability assessment in the sector were formulated. The findings presented in the paper were obtained as a result of the Research Program titled Economy of the Czech Agriculture Resources and Their Efficient Use within the Framework of the Multifunctional Agri-food Systems of the Czech Ministry of Education, Youth and Sports number VZ MSM 6046070906 and Grant No. 20121057 of the Internal Grant Agency titled Organic Farming – Map Portal Presentation Opportunities.

  5. Cannabidiol attenuates the appetitive effects of Delta 9-tetrahydrocannabinol in humans smoking their chosen cannabis.

    Science.gov (United States)

    Morgan, Celia J A; Freeman, Tom P; Schafer, Gráinne L; Curran, H Valerie

    2010-08-01

    Worldwide cannabis dependence is increasing, as is the concentration of Delta(9)-tetrahydrocannabinol (THC) in street cannabis. At the same time, the concentration of the second most abundant cannabinoid in street cannabis, cannabidiol (CBD), is decreasing. These two cannabinoids have opposing effects both pharmacologically and behaviorally when administered in the laboratory. No research has yet examined how the ratio of these constituents impacts on the appetitive/reinforcing effects of cannabis in humans. A total of 94 cannabis users were tested 7 days apart, once while non-intoxicated and once while acutely under the influence of their own chosen smoked cannabis on dependence-related measures. Using an unprecedented methodology, a sample of cannabis (as well as saliva) was collected from each user and analyzed for levels of cannabinoids. On the basis of CBD : THC ratios in the cannabis, individuals from the top and bottom tertiles were directly compared on indices of the reinforcing effects of drugs, explicit liking, and implicit attentional bias to drug stimuli. When intoxicated, smokers of high CBD : THC strains showed reduced attentional bias to drug and food stimuli compared with smokers of low CBD : THC. Those smoking higher CBD : THC strains also showed lower self-rated liking of cannabis stimuli on both test days. Our findings suggest that CBD has potential as a treatment for cannabis dependence. The acute modulation of the incentive salience of drug cues by CBD may possibly generalize to a treatment for other addictive disorders.

  6. Floristic Survey of Summer Aspect in Chosen China Clay Pits in Western Bohemia

    Directory of Open Access Journals (Sweden)

    Kamila Botková

    2016-01-01

    Full Text Available Five different china clay pits in the western part of the Czech Republic were explored and plant species were determined. These chosen pits were: Hájek-western part, Chlumčany, Horní Bříza, Otovice and Podlesí II. China clay pits with active excavation represent a specific environment concerning both physical and chemical characteristics. This article is presenting a list of the higher plants which were found within active excavation or former excavation areas. Species with a protection status according to the Czech legislation are presented in more detail. 189 different species have been found in total, including 2 species from category C4 – potentially vulnerable taxa, 6 species from category C3 – endangered taxa and 1 species from the C1 – critically threatened taxa from the Red List of Vascular Plants of the Czech Republic. 28 different species occurred at each of the five sites. Predominant species favour sandy substratum and bare surface.

  7. An Experimental Investigation into Chosen Parameters of Diesel-Water Emulsion on Combustion Processes

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    Pradeep Kumar Arokiasamy Remigious

    2013-01-01

    Full Text Available The purpose of this research is to investigate the effect of mixing water with diesel to make an emulsified fuel considering the needs for the vehicle performance and its cleanest possible operation. The test fuels chosen for the investigation are termed Emulsion 1 (EM1 and Emulsion 2 (EM2. EM1 is prepared in the ratio of 91/8/1 which represents 91% diesel, 8% water, 0.5% surfactant (Span 20, and 0.5% cosurfactant (Tween 20 with continuous stirring. EM2 has a composition of 94% diesel, 5% water, 0.5% Span 20, and 0.5% Tween 20. The stability of the emulsified fuel is checked for 8 hours. The performance and emission characteristics of EM1 and EM2 are compared with diesel fuel. The emission parameters such as hydrocarbon emission, carbon monoxide (CO emission, smoke opacity, and oxides of nitrogen (NOx emission have been measured. To compare the difference in performance characteristics between diesel fuel and emulsified fuel, brake thermal efficiency has been taken into account as a measure. Appreciable reductions of emission parameters have been obtained, and hence the investigation assures that this research could be further extended to biodiesel fuel as it produces more NOx than diesel fuel.

  8. Acute caffeine ingestion's increase of voluntarily chosen resistance-training load after limited sleep.

    Science.gov (United States)

    Cook, Christian; Beaven, C Martyn; Kilduff, Liam P; Drawer, Scott

    2012-06-01

    This study aimed to determine whether caffeine ingestion would increase the workload voluntarily chosen by athletes in a limited-sleep state. In a double-blind, crossover study, 16 professional rugby players ingested either a placebo or 4 mg/kg caffeine 1 hr before exercise. Athletes classified themselves into nondeprived (8 hr+) or sleep-deprived states (6 hr or less). Exercise comprised 4 sets of bench press, squats, and bent rows at 85% 1-repetition maximum. Athletes were asked to perform as many repetitions on each set as possible without failure. Saliva was collected before administration of placebo or caffeine and again before and immediately after exercise and assayed for testosterone and cortisol. Sleep deprivation produced a very large decrease in total load (p = 1.98 × 10(-7)). Caffeine ingestion in the nondeprived state resulted in a moderate increase in total load, with a larger effect in the sleep-deprived state, resulting in total load similar to those observed in the nondeprived placebo condition. Eight of the 16 athletes were identified as caffeine responders. Baseline testosterone was higher (p sleep-deprived athletes. Changes in hormones from predose to preexercise correlated to individual workload responses to caffeine. Testosterone response to exercise increased with caffeine compared with placebo, as did cortisol response. Caffeine increased voluntary workload in professional athletes, even more so under conditions of self-reported limited sleep. Caffeine may prove worthwhile when athletes are tired, especially in those identified as responders.

  9. Experimental determination of chosen document elements parameters from raster graphics sources

    Directory of Open Access Journals (Sweden)

    Jiří Rybička

    2010-01-01

    Full Text Available Visual appearance of documents and their formal quality is considered to be as important as the content quality. Formal and typographical quality of documents can be evaluated by an automated system that processes raster images of documents. A document is described by a formal model that treats a page as an object and also as a set of elements, whereas page elements include text and graphic object. All elements are described by their parameters depending on elements’ type. For future evaluation, mainly text objects are important. This paper describes the experimental determination of chosen document elements parameters from raster images. Techniques for image processing are used, where an image is represented as a matrix of dots and parameter values are extracted. Algorithms for parameter extraction from raster images were designed and were aimed mainly at typographical parameters like indentation, alignment, font size or spacing. Algorithms were tested on a set of 100 images of paragraphs or pages and provide very good results. Extracted parameters can be directly used for typographical quality evaluation.

  10. A study protocol of a three-group randomized feasibility trial of an online yoga intervention for mothers after stillbirth (The Mindful Health Study).

    Science.gov (United States)

    Huberty, Jennifer; Matthews, Jeni; Leiferman, Jenn; Cacciatore, Joanne; Gold, Katherine J

    2018-01-01

    In the USA, stillbirth (in utero fetal death ≥20 weeks gestation) is a major public health issue. Women who experience stillbirth, compared to women with live birth, have a nearly sevenfold increased risk of a positive screen for post-traumatic stress disorder (PTSD) and a fourfold increased risk of depressive symptoms. Because the majority of women who have experienced the death of their baby become pregnant within 12-18 months and the lack of intervention studies conducted within this population, novel approaches targeting physical and mental health, specific to the needs of this population, are critical. Evidence suggests that yoga is efficacious, safe, acceptable, and cost-effective for improving mental health in a variety of populations, including pregnant and postpartum women. To date, there are no known studies examining online-streaming yoga as a strategy to help mothers cope with PTSD symptoms after stillbirth. The present study is a two-phase randomized controlled trial. Phase 1 will involve (1) an iterative design process to develop the online yoga prescription for phase 2 and (2) qualitative interviews to identify cultural barriers to recruitment in non-Caucasian women (i.e., predominately Hispanic and/or African American) who have experienced stillbirth (N = 5). Phase 2 is a three-group randomized feasibility trial with assessments at baseline, and at 12 and 20 weeks post-intervention. Ninety women who have experienced a stillbirth within 6 weeks to 24 months will be randomized into one of the following three arms for 12 weeks: (1) intervention low dose (LD) = 60 min/week online-streaming yoga (n = 30), (2) intervention moderate dose (MD) = 150 min/week online-streaming yoga (n = 30), or (3) stretch and tone control (STC) group = 60 min/week of stretching/toning exercises (n = 30). This study will explore the feasibility and acceptability of a 12-week, home-based, online-streamed yoga intervention, with varying doses among

  11. Short-term intensive psychodynamic group therapy versus cognitive-behavioral group therapy in day treatment of anxiety disorders and comorbid depressive or personality disorders: study protocol for a randomized controlled trial.

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    Suszek, Hubert; Holas, Paweł; Wyrzykowski, Tomasz; Lorentzen, Steinar; Kokoszka, Andrzej

    2015-07-29

    Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals for the treatment of anxiety disorders and comorbid depressive or personality disorders in Poland and other Eastern European countries. Yet there is not enough evidence as to their effectiveness in this environment; this study addresses this gap. The aim of the study is to determine the effectiveness of these two kinds of day treatment care consisting of intensive, short-term group psychodynamic and cognitive-behavioral therapy, for patients with anxiety disorders and/or comorbid depressive or personality disorders. Our objectives are to: 1) show the effectiveness of each treatment in a day-care setting relative to the wait-list control group; 2) demonstrate the relative short- and long-term effectiveness of the two active treatments; 3) carry out a preliminary examination of the predictors and moderators of treatment response; 4) carry out a preliminary examination of the mediators of therapeutic change; and 5) compare the impact of both methods of treatment on the outcome of the measures used in this study. In this randomized controlled trial, a total of 199 patients with anxiety disorders and comorbid depressive and/or personality disorders will be assigned to one of three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; or 3) wait-list control group. The therapy will last 12 weeks. Both treatments will be manualized (the manuals will address comorbidity). Primary outcome measures will include self-reported symptoms of anxiety, observer-rated symptoms of anxiety, global improvement, and recovery rate. Secondary outcome measures will include the number of pathological personality traits, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, and quality of life. Measures will be taken at baseline, post-treatment, and at six months following

  12. Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes: A three-year, prospective, randomized, clinical-based, Mediterranean lifestyle interventional study with parallel groups.

    Science.gov (United States)

    Pérez-Ferre, Natalia; Del Valle, Laura; Torrejón, Maria José; Barca, Idoya; Calvo, María Isabel; Matía, Pilar; Rubio, Miguel A; Calle-Pascual, Alfonso L

    2015-08-01

    Women with prior gestational diabetes mellitus (GDM) have a high risk of developing type 2 diabetes mellitus (DM2) in later life. The study aim was to evaluate the efficacy of a lifestyle intervention for the prevention of glucose disorders (impaired fasting glucose, impaired glucose tolerance or DM2) in women with prior GDM. A total of 260 women with prior GDM who presented with normal fasting plasma glucose at six to twelve weeks postpartum were randomized into two groups: a Mediterranean lifestyle intervention group (n = 130) who underwent an educational program on nutrition and a monitored physical activity program and a control group (n = 130) with a conventional follow-up. A total of 237 women completed the three-year follow-up (126 in the intervention group and 111 in the control group). Their glucose disorders rates, clinical and metabolic changes and rates of adherence to the Mediterranean lifestyle were analyzed. Less women in the intervention group (42.8%) developed glucose disorders at the end of the three-year follow-up period compared with the control group (56.75%), p < 0.05. The multivariate analysis indicated a reduction in the rate of glucose disorders with a BMI of less than 27 kg/m(2) (OR 0.28; 0.12-0.65; p < 0.003), low fat intake pattern (OR 0.30; 0.13-0.70; p < 0.005), low saturated fat pattern (OR 0.30; 0.13-0.69; p < 0.005) and healthy fat pattern (OR 0.34; 0.12-0.94; p < 0.04). Lifestyle intervention was effective for the prevention of glucose disorders in women with prior GDM. Body weight gain and an unhealthy fat intake pattern were found to be the most predictive factors for the development of glucose disorders. Current Controlled trials: ISRCTN24165302. http://www.controlled-trials.com/isrctn/pf/24165302. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  13. Effectiveness of adaptive physical activity combined with therapeutic patient education in stroke survivors at twelve months: a non-randomized parallel group study.

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    Calugi, Simona; Taricco, Mariangela; Rucci, Paola; Fugazzaro, Stefania; Stuart, Mary; Dallolio, Laura; Pillastrini, Paolo; Fantini, Maria P

    2016-02-01

    Adaptive physical activity (APA) is a community-based exercise program for chronic stroke survivors that proved to be effective in improving physical functioning and psychological well-being in the short term. The aim of the present paper is to determine the effectiveness at twelve months of an intervention of APA combined with therapeutic patient education (TPE) in stroke survivors. This study is a non-randomized parallel group study comparing APA-TPE intervention with treatment as usual (TAU). Patients were recruited after discharge from two Physical Medicine and Rehabilitation Units, 3 to 18 months after the stroke event. The APA-TPE intervention was conducted in local gymnasiums. The study population includes consecutive adult stroke survivors with mild to moderate hemiparesis who were able to walk 25 m independently and had no need of physical therapy. The experimental group (N.=126) underwent 16 biweekly sessions of APA and 3 TPE sessions and controls (N.=103) underwent TAU. Twelve-month outcomes included the Modified Barthel Index, the Caregiver Strain Index, SF-12 health-related quality of life, medical complications and health services use. At twelve months, the ability to perform daily living activities, assessed using Modified Barthel Index, was decreased in the TAU group and improved in the APA-TPE group. The physical and mental components of quality of life were significantly improved in both groups. The risk of fractures (OR=0.09, 95% CI 0.01-0.79) and recourse to rehabilitation treatments (OR=0.24, 95% CI 0.08-0.77) were lower in the APA-TPE compared with the TAU group. No difference was found between groups concerning the caregiver burden. APA-TPE is an effective intervention to maintain and improve activities of daily living, reduce falls and recourse to rehabilitation treatments at twelve months. Structured physical activity programs that can be performed also at home, when combined with therapeutic education focused on benefits of physical

  14. Assessing the efficacy of imagery-enhanced cognitive behavioral group therapy for social anxiety disorder: Study protocol for a randomized controlled trial.

    Science.gov (United States)

    McEvoy, Peter M; Moulds, Michelle L; Grisham, Jessica R; Holmes, Emily A; Moscovitch, David A; Hendrie, Delia; Saulsman, Lisa M; Lipp, Ottmar V; Kane, Robert T; Rapee, Ronald M; Hyett, Matthew P; Erceg-Hurn, David M

    2017-09-01

    Cognitive behavior group therapy (CBGT) is effective for social anxiety disorder (SAD), but a substantial proportion of patients do not typically achieve normative functioning. Cognitive behavioral models of SAD emphasize negative self-imagery as an important maintaining factor, and evidence suggests that imagery is a powerful cognitive mode for facilitating affective change. This study will compare two group CBGT interventions, one that predominantly uses verbally-based strategies (VB-CBGT) and another that predominantly uses imagery-enhanced strategies (IE-CBGT), in terms of (a) efficacy, (b) mechanisms of change, and (c) cost-effectiveness. This study is a parallel groups (two-arm) single-blind randomized controlled trial. A minimum of 96 patients with SAD will be recruited within a public outpatient community mental health clinic in Perth, Australia. The primary outcomes will be self-reported symptom severity, caseness (SAD present: yes/no) based on a structured diagnostic interview, and clinician-rated severity and life impact. Secondary outcomes and mechanism measures include blind observer-rated use of safety behaviors, physiological activity (heart rate variability and skin conductance level) during a standardized speech task, negative self-beliefs, imagery suppression, fear of negative and positive evaluation, repetitive negative thinking, anxiety, depression, self-consciousness, use of safety behaviors, and the EQ-5D-5L and TiC-P for the health economic analysis. Homework completion, group cohesion, and working alliance will also be monitored. The outcomes of this trial will inform clinicians as to whether integrating imagery-based strategies in cognitive behavior therapy for SAD is likely to improve outcomes. Common and distinct mechanisms of change might be identified, along with relative cost-effectiveness of each intervention. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Critical appraisal of arguments for the delayed-start design proposed as alternative to the parallel-group randomized clinical trial design in the field of rare disease.

    Science.gov (United States)

    Spineli, Loukia M; Jenz, Eva; Großhennig, Anika; Koch, Armin

    2017-08-17

    A number of papers have proposed or evaluated the delayed-start design as an alternative to the standard two-arm parallel group randomized clinical trial (RCT) design in the field of rare disease. However the discussion is felt to lack a sufficient degree of consideration devoted to the true virtues of the delayed start design and the implications either in terms of required sample-size, overall information, or interpretation of the estimate in the context of small populations. To evaluate whether there are real advantages of the delayed-start design particularly in terms of overall efficacy and sample size requirements as a proposed alternative to the standard parallel group RCT in the field of rare disease. We used a real-life example to compare the delayed-start design with the standard RCT in terms of sample size requirements. Then, based on three scenarios regarding the development of the treatment effect over time, the advantages, limitations and potential costs of the delayed-start design are discussed. We clarify that delayed-start design is not suitable for drugs that establish an immediate treatment effect, but for drugs with effects developing over time, instead. In addition, the sample size will always increase as an implication for a reduced time on placebo resulting in a decreased treatment effect. A number of papers have repeated well-known arguments to justify the delayed-start design as appropriate alternative to the standard parallel group RCT in the field of rare disease and do not discuss the specific needs of research methodology in this field. The main point is that a limited time on placebo will result in an underestimated treatment effect and, in consequence, in larger sample size requirements compared to those expected under a standard parallel-group design. This also impacts on benefit-risk assessment.

  16. Prevention of poststroke cognitive decline: ASPIS--a multicenter, randomized, observer-blind, parallel group clinical trial to evaluate multiple lifestyle interventions--study design and baseline characteristics.

    Science.gov (United States)

    Brainin, Michael; Matz, Karl; Nemec, Matthias; Teuschl, Yvonne; Dachenhausen, Alexandra; Asenbaum-Nan, Susanne; Bancher, Christian; Kepplinger, Berthold; Oberndorfer, Stefan; Pinter, Michaela; Schnider, Peter; Tuomilehto, Jaakko

    2015-06-01

    Cognitive impairment after stroke is a considerable burden to patients and their caregivers and occurs in one-third of stroke survivors. No strategy to prevent cognitive decline after stroke exists thus far. Established vascular risk factors have been associated with cognitive decline and may be a target for therapeutic interventions in stroke survivors. To test whether intensive multifactorial non-pharmacologic interventions based on lifestyle modification can reduce the risk of cognitive decline in patients who recently suffered ischemic stroke. A randomized, controlled, multicenter, observer-blind trial was designed. The reference group obtains stroke care according to standard guidelines. The intervention group additionally receives intensive control and motivation for better compliance with prescribed evidence-based medication, regular blood pressure measurements, healthy diet, regular physical activity and cognitive training. Primary outcomes are the rate of cognitive decline at 24 months, assessed by a neuropsychological test battery and the cognitive subscale of the Alzheimer's Disease Assessment Scale. 202 patients (29% women), aged 62 ± 9 years, were recruited during 2010 to 2012. Stroke related impairment at inclusion was low (mean National Institutes of Health Stroke Scale: 1.9±1.8, median modified Rankin Scale: 1 (0-1)). At baseline, groups did not differ significantly in demographic, clinical or lifestyle characteristics. The recruitment was successful and the groups are balanced regarding potential confounding variables. The study will provide essential data about the feasibility and efficacy of lifestyle intervention after stroke in order to develop a new approach to prevent cognitive decline in patients with mild ischemic stroke. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

  17. Outcomes with individual versus group physical therapy for treating urinary incontinence and low back pain: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Robertson, Belinda; Harding, Katherine E

    2014-11-01

    To evaluate the existing evidence comparing the outcomes of rehabilitation conducted in a group setting and individual therapy for patients receiving rehabilitation. Electronic databases MEDLINE, CINAHL, EMBASE, PEDro, and OT Seeker were searched from the earliest date possible to July 2013. Additional references were identified by manual scanning of reference lists. Randomized controlled trials investigating the effect of group therapy compared with individual therapy for patients receiving rehabilitation were included for review. Two reviewers independently applied the inclusion and exclusion criteria to identify included articles. Initial search identified 1527 potential articles, of which 16 trials with 2337 participants were included in the final review. Data extraction was completed for all included trials by one reviewer, using a customized data extraction form. Data were checked for accuracy by a second reviewer. Trials were independently assessed by 2 reviewers for methodological quality using the PEDro scale. Trials meeting inclusion criteria had been conducted in back pain (n=6 studies), urinary incontinence (n=5), learning disability (n=2), hearing loss (n=1), joint replacement (n=1), and aphasia (n=1). Meta-analysis of physical therapy trials in back pain and urinary incontinence reporting sufficient homogeneous data showed no significant difference in outcomes for group versus individual therapy. These results were also supported by qualitative analysis of the remaining studies in these populations, but there is insufficient evidence to draw conclusions regarding other clinical areas. Evidence shows that providing rehabilitation in a group format results in equivalent clinical outcomes to provision of similar therapy in an individual format in the treatment of back pain and urinary incontinence. There is currently insufficient evidence to draw similar conclusions in other populations or fields of rehabilitation. Copyright © 2014 American Congress of

  18. Chosen risk factors for osteoporosis and the level of knowledge about the disease in peri- and postmenopausal women.

    Science.gov (United States)

    Janiszewska, Mariola; Kulik, Teresa; Dziedzic, Małgorzata A; Żołnierczuk-Kieliszek, Dorota

    2015-03-01

    Osteoporosis as a chronic disease, affecting especially women in postmenopausal age, is an important, social and economic health problem especially of women of today's world. The aim of the study was to assess the level of knowledge of women in the peri- and postmenopausal period about the prevention of osteoporosis and show the influence of chosen risk factors on the level of this knowledge. A group of 300 women aged 45-65, being patients of healthcare centres in Chełm, Lublin and Zamość (Lublin voivodeship, south-eastern Poland) were included in the study. The purposive sampling was used. Osteoporosis Knowledge Test (OKT) 2011 was the research tool. Gathered material was subjected to descriptive and statistical analysis. Tukey's test, t-student test and variance analysis (ANOVA) were all applied. An accepted p materiality level was average level of knowledge about the role of physical activity in the prevention of osteoporosis (M = 13.93) and a low level of knowledge about well-balanced diet rich in calcium (M = 9.77). The knowledge about risk factors, screening and treatment remained on the average level (M = 8.00). An influence of socio-demographic factors on the level of knowledge was shown. Also some behaviours, associated with the lifestyle indeed influenced the level of this knowledge. Professional educational programs on osteoporosis should be implemented in the population of Polish peri- and postmenopausal women.

  19. Chosen single nucleotide polymorphisms (SNPs) of enamel formation genes and dental caries in a population of Polish children.

    Science.gov (United States)

    Gerreth, Karolina; Zaorska, Katarzyna; Zabel, Maciej; Borysewicz-Lewicka, Maria; Nowicki, Michał

    2017-09-01

    It is increasingly emphasized that the influence of a host's factors in the etiology of dental caries are of most interest, particularly those concerned with genetic aspect. The aim of the study was to analyze the genotype and allele frequencies of single nucleotide polymorphisms (SNPs) in AMELX, AMBN, TUFT1, TFIP11, MMP20 and KLK4 genes and to prove their association with dental caries occurrence in a population of Polish children. The study was performed in 96 children (48 individuals with caries - "cases" and 48 free of this disease - "controls"), aged 20-42 months, chosen out of 262 individuals who had dental examination performed and attended 4 day nurseries located in Poznań (Poland). From both groups oral swab was collected for molecular evaluation. Eleven selected SNPs markers were genotyped by Sanger sequencing. Genotype and allele frequencies were calculated and a standard χ2 analysis was used to test for deviation from Hardy-Weinberg equilibrium. The association of genetic variations with caries susceptibility or resistance was assessed by the Fisher's exact test and p ≤ 0.05 was considered statistically significant. Five markers were significantly associated with caries incidence in children in the study: rs17878486 in AMELX (p dental caries occurrence in Polish children.

  20. Effect of chosen factors on growth of lambs crossbreeds with using Suffolk in sire position

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    Igor Dobeš

    2007-01-01

    Full Text Available The aim of the study was evaluated the effect of chosen factors (sex, litter size, year of the study on the growth of lambs crossbreeds with using Suffolk (Sf in the sire position. In the mother position there were used following genotypes: Charollais (Ch, Sf 50 Ch, Improved Wallachian (IW and IW 50 Sf. The evaluation was carried out during two successive years (2004–2005 on the farm Růžďka and involved altogether 141 lambs. The growth of lambs was evaluated in the following crossbreeds: Ch 50 Sf (n = 38, Sf 75 Ch (n = 40, IW 50 Sf (n = 29 and Sf 75 IW (n = 34. All lambs were born indoor in the period from January until the end of first decade of February. Lambs were kept indoor till the end of the study. Genotype had significant effect (P ≤ 0.01 only on birth weight. The highest daily gain (DG from birth to 100 days of age (201 g and the highest body weight (BW at 100 days of age (24.26 kg were found out in IW 50 Sf. Effect of sex had highly significant effect (P ≤ 0.01 only on birth weight and significant effect (P ≤ 0.05 only on BW at 100 days of age. Litter size was the most important factor that influenced the growth of lambs whereas this factor highly significantly (P ≤ 0.01 influenced all parameters under study excerpt the DG between 70 and 100 days of age. Monitoring year had highly significant effect (P ≤ 0.01 on BW at 100 days of age and on daily gains between 70 and 100 days of age and between birth and 100 days of age.

  1. The theoretical aspects of the methodology of risk analysis in chosen business enterprise

    Directory of Open Access Journals (Sweden)

    Josef Zrůst

    2010-01-01

    Full Text Available The risk, crisis, crisis management, crisis regulation and risk management are currently often used terms. It is late to search a cause of crisis in time, when the crisis had broken out and their destructive effects are displaying. It is more suitable to focus on preventive control of business assets. The goal of this article is to suggest a methodical process of risk analysis with focus on protection of carrying business assets. The suggested methodical process of the analysis comes out a persuasion that primary attention is needed to give a protection of carrying business assets. Carrying assets are those which create potentials of business success and in case of their destroying, damaging or loss will originate to subject major or even existence loss. To such chosen carrying business assets are identified threats coming out parts of macro environment (political, legal, economical, social, demographic, technical and technological, ecological and threats from an field environment. To the identification of threats in field environment is used an analysis of five forces model according Porter. As a final step of the suggested methodical process of risk analysis is a creation of a risk matrix to each carrying asset. In this matrix is drawn the risk, which is described with a qualified estimation of occurrence its proba­bility and with an estimation of amount of possible damage, which can be caused by risk. According location the identified risk in the risk matrix is suggested the way of the regulation single risks.It is possible to choose between five basic strategies: Strategy “Take”, Strategy of crisis plans, Strategy of risk treatment, Strategy of risk transfer and Strategy “Terminate”. Single strategies are possible to combine between each other. The combination is suitable in cases, when there is threaten a big loss with a high probability.

  2. Effects of the It's Your Game . . . Keep It Real program on dating violence in ethnic-minority middle school youths: a group randomized trial.

    Science.gov (United States)

    Peskin, Melissa F; Markham, Christine M; Shegog, Ross; Baumler, Elizabeth R; Addy, Robert C; Tortolero, Susan R

    2014-08-01

    We examined whether It's Your Game . . . Keep It Real (IYG) reduced dating violence among ethnic-minority middle school youths, a population at high risk for dating violence. We analyzed data from 766 predominantly ethnic-minority students from 10 middle schools in southeast Texas in 2004 for a group randomized trial of IYG. We estimated logistic regression models, and the primary outcome was emotional and physical dating violence perpetration and victimization by ninth grade. Control students had significantly higher odds of physical dating violence victimization (adjusted odds ratio [AOR] = 1.52; 95% confidence interval [CI] = 1.20, 1.92), emotional dating violence victimization (AOR = 1.74; 95% CI = 1.36, 2.24), and emotional dating violence perpetration (AOR = 1.58; 95% CI = 1.11, 2.26) than did intervention students. The odds of physical dating violence perpetration were not significantly different between the 2 groups. Program effects varied by gender and race/ethnicity. IYG significantly reduced 3 of 4 dating violence outcomes among ethnic-minority middle school youths. Although further study is warranted to determine if IYG should be widely disseminated to prevent dating violence, it is one of only a handful of school-based programs that are effective in reducing adolescent dating violence behavior.

  3. Effects of the It’s Your Game . . . Keep It Real Program on Dating Violence in Ethnic-Minority Middle School Youths: A Group Randomized Trial

    Science.gov (United States)

    Markham, Christine M.; Shegog, Ross; Baumler, Elizabeth R.; Addy, Robert C.; Tortolero, Susan R.

    2014-01-01

    Objectives. We examined whether It’s Your Game . . . Keep It Real (IYG) reduced dating violence among ethnic-minority middle school youths, a population at high risk for dating violence. Methods. We analyzed data from 766 predominantly ethnic-minority students from 10 middle schools in southeast Texas in 2004 for a group randomized trial of IYG. We estimated logistic regression models, and the primary outcome was emotional and physical dating violence perpetration and victimization by ninth grade. Results. Control students had significantly higher odds of physical dating violence victimization (adjusted odds ratio [AOR] = 1.52; 95% confidence interval [CI] = 1.20, 1.92), emotional dating violence victimization (AOR = 1.74; 95% CI = 1.36, 2.24), and emotional dating violence perpetration (AOR = 1.58; 95% CI = 1.11, 2.26) than did intervention students. The odds of physical dating violence perpetration were not significantly different between the 2 groups. Program effects varied by gender and race/ethnicity. Conclusions. IYG significantly reduced 3 of 4 dating violence outcomes among ethnic-minority middle school youths. Although further study is warranted to determine if IYG should be widely disseminated to prevent dating violence, it is one of only a handful of school-based programs that are effective in reducing adolescent dating violence behavior. PMID:24922162

  4. An intervention for reducing secondary traumatization and improving professional self-efficacy in well baby clinic nurses following war and terror: a random control group trial.

    Science.gov (United States)

    Berger, Rony; Gelkopf, Marc

    2011-05-01

    Due to the terror and war-related situation in Israel, well baby clinic nurses dealing with a large number of traumatized and highly distressed infants, toddlers and their parents have become overwhelmed. (1) Assess the level of secondary traumatization, including lack of compassion satisfaction, burnout and compassion fatigue of well baby clinic nurses living under chronic threat of war and terror. (2) Assess the efficacy of an intervention aimed at providing well baby clinic nurses with psycho-educational knowledge pertaining to stress and trauma in infants, young children and parents. This intervention provides the nurses with screening tools for identifying children and parents at risk of developing stress-related problems and equips them with stress management techniques. Quasi-random control trial. The intervention took place in Israel, in war (North) and terror (South) affected areas. Ninety well baby clinic nurses from the most war and terror affected areas in Israel were approached, 42 were randomly assigned the experimental intervention and 38 served as a waiting list group. The intervention was comprised of 12 weekly 6-h sessions. Each session included theoretical knowledge, experiential exercises based on the nurses' work or personal life experience, and the learning of skills accompanied by homework assignments. Participants were assessed on self-report measures of secondary traumatization, professional self-efficacy, hope, sense of mastery and self-esteem before and after the intervention. (1) Well baby clinic nurses were found to have elevated secondary traumatization levels. (2) Compared to the waiting list group, the intervention group improved significantly on the professional self-efficacy measure as well as reducing the level of secondary traumatization. Furthermore, improvement on all secondary traumatization measures covaried with the improvement on the professional self-efficacy assessments. Based on additional informal reports, the

  5. A 9-year follow-up of a self-management group intervention for persistent neck pain in primary health care: a randomized controlled trial

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    Gustavsson C

    2016-12-01

    Full Text Available Catharina Gustavsson,1,2 Lena von Koch1,3,4 1Center for Clinical Research Dalarna, Department of Public Health and Caring Science, Uppsala University, Uppsala, 2School of Education, Health and Social Studies, Dalarna University, Falun, 3Department of Neurobiology, Care Science and Society, Karolinska Institutet, 4Department of Neurology, Karolinska University Hospital, Stockholm, Sweden Background and objective: In previous short-term and 2-year follow-ups, a pain and stress self-management group intervention (PASS had better effect on pain-related disability, self-efficacy, catastrophizing, and perceived pain control than individually administered physiotherapy (IAPT for patients with persistent tension-type neck pain. Studies that have evaluated long-term effects of self-management approaches toward persistent neck pain are sparse. The objective of this study was to compare pain-related disability, self-efficacy for activities of daily living (ADL, catastrophizing, pain, pain control, use of analgesics, and health care utilization in people with persistent tension-type neck pain 9 years after they received the PASS or IAPT. Materials and methods: Of 156 people (PASS, n = 77; IAPT, n = 79 originally included in a randomized controlled trial, 129 people (PASS, n = 63; IAPT, n = 66 were eligible and were approached for the 9-year follow-up. They were sent a self-assessment questionnaire, comprising the Neck Disability Index, the Self-Efficacy Scale, the Coping Strategies Questionnaire, and questions regarding pain, analgesics, and health care utilization. Mixed linear models for repeated measures analysis or generalized estimating equations were used to evaluate the differences between groups and within groups over time (baseline, previous follow-ups, and 9-year follow-up and the interaction effect of “time by group”. Results: Ninety-four participants (73% responded (PASS, n = 48; IAPT, n = 46. At 9 years, PASS participants reported less

  6. An intervention to reduce sitting and increase light-intensity physical activity at work: Design and rationale of the 'Stand & Move at Work' group randomized trial.

    Science.gov (United States)

    Buman, Matthew P; Mullane, Sarah L; Toledo, Meynard J; Rydell, Sarah A; Gaesser, Glenn A; Crespo, Noe C; Hannan, Peter; Feltes, Linda; Vuong, Brenna; Pereira, Mark A

    2017-02-01

    American workers spend 70-80% of their time at work being sedentary. Traditional approaches to increase moderate-vigorous physical activity (MVPA) may be perceived to be harmful to productivity. Approaches that target reductions in sedentary behavior and/or increases in standing or light-intensity physical activity [LPA] may not interfere with productivity and may be more feasible to achieve through small changes accumulated throughout the workday METHODS/DESIGN: This group randomized trial (i.e., cluster randomized trial) will test the relative efficacy of two sedentary behavior focused interventions in 24 worksites across two states (N=720 workers). The MOVE+ intervention is a multilevel individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace. The STAND+ intervention is the MOVE+ intervention with the addition of the installation and use of sit-stand workstations to reduce sedentary behavior and enhance light-intensity physical activity opportunities. Our primary outcome will be objectively-measured changes in sedentary behavior and light-intensity physical activity over 12months, with additional process measures at 3months and longer-term sustainability outcomes at 24months. Our secondary outcomes will be a clustered cardiometabolic risk score (comprised of fasting glucose, insulin, triglycerides, HDL-cholesterol, and blood pressure), workplace productivity, and job satisfaction DISCUSSION: This study will determine the efficacy of a multi-level workplace intervention (including the use of a sit-stand workstation) to reduce sedentary behavior and increase LPA and concomitant impact on cardiometabolic health, workplace productivity, and satisfaction. ClinicalTrials.gov Identifier: NCT02566317 (date of registration: 10/1/2015). Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Ancient DNA from hunter-gatherer and farmer groups from Northern Spain supports a random dispersion model for the Neolithic expansion into Europe.

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    Montserrat Hervella

    Full Text Available BACKGROUND/PRINCIPAL FINDINGS: The phenomenon of Neolithisation refers to the transition of prehistoric populations from a hunter-gatherer to an agro-pastoralist lifestyle. Traditionally, the spread of an agro-pastoralist economy into Europe has been framed within a dichotomy based either on an acculturation phenomenon or on a demic diffusion. However, the nature and speed of this transition is a matter of continuing scientific debate in archaeology, anthropology, and human population genetics. In the present study, we have analyzed the mitochondrial DNA diversity in hunter-gatherers and first farmers from Northern Spain, in relation to the debate surrounding the phenomenon of Neolithisation in Europe. METHODOLOGY/SIGNIFICANCE: Analysis of mitochondrial DNA was carried out on 54 individuals from Upper Paleolithic and Early Neolithic, which were recovered from nine archaeological sites from Northern Spain (Basque Country, Navarre and Cantabria. In addition, to take all necessary precautions to avoid contamination, different authentication criteria were applied in this study, including: DNA quantification, cloning, duplication (51% of the samples and replication of the results (43% of the samples by two independent laboratories. Statistical and multivariate analyses of the mitochondrial variability suggest that the genetic influence of Neolithisation did not spread uniformly throughout Europe, producing heterogeneous genetic consequences in different geographical regions, rejecting the traditional models that explain the Neolithisation in Europe. CONCLUSION: The differences detected in the mitochondrial DNA lineages of Neolithic groups studied so far (including these ones of this study suggest different genetic impact of Neolithic in Central Europe, Mediterranean Europe and the Cantabrian fringe. The genetic data obtained in this study provide support for a random dispersion model for Neolithic farmers. This random dispersion had a different

  8. Efficacy and safety of bilastine in Japanese patients with perennial allergic rhinitis: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III study.

    Science.gov (United States)

    Okubo, Kimihiro; Gotoh, Minoru; Asako, Mikiya; Nomura, Yasuyuki; Togawa, Michinori; Saito, Akihiro; Honda, Takayuki; Ohashi, Yoshihiro

    2017-01-01

    Bilastine, a novel non-sedating second-generation H 1 antihistamine, has been approved in most European countries since 2010. This study aimed to evaluate the superiority of bilastine over placebo in Japanese patients with perennial allergic rhinitis (PAR). This randomized, double-blind, placebo-controlled, parallel-group, phase III study (trial registration number JapicCTI-142600) evaluated the effect of a 2-week treatment period with bilastine (20 mg once daily), fexofenadine (60 mg twice daily), or a matched placebo (double dummy) in patients with PAR. All patients were instructed to record individual nasal and ocular symptoms in diaries daily. The primary endpoint was the mean change in total nasal symptom scores (TNSS) from baseline to Week 2 (Days 10-13). A total of 765 patients were randomly allocated to receive bilastine, fexofenadine, or placebo (256, 254, and 255 patients, respectively). The mean change in TNSS from baseline at Week 2 was significantly decreased by bilastine (-0.98) compared to placebo (-0.63, P = 0.023). Bilastine and fexofenadine showed no significant difference in the primary endpoint. However, the mean change in TNSS from baseline on Day 1 was more significantly decreased by bilastine (-0.99) than by placebo (-0.28, P bilastine 20 mg once daily was effective and tolerable in Japanese patients with PAR, and exhibited a rapid onset of action. Copyright © 2016 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

  9. Using ecological momentary assessment in testing the effectiveness of an alcohol intervention: a two-arm parallel group randomized controlled trial.

    Science.gov (United States)

    Voogt, Carmen V; Kuntsche, Emmanuel; Kleinjan, Marloes; Poelen, Evelien A P; Lemmers, Lex A C J; Engels, Rutger C M E

    2013-01-01

    Alcohol consumption of college students has a fluctuating nature, which might impact the measurement of intervention effects. By using 25 follow-up time-points, this study tested whether intervention effects are robust or might vary over time. Data were used from a two-arm parallel group randomized controlled trial applying ecological momentary assessment (EMA) with 30 data time-points in total. Students between 18 and 24 years old who reported heavy drinking in the past six months and who were ready to change their alcohol consumption were randomly assigned to the experimental (n = 456: web-based brief alcohol intervention) and control condition (n = 451: no intervention). Outcome measures were weekly alcohol consumption, frequency of binge drinking, and heavy drinking status. According to the intention-to-treat principle, regression analyses revealed that intervention effects on alcohol consumption varied when exploring multiple follow-up time-points. Intervention effects were found for a) weekly alcohol consumption at 1, 2, 3, 4, and 7 weeks follow-up, b) frequency of binge drinking at 1, 2, 7, and 12 weeks follow-up, and c) heavy drinking status at 1, 2, 7, and 16 weeks follow-up. This research showed that the commonly used one and six month follow-up time-points are relatively arbitrary and not using EMA might bring forth erroneous conclusions on the effectiveness of interventions. Therefore, future trials in alcohol prevention research and beyond are encouraged to apply EMA when assessing outcome measures and intervention effectiveness. Netherlands Trial Register NTR2665.

  10. An Exploratory Analysis of the Smoking and Physical Activity Outcomes From a Pilot Randomized Controlled Trial of an Exercise Assisted Reduction to Stop Smoking Intervention in Disadvantaged Groups.

    Science.gov (United States)

    Thompson, Tom Paul; Greaves, Colin J; Ayres, Richard; Aveyard, Paul; Warren, Fiona C; Byng, Richard; Taylor, Rod S; Campbell, John L; Ussher, Michael; Green, Colin; Michie, Susan; West, Robert; Taylor, Adrian

    2016-03-01

    Economically disadvantaged smokers not intending to stop may benefit from interventions aimed at reducing their smoking. This study assessed the effects of a behavioral intervention promoting an increase in physical activity versus usual care in a pilot randomized controlled trial. Disadvantaged smokers who wanted to reduce but not quit were randomized to either a counseling intervention of up to 12 weeks to support smoking reduction and increased physical activity (n = 49) or usual care (n = 50). Data at 16 weeks were collected for various smoking and physical activity outcomes. Primary analyses consisted of an intention to treat analysis based on complete case data. Secondary analyses explored the impact of handling missing data. Compared with controls, intervention smokers were more likely to initiate a quit attempt (36 vs. 10%; odds ratio 5.05, [95% CI: 1.10; 23.15]), and a greater proportion achieved at least 50% reduction in cigarettes smoked (63 vs. 32%; 4.21 [1.32; 13.39]). Postquit abstinence measured by exhaled carbon monoxide at 4-week follow-up showed promising differences between groups (23% vs. 6%; 4.91 [0.80; 30.24]). No benefit of intervention on physical activity was found. Secondary analyses suggested that the standard missing data assumption of "missing" being equivalent to "smoking" may be conservative resulting in a reduced intervention effect. A smoking reduction intervention for economically disadvantaged smokers which involved personal support to increase physical activity appears to be more effective than usual care in achieving reduction and may promote cessation. The effect does not appear to be influenced by an increase in physical activity. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  11. Using ecological momentary assessment in testing the effectiveness of an alcohol intervention: a two-arm parallel group randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Carmen V Voogt

    Full Text Available BACKGROUND: Alcohol consumption of college students has a fluctuating nature, which might impact the measurement of intervention effects. By using 25 follow-up time-points, this study tested whether intervention effects are robust or might vary over time. METHODS: Data were used from a two-arm parallel group randomized controlled trial applying ecological momentary assessment (EMA with 30 data time-points in total. Students between 18 and 24 years old who reported heavy drinking in the past six months and who were ready to change their alcohol consumption were randomly assigned to the experimental (n = 456: web-based brief alcohol intervention and control condition (n = 451: no intervention. Outcome measures were weekly alcohol consumption, frequency of binge drinking, and heavy drinking status. RESULTS: According to the intention-to-treat principle, regression analyses revealed that intervention effects on alcohol consumption varied when exploring multiple follow-up time-points. Intervention effects were found for a weekly alcohol consumption at 1, 2, 3, 4, and 7 weeks follow-up, b frequency of binge drinking at 1, 2, 7, and 12 weeks follow-up, and c heavy drinking status at 1, 2, 7, and 16 weeks follow-up. CONCLUSIONS: This research showed that the commonly used one and six month follow-up time-points are relatively arbitrary and not using EMA might bring forth erroneous conclusions on the effectiveness of interventions. Therefore, future trials in alcohol prevention research and beyond are encouraged to apply EMA when assessing outcome measures and intervention effectiveness. TRIAL REGISTRATION: Netherlands Trial Register NTR2665.

  12. Quality Improvement of Ground Works Process with the Use of Chosen Lean Management Tools – Case Study

    Science.gov (United States)

    Nowotarski, Piotr; Paslawski, Jerzy; Wysocki, Bartosz

    2017-12-01

    Ground works are one of the first processes connected with erecting structures. Based on ground conditions like the type of soil or level of underground water different types and solutions for foundations are designed. Foundations are the base for the buildings, and their proper design and execution is the key for the long and faultless use of the whole construction and might influence on the future costs of the eventual repairs (especially when ground water level is high, and there is no proper water insulation made). Article presents the introduction of chosen Lean Management tools for quality improvement of the process of ground works based on the analysis made on the construction site of vehicle control station located in Poznan, Poland. Processes assessment is made from different perspectives taking into account that 3 main groups of workers were directly involved in the process: blue collar-workers, site manager and site engineers. What is more comparison is made on the 3 points of view to the problems that might occur during this type of works, with details analysis on the causes of such situation? Authors presents also the change of approach of workers directly involved in the mentioned processes regarding introduction of Lean Management methodology, which illustrates the problem of scepticism for new ideas of the people used to perform works and actions in traditional way. Using Lean Management philosophy in construction is a good idea to streamline processes in company, get rid of constantly recurring problems, and in this way improve the productivity and quality of executed activities. Performed analysis showed that different groups of people have very different idea and opinion on the problems connected with executing the same process – ground works and only having full picture of the situation (especially in construction processes) management can take proper problems-preventing actions that consequently can influence on the amount of waste generated

  13. Effect of sodium selenite on chosen anti- and pro-oxidative parameters in rats treated with lithium: A pilot study.

    Science.gov (United States)

    Musik, Irena; Kocot, Joanna; Kiełczykowska, Małgorzata

    2015-06-01

    Selenium is an essential element of antioxidant properties. Lithium is widely used in medicine but its administration can cause numerous side effects including oxidative stress. The present study aimed at evaluating if sodium selenite could influence chosen anti- and pro-oxidant parameters in rats treated with lithium. The experiment was performed on four groups of Wistar rats: I (control) - treated with saline; II (Li) - treated with lithium (2.7 mgLi/kg b.w. as Li2CO3), III (Se) - treated with selenium (0.5 mgSe/kg b.w. as Na2SeO3), IV (Li+Se) - treated with Li2CO3 and Na2SeO3 together at the same doses as in group II and III, respectively. All treatments were performed by stomach tube for three weeks in form of water solutions. The following anti- and pro-oxidant parameters: total antioxidant status (TAS) value, catalase (CAT) activity, concentrations of ascorbic acid (AA) and malonyldialdehyde (MDA) in plasma as well as whole blood superoxide dismutase (SOD) and glutathione peroxidase (GPx) activities were measured. Selenium given alone markedly enhanced whole blood GPx and diminished plasma CAT vs. Lithium significantly decreased plasma CAT and slightly increased AA vs. Selenium co-administration restored these parameters to the values observed in control animals. Furthermore, selenium co-administration significantly increased GPx in Li-treated rats. All other parameters (TAS, SOD and MDA) were not affected by lithium and/or selenium. Further research seems to be warranted to decide if application of selenium as an adjuvant in lithium therapy is worth considering. Copyright © 2014 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

  14. Intake of black-vinegar-mash-garlic enhances salivary release of secretory IgA: A randomized, double-blind, placebo-controlled, parallel-group study.

    Science.gov (United States)

    Nakasone, Yasushi; Sato, Norimasa; Azuma, Takayuki; Hasumi, Keiji

    2016-07-01

    Several previous studies have provided evidence that suggests the beneficial effects of garlic and black vinegar on human health, including benefits to immune function. The preliminary study indicated that the intake of black-vinegar-mash-garlic-containing food, created from aged garlic pickled in the mash of black vinegar, enhanced the release of secretory immunoglobulin A (sIgA) in the saliva. The aim of the present study was to evaluate the effect of the food in a randomized, double-blind, placebo-controlled, parallel-group trial. The trial was conducted in subjects aged between 30 and 60 years whose rate of salivary sIgA release was moderately low. Subjects consumed 2.49 g of placebo or black-vinegar-mash-garlic-containing food (active food) daily for 8 weeks. The data obtained with 54 eligible subjects (n=28 and 26 for placebo and active, respectively) were analyzed for efficacy. The rates of salivary sIgA release in the active food group (35.9±84.6 and 47.9±123.4 µg/min at weeks 4 and 8 of intake; changes from pretrial value) were higher compared to the respective rates in the placebo food group (-12.3±72.1 and -3.2±85.9 µg/min, P=0.028 and 0.082, respectively). These findings indicate that intake of black-vinegar-mash-garlic-containing food enhanced the intraoral immune response. There was no adverse event associated with the intake of active food.

  15. Randomized-controlled trial of mindfulness-based cancer recovery versus supportive expressive group therapy among distressed breast cancer survivors (MINDSET): long-term follow-up results.

    Science.gov (United States)

    Carlson, Linda E; Tamagawa, Rie; Stephen, Joanne; Drysdale, Elaine; Zhong, Lihong; Speca, Michael

    2016-07-01

    Mindfulness-based cancer recovery (MBCR) and supportive expressive group therapy (SET) are two well-validated psychosocial interventions, but they have not been directly compared, and little is known about long-term outcomes. This comparative effectiveness study measured the effects of these two interventions immediately following the groups and for 1 year thereafter in distressed breast cancer survivors. Two hundred fifty-two distressed Stage I-III breast cancer survivors were randomized into either MBCR or SET. Women completed questionnaires addressing mood, stress symptoms, quality of life, social support, spirituality and post-traumatic growth before and after the interventions, and 6 and 12 months later. Immediately following the intervention, women in MBCR reported greater reduction in mood disturbance (primarily fatigue, anxiety and confusion) and stress symptoms including tension, sympathetic arousal and cognitive symptoms than those in SET. They also reported increased emotional and functional quality of life, emotional, affective and positive social support, spirituality (feelings of peace and meaning in life) and post-traumatic growth (appreciation for life and ability to see new possibilities) relative to those in SET, who also improved to a lesser degree on many outcomes. Effect sizes of the time × group interactions were small to medium, and most benefits were maintained over 12 months of follow-up. This study is the first and largest to demonstrate sustained benefits of MBCR in distressed breast cancer survivors relative to an active control. MBCR was superior to SET for improving psychological well-being with lasting benefits over 1 year, suggesting these women gained long-lasting and efficacious tools to cope with cancer. Registered on clinicaltrials.gov number NCT00390169, October 2006. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  16. Economic Evaluation Alongside a Randomized Controlled Crossover Trial of Modified Group Cognitive–Behavioral Therapy for Anxiety Compared to Treatment-as-Usual in Adults With Asperger Syndrome

    Directory of Open Access Journals (Sweden)

    Brett Doble PhD

    2017-08-01

    Full Text Available Background: There is a growing interest in using group cognitive–behavioral therapy (CBT with people who have Asperger syndrome (AS and comorbid mental health problems. This study aims to assess the cost-effectiveness of modified group CBT for adults with AS experiencing co-occurring anxiety compared to treatment-as-usual. Methods: Economic evaluation alongside a pilot, multicenter, single-blind, randomized controlled crossover trial. Costs from the UK public sector (National Health Service and Social Services and societal perspectives, quality-adjusted life years (QALYs, incremental net (monetary benefit (INB, expected value of perfect information, expected value of sample information, expected net gain of sampling, and efficient sample size of a future trial are reported. Results: Over 48 weeks, from the societal perspective, CBT results in additional costs of £6,647, with only a 0.015 incremental gain in QALYs, leading to a negative INB estimate of £6,206 and a 23% probability of cost-effectiveness at a threshold of £30,000/QALY. Results from sensitivity analyses support the unlikely cost-effectiveness of CBT but indicate the potential for cost-effectiveness over longer time horizons. Eliminating decision uncertainty is valued at £277 million, and the efficient sample size for a future trial is estimated at 1,200 participants per arm. Limitations: Relatively small sample size and prevalence of missing data present challenges to the interpretation of the results. Conclusions: Current evidence from this small pilot study suggests that, on average, modified group CBT is not cost-effective. However, there is much decision uncertainty so such a conclusion could be wrong. A large, full-scale trial to reduce uncertainty would be an efficient investment for the UK health economy.

  17. Human computation as a new method for evidence-based knowledge transfer in Web-based guideline development groups: proof of concept randomized controlled trial.

    Science.gov (United States)

    Heselmans, Annemie; Aertgeerts, Bert; Donceel, Peter; Van de Velde, Stijn; Vanbrabant, Peter; Ramaekers, Dirk

    2013-01-17

    Guideline developers use different consensus methods to develop evidence-based clinical practice guidelines. Previous research suggests that existing guideline development techniques are subject to methodological problems and are logistically demanding. Guideline developers welcome new methods that facilitate a methodologically sound decision-making process. Systems that aggregate knowledge while participants play a game are one class of human computation applications. Researchers have already proven that these games with a purpose are effective in building common sense knowledge databases. We aimed to evaluate the feasibility of a new consensus method based on human computation techniques compared to an informal face-to-face consensus method. We set up a randomized design to study 2 different methods for guideline development within a group of advanced students completing a master of nursing and obstetrics. Students who participated in the trial were enrolled in an evidence-based health care course. We compared the Web-based method of human-based computation (HC) with an informal face-to-face consensus method (IC). We used 4 clinical scenarios of lower back pain as the subject of the consensus process. These scenarios concerned the following topics: (1) medical imaging, (2) therapeutic options, (3) drugs use, and (4) sick leave. Outcomes were expressed as the amount of group (dis)agreement and the concordance of answers with clinical evidence. We estimated within-group and between-group effect sizes by calculating Cohen's d. We calculated within-group effect sizes as the absolute difference between the outcome value at round 3 and the baseline outcome value, divided by the pooled standard deviation. We calculated between-group effect sizes as the absolute difference between the mean change in outcome value across rounds in HC and the mean change in outcome value across rounds in IC, divided by the pooled standard deviation. We analyzed statistical significance of

  18. The ACTIVATE study: results from a group-randomized controlled trial comparing a traditional worksite health promotion program with an activated consumer program.

    Science.gov (United States)

    Terry, Paul E; Fowles, Jinnet Briggs; Xi, Min; Harvey, Lisa

    2011-01-01

    PURPOSE. Th