Psychological treatments for adults and children with epilepsy: Evidence-based recommendations by the International League Against Epilepsy Psychology Task Force.

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Michaelis, Rosa; Tang, Venus; Goldstein, Laura H; Reuber, Markus; LaFrance, William Curt; Lundgren, Tobias; Modi, Avani C; Wagner, Janelle L

2018-06-19

Given the significant impact that psychosocial factors and epilepsy treatments can have on the health-related quality of life (HRQOL) of individuals with epilepsy and their families, there is great clinical interest in the role of psychological evaluation and treatments to improve HRQOL and comorbidities. Therefore, the International League Against Epilepsy (ILAE) charged the Psychology Task Force with the development of recommendations for clinical care based on evaluation of the evidence from their recent Cochrane review of psychological treatments in individuals with epilepsy. The literature search for a recent Cochrane review of randomized controlled trials investigating psychological treatments for individuals with epilepsy constitutes the key source of evidence for this article. To provide practical guidance to service providers, we provide ratings on study research designs based on (1) the American Academy of Neurology's Level of Evidence system and (2) the Grading of Recommendations, Assessment, Development, and Evaluation system. This paper is the culmination of an international collaboration process involving pediatric and adult psychologists, neurologists, psychiatrists, and neuropsychiatrists. The process and conclusions were reviewed and approved by the ILAE Executive Committee. The strongest evidence for psychological interventions was identified for the most common mental health problems, including depression, neurocognitive disturbances, and medication adherence. Psychological interventions targeting the enhancement of HRQOL and adherence and a decrease in comorbidity symptoms (anxiety, depression) should be incorporated into comprehensive epilepsy care. There is a range of psychological strategies (ie, cognitive behavioral therapy and mindfulness-based therapies) that show promise for improving the lives of persons with epilepsy, and clinical recommendations are provided to assist epilepsy health care providers in treating the comorbidities and

Psychological Treatment

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... cognitive-behavioral therapy ), relaxation therapy , hypnotherapy , and biofeedback therapy . Psychological treatments can also be combined. Review of well- ... Antidepressant Medications Newer IBS Medications Probiotics and Antibiotics ... Cognitive Behavioral Therapy Relaxation Techniques for IBS Take Part in Online ...

How many individuals achieve symptom abstinence following psychological treatments for bulimia nervosa? A meta-analytic review.

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Linardon, Jake; Wade, Tracey D

2018-04-01

It is unclear how many patients with bulimia nervosa (BN) completely abstain from the core behavioral symptoms after receiving psychological treatment. The present meta-analysis of randomized controlled trials (RCTs) aimed to (a) estimate the prevalence of patients who abstain from binge eating and/or purging following all psychological treatments for BN, and (b) test whether these abstinence estimates are moderated by the type of treatment modality delivered, the definition of abstinence applied, and trial quality. Forty-five RCTs were included, with 78 psychotherapy conditions. Pooled event rates were calculated using random effects models. At post-treatment, the total weighted percentage of treatment-completers who achieved abstinence was 35.4% (95% CI = 29.6, 41.7), while the total weighted percentage of abstinence for all randomized patients (intention-to-treat) was 29.9% (95% CI = 25.7, 33.2). Abstinence estimates were highest in trials that used behavioral-based treatments (e.g., cognitive-behavioral therapy, behavior therapy). There was also evidence that guided self-help interventions produced the lowest post-treatment abstinence rates, but with no difference at follow-up from clinician-led treatments, and studies that used a shorter timeframe for defining abstinence (i.e., 14 days symptom-free compared to 28-days symptom-free) produced the highest abstinence rates. Abstinence estimates at follow-up for both the completer (34.6%; 95% CI = 29.3, 40.2) and intention-to-treat (28.6%; 95% CI = 25.1, 32.3) analyses were essentially the same as the post-treatment estimates. Over 60% of patients fail to fully abstain from core BN symptoms even after receiving our most empirically-supported treatments. The present findings highlight the urgency toward improving the effectiveness of psychological treatments for BN. © 2018 Wiley Periodicals, Inc.

A meta-analytic review of psychological treatments for tinnitus.

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Andersson, G; Lyttkens, L

1999-08-01

Meta-analysis is a technique of combining results from different trials in order to obtain estimates of effects across studies. Meta-analysis has, as yet, rarely been used in audiological research. The aim of this paper was to conduct a meta-analysis on psychological treatment of tinnitus. The outcomes of 18 studies, including a total of 24 samples and up to 700 subjects, were included and coded. Included were studies on cognitive/cognitive-behavioural treatment, relaxation, hypnosis, biofeedback, educational sessions and problem-solving. Effect sizes for perceived tinnitus loudness, annoyance, negative affect (e.g. depression) and sleep problems were calculated for randomized controlled studies, pre-post-treatment design studies and follow-up results. Results showed strong to moderate effects on tinnitus annoyance for controlled studies (d = 0.86), pre-post designs (d = 0.5) and at follow-up (d = 0.48). Results on tinnitus loudness were weaker and disappeared at follow-up. Lower effect sizes were also obtained for measures of negative affect and sleep problems. Exploratory analyses revealed that cognitive-behavioural treatments were more effective on ratings of annoyance in the controlled studies. It is concluded that psychological treatment for tinnitus is effective, but that aspects such as depression and sleep problems may need to be targeted in future studies.

Psychological aspects of male fertility treatment

DEFF Research Database (Denmark)

Mikkelsen, Alice Toft; Madsen, Svend Aage Lykke; Humaidan, Peter

2013-01-01

To explore and to identify the possible need for psychological communicative support in men undergoing fertility treatment.......To explore and to identify the possible need for psychological communicative support in men undergoing fertility treatment....

Psychological Treatments for the World: Lessons from Low- and Middle-Income Countries.

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Singla, Daisy R; Kohrt, Brandon A; Murray, Laura K; Anand, Arpita; Chorpita, Bruce F; Patel, Vikram

2017-05-08

Common mental disorders, including depression, anxiety, and posttraumatic stress, are leading causes of disability worldwide. Treatment for these disorders is limited in low- and middle-income countries. This systematic review synthesizes the implementation processes and examines the effectiveness of psychological treatments for common mental disorders in adults delivered by nonspecialist providers in low- and middle-income countries. In total, 27 trials met the eligibility criteria; most treatments targeted depression or posttraumatic stress. Treatments were commonly delivered by community health workers or peers in primary care or community settings; they usually were delivered with fewer than 10 sessions over 2-3 months in an individual, face-to-face format. Treatments included common elements, such as nonspecific engagement and specific domains of behavioral, interpersonal, emotional, and cognitive elements. The pooled effect size was 0.49 (95% confidence interval = 0.36-0.62), favoring intervention conditions. Our review demonstrates that psychological treatments-comprising a parsimonious set of common elements and delivered by a low-cost, widely available human resource-have moderate to strong effects in reducing the burden of common mental disorders.

Psychological Treatment of Depression in People Aged 65 Years and Over: A Systematic Review of Efficacy, Safety, and Cost-Effectiveness.

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Ulf Jonsson

Full Text Available Depression in elderly people is a major public health concern. As response to antidepressants is often unsatisfactory in this age group, there is a need for evidence-based non-pharmacological treatment options. Our objectives were twofold: firstly, to synthesize published trials evaluating efficacy, safety and cost-effectiveness of psychological treatment of depression in the elderly and secondly, to assess the quality of evidence.The electronic databases PubMed, EMBASE, Cochrane Library, CINAL, Scopus, and PsycINFO were searched up to 23 May 2016 for randomized controlled trials (RCTs of psychological treatment for depressive disorders or depressive symptoms in people aged 65 years and over. Two reviewers independently assessed relevant studies for risk of bias. Where appropriate, the results were synthesized in meta-analyses. The quality of the evidence was graded according to GRADE (Grading of Recommendations Assessment, Development and Evaluation.Twenty-two relevant RCTs were identified, eight of which were excluded from the synthesis due to a high risk of bias. Of the remaining trials, six evaluated problem-solving therapy (PST, five evaluated other forms of cognitive behavioural therapy (CBT, and three evaluated life review/reminiscence therapy. In frail elderly with depressive symptoms, the evidence supported the efficacy of PST, with large but heterogeneous effect sizes compared with treatment as usual. The results for life-review/reminiscence therapy and CBT were also promising, but because of the limited number of trials the quality of evidence was rated as very low. Safety data were not reported in any included trial. The only identified cost-effectiveness study estimated an incremental cost per additional point reduction in Beck Depression Inventory II score for CBT compared with talking control and treatment as usual.Psychological treatment is a feasible option for frail elderly with depressive symptoms. However, important questions

Internet-Based Acceptance and Commitment Therapy for Psychological Distress Experienced by People With Hearing Problems: Study Protocol for a Randomized Controlled Trial.

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Molander, Peter; Hesser, Hugo; Weineland, Sandra; Bergwall, Kajsa; Buck, Sonia; Hansson-Malmlöf, Johan; Lantz, Henning; Lunner, Thomas; Andersson, Gerhard

2015-09-01

Psychological distress and psychiatric symptoms are prevalent among people with hearing loss or other audiological conditions, but psychological interventions for these groups are rare. This article describes the study protocol for a randomized controlled trial for evaluating the effect of a psychological treatment delivered over the Internet for individuals with hearing problems and concurrent psychological distress. Participants who are significantly distressed will be randomized to either an 8-week Internet-delivered acceptance-based cognitive behavioral therapy (i.e., acceptance and commitment therapy [ACT]), or wa it-list control. We aim to include measures of distress associated with hearing difficulties, anxiety, and depression. In addition, we aim to measure acceptance associated with hearing difficulties as well as quality of life. The results of the trial may further our understanding of how to best treat people who present problems with both psychological distress and hearing in using the Internet.

Psychological treatments in intellectual disability: the challenges of building a good evidence base.

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Bhaumik, Sabyasachi; Gangadharan, Satheesh; Hiremath, Avinash; Russell, Paul Swamidhas Sudhakar

2011-06-01

Psychological treatments are widely used for the management of mental health and behavioural problems in people with intellectual disabilities. The evidence base, including the cost-effectiveness of such interventions, is limited. This editorial explores the current evidence base and analyses its strengths and limitations. The editorial also highlights current problems in conducting randomised controlled trials in this area and suggests a way forward.

Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial

OpenAIRE

Till Beiwinkel; Stefan Hey; Olaf Bock; Wulf Rössler; Wulf Rössler; Wulf Rössler

2017-01-01

Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N = 186 smartphone users will be recruited, with an over-sampling of persons...

Treatment of Bulimia Nervosa: Psychological and Psychopharmacologic Considerations.

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Phillips, Elaine L.; Greydanus, Donald E.; Pratt, Helen D.; Patel, Dilip R.

2003-01-01

Reviews the current literature on psychological and psychopharmacologic treatments for bulimia nervosa in the adolescent population. Describes the two most researched psychological treatments--cognitive behavior therapy and interpersonal therapy--in terms of treatment protocols and outcome research. Reviews psychopharmacologic treatment, including…

A randomised controlled trial of time limited CBT informed psychological therapy for anxiety in bipolar disorder.

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Jones, Steven; McGrath, Elly; Hampshire, Kay; Owen, Rebecca; Riste, Lisa; Roberts, Chris; Davies, Linda; Mayes, Debbie

2013-02-15

Anxiety comorbidity is common in bipolar disorder and is associated with worse treatment outcomes, greater risk of self harm, suicide and substance misuse. To date however there have been no psychological interventions specifically designed to address this problem. The primary objective of this trial is to establish the acceptability and feasibility of a new integrated intervention for anxiety in bipolar disorder designed in collaboration with individuals with personal experience of both problems. Single blind randomised controlled trials to assess the feasibility and acceptability of a time limited CBT informed psychological intervention for anxiety in bipolar disorder (AIBD) compared with treatment as usual. Participants will be recruited from across the North West of England from specialist mental health services and through primary care and self referral. The primary outcome of the study is the feasibility and acceptability of AIBD assessed by recruitment to target and retention to follow-up, as well as absence of untoward incidents associated with AIBD. We will also estimate the effect size of the impact of the intervention on anxiety and mood outcomes, as well as calculate preliminary estimates of cost-effectiveness and investigate potential mechanisms for this (stigma, self appraisal and stability of social rhythms). This is the first trial of an integrated intervention for anxiety in bipolar disorder. It is of interest to researchers involved in the development of new therapies for bipolar disorder as well as indicating the wider potential for evaluating approaches to the treatment of comorbidity in severe mental illness.

Efficacy of “Attachment-Based Compassion Therapy” in the Treatment of Fibromyalgia: A Randomized Controlled Trial

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Jesús Montero-Marín

2018-01-01

Full Text Available ObjectiveThere is a growing interest in evaluating the effectiveness of compassion interventions for treating psychological disorders. The present study evaluated the effectiveness of “attachment-based compassion therapy” (ABCT in the treatment of fibromyalgia (FM, and the role of psychological flexibility as a mediator of improvements.MethodsA total of 42 patients with FM were randomly assigned to ABCT or relaxation (active control group. Both the intervention and control condition were combined with treatment as usual (TAU. The primary outcome was functional status (FIQ, and the secondary outcomes were clinical severity (CGI-S, pain catastrophizing (PCS, anxiety (HADS-A, depression (HADS-D, quality of life (EQ-5D, and psychological flexibility (AAQ-II. Differences between the groups were estimated using mixed-effects models, and mediation assessments were conducted using path analyses.ResultsThe ABCT group demonstrated superior outcomes compared to the relaxation group, including better FIQ values after treatment (B = −3.01; p = 0.003. Differences in FIQ were maintained at 3-month follow-up (B = −3.33; p = 0.001. The absolute risk reduction in ABCT compared to relaxation increased by 40.0%, with an NNT = 3 based on criteria of ≥50% FIQ reduction after treatment. Psychological flexibility had a significant mediating effect on improvements.ConclusionThese results suggest that ABCT combined with TAU appears to be effective in the treatment of FM symptoms.Clinical Trial Registrationhttp://ClinicalTrials.gov, identifier NCT02454244.

Improving transparency and reproducibility through registration: The status of intervention trials published in clinical psychology journals.

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Cybulski, Lukasz; Mayo-Wilson, Evan; Grant, Sean

2016-09-01

Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Experiences and psychological distress of fertility treatment and employment.

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Payne, Nicola; Seenan, Susan; van den Akker, Olga

2018-04-16

This study examined experiences and psychological distress about fertility treatment in people combining work and treatment. Five hundred and sixty-three participants in the UK completed an online survey asking about difficulties in combining work and treatment; workplace disclosure, support, absence and policy; and psychological distress about treatment. Absence from work and perceptions that treatment has an impact on work and career prospects were reported by the majority of participants and this was related to the psychological distress of treatment. Around three quarters of participants disclosed to their employer and colleagues. The key reason for disclosure was needing to ask for absence from work and the main reason for non-disclosure was privacy. Workplace policy relating to managing fertility treatment and support from colleagues and their employer was related to reduced psychological distress but workplace policy was reported by less than one quarter of participants. Difficulties experienced in combining work and treatment suggest that support is needed. Specific workplace policy, guidance for supervisors and flexibility in fertility clinic times should help support employees during treatment and reduce psychological distress, thereby potentially influencing physical health and treatment outcomes.

Treatment of depressive disorders in primary care - protocol of a multiple treatment systematic review of randomized controlled trials

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Linde Klaus

2011-11-01

Full Text Available Abstract Background Several systematic reviews have summarized the evidence for specific treatments of primary care patients suffering from depression. However, it is not possible to answer the question how the available treatment options compare with each other as review methods differ. We aim to systematically review and compare the available evidence for the effectiveness of pharmacological, psychological, and combined treatments for patients with depressive disorders in primary care. Methods/Design To be included, studies have to be randomized trials comparing antidepressant medication (tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs, hypericum extracts, other agents and/or psychological therapies (e.g. interpersonal psychotherapy, cognitive therapy, behavioural therapy, short dynamically-oriented psychotherapy with another active therapy, placebo or sham intervention, routine care or no treatment in primary care patients in the acute phase of a depressive episode. Main outcome measure is response after completion of acute phase treatment. Eligible studies will be identified from available systematic reviews, from searches in electronic databases (Medline, Embase and Central, trial registers, and citation tracking. Two reviewers will independently extract study data and assess the risk of bias using the Cochrane Collaboration's corresponding tool. Meta-analyses (random effects model, inverse variance weighting will be performed for direct comparisons of single interventions and for groups of similar interventions (e.g. SSRIs vs. tricyclics and defined time-windows (up to 3 months and above. If possible, a global analysis of the relative effectiveness of treatments will be estimated from all available direct and indirect evidence that is present in a network of treatments and comparisons. Discussion Practitioners do not only want to know whether there is evidence that a specific treatment is more effective than

Comparison of Pharmaceutical, Psychological, and Exercise Treatments for Cancer-Related Fatigue: A Meta-analysis.

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Mustian, Karen M; Alfano, Catherine M; Heckler, Charles; Kleckner, Amber S; Kleckner, Ian R; Leach, Corinne R; Mohr, David; Palesh, Oxana G; Peppone, Luke J; Piper, Barbara F; Scarpato, John; Smith, Tenbroeck; Sprod, Lisa K; Miller, Suzanne M

2017-07-01

Cancer-related fatigue (CRF) remains one of the most prevalent and troublesome adverse events experienced by patients with cancer during and after therapy. To perform a meta-analysis to establish and compare the mean weighted effect sizes (WESs) of the 4 most commonly recommended treatments for CRF-exercise, psychological, combined exercise and psychological, and pharmaceutical-and to identify independent variables associated with treatment effectiveness. PubMed, PsycINFO, CINAHL, EMBASE, and the Cochrane Library were searched from the inception of each database to May 31, 2016. Randomized clinical trials in adults with cancer were selected. Inclusion criteria consisted of CRF severity as an outcome and testing of exercise, psychological, exercise plus psychological, or pharmaceutical interventions. Studies were independently reviewed by 12 raters in 3 groups using a systematic and blinded process for reconciling disagreement. Effect sizes (Cohen d) were calculated and inversely weighted by SE. Severity of CRF was the primary outcome. Study quality was assessed using a modified 12-item version of the Physiotherapy Evidence-Based Database scale (range, 0-12, with 12 indicating best quality). From 17 033 references, 113 unique studies articles (11 525 unique participants; 78% female; mean age, 54 [range, 35-72] years) published from January 1, 1999, through May 31, 2016, had sufficient data. Studies were of good quality (mean Physiotherapy Evidence-Based Database scale score, 8.2; range, 5-12) with no evidence of publication bias. Exercise (WES, 0.30; 95% CI, 0.25-0.36; P psychological (WES, 0.27; 95% CI, 0.21-0.33; P psychological interventions (WES, 0.26; 95% CI, 0.13-0.38; P psychological mode, type of control condition, use of intention-to-treat analysis, and fatigue measures (WES range, -0.91 to 0.99). Results suggest that the effectiveness of behavioral interventions, specifically exercise and psychological interventions, is not attributable to

An open trial of individualized face-to-face cognitive behavior therapy for psychological distress in parents of children after end of treatment for childhood cancer including a cognitive behavioral conceptualization

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Lisa Ljungman

2018-04-01

Full Text Available Objective A subgroup of parents of children who have been treated for childhood cancer report high levels of psychological distress. To date there is no empirically supported psychological treatment targeting cancer-related psychological distress in this population. The aim of the current study was to test the feasibility and preliminarily evaluate the effect of individualized face-to-face cognitive behavior therapy (CBT for parents of children after the end of treatment for childhood cancer. A secondary aim was to present a cognitive behavioral conceptualization of cancer-related distress for these parents. Methods An open trial was conducted where 15 parents of children who had completed successful treatment for cancer three months to five years earlier and who reported psychological distress related to a child’s previous cancer disease were provided CBT at a maximum of 15 sessions. Participants were assessed at baseline, post-intervention, and three-month follow-up using self-reported psychological distress (including posttraumatic stress symptoms (PTSS, depression, and anxiety and the diagnostic Mini-International Neuropsychiatric Interview. Feasibility outcomes relating to recruitment, data collection, and delivery of the treatment were also examined. Individual case formulations for each participant guided the intervention and these were aggregated and presented in a conceptualization detailing core symptoms and their suggested maintenance mechanisms. Results A total of 93% of the participants completed the treatment and all of them completed the follow-up assessment. From baseline to post-assessment, parents reported significant improvements in PTSS, depression, and anxiety with medium to large effect sizes (Cohen’s d = 0.65–0.92. Results were maintained or improved at a three-month follow-up. At baseline, seven (47% participants fulfilled the diagnostic criteria for major depressive disorder and four (29% fulfilled the criteria for

An open trial of individualized face-to-face cognitive behavior therapy for psychological distress in parents of children after end of treatment for childhood cancer including a cognitive behavioral conceptualization.

Science.gov (United States)

Ljungman, Lisa; Cernvall, Martin; Ghaderi, Ata; Ljungman, Gustaf; von Essen, Louise; Ljótsson, Brjánn

2018-01-01

A subgroup of parents of children who have been treated for childhood cancer report high levels of psychological distress. To date there is no empirically supported psychological treatment targeting cancer-related psychological distress in this population. The aim of the current study was to test the feasibility and preliminarily evaluate the effect of individualized face-to-face cognitive behavior therapy (CBT) for parents of children after the end of treatment for childhood cancer. A secondary aim was to present a cognitive behavioral conceptualization of cancer-related distress for these parents. An open trial was conducted where 15 parents of children who had completed successful treatment for cancer three months to five years earlier and who reported psychological distress related to a child's previous cancer disease were provided CBT at a maximum of 15 sessions. Participants were assessed at baseline, post-intervention, and three-month follow-up using self-reported psychological distress (including posttraumatic stress symptoms (PTSS), depression, and anxiety) and the diagnostic Mini-International Neuropsychiatric Interview. Feasibility outcomes relating to recruitment, data collection, and delivery of the treatment were also examined. Individual case formulations for each participant guided the intervention and these were aggregated and presented in a conceptualization detailing core symptoms and their suggested maintenance mechanisms. A total of 93% of the participants completed the treatment and all of them completed the follow-up assessment. From baseline to post-assessment, parents reported significant improvements in PTSS, depression, and anxiety with medium to large effect sizes (Cohen's d = 0.65-0.92). Results were maintained or improved at a three-month follow-up. At baseline, seven (47%) participants fulfilled the diagnostic criteria for major depressive disorder and four (29%) fulfilled the criteria for posttraumatic stress disorder, compared to

Rock climbing and acute emotion regulation in patients with major depressive disorder in the context of a psychological inpatient treatment: a controlled pilot trial

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Kleinstäuber M

2017-08-01

Full Text Available Maria Kleinstäuber,1,2 Merle Reuter,3 Norbert Doll,4 Andreas J Fallgatter4 1Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, Philipps University, Marburg, Germany; 2Department of Psychological Medicine, School of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand; 3Department of Educational Psychology, Faculty of Psychology, Eberhard Karls University, Tübingen, Germany, 4Department of General Psychiatry and Psychotherapy, University Hospital for Psychiatry and Psychotherapy, Eberhard Karls University, Tübingen, Germany Background: Major depressive disorder is characterized by deficits in emotion regulation. This study examined associations between rock climbing and acute emotion regulating effects in patients with major depression. Patients and methods: In a nonrandomized, controlled study, 40 major depressive disorder inpatients were assigned to either a climbing session (n=20 or a relaxation session (n=20. Positive and negative affect, depressiveness, and coping emotions were assessed immediately before and after the session. Results: Mixed analyses of variance and covariance revealed significant time × group interaction effects for all assessed outcomes (p≤0.012: positive affect and coping emotions significantly increased and negative affect and depressiveness significantly decreased after the climbing session (1.04≤ Cohen’s d ≤1.30, in contrast to a relaxation session (0.16≤ Cohen’s d ≤0.36. Conclusion: The results show that rock climbing is associated with acute emotion regulatory effects. These findings have to be replicated with a randomized design, and future research should pay attention to possible mechanisms of rock climbing in regard to emotion regulation. Keywords: physical activity, controlled trial, relaxation, inpatient treatment

An open trial of Acceptance-based Separated Family Treatment (ASFT) for adolescents with anorexia nervosa.

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Timko, C Alix; Zucker, Nancy L; Herbert, James D; Rodriguez, Daniel; Merwin, Rhonda M

2015-06-01

Family based-treatments have the most empirical support in the treatment of adolescent anorexia nervosa; yet, a significant percentage of adolescents and their families do not respond to manualized family based treatment (FBT). The aim of this open trial was to conduct a preliminary evaluation of an innovative family-based approach to the treatment of anorexia: Acceptance-based Separated Family Treatment (ASFT). Treatment was grounded in Acceptance and Commitment Therapy (ACT), delivered in a separated format, and included an ACT-informed skills program. Adolescents (ages 12-18) with anorexia or sub-threshold anorexia and their families received 20 treatment sessions over 24 weeks. Outcome indices included eating disorder symptomatology reported by the parent and adolescent, percentage of expected body weight achieved, and changes in psychological acceptance/avoidance. Half of the adolescents (48.0%) met criteria for full remission at the end of treatment, 29.8% met criteria for partial remission, and 21.3% did not improve. Overall, adolescents had a significant reduction in eating disorder symptoms and reached expected body weight. Treatment resulted in changes in psychological acceptance in the expected direction for both parents and adolescents. This open trial provides preliminary evidence for the feasibility, acceptability, and efficacy of ASFT for adolescents with anorexia. Directions for future research are discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Experiential Virtual Scenarios With Real-Time Monitoring (Interreality) for the Management of Psychological Stress: A Block Randomized Controlled Trial

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Pallavicini, Federica; Morganti, Luca; Serino, Silvia; Scaratti, Chiara; Briguglio, Marilena; Crifaci, Giulia; Vetrano, Noemi; Giulintano, Annunziata; Bernava, Giuseppe; Tartarisco, Gennaro; Pioggia, Giovanni; Raspelli, Simona; Cipresso, Pietro; Vigna, Cinzia; Grassi, Alessandra; Baruffi, Margherita; Wiederhold, Brenda; Riva, Giuseppe

2014-01-01

Background The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care. Among these, an emerging approach is the use of virtual reality (VR) within exposure-based protocols for anxiety disorders, and in particular posttraumatic stress disorder. However, no systematically tested VR protocols are available for the management of psychological stress. Objective Our goal was to evaluate the efficacy of a new technological paradigm, Interreality, for the management and prevention of psychological stress. The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios (fully controlled by the therapist, used to learn coping skills and improve self-efficacy) with real-time monitoring and support (identifying critical situations and assessing clinical change) using advanced technologies (virtual worlds, wearable biosensors, and smartphones). Methods The study was designed as a block randomized controlled trial involving 121 participants recruited from two different worker populations—teachers and nurses—that are highly exposed to psychological stress. Participants were a sample of teachers recruited in Milan (Block 1: n=61) and a sample of nurses recruited in Messina, Italy (Block 2: n=60). Participants within each block were randomly assigned to the (1) Experimental Group (EG): n=40; B1=20, B2=20, which received a 5-week treatment based on the Interreality paradigm; (2) Control Group (CG): n=42; B1=22, B2=20, which received a 5-week traditional stress management training based on cognitive behavioral therapy (CBT); and (3) the Wait-List group (WL): n=39, B1=19, B2=20, which was reassessed and compared with the two other groups 5 weeks after the initial evaluation. Results Although both treatments were able to significantly reduce perceived stress better than WL, only EG participants reported a significant reduction (EG=12% vs CG=0

Pilot of a randomised controlled trial of the selective serotonin reuptake inhibitor sertraline versus cognitive behavioural therapy for anxiety symptoms in people with generalised anxiety disorder who have failed to respond to low-intensity psychological treatments as defined by the National Institute for Health and Care Excellence guidelines.

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Buszewicz, Marta; Cape, John; Serfaty, Marc; Shafran, Roz; Kabir, Thomas; Tyrer, Peter; Clarke, Caroline S; Nazareth, Irwin

2017-08-01

Generalised anxiety disorder (GAD) is common, causing unpleasant symptoms and impaired functioning. The National Institute for Health and Care Excellence (NICE) guidelines have established good evidence for low-intensity psychological interventions, but a significant number of patients will not respond and require more intensive step 3 interventions, recommended as either high-intensity cognitive behavioural therapy (CBT) or a pharmacological treatment such as sertraline. However, there are no head-to-head comparisons evaluating which is more clinically effective and cost-effective, and current guidelines suggest that treatment choice at step 3 is based mainly on patient preference. To assess clinical effectiveness and cost-effectiveness at 12 months of treatment with the selective serotonin reuptake inhibitor (SSRI) sertraline compared with CBT for patients with persistent GAD not improved with NICE-defined low-intensity psychological interventions. Participant randomised trial comparing treatment with sertraline with high-intensity CBT for patients with GAD who had not responded to low-intensity psychological interventions. Community-based recruitment from local Improving Access to Psychological Therapies (IAPT) services. Four pilot services located in urban, suburban and semirural settings. People considered likely to have GAD and not responding to low-intensity psychological interventions identified at review by IAPT psychological well-being practitioners (PWPs). Those scoring ≥ 10 on the Generalised Anxiety Disorder-7 (GAD-7) anxiety measure were asked to consider involvement in the trial. Aged ≥ 18 years, a score of ≥ 10 on the GAD-7, a primary diagnosis of GAD diagnosed on the Mini International Neuropsychiatric Interview questionnaire and failure to respond to NICE-defined low-intensity interventions. Inability to participate because of insufficient English or cognitive impairment, current major depression, comorbid anxiety disorder(s) causing

Psychological therapy for inpatients receiving acute mental health care: A systematic review and meta-analysis of controlled trials.

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Paterson, Charlotte; Karatzias, Thanos; Dickson, Adele; Harper, Sean; Dougall, Nadine; Hutton, Paul

2018-04-16

The effectiveness of psychological therapies for those receiving acute adult mental health inpatient care remains unclear, partly because of the difficulty in conducting randomized controlled trials (RCTs) in this setting. The aim of this meta-analysis was to synthesize evidence from all controlled trials of psychological therapy carried out with this group, to estimate its effects on a number of important outcomes and examine whether the presence of randomization and rater blinding moderated these estimates. A systematic review and meta-analysis of all controlled trials of psychological therapy delivered in acute inpatient settings was conducted, with a focus on psychotic symptoms, readmissions or emotional distress (anxiety and depression). Studies were identified through ASSIA, EMBASE, CINAHL, Cochrane, MEDLINE, and PsycINFO using a combination of the key terms 'inpatient', 'psychological therapy', and 'acute'. No restriction was placed on diagnosis. The moderating effect of the use of assessor-blind RCT methodology was examined via subgroup and sensitivity analyses. Overall, psychological therapy was associated with small-to-moderate improvements in psychotic symptoms at end of therapy but the effect was smaller and not significant at follow-up. Psychological therapy was also associated with reduced readmissions, depression, and anxiety. The use of single-blind randomized controlled trial methodology was associated with significantly reduced benefits on psychotic symptoms and was also associated with reduced benefits on readmission and depression; however, these reductions were not statistically significant. The provision of psychological therapy to acute psychiatric inpatients is associated with improvements; however, the use of single-blind RCT methodology was associated with reduced therapy-attributable improvements. Whether this is a consequence of increased internal validity or reduced external validity is unclear. Trials with both high internal and

Online psycho-education to the treatment of bipolar disorder: protocol of a randomized controlled trial.

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González-Ortega, Itxaso; Ugarte, Amaia; Ruiz de Azúa, Sonia; Núñez, Nuria; Zubia, Marta; Ponce, Sara; Casla, Patricia; Llano, Josu Xabier; Faria, Ángel; González-Pinto, Ana

2016-12-22

Bipolar disorder patients frequently present recurrent episodes and often experience subsyndromal symptoms, cognitive impairment and difficulties in functioning, with a low quality of life, illness relapses and recurrent hospitalization. Early diagnosis and appropriate intervention may play a role in preventing neuroprogression in this disorder. New technologies represent an opportunity to develop standardized psychological treatments using internet-based tools that overcome some of the limitations of face-to-face treatments, in that they are readily accessible and the timing of therapy can be tailored to user needs and availability. However, although many psychological programs are offered through the web and mobile devices for bipolar disorder, there is a lack of high quality evidence concerning their efficacy and effectiveness due to the great variability in measures and methodology used. This clinical trial is a simple-blind randomized trial within a European project to compare an internet-based intervention with treatment as usual. Bipolar disorder patients are to be included and randomly assigned to one of two groups: 1) the experimental group (tele-care support) and 2) the control group. Participants in both groups will be evaluated at baseline (pre-treatment) and post-treatment. This study describes the design of a clinical trial based on psychoeducation intervention that may have a significant impact on both prognosis and treatment in bipolar disorder. Specifically, bringing different services together (service aggregation), it is hoped that the approach proposed will significantly increase the impact of information and communication technologies on access and adherence to treatment, quality of the service, patient safety, patient and professional satisfaction, and quality of life of patients. NCT02924415 . Retrospectively registered 27 September 2016.

An online psychological intervention can improve the sexual satisfaction of men following treatment for localized prostate cancer: outcomes of a Randomised Controlled Trial evaluating My Road Ahead.

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Wootten, Addie C; Meyer, Denny; Abbott, Jo-Anne M; Chisholm, Katherine; Austin, David W; Klein, Britt; McCabe, Marita; Murphy, Declan G; Costello, Anthony J

2017-07-01

Prostate cancer treatment often results in significant psycho-sexual challenges for men following treatment; however, many men report difficulty in accessing appropriate care. A randomized controlled trial was undertaken to assess the efficacy of a 10-week self-guided online psychological intervention called My Road Ahead (MRA) for men with localized prostate cancer in improving sexual satisfaction. Participants were randomized to 1 of 3 conditions MRA alone or MRA plus online forum, or forum access alone. Pre, post, and follow-up assessments of overall sexual satisfaction were conducted. Mixed models and structural equation modeling were used to analyze the data. One hundred forty-two men (mean age 61 y; SD = 7) participated. The majority of participants had undergone radical prostatectomy (88%) and all men had received treatment for localized prostate cancer. Significant differences were obtained for the 3 groups (P = .026) and a significant improvement in total sexual satisfaction was observed only for participants who were allocated to MRA + forum with a large effect size (P = .004, partial η 2  = 0.256). Structural equation modeling indicated that increases in sexual function, masculine self-esteem, and sexual confidence contributed significantly to overall sexual satisfaction for the MRA + forum plus forum condition. This study is the first, to our knowledge, that has evaluated a self-guided online psychological intervention tailored to the specific needs of men with prostate cancer. The findings indicate the potential for MRA to deliver support that men may not otherwise receive and also highlight the importance of psychological intervention to facilitate improved sexual outcomes. Copyright © 2016 John Wiley & Sons, Ltd.

The effects of psychological interventions on wound healing: A systematic review of randomized trials.

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Robinson, Hayley; Norton, Sam; Jarrett, Paul; Broadbent, Elizabeth

2017-11-01

Psychological stress has been shown to delay wound healing. Several trials have investigated whether psychological interventions can improve wound healing, but to date, this evidence base has not been systematically synthesized. The objective was to conduct a systematic review of randomized controlled trials in humans investigating whether psychological interventions can enhance wound healing. A systematic review was performed using PsychINFO, CINAHL, Web of Science, and MEDLINE. The searches included all papers published in English up until September 2016. The reference lists of relevant papers were screened manually to identify further review articles or relevant studies. Nineteen studies met inclusion criteria and were included in the review. Fifteen of nineteen studies were of high methodological quality. Six studies were conducted with acute experimentally created wounds, five studies with surgical patients, two studies with burn wounds, two studies with fracture wounds, and four studies were conducted with ulcer wounds. Post-intervention standardized mean differences (SMD) between groups across all intervention types ranged from 0.13 to 3.21, favouring improved healing, particularly for surgical patients and for relaxation interventions. However, there was some evidence for publication bias suggesting negative studies may not have been reported. Due to the heterogeneity of wound types, population types, and intervention types, it is difficult to pool effect sizes across studies. Current evidence suggests that psychological interventions may aid wound healing. Although promising, more research is needed to assess the efficacy of each intervention on different wound types. Statement of contribution What is already known on this subject? Psychological stress negatively affects wound healing. A number of studies have investigated whether psychological interventions can improve healing. However, no systematic reviews have been conducted. What does this study add

An integrated intervention to reduce intimate partner violence and psychological distress with refugees in low-resource settings: study protocol for the Nguvu cluster randomized trial.

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Tol, Wietse A; Greene, M Claire; Likindikoki, Samuel; Misinzo, Lusia; Ventevogel, Peter; Bonz, Ann G; Bass, Judith K; Mbwambo, Jessie K K

2017-05-18

Intimate partner violence (IPV) is a critical public health and human rights concern globally, including for refugee women in low-resource settings. Little is known about effective interventions for this population. IPV and psychological distress have a bi-directional relationship, indicating the potential benefit of a structured psychological component as part of efforts to reduce IPV for women currently in violent relationships. This protocol describes a cluster randomized controlled trial aimed at evaluating an 8-session integrated psychological and advocacy intervention (Nguvu) with female adult survivors of past-year IPV displaying moderate to severe psychological distress. Outcomes are reductions in: recurrence of IPV; symptoms of anxiety, depression and post-traumatic stress (primary); and functional impairment (secondary). Hypothesized mediators of the intervention are improvements in social support, coping skills and support seeking. We will recruit 400 participants from existing women's support groups operating within villages in Nyarugusu refugee camp, Tanzania. Women's groups will be randomized to receive the intervention (Nguvu and usual care) or usual care alone. All eligible women will complete a baseline assessment (week 0) followed by a post-treatment (week 9) and a 3-month post-treatment assessment (week 20). The efficacy of the intervention will be determined by between-group differences in the longitudinal trajectories of primary outcomes evaluated using mixed-effects models. Study procedures have been approved by Institutional Review Boards in the United States and Tanzania. This trial will provide evidence on the efficacy of a novel integrated group intervention aimed at secondary prevention of IPV that includes a structured psychological component to address psychological distress. The psychological and advocacy components of the proposed intervention have been shown to be efficacious for their respective outcomes when delivered in

[Analysis of psychological conditions of parents of children with cleft lip and palate by using psychological scales before and after psychological treatment].

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Gong, Cai-xia; Zheng, Qian; Shi, Bing

2011-02-01

To evaluate the psychological conditions of parents of children with cleft lip and palate, and to discuss the clinical psychological treatment methods of these parents. 100 parents of children with cleft lip and palate were selected as the parents of children with cleft lip and palate group, and 34 normal adults were selected as the control group. Two groups were tested by the life event scale (LES) and self-rating anxiety scale (SAS) to analyze their psychological states. After the study group was treated by psychological counseling, two groups were tested by the LES and SAS again. The LES total scores of the patients of children with cleft lip and palate had significant differences compared with the normal adults (P palate had no significant differences compared with the normal adults before and after psychological counseling (P > 0.05). Analyzing the psychological conditions of parents of children with cleft lip and palate by using psychological scales and then treating them by counseling, is an effective psychological treatment method.

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

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Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

2015-01-01

Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

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Marleine Azar

Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

Treatment of depressed mothers in home visiting: impact on psychological distress and social functioning.

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Ammerman, Robert T; Putnam, Frank W; Altaye, Mekibib; Teeters, Angelique R; Stevens, Jack; Van Ginkel, Judith B

2013-08-01

Depression is prevalent in mothers receiving home visiting. Little is known about the impact of treatment on associated features of maternal depression in this population. The purpose of this study was to examine the impact of a novel, adapted treatment for depressed mothers in home visiting on psychological distress and social functioning. In-Home Cognitive Behavioral Therapy (IH-CBT) was developed to treat depressed mothers in home visiting. A randomized clinical trial design was used in which subjects were 93 new mothers in a home visiting program. Mothers with major depressive disorder identified at 3 months postpartum were randomized into IH-CBT and ongoing home visiting (n = 47) or standard home visiting (SHV; n = 46) in which they received home visitation alone and could obtain treatment in the community. Measures of psychological distress, social support, and social network were measured at pre-treatment, post-treatment, and three-month follow-up. Clinical features of depression and home visiting parameters were examined as potential moderators. Subjects receiving IH-CBT reported decreased psychological distress at post-treatment (ES = 0.77) and follow-up (ES = 0.73). Examination of types of psychological distress indicated broad improvements at both time points. Those receiving IH-CBT reported increased social support over time relative to those in the SHV condition. Effect sizes were modest at post-treatment (ES = 0.38) but increased at follow-up (ES = 0.65). Improvements were seen in affiliative and belonginess aspects of social support, in contrast to tangible support which was statistically non-significant. Findings were not moderated by clinical features of depression or home visiting parameters. No group differences were found in size of and involvement with social networks. IH-CBT is effective in reducing psychological distress and improving perceived social support in depressed mothers receiving home visiting. To the extent that mothers are better

Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial

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Tulbure Bogdan Tudor

2012-10-01

Full Text Available Abstract Background Social anxiety disorder (SAD is one of the most common anxiety disorders and is associated with marked impairments. However, a small proportion of individuals with SAD seek and receive treatment. Internet-administrated cognitive behavior therapy (iCBT has been found to be an effective treatment for SAD. This trial will be the first Internet-delivered guided self-help intervention for SAD in Romania. Methods Participants with social anxiety disorder (N = 96 will be recruited via newspapers, online banners and Facebook. Participants will be randomized to either: a an active treatment, or b a waiting list control group. The treatment will have a guided iCBT format and will last for nine weeks. Self-report questionnaires on social phobia, anxiety, depression, treatment credibility and irrational thinking will be used. All assessments will be collected pre, post and at follow-up (six months after intervention. Liebowitz Social Anxiety Scale – Self-Report version (LSAS-SR will be the primary outcome measure and will be administrated on a weekly basis in both conditions. Discussion The present randomized controlled trial investigates the efficacy of an Internet-administered intervention in reducing social anxiety symptoms in a culture where this form of treatment has not been tested. This trial will add to the body of knowledge on the efficacy of iCBT, and the results might lead to an increase of the accessibility of evidence-based psychological treatment in Romania. Trial registration ClinicalTrials.gov: NCT01557894

Psychological issues in the evaluation and treatment of tension-type headache.

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Rosen, Noah L

2012-12-01

Tension-type headache is the most common headache disorder, affecting approximately 40 % of Americans within a one-year span. Although the most common form, episodic tension-type headache, is rarely impairing, more frequent tension-type headache can occur with significant disability and psychological comorbidity. Appreciating the psychological impact, assessing the associated biopsychosocial issues, and understanding patients' coping styles are important in forming an appropriate treatment plan and maximizing treatment outcomes. A range of psychological therapies including relaxation training, cognitive behavioral therapy, biofeedback and mindfulness have demonstrated utility in treating chronic pain conditions and reducing the associated disability. This may be particularly applicable to special populations, including pediatric patients, pregnant patients and geriatric. Psychological assessment and treatment may be done conjointly with medication management and expands treatment options. There is great need to continue researching the effects of psychological treatments, standardizing interventions and making them available to the wider population.

Psychological therapies for children and adolescents exposed to trauma.

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Gillies, Donna; Maiocchi, Licia; Bhandari, Abhishta P; Taylor, Fiona; Gray, Carl; O'Brien, Louise

2016-10-11

Children and adolescents who have experienced trauma are at high risk of developing post-traumatic stress disorder (PTSD) and other negative emotional, behavioural and mental health outcomes, all of which are associated with high personal and health costs. A wide range of psychological treatments are used to prevent negative outcomes associated with trauma in children and adolescents. To assess the effects of psychological therapies in preventing PTSD and associated negative emotional, behavioural and mental health outcomes in children and adolescents who have undergone a traumatic event. We searched the Cochrane Common Mental Disorders Group's Specialised Register to 29 May 2015. This register contains reports of relevant randomised controlled trials from The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). We also checked reference lists of relevant studies and reviews. We did not restrict the searches by date, language or publication status. All randomised controlled trials of psychological therapies compared with a control such as treatment as usual, waiting list or no treatment, pharmacological therapy or other treatments in children or adolescents who had undergone a traumatic event. Two members of the review group independently extracted data. We calculated odds ratios for binary outcomes and standardised mean differences for continuous outcomes using a random-effects model. We analysed data as short-term (up to and including one month after therapy), medium-term (one month to one year after therapy) and long-term (one year or longer). Investigators included 6201 participants in the 51 included trials. Twenty studies included only children, two included only preschool children and ten only adolescents; all others included both children and adolescents. Participants were exposed to sexual abuse in 12 trials, to war or community violence in ten, to physical trauma and natural disaster in six each and to

Barriers to Implementing Treatment Integrity Procedures in School Psychology Research: Survey of Treatment Outcome Researchers

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Sanetti, Lisa M. Hagermoser; DiGennaro Reed, Florence D.

2012-01-01

Treatment integrity data are essential to drawing valid conclusions in treatment outcome studies. Such data, however, are not always included in peer-reviewed research articles in school psychology or related fields. To gain a better understanding of why treatment integrity data are lacking in the school psychology research, we surveyed the…

Adolescents’ Pain Coping Profiles: Expectations for Treatment, Functional Outcomes and Adherence to Psychological Treatment Recommendations

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Robyn Lewis Claar

2011-01-01

Full Text Available OBJECTIVES: To explore how adolescents’ pain coping profiles relate to their expectations regarding psychological treatment recommendations, and to examine patients’ functioning and engagement in psychological treatment three months following a multidisciplinary pain clinic evaluation.

Psychological distress and its effect on tuberculosis treatment outcomes in Ethiopia

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Habteyes Hailu Tola

2015-11-01

Full Text Available Background: Psychological distress is the major comorbidity among tuberculosis (TB patients. However, its magnitude, associated factors, and effect on treatment outcome have not been adequately studied in low-income countries. Objective: This study aimed to determine the magnitude of psychological distress and its effect on treatment outcome among TB patients on treatment. Design: A follow-up study was conducted in Addis Ababa, Ethiopia, from May to December 2014. Patients (N=330 diagnosed with all types of TB who had been on treatment for 1–2 months were enrolled consecutively from 15 randomly selected health centers and one TB specialized hospital. Data on sociodemographic variables and economic status were collected using a structured questionnaire. The presence of psychological distress was assessed at baseline (within 1–2 months after treatment initiation and end point (6 months after treatment initiation using the 10-item Kessler (K-10 scale. Alcohol use and tobacco smoking history were assessed using WHO Alcohol Use Disorder Identification Test and Australian Smoking Assessment Checklist, respectively. The current WHO TB treatment outcome definition was used to differentiate the end result of each patient at completion of the treatment. Results: The overall psychological distress was 67.6% at 1–2 months and 48.5% at 6 months after treatment initiation. Multiple logistic regression analysis revealed that past TB treatment history [adjusted odds ratio (AOR: 3.76; 95% confidence interval (CI: 1.67–8.45], being on anti-TB and anti-HIV treatments (AOR: 5.35; 95% CI: 1.83–15.65, being unmarried (AOR: 4.29; 95% CI: 2.45–7.53, having alcohol use disorder (AOR: 2.95; 95% CI: 1.25–6.99, and having low economic status (AOR: 4.41; 95% CI: 2.44–7.97 were significantly associated with psychological distress at baseline. However, at 6 months after treatment initiation, only being a multidrug-resistant tuberculosis (MDR-TB patient (AOR: 3

Effect of antidepressants and psychological therapies, including hypnotherapy, in irritable bowel syndrome: systematic review and meta-analysis.

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Ford, Alexander C; Quigley, Eamonn M M; Lacy, Brian E; Lembo, Anthony J; Saito, Yuri A; Schiller, Lawrence R; Soffer, Edy E; Spiegel, Brennan M R; Moayyedi, Paul

2014-09-01

Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder. Evidence relating to the treatment of this condition with antidepressants and psychological therapies continues to accumulate. We performed an updated systematic review and meta-analysis of randomized controlled trials (RCTs). MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were searched (up to December 2013). Trials recruiting adults with IBS, which compared antidepressants with placebo, or psychological therapies with control therapy or "usual management," were eligible. Dichotomous symptom data were pooled to obtain a relative risk (RR) of remaining symptomatic after therapy, with a 95% confidence interval (CI). The search strategy identified 3,788 citations. Forty-eight RCTs were eligible for inclusion: thirty-one compared psychological therapies with control therapy or "usual management," sixteen compared antidepressants with placebo, and one compared both psychological therapy and antidepressants with placebo. Ten of the trials of psychological therapies, and four of the RCTs of antidepressants, had been published since our previous meta-analysis. The RR of IBS symptom not improving with antidepressants vs. placebo was 0.67 (95% CI=0.58-0.77), with similar treatment effects for both tricyclic antidepressants and selective serotonin reuptake inhibitors. The RR of symptoms not improving with psychological therapies was 0.68 (95% CI=0.61-0.76). Cognitive behavioral therapy, hypnotherapy, multicomponent psychological therapy, and dynamic psychotherapy were all beneficial. Antidepressants and some psychological therapies are effective treatments for IBS. Despite the considerable number of studies published in the intervening 5 years since we last examined this issue, the overall summary estimates of treatment effect have remained remarkably stable.

Internet-delivered psychological treatments for mood and anxiety disorders: a systematic review of their efficacy, safety, and cost-effectiveness.

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Filip K Arnberg

Full Text Available Greater access to evidence-based psychological treatments is needed. This review aimed to evaluate whether internet-delivered psychological treatments for mood and anxiety disorders are efficacious, noninferior to established treatments, safe, and cost-effective for children, adolescents and adults.We searched the literature for studies published until March 2013. Randomized controlled trials (RCTs were considered for the assessment of short-term efficacy and safety and were pooled in meta-analyses. Other designs were also considered for long-term effect and cost-effectiveness. Comparisons against established treatments were evaluated for noninferiority. Two reviewers independently assessed the relevant studies for risk of bias. The quality of the evidence was graded using an international grading system.A total of 52 relevant RCTs were identified whereof 12 were excluded due to high risk of bias. Five cost-effectiveness studies were identified and three were excluded due to high risk of bias. The included trials mainly evaluated internet-delivered cognitive behavioral therapy (I-CBT against a waiting list in adult volunteers and 88% were conducted in Sweden or Australia. One trial involved children. For adults, the quality of evidence was graded as moderate for the short-term efficacy of I-CBT vs. waiting list for mild/moderate depression (d = 0.83; 95% CI 0.59, 1.07 and social phobia (d = 0.85; 95% CI 0.66, 1.05, and moderate for no efficacy of internet-delivered attention bias modification vs. sham treatment for social phobia (d =  -0.04; 95% CI -0.24, 0.35. The quality of evidence was graded as low/very low for other disorders, interventions, children/adolescents, noninferiority, adverse events, and cost-effectiveness.I-CBT is a viable treatment option for adults with depression and some anxiety disorders who request this treatment modality. Important questions remain before broad implementation can be supported. Future research would

A Randomized Controlled Trial of Tong Len Meditation Practice in Cancer Patients: Evaluation of a Distant Psychological Healing Effect.

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Pagliaro, Gioacchino; Pandolfi, Paolo; Collina, Natalina; Frezza, Giovanni; Brandes, Alba; Galli, Margherita; Avventuroso, Federica Marzocchi; De Lisio, Sara; Musti, Muriel Assunta; Franceschi, Enrico; Esposti, Roberta Degli; Lombardo, Laura; Cavallo, Giovanna; Di Battista, Monica; Rimondini, Simonetta; Poggi, Rosalba; Susini, Cinzia; Renzi, Rina; Marconi, Linda

2016-01-01

Tong Len meditation is an important therapeutic tool in the Tibetan medicine, and it can be used for self-healing and/or to heal others. Currently, in the West, there is no scientific study concerning the efficacy of a Tong Len distant healing effect on psychological disorders in cancer patients. To evaluate a distant healing effect of Tong Len meditation on stress, anxiety, depression, fatigue, and self-perceived quality of life in cancer patients. These psychological objectives were chosen as a consequence of the limited scientific literature of present day. We performed a double-blind randomized controlled trial on 103 cancer patients with tumors. Overall, 12 meditators used Tong Len in aid of 52 patients randomly selected as experimental group, while the remaining 51 patients constituted the control group. Patients and meditators did not know each other. All patients completed profile of mood states (POMS) and European Quality of Life-5 dimensions (EQ-5D) questionnaires before treatment (T0), after two (T1) and three months of treatment (T2), and one month after treatment cessation (T3). With regard to the parameters related to depression, a statistically significant improvement (P = .003) was observed in the treatment group compared to controls. On the other hand, the vigor/activity parameter saw significant improvements in the control group (P = .009). Both groups exhibited significant improvements in the other factors assessed in the POMS and EQ-5D questionnaires. This study did not provide sufficient evidence supporting an efficacy of Tong Len meditation in distant psychological healing as compared to a control condition. The research highlighted some psychological improvements through Tong Len distant meditation in a group of patients unknown to meditators. Therefore, the enhancement detected in most parameters in both treatment and control groups raises interest on in-depth analysis and evaluation of distant meditation on cancer patients to mitigate

Mindfulness-Based Cognitive Therapy as a Treatment for Chronic Tinnitus: A Randomized Controlled Trial

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McKenna, L.; Marks, E. M.; Hallsworth, C. A.; Schaette, R.

2017-01-01

BACKGROUND: Tinnitus is experienced by up to 15% of the population and can lead to significant disability and distress. There is rarely a medical or surgical target and psychological therapies are recommended. We investigated whether mindfulness-based cognitive therapy (MBCT) could offer an effective new therapy for tinnitus. METHODS: This single-site randomized controlled trial compared MBCT to intensive relaxation training (RT) for chronic, distressing tinnitus in adults. Both treatments in...

Practitioner Review: Psychological treatments for children and adolescents with conduct disorder problems - a systematic review and meta-analysis.

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Bakker, M J; Greven, C U; Buitelaar, J K; Glennon, J C

2017-01-01

This meta-analysis evaluates the efficacy of nonpharmacological treatments for conduct disorder (CD) problems in children and adolescents, based on child, parent and teacher report. PubMed, PsycINFO and EMBASE were searched for peer-reviewed articles published between January 1970 and March 2015. Main inclusion criteria were nonpharmacological treatment, participants younger than 18 years, clinical CD problems/diagnosis, randomized controlled trials and inclusion of at least one CD problem-related outcome. Treatment efficacy is expressed in effect sizes (ESs) calculated for each rater (parent, teacher, self and blinded observer). Of 1,549 articles retrieved, 17 (published between June 2004 and January 2014) describing 19 interventions met the inclusion criteria. All studies used psychological treatments; only three studies included a blinded observer to rate CD problems. Most studies were of very poor to fair quality. ESs were significant but small for parent-reported outcomes (0.36, 95% CI = 0.27-0.47), teacher-reported outcomes (0.26, 95% CI = 0.12-0.49) and blinded observer outcomes (0.26, 95% CI = 0.06-0.47), and they were nonsignificant for self-reported outcomes (-0.01, 95% CI = -0.25 to 0.23). Comorbidity, gender, age, number of sessions, duration, intervention type, setting, medication use or dropout percentage did not influence the effect of treatment. Psychological treatments have a small effect in reducing parent-, teacher- and observer-rated CD problems in children and adolescents with clinical CD problems/diagnosis. There is not enough evidence to support one specific psychological treatment over another. Future studies should investigate the influence of participant characteristics (e.g. age of CD onset), use more homogeneous outcome measures and allow better evaluation of study quality. Many reports failed to provide detailed information to allow optimization of psychological treatment strategies. © 2016 Association for Child and Adolescent

Psychological background of prevention and treatment in geriatrics

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Nazarov M.l.

2015-03-01

Full Text Available Confidentiality as the component of an interpersonal "patient — medical practitioner" contact formation can be considered as a corner stone of geriatric practice. Major psychological pitfalls of geriatric practice have been reviewed. The main issue of the paper is psychological substantiation of treatment and prevention of elderly.

Experiential virtual scenarios with real-time monitoring (interreality) for the management of psychological stress: a block randomized controlled trial.

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Gaggioli, Andrea; Pallavicini, Federica; Morganti, Luca; Serino, Silvia; Scaratti, Chiara; Briguglio, Marilena; Crifaci, Giulia; Vetrano, Noemi; Giulintano, Annunziata; Bernava, Giuseppe; Tartarisco, Gennaro; Pioggia, Giovanni; Raspelli, Simona; Cipresso, Pietro; Vigna, Cinzia; Grassi, Alessandra; Baruffi, Margherita; Wiederhold, Brenda; Riva, Giuseppe

2014-07-08

The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care. Among these, an emerging approach is the use of virtual reality (VR) within exposure-based protocols for anxiety disorders, and in particular posttraumatic stress disorder. However, no systematically tested VR protocols are available for the management of psychological stress. Our goal was to evaluate the efficacy of a new technological paradigm, Interreality, for the management and prevention of psychological stress. The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios (fully controlled by the therapist, used to learn coping skills and improve self-efficacy) with real-time monitoring and support (identifying critical situations and assessing clinical change) using advanced technologies (virtual worlds, wearable biosensors, and smartphones). The study was designed as a block randomized controlled trial involving 121 participants recruited from two different worker populations-teachers and nurses-that are highly exposed to psychological stress. Participants were a sample of teachers recruited in Milan (Block 1: n=61) and a sample of nurses recruited in Messina, Italy (Block 2: n=60). Participants within each block were randomly assigned to the (1) Experimental Group (EG): n=40; B1=20, B2=20, which received a 5-week treatment based on the Interreality paradigm; (2) Control Group (CG): n=42; B1=22, B2=20, which received a 5-week traditional stress management training based on cognitive behavioral therapy (CBT); and (3) the Wait-List group (WL): n=39, B1=19, B2=20, which was reassessed and compared with the two other groups 5 weeks after the initial evaluation. Although both treatments were able to significantly reduce perceived stress better than WL, only EG participants reported a significant reduction (EG=12% vs. CG=0.5%) in chronic "trait" anxiety. A similar

Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials.

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Melin, Eva O; Svensson, Ralph; Gustavsson, Sven-Åke; Winberg, Agneta; Denward-Olah, Ewa; Landin-Olsson, Mona; Thulesius, Hans O

2016-04-27

Depression is linked with alexithymia, anxiety, high HbA1c concentrations, disturbances of cortisol secretion, increased prevalence of diabetes complications and all-cause mortality. The psycho-educational method 'affect school with script analysis' and the mind-body therapy 'basic body awareness treatment' will be trialled in patients with diabetes, high HbA1c concentrations and psychological symptoms. The primary outcome measure is change in symptoms of depression. Secondary outcome measures are changes in HbA1c concentrations, midnight salivary cortisol concentration, symptoms of alexithymia, anxiety, self-image measures, use of antidepressants, incidence of diabetes complications and mortality. Two studies will be performed. Study I is an open-labeled parallel-group study with a two-arm randomized controlled trial design. Patients are randomized to either affect school with script analysis or to basic body awareness treatment. According to power calculations, 64 persons are required in each intervention arm at the last follow-up session. Patients with type 1 or type 2 diabetes were recruited from one hospital diabetes outpatient clinic in 2009. The trial will be completed in 2016. Study II is a multicentre open-labeled parallel-group three-arm randomized controlled trial. Patients will be randomized to affect school with script analysis, to basic body awareness treatment, or to treatment as usual. Power calculations show that 70 persons are required in each arm at the last follow-up session. Patients with type 2 diabetes will be recruited from primary care. This study will start in 2016 and finish in 2023. For both studies, the inclusion criteria are: HbA1c concentration ≥62.5 mmol/mol; depression, alexithymia, anxiety or a negative self-image; age 18-59 years; and diabetes duration ≥1 year. The exclusion criteria are pregnancy, severe comorbidities, cognitive deficiencies or inadequate Swedish. Depression, anxiety, alexithymia and self-image are assessed

[Effects of group psychological counseling on self-confidence and social adaptation of burn patients].

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Dang, Rui; Wang, Yishen; Li, Na; He, Ting; Shi, Mengna; Liang, Yanyan; Zhu, Chan; Zhou, Yongbo; Qi, Zongshi; Hu, Dahai

2014-12-01

To explore the effects of group psychological counseling on the self-confidence and social adaptation of burn patients during the course of rehabilitation. Sixty-four burn patients conforming to the inclusion criteria and hospitalized from January 2012 to January 2014 in Xijing Hospital were divided into trial group and control group according to the method of rehabilitation, with 32 cases in each group. Patients in the two groups were given ordinary rehabilitation training for 8 weeks, and the patients in trial group were given a course of group psychological counseling in addition. The Rosenberg's Self-Esteem Scale was used to evaluate the changes in self-confidence levels, and the number of patients with inferiority complex, normal feeling, self-confidence, and over self-confidence were counted before and after treatment. The Abbreviated Burn-Specific Health Scale was used to evaluate physical function, psychological function, social relationship, health condition, and general condition before and after treatment to evaluate the social adaptation of patients. Data were processed with t test, chi-square test, Mann-Whitney U test, and Wilcoxon test. (1) After treatment, the self-confidence levels of patients in trial group were significantly higher than those in control group (Z = -2.573, P 0.05). (2) After treatment, the scores of psychological function, social relationship, health condition, and general condition were (87 ± 3), (47.8 ± 3.6), (49 ± 3), and (239 ± 10) points in trial group, which were significantly higher than those in control group [(79 ± 4), (38.3 ± 5.6), (46 ± 4), and (231 ± 9) points, with t values respectively -8.635, -8.125, -3.352, -3.609, P values below 0.01]. After treatment, the scores of physical function, psychological function, social relationship, health condition, and general condition in trial group were significantly higher than those before treatment (with t values from -33.282 to -19.515, P values below 0.05). The scores

Psychological aspects of male fertility treatment.

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Mikkelsen, Alice Toft; Madsen, Svend Aage; Humaidan, Peter

2013-09-01

To explore and to identify the possible need for psychological communicative support in men undergoing fertility treatment. Male infertility affects many aspects of a man's life and may cause a life crisis. Although infertility treatment is now commonplace in men, they often feel remote and disconnected from the treatment process. A descriptive survey. A questionnaire with structured and open-ended questions was completed by 210 Danish men undergoing fertility treatment. The questionnaire covered three issues: individual perception of male infertility, gender equality issues, and communication with health professionals in the clinic. Data were collected during 2008. Of the participants, 28% believed that their reduced sperm quality affected their perception of masculinity. 46% stated that equal involvement between partners was a very important element of the treatment; however, 63% said that the health professionals communicated primarily with their female partner. Finally, 62% found that there was a need for a deeper dialogue with the nurses concerning male infertility and 72% lacked information about the psychological consequences of male infertility. In general, participants wanted a more open and balanced dialogue about infertility treatment and the role of the male partner during this process. Infertile men want health professionals to view them on equal terms with their partner. When treating the infertile man, there is a further need to develop more inclusive communication skills. © 2012 Blackwell Publishing Ltd.

Mediation and moderation of treatment effects in randomised controlled trials of complex interventions.

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Emsley, Richard; Dunn, Graham; White, Ian R

2010-06-01

Complex intervention trials should be able to answer both pragmatic and explanatory questions in order to test the theories motivating the intervention and help understand the underlying nature of the clinical problem being tested. Key to this is the estimation of direct effects of treatment and indirect effects acting through intermediate variables which are measured post-randomisation. Using psychological treatment trials as an example of complex interventions, we review statistical methods which crucially evaluate both direct and indirect effects in the presence of hidden confounding between mediator and outcome. We review the historical literature on mediation and moderation of treatment effects. We introduce two methods from within the existing causal inference literature, principal stratification and structural mean models, and demonstrate how these can be applied in a mediation context before discussing approaches and assumptions necessary for attaining identifiability of key parameters of the basic causal model. Assuming that there is modification by baseline covariates of the effect of treatment (i.e. randomisation) on the mediator (i.e. covariate by treatment interactions), but no direct effect on the outcome of these treatment by covariate interactions leads to the use of instrumental variable methods. We describe how moderation can occur through post-randomisation variables, and extend the principal stratification approach to multiple group methods with explanatory models nested within the principal strata. We illustrate the new methodology with motivating examples of randomised trials from the mental health literature.

A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial

Directory of Open Access Journals (Sweden)

Prchal Alice

2012-01-01

Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration ClinicalTrials.gov NCT00296907

The InterHerz project--a web-based psychological treatment for cardiac patients with depression: study protocol of a randomized controlled trial

OpenAIRE

Messerli-Bürgy, Nadine; Barth, Jürgen; Berger, Thomas

2012-01-01

Abstract Background Patients with heart disease often suffer from difficulties in psychological adaptation during cardiac rehabilitation. Mood disorders such as depression are known to be highly prevalent in cardiac patients and to have a negative impact on the progression of coronary heart disease. However, cardiac patients have difficulties to get psychological treatments due to low availability and motivational difficulties. Web-based interventions have been proven to be effective in treat...

Day Hospital Mentalization-Based Treatment (MBT-DH) versus treatment as usual in the treatment of severe borderline personality disorder: protocol of a randomized controlled trial

Science.gov (United States)

2014-01-01

Background Severe borderline personality disorder is associated with a very high psychosocial and economic burden. Current treatment guidelines suggest that several manualized treatments, including day hospital Mentalization-Based Treatment (MBT-DH), are effective in these patients. However, only two randomized controlled trials have compared manualized MBT-DH with treatment as usual. Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH, the possible influence of researcher allegiance in one of the trials, and potential problems with the generalization of findings to mental health systems in other countries, this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands. Methods/design The trial is being conducted at two sites in The Netherlands. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual. The MBT-DH program consists of a maximum of 18 months’ intensive treatment, followed by a maximum of 18 months of maintenance therapy. Specialist treatment as usual is provided by the City Crisis Service in Amsterdam, a service that specializes in treating patients with personality disorders, offering manualized, non-MBT interventions including family interventions, Linehan training, social skills training, and pharmacotherapy, without a maximum time limit. Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment. The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index. Secondary outcome measures include parasuicidal behaviour, symptomatic distress, social and interpersonal functioning

Psychological, social and welfare interventions for psychological health and well-being of torture survivors.

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Patel, Nimisha; Kellezi, Blerina; Williams, Amanda C de C

2014-11-11

Torture is widespread, with potentially broad and long-lasting impact across physical, psychological, social and other areas of life. Its complex and diverse effects interact with ethnicity, gender, and refugee experience. Health and welfare agencies offer varied rehabilitation services, from conventional mental health treatment to eclectic or needs-based interventions. This review is needed because relatively little outcome research has been done in this field, and no previous systematic review has been conducted. Resources are scarce, and the challenges of providing services can be considerable. To assess beneficial and adverse effects of psychological, social and welfare interventions for torture survivors, and to compare these effects with those reported by active and inactive controls. Randomised controlled trials (RCTs) were identified through a search of PsycINFO, MEDLINE, EMBASE, Web of Science, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Depression, Anxiety and Neurosis Specialised Register (CCDANCTR), the Latin American and Caribbean Health Science Information Database (LILACS), the Open System for Information on Grey Literature in Europe (OpenSIGLE), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and Published International Literature On Traumatic Stress (PILOTS) all years to 11 April 2013; searches of Cochrane resources, international trial registries and the main biomedical databases were updated on 20 June 2014. We also searched the Online Library of Dignity (Danish Institute against Torture), reference lists of reviews and included studies and the most frequently cited journals, up to April 2013 but not repeated for 2014. Investigators were contacted to provide updates or details as necessary. Full publications of RCTs or quasi-RCTs of psychological, social or welfare interventions for survivors of

The effects of providing periodontal disease risk information on psychological outcomes - a randomized controlled trial.

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Asimakopoulou, Koula; Newton, Jonathon Tim; Daly, Blánaid; Kutzer, Yvonne; Ide, Mark

2015-04-01

In a two arm randomized controlled trial this study compared the effects of a routine periodontal assessment consultation versus a routine consultation + individualized risk assessment communication intervention on patient thoughts and emotions about periodontal disease. Adults (N = 102) with moderate/advanced chronic periodontitis referred to a Periodontology Department of a large UK dental school, completed psychological measures before a periodontal assessment and again at the end of the visit. Intervention participants received an individualized calculation of their periodontal disease risk using PreViser Risk Calculator in addition to their routine assessment consultation. In routine care, patients' thoughts about periodontal disease seriousness (p periodontal disease. These effects were also seen in intervention participants. Additionally, the individualized risk communication intervention led to patients reporting i) periodontal disease treatment as more effective than they did pre-consultation (p periodontal management (p periodontal disease risk communication influences psychological variables that underpin adherence with periodontal instructions. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Psychological interventions for cystic fibrosis.

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Glasscoe, C A; Quittner, A L

2003-01-01

As survival estimates for cystic fibrosis (CF) steadily increase long-term management has become an important focus for intervention. Psychological interventions are largely concerned with emotional and social adjustments, adherence to treatment and quality of life, however no systematic review of such interventions has been undertaken for this disease. To describe the extent and quality of effectiveness studies utilising psychological interventions for CF and whether these interventions provide significant psychosocial and physical benefits in addition to standard care. Relevant trials were identified from searches of Ovid MEDLINE, the Cochrane trial registers for CF and Depression, Anxiety and Neurosis Groups and PsychINFO; unpublished trials were located through professional networks and Listserves. Most recent search: April 2003. This review included RCTs and quasi-randomised trials. Study participants were children and adults diagnosed with CF, and their immediate family members. Psychological interventions were from a broad range of modalities and outcomes were primarily psychosocial, although physical outcomes and cost effectiveness were also considered. Two reviewers independently selected relevant trials and assessed their methodological quality. For binary and continuous outcomes a pooled estimate of treatment effect was calculated for each outcome. This review is based on the findings of eight studies, representing data from a total of 358 participants. Studies fell into four conceptually similar groups: (1) gene pre-test education counselling for relatives of those with CF (one study); (2) biofeedback, massage and music therapy to assist physiotherapy (three studies); (3) behavioural intervention to improve dietary intake in children up to 12 years (three studies); and (4) self-administration of treatments to improve quality of life in adults (one study). Interventions were largely educational or behavioural, targeted at specific treatment concerns

Characteristics of effective collaborative care for treatment of depression: a systematic review and meta-regression of 74 randomised controlled trials.

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Peter A Coventry

Full Text Available Collaborative care is a complex intervention based on chronic disease management models and is effective in the management of depression. However, there is still uncertainty about which components of collaborative care are effective. We used meta-regression to identify factors in collaborative care associated with improvement in patient outcomes (depressive symptoms and the process of care (use of anti-depressant medication.Systematic review with meta-regression. The Cochrane Collaboration Depression, Anxiety and Neurosis Group trials registers were searched from inception to 9th February 2012. An update was run in the CENTRAL trials database on 29th December 2013. Inclusion criteria were: randomised controlled trials of collaborative care for adults ≥18 years with a primary diagnosis of depression or mixed anxiety and depressive disorder. Random effects meta-regression was used to estimate regression coefficients with 95% confidence intervals (CIs between study level covariates and depressive symptoms and relative risk (95% CI and anti-depressant use. The association between anti-depressant use and improvement in depression was also explored. Seventy four trials were identified (85 comparisons, across 21,345 participants. Collaborative care that included psychological interventions predicted improvement in depression (β coefficient -0.11, 95% CI -0.20 to -0.01, p = 0.03. Systematic identification of patients (relative risk 1.43, 95% CI 1.12 to 1.81, p = 0.004 and the presence of a chronic physical condition (relative risk 1.32, 95% CI 1.05 to 1.65, p = 0.02 predicted use of anti-depressant medication.Trials of collaborative care that included psychological treatment, with or without anti-depressant medication, appeared to improve depression more than those without psychological treatment. Trials that used systematic methods to identify patients with depression and also trials that included patients with a chronic physical

[Psychological aspects of immunotherapies in the treatment of malignant melanoma].

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Kovács, Péter; Pánczél, Gitta; Melegh, Krisztina; Balatoni, Tímea; Pörneczy, Edit; Lõrincz, Lenke; Czirbesz, Kata; Gorka, Eszter; Liszkay, Gabriella

2016-03-02

Psychological problems may arise in connection with oncomedical treatments in three ways: 1. acute and/or 2. chronic ways, as well as 3. co-morbid psychiatric diseases that already exist must also be taken into account. Immunotherapies have the most common and also clinically relevant psychological side effects. Fatigue, anhedonia, social isolation, psychomotor slowness is reported during treatment. Anti-CTLA-4 antibody (ipilimumab) immunotherapy can present one of the most modern opportunities for adequate treatment for patients having distant metastasis or unresectable tumour. In relation to immunotherapies, acute psychological side effects (acute stress) emerging during treatments develop in a way that can mostly be linked to environmental factors, e.g. notification of diagnosis, hospitalisation, progression, deterioration in quality of life, imminent dates of control. Crisis is a temporary and threatening condition that endangers psychological balance. In such conditions, enhanced psychological vulnerability must be taken into account and doctors play a key role in the rapid recognition of the condition. Chronic psychological problems, which may arise from the depressogenic effect of the applied treatment or originated from a pre-melanoma psychiatric condition, may exceed the diagnostic and psychotherapeutic competences of a clinical psychologist. Even in case of a well-defined depressogenic biological mechanism such as the activation of the pro-inflammatory cytokine pathway, positive environmental effects can reduce symptoms and thus increase compliance. Side effects can be treated successfully using psychotherapeutic methods and/or psychiatric medicines. The application of routinely used complex psychosocial screening packages can provide the easiest method to identify worsening psychological condition during immunotherapy and give rapid feedback to the oncologist and the patient. Team work is of particular importance in a situation like this as it requires

Efficacy and safety of pharmacological and psychological interventions for the treatment of psychosis and schizophrenia in children, adolescents and young adults: a systematic review and meta-analysis.

Directory of Open Access Journals (Sweden)

Megan R Stafford

Full Text Available Studies report contrasting results regarding the efficacy and safety of pharmacological, psychological, and combined interventions in psychosis and schizophrenia in children, adolescents and young adults.Systematic review and meta-analysis. Embase, Medline, PreMedline, PsycINFO, and CENTRAL were searched to July 2013 without restriction to publication status. Randomised trials comparing any pharmacological, psychological, or combined intervention for psychosis and schizophrenia in children, adolescents and young adults were included. Studies were assessed for bias, and GRADE criteria were used to describe the quality of the results.Twenty-seven trials including 3067 participants were identified. Meta-analyses were performed for 12 comparisons: symptoms, relapse, global state, psychosocial functioning, depression, weight and discontinuation. Low quality evidence demonstrated that antipsychotics have small beneficial effects on psychotic symptoms (SMD = -0.42, 95% CI -0.58 to -0.26, and a medium adverse effect on weight gain (WMD = 1.61, 95% CI 0.61 to 2.60 and discontinuation due to side effects (RR = 2.44, 95% CI, 1.12 to 5.31. There were no trials of psychological treatments in under-18 year olds. There was no evidence of an effect of psychological interventions on psychotic symptoms in an acute episode, or relapse rate, but low quality evidence of a large effect for family plus individual CBT on the number of days to relapse (WMD = 32.25, 95% CI -36.52 to -27.98.For children, adolescents and young adults, the balance of risk and benefit of antipsychotics appears less favourable than in adults. Research is needed to establish the potential for psychological treatments, alone and in combination with antipsychotics, in this population.

Psychological effects of diagnosis and treatment of cervical intraepithelial neoplasia

DEFF Research Database (Denmark)

Frederiksen, Maria Eiholm; Njor, Sisse; Lynge, Elsebeth

2015-01-01

BACKGROUND: Treatment of cervical intraepithelial neoplasia (CIN) is a common minor surgical procedure to prevent uterine cervical cancer. However, news of an abnormality detected at screening for cancer might cause the woman to worry. OBJECTIVES: To investigate the psychological consequences...... test results, but the impact decreased over time. In several but not all studies, CIN appeared to have similar psychological consequences to abnormal smears. No study showed a difference in psychological outcomes between CIN and cervical cancer diagnosis when these were measured some years after...... psychological outcomes in women with a histological diagnosis or treatment of CIN, and in women having an outcome other than CIN at cervical screening. DATA COLLECTION AND ANALYSIS: We abstracted the data using a pre-specified list of study characteristics and measured outcomes. For studies not reporting...

Protocol for a systematic review of psychological treatment for methamphetamine use: an analysis of methamphetamine use and mental health symptom outcomes.

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Stuart, Alexandra; Baker, Amanda L; Bowman, Jenny; McCarter, Kristen; Denham, Alexandra Mary Janice; Lee, Nicole; Colyvas, Kim; Dunlop, Adrian

2017-09-07

People who use methamphetamine (MA) regularly, often experience symptoms of mental ill health associated with the use of the drug. These include symptoms of psychosis, depression, anxiety and also cognitive deficits. Accordingly, psychological treatments aim to reduce MA use and related problems, including symptoms of mental ill health. Although there has been a substantial body of research reporting on the evidence of effectiveness of psychological treatments for MA use, there is a paucity of research addressing the effectiveness of these treatments for coexisting symptoms of mental ill health. We aim to address this gap by providing a comprehensive overview of the evidence for psychological treatments for MA use and associated symptoms of mental ill health in experimental/controlled clinical studies. In addition, a critical evaluation of study methods and the outcomes of psychological interventions on MA use and symptoms of mental ill health will be conducted. The Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement will be used to inform the methods of this review. Eight electronic peer-reviewed databases will be searched. Pilot searches have been conducted for MA literature considering controlled clinical trials only. Eligible articles will be independently assessed against inclusion criteria. Before final analyses are completed, searches will be rerun and if eligible, additional studies will be retrieved for inclusion. A quantitative synthesis of the findings will be reported where possible, and 'summary of findings' tables will be generated for each comparison. Risk ratios and 95% CI (dichotomous outcomes) will be calculated and/or effect size according to Cohen's formula (continuous outcomes) for the primary outcome of each trial. No ethical issues are foreseen. Findings will be disseminated widely to clinicians and researchers via journal publication and conference

Acne in adolescents: quality of life, self-esteem, mood, and psychological disorders.

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Dunn, Lauren K; O'Neill, Jenna L; Feldman, Steven R

2011-01-15

Acne is a significant adolescent problem and may precipitate emotional and psychological effects. The impact of acne on psychological parameters and implications for acne treatment are not fully understood. We performed a MEDLINE search using the terms "acne" and "adolescent" along with "psychological," "depression," or "psychiatric," which yielded 16 reviewed studies. Qualitative review of the selected articles revealed that the presence of acne has a significant impact on self-esteem and quality of life. Depression and other psychological disorders are more prevalent in acne patients and acne treatment may improve symptoms of these disorders. The reviewed studies were semi-quantitative analyses utilizing various standardized surveys or questionnaires. Therefore, quantitative analysis of selected studies was not possible. The presence of co-morbid psychological disorders should be considered in the treatment of acne patients and future prospective trials are needed to assess the impact of treatment on psychological outcomes.

Psychology and criminal justice

OpenAIRE

Adler, Joanna R.

2013-01-01

This chapter is designed to give the reader a flavour of a few areas in which psychology has been applied to criminal justice. It begins by providing some historical context and showing the development of some applications of psychology to criminal justice. The chapter is broadly split into 3 sections: Pre Trial; Trial; and Post Trial. In most of this chapter, the areas considered assess how psychology has had an influence on the law and how psychologists work within criminal justice settings...

Day Hospital Mentalization-Based Treatment (MBT-DH) versus treatment as usual in the treatment of severe borderline personality disorder: protocol of a randomized controlled trial.

Science.gov (United States)

Laurenssen, Elisabeth M P; Westra, Dieuwertje; Kikkert, Martijn J; Noom, Marc J; Eeren, Hester V; van Broekhuyzen, Anna J; Peen, Jaap; Luyten, Patrick; Busschbach, Jan J V; Dekker, Jack J M

2014-05-22

Severe borderline personality disorder is associated with a very high psychosocial and economic burden. Current treatment guidelines suggest that several manualized treatments, including day hospital Mentalization-Based Treatment (MBT-DH), are effective in these patients. However, only two randomized controlled trials have compared manualized MBT-DH with treatment as usual. Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH, the possible influence of researcher allegiance in one of the trials, and potential problems with the generalization of findings to mental health systems in other countries, this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands. The trial is being conducted at two sites in The Netherlands. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual. The MBT-DH program consists of a maximum of 18 months' intensive treatment, followed by a maximum of 18 months of maintenance therapy. Specialist treatment as usual is provided by the City Crisis Service in Amsterdam, a service that specializes in treating patients with personality disorders, offering manualized, non-MBT interventions including family interventions, Linehan training, social skills training, and pharmacotherapy, without a maximum time limit. Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment. The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index. Secondary outcome measures include parasuicidal behaviour, symptomatic distress, social and interpersonal functioning, personality functioning

A Randomized Controlled Trial of Internet-Delivered Cognitive Behavior Therapy and Acceptance and Commitment Therapy in the Treatment of Tinnitus

Science.gov (United States)

Hesser, Hugo; Gustafsson, Tore; Lunden, Charlotte; Henrikson, Oskar; Fattahi, Kidjan; Johnsson, Erik; Westin, Vendela Zetterqvist; Carlbring, Per; Maki-Torkko, Elina; Kaldo, Viktor; Andersson, Gerhard

2012-01-01

Objective: Our aim in this randomized controlled trial was to investigate the effects on global tinnitus severity of 2 Internet-delivered psychological treatments, acceptance and commitment therapy (ACT) and cognitive behavior therapy (CBT), in guided self-help format. Method: Ninety-nine participants (mean age = 48.5 years; 43% female) who were…

Procedures for identifying evidence-based psychological treatments for older adults.

Science.gov (United States)

Yon, Adriana; Scogin, Forrest

2007-03-01

The authors describe the methods used to identify evidence-based psychological treatments for older adults in this contribution to the special section. Coding teams were assembled to review the literature on several problems relevant to mental health and aging. These teams used the manual developed by the Committee on Science and Practice of the Society for Clinical Psychology (Division 12) of the American Psychological Association that provided definitions of key constructs used in coding. The authors provide an overview of the process followed by the review teams and of some of the issues that emerged to illustrate the steps involved in the coding procedure. Identifying evidence-based treatments is a fundamental aspect of promoting evidence-based practice with older adults; such practice is advocated by most health care disciplines, including psychology. ((c) 2007 APA, all rights reserved).

The Healthy Activity Program (HAP), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in India: a randomised controlled trial.

Science.gov (United States)

Patel, Vikram; Weobong, Benedict; Weiss, Helen A; Anand, Arpita; Bhat, Bhargav; Katti, Basavraj; Dimidjian, Sona; Araya, Ricardo; Hollon, Steve D; King, Michael; Vijayakumar, Lakshmi; Park, A-La; McDaid, David; Wilson, Terry; Velleman, Richard; Kirkwood, Betty R; Fairburn, Christopher G

2017-01-14

Although structured psychological treatments are recommended as first-line interventions for depression, only a small fraction of people globally receive these treatments because of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of a brief psychological treatment (Healthy Activity Program [HAP]) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care settings. In this randomised controlled trial, we recruited participants aged 18-65 years scoring more than 14 on the Patient Health Questionnaire 9 (PHQ-9) indicating moderately severe to severe depression from ten primary health centres in Goa, India. Pregnant women or patients who needed urgent medical attention or were unable to communicate clearly were not eligible. Participants were randomly allocated (1:1) to enhanced usual care (EUC) alone or EUC combined with HAP in randomly sized blocks (block size four to six [two to four for men]), stratified by primary health centre and sex, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC were masked. Primary outcomes were depression symptom severity on the Beck Depression Inventory version II and remission from depression (PHQ-9 score of better results than did EUC alone for the secondary outcomes of disability (adjusted mean difference -2·73 [-4·39 to -1·06]; p=0·001), days out of work (-2·29 [-3·84 to -0·73]; p=0·004), intimate partner physical violence in women (0·53 [0·29-0·96]; p=0·04), behavioural activation (2·17 [1·34-3·00]; pbetter than EUC alone was for patients with moderately severe to severe depression in routine primary care in Goa, India. HAP was readily accepted by this previously untreated population and was cost-effective in this setting. HAP could be a key strategy to reduce the treatment gap for depressive disorders, the leading mental health disorder worldwide. Wellcome Trust

Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial

Directory of Open Access Journals (Sweden)

Hayes Rachel

2010-10-01

Full Text Available Abstract Background Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depressive relapse/recurrence. A recently developed treatment, Mindfulness-based Cognitive Therapy (MBCT, see http://www.mbct.co.uk shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to usual care. This trial asks the policy research question, is MBCT superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and, secondary outcomes of (a depression free days, (b residual depressive symptoms, (c antidepressant (ADM usage, (d psychiatric and medical co-morbidity, (e quality of life, and (f cost effectiveness? An explanatory research question asks is an increase in mindfulness skills the key mechanism of change? Methods/Design The design is a single blind, parallel RCT examining MBCT vs. m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT plus ADM-tapering with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. Depressive relapse/recurrence over two years is the primary outcome variable. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre/post-treatment and a qualitative study of service users' views and experiences

Vaginismus Treatment: Clinical Trials Follow Up 241 Patients.

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Pacik, Peter T; Geletta, Simon

2017-06-01

Vaginismus is mostly unknown among clinicians and women. Vaginismus causes women to have fear, anxiety, and pain with penetration attempts. To present a large cohort of patients based on prior published studies approved by an institutional review board and the Food and Drug Administration using a comprehensive multimodal vaginismus treatment program to treat the physical and psychologic manifestations of women with vaginismus and to record successes, failures, and untoward effects of this treatment approach. Assessment of vaginismus included a comprehensive pretreatment questionnaire, the Female Sexual Function Index (FSFI), and consultation. All patients signed a detailed informed consent. Treatment consisted of a multimodal approach including intravaginal injections of onabotulinumtoxinA (Botox) and bupivacaine, progressive dilation under conscious sedation, indwelling dilator, follow-up and support with office visits, phone calls, e-mails, dilation logs, and FSFI reports. Logs noting dilation progression, pain and anxiety scores, time to achieve intercourse, setbacks, and untoward effects. Post-treatment FSFI scores were compared with preprocedure scores. One hundred seventy-one patients (71%) reported having pain-free intercourse at a mean of 5.1 weeks (median = 2.5). Six patients (2.5%) were unable to achieve intercourse within a 1-year period after treatment and 64 patients (26.6%) were lost to follow-up. The change in the overall FSFI score measured at baseline, 3 months, 6 months, and 1 year was statistically significant at the 0.05 level. Three patients developed mild temporary stress incontinence, two patients developed a short period of temporary blurred vision, and one patient developed temporary excessive vaginal dryness. All adverse events resolved by approximately 4 months. One patient required retreatment followed by successful coitus. A multimodal program that treated the physical and psychologic aspects of vaginismus enabled women to achieve

[Psychological Treatments for Borderline Personality Disorder: A Review of Cognitive-Behavioral Oriented Therapies].

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Marques, Sofia; Barrocas, Daniel; Rijo, Daniel

2017-04-28

Borderline personality disorder is the most common personality disorder, with a global prevalence rate between 1.6% and 6%. It is characterized by affective disturbance and impulsivity, which lead to a high number of self-harm behaviors and great amount of health services use. International guidelines recommend psychotherapy as the primary treatment for borderline personality disorder. This paper reviews evidence about the effects and efficacy of cognitive-behavioral oriented psychological treatments for borderline personality disorder. A literature review was conducted in Medline and PubMed databases, using the following keywords: borderline personality disorder, cognitive-behavioral psychotherapy and efficacy. Sixteen randomized clinical trials were evaluate in this review, which analyzed the effects of several cognitive-behavioral oriented psychotherapeutic interventions, namely dialectical behavioral therapy, cognitive behavioral therapy, schema-focused therapy and manual-assisted cognitive therapy. All above stated treatments showed clinical beneficial effects, by reducing borderline personality disorder core pathology and associated general psychopathology, as well as by reducing the severity and frequency of self-harm behaviors, and by improving the overall social, interpersonal and global adjustment. Dialectical behavioral therapy and schema-focused therapy also caused a soaring remission rate of diagnostic borderline personality disorder criteria of 57% and 94%, respectively. Although there were differences between the psychotherapeutic interventions analysed in this review, all showed clinical benefits in the treatment of borderline personality disorder. Dialectical behavioral therapy and schema-focused therapy presented the strongest scientific data documenting their efficacy, but both interventions are integrative cognitive-behavioral therapies which deviate from the traditional cognitive-behavioral model. In summary, the available studies support

Psychological treatments for fibromyalgia: A meta-analysis

NARCIS (Netherlands)

Glombiewski, J.A.; Sawyer, A.T.; Gutermann, J.; Koenig, K.; Rief, W.; Hofmann, S.G.

2010-01-01

The aims of the present analysis were to investigate the short-and long-term efficacies and treatment moderators of psychological interventions for fibromyalgia. A literature search using PubMed, PsychINFO, the Cochrane Library, and manual searches identified 23 eligible studies including 30

New Developments in the Psychological Management of Chronic Pain

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Morley, Stephen; Williams, Amanda

2015-01-01

After reviewing how psychological treatment for chronic pain comes to have its current form, and summarizing treatment effectiveness, we explore several areas of development. We describe third wave therapies, such as mindfulness; we discuss what the research literature aggregated can tell us about what trials are more useful to conduct; and we outline some areas of promise and some failures to deliver on promise. The article is drawn together using the framework of the normal psychology of pain, identifying some of its most important implications for improving life for people with chronic pain. PMID:26174216

Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial.

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Hudson, Joanna L; Moss-Morris, Rona; Norton, Sam; Picariello, Federica; Game, David; Carroll, Amy; Spencer, Jonathan; McCrone, Paul; Hotopf, Matthew; Yardley, Lucy; Chilcot, Joseph

2017-11-01

Psychological distress is prevalent in haemodialysis (HD) patients yet access to psychotherapy remains limited. This study assessed the feasibility and acceptability of online cognitive-behavioural therapy (CBT) tailored for HD patients, with or without therapist support, for managing psychological distress. This feasibility randomised controlled trial recruited patients from a UK HD centre. Following psychological distress screens, patients with mild-moderate psychological distress (Patient Health Questionnaire PHQ-9; score: 5-19 and/or Generalised Anxiety Disorder; GAD-7 score: 5-14) who met remaining inclusion criteria were approached for consent. Consenters were individually randomised (1:1) to online-CBT or online-CBT plus three therapist support calls. Outcomes included recruitment, retention, and adherence rates. Exploratory change analyses were performed for: psychological distress, quality of life (QoL), illness perceptions, and costs. The statistician was blinded to allocation. 182 (44%) out of 410 patients approached completed psychological distress screens. 26% found screening unacceptable; a further 30% found it unfeasible. Psychological distress was detected in 101 (55%) patients, 60 of these met remaining inclusion criteria. The primary reason for ineligibility was poor computer literacy (N=17, 53%). Twenty-five patients were randomised to the supported (N=18) or unsupported arm (N=7); 92% were retained at follow-up. No differences in psychological distress or cost-effectiveness were observed. No trial adverse events occurred. Online CBT appears feasible but only for computer literate patients who identify with the label psychological distress. A definitive trial using the current methods for psychological distress screening and online care delivery is unfeasible. ClinicalTrials.gov Identifier: NCT02352870. Copyright © 2017 Elsevier Inc. All rights reserved.

Assessing treatment fidelity and contamination in a cluster randomised controlled trial of motivational interviewing and cognitive behavioural therapy skills in type 2 diabetes.

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Magill, Nicholas; Graves, Helen; de Zoysa, Nicole; Winkley, Kirsty; Amiel, Stephanie; Shuttlewood, Emma; Landau, Sabine; Ismail, Khalida

2018-05-10

Competencies in psychological techniques delivered by primary care nurses to support diabetes self-management were compared between the intervention and control arms of a cluster randomised controlled trial as part of a process evaluation. The trial was pragmatic and designed to assess effectiveness. This article addresses the question of whether the care that was delivered in the intervention and control trial arms represented high fidelity treatment and attention control, respectively. Twenty-three primary care nurses were either trained in motivational interviewing (MI) and cognitive behavioural therapy (CBT) skills or delivered attention control. Nurses' skills in these treatments were evaluated soon after training (treatment arm) and treatment fidelity was assessed after treatment delivery for sessions midway through regimen (both arms) using the Motivational Interviewing Treatment Integrity (MITI) domains and Behaviour Change Counselling Index (BECCI) based on consultations with 151 participants (45% of those who entered the study). The MITI Global Spirit subscale measured demonstration of MI principles: evocation, collaboration, autonomy/support. After training, median MITI MI-Adherence was 86.2% (IQR 76.9-100%) and mean MITI Empathy was 4.09 (SD 1.04). During delivery of treatment, in the intervention arm mean MITI Spirit was 4.03 (SD 1.05), mean Empathy was 4.23 (SD 0.89), and median Percentage Complex Reflections was 53.8% (IQR 40.0-71.4%). In the attention control arm mean Empathy was 3.40 (SD 0.98) and median Percentage Complex Reflections was 55.6% (IQR 41.9-71.4%). After MI and CBT skills training, detailed assessment showed that nurses had basic competencies in some psychological techniques. There appeared to be some delivery of elements of psychological treatment by nurses in the control arm. This model of training and delivery of MI and CBT skills integrated into routine nursing care to support diabetes self-management in primary care was not

Effects of a Tailored Positive Psychology Intervention on Well-Being and Pain in Individuals With Chronic Pain and a Physical Disability: A Feasibility Trial.

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Müller, Rachel; Gertz, Kevin J; Molton, Ivan R; Terrill, Alexandra L; Bombardier, Charles H; Ehde, Dawn M; Jensen, Mark P

2016-01-01

To determine the feasibility, acceptability, and efficacy of a computer-based positive psychology intervention in individuals with a physical disability and chronic pain. Individuals with spinal cord injury, multiple sclerosis, neuromuscular disease, or postpolio syndrome and chronic pain were randomly assigned to a positive psychology or a control condition. Participants in the intervention group were instructed to practice 4 personalized positive psychology exercises. Participants in the control group were instructed to write about life details for 8 weeks. Participants completed online well-being and pain-related questionnaires at baseline, posttreatment, and at the 2.5-month follow-up, and rated treatment satisfaction at posttreatment. Ninety-six participants were randomized and 68 (70%) completed follow-up assessments. Participants in the positive psychology intervention group reported significant pretreatment to posttreatment improvements in pain intensity, pain control, pain catastrophizing, pain interference, life satisfaction, positive affect, and depression. Improvements in life satisfaction, depression, pain intensity, pain interference, and pain control were maintained to the 2.5-month follow-up. Participants in the control group reported significant pretreatment to posttreatment improvements in life satisfaction, and pretreatment to follow-up improvements in pain intensity and pain control. Significant between-group differences, favoring the treatment group, emerged for pretreatment to posttreatment improvements in pain intensity and pain control. Participants were similarly satisfied with both treatments. The results support the feasibility, acceptability, and potential efficacy of a computer-based positive psychology intervention for improving well-being and pain-related outcomes in individuals with physical disabilities and chronic pain, and indicate that a full trial of the intervention is warranted.

A Couple-Based Psychological Treatment for Chronic Pain and Relationship Distress.

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Cano, Annmarie; Corley, Angelia M; Clark, Shannon M; Martinez, Sarah C

2018-02-01

Chronic pain impacts individuals with pain as well as their loved ones. Yet, there has been little attention to the social context in individual psychological treatment approaches to chronic pain management. With this need in mind, we developed a couple-based treatment, "Mindful Living and Relating," aimed at alleviating pain and suffering by promoting couples' psychological and relational flexibility skills. Currently, there is no integrative treatment that fully harnesses the power of the couple, treating both the individual with chronic pain and the spouse as two individuals who are each in need of developing greater psychological and relational flexibility to improve their own and their partners' health. Mindfulness, acceptance, and values-based action exercises were used to promote psychological flexibility. The intervention also targets relational flexibility, which we define as the ability to interact with one's partner, fully attending to the present moment, and responding empathically in a way that serves one's own and one's partner's values. To this end, the intervention also included exercises aimed at applying psychological flexibility skills to social interactions as well as emotional disclosure and empathic responding exercises to enhance relational flexibility. The case presented demonstrates that healthy coping with pain and stress may be most successful and sustainable when one is involved in a supportive relationship with someone who also practices psychological flexibility skills and when both partners use relational flexibility skills during their interactions.

Designing Psychological Treatments for Scalability: The PREMIUM Approach.

Directory of Open Access Journals (Sweden)

Sukumar Vellakkal

Full Text Available Lack of access to empirically-supported psychological treatments (EPT that are contextually appropriate and feasible to deliver by non-specialist health workers (referred to as 'counsellors' are major barrier for the treatment of mental health problems in resource poor countries. To address this barrier, the 'Program for Effective Mental Health Interventions in Under-resourced Health Systems' (PREMIUM designed a method for the development of EPT for severe depression and harmful drinking. This was implemented over three years in India. This study assessed the relative usefulness and costs of the five 'steps' (Systematic reviews, In-depth interviews, Key informant surveys, Workshops with international experts, and Workshops with local experts in the first phase of identifying the strategies and theoretical model of the treatment and two 'steps' (Case series with specialists, and Case series and pilot trial with counsellors in the second phase of enhancing the acceptability and feasibility of its delivery by counsellors in PREMIUM with the aim of arriving at a parsimonious set of steps for future investigators to use for developing scalable EPT.The study used two sources of data: the usefulness ratings by the investigators and the resource utilization. The usefulness of each of the seven steps was assessed through the ratings by the investigators involved in the development of each of the two EPT, viz. Healthy Activity Program for severe depression and Counselling for Alcohol Problems for harmful drinking. Quantitative responses were elicited to rate the utility (usefulness/influence, followed by open-ended questions for explaining the rankings. The resources used by PREMIUM were computed in terms of time (months and monetary costs.The theoretical core of the new treatments were consistent with those of EPT derived from global evidence, viz. Behavioural Activation and Motivational Enhancement for severe depression and harmful drinking respectively

Sequential psychological and pharmacological therapies for comorbid and primary insomnia: study protocol for a randomized controlled trial.

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Morin, Charles M; Edinger, Jack D; Krystal, Andrew D; Buysse, Daniel J; Beaulieu-Bonneau, Simon; Ivers, Hans

2016-03-03

Chronic insomnia is a prevalent disorder associated with significant psychosocial, health, and economic impacts. Cognitive behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications are the most widely supported therapeutic approaches for insomnia management. However, few investigations have directly compared their relative and combined benefits, and even fewer have tested the benefits of sequential treatment for those who do not respond to initial insomnia therapy. Moreover, insomnia treatment studies have been limited by small, highly screened study samples, fixed-dose, and fixed-agent pharmacotherapy strategies that do not represent usual clinical practices. This study will address these limitations. This is a two-site randomized controlled trial, which will enroll 224 adults who meet the criteria for a chronic insomnia disorder with or without comorbid psychiatric disorders. Prospective participants will complete clinical assessments and polysomnography and then will be randomly assigned to first-stage therapy involving either behavioral therapy (BT) or zolpidem. Treatment outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the next 12 months on maintenance therapy. Those not achieving remission will be offered randomization to a second, 6-week treatment, again involving either pharmacotherapy (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy (CT)). All participants will be re-evaluated 12 weeks after the protocol initiation and at 3-, 6-, 9-, and 12-month follow-ups. Insomnia remission, defined categorically as a score Insomnia Severity Index, a patient-reported outcome, will serve as the primary endpoint for treatment comparisons. Secondary outcomes will include sleep parameters derived from daily sleep diaries and from polysomnography, subjective measures of fatigue, mood, quality of life, and functional impairments; and measures of adverse events; dropout rates; and treatment

Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme.

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Dunn, Graham; Emsley, Richard; Liu, Hanhua; Landau, Sabine; Green, Jonathan; White, Ian; Pickles, Andrew

2015-11-01

The development of the capability and capacity to evaluate the outcomes of trials of complex interventions is a key priority of the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The evaluation of complex treatment programmes for mental illness (e.g. cognitive-behavioural therapy for depression or psychosis) not only is a vital component of this research in its own right but also provides a well-established model for the evaluation of complex interventions in other clinical areas. In the context of efficacy and mechanism evaluation (EME) there is a particular need for robust methods for making valid causal inference in explanatory analyses of the mechanisms of treatment-induced change in clinical outcomes in randomised clinical trials. The key objective was to produce statistical methods to enable trial investigators to make valid causal inferences about the mechanisms of treatment-induced change in these clinical outcomes. The primary objective of this report is to disseminate this methodology, aiming specifically at trial practitioners. The three components of the research were (1) the extension of instrumental variable (IV) methods to latent growth curve models and growth mixture models for repeated-measures data; (2) the development of designs and regression methods for parallel trials; and (3) the evaluation of the sensitivity/robustness of findings to the assumptions necessary for model identifiability. We illustrate our methods with applications from psychological and psychosocial intervention trials, keeping the technical details to a minimum, leaving the reporting of the more theoretical and mathematically demanding results for publication in appropriate specialist journals. We show how to estimate treatment effects and introduce methods for EME. We explain the use of IV methods and principal stratification to evaluate the role of putative treatment effect mediators and therapeutic process measures. These results are

Psychological therapies for pathological and problem gambling.

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Cowlishaw, Sean; Merkouris, Stephanie; Dowling, Nicki; Anderson, Christopher; Jackson, Alun; Thomas, Shane

2012-11-14

Various psychological therapies for pathological and problem gambling have been evaluated in randomised trials. A synthesis of best-quality evidence is required. The objective was to synthesise evidence from randomised trials of psychological therapies for pathological and problem gambling (cognitive-behaviour therapy (CBT), motivational interviewing therapy, integrative therapy, other psychological therapy), in order to indicate the efficacy of therapies and durability of therapy effects, relative to control conditions. We conducted a search of the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR), which includes relevant randomised controlled trials from the following bibliographic databases: CENTRAL (The Cochrane Central Register of Controlled Trials) (all years), EMBASE (1974 -), MEDLINE (1950 -) and PsycINFO (1967 -). We also carried out complementary searches of MEDLINE, EMBASE, PsycINFO, LILACS and CENTRAL for studies published between January 1980 and October 2011. We examined the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov and also conducted manual searches of selected journals and reference lists of included studies. Included studies were clinical trials using random allocation to groups, considering pathological or problem gamblers, and evaluating a psychological therapy for pathological or problem gambling. Control conditions included 'no treatment' controls, referral to Gamblers Anonymous and non-specific treatment component controls. We systematically extracted data on the characteristics and results of studies. Primary outcomes were measures of gambling symptom severity, financial loss from gambling and frequency of gambling. Secondary outcomes were occurrence of pathological gambling diagnoses and depression and anxiety symptoms. Treatment effects were defined by comparisons between therapy and control conditions at post-treatment assessments (conducted from 0 to 3 months

Psychological interventions for adults with bipolar disorder: systematic review and meta-analysis.

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Oud, Matthijs; Mayo-Wilson, Evan; Braidwood, Ruth; Schulte, Peter; Jones, Steven H; Morriss, Richard; Kupka, Ralph; Cuijpers, Pim; Kendall, Tim

2016-03-01

Psychological interventions may be beneficial in bipolar disorder. To evaluate the efficacy of psychological interventions for adults with bipolar disorder. A systematic review of randomised controlled trials was conducted. Outcomes were meta-analysed using RevMan and confidence assessed using the GRADE method. We included 55 trials with 6010 participants. Moderate-quality evidence associated individual psychological interventions with reduced relapses at post-treatment (risk ratio (RR) = 0.66, 95% CI 0.48-0.92) and follow-up (RR = 0.74, 95% CI 0.63-0.87), and collaborative care with a reduction in hospital admissions (RR = 0.68, 95% CI 0.49-0.94). Low-quality evidence associated group interventions with fewer depression relapses at post-treatment and follow-up, and family psychoeducation with reduced symptoms of depression and mania. There is evidence that psychological interventions are effective for people with bipolar disorder. Much of the evidence was of low or very low quality thereby limiting our conclusions. Further research should identify the most effective (and cost-effective) interventions for each phase of this disorder. © The Royal College of Psychiatrists 2016.

Psychological treatments for gambling disorder

Directory of Open Access Journals (Sweden)

Rash CJ

2014-10-01

Full Text Available Carla J Rash, Nancy M Petry Department of Medicine, University of Connecticut Health Center, Farmington, CT, USA Abstract: This review discusses the research evidence for psychological treatment of gambling disorder. Several treatment options for gamblers have been explored, ranging from self-help and peer support, to brief and motivational interventions, to more intensive therapy approaches. Involvement in peer support programs seems to be optimal when combined with professional treatment; however, engagement and retention in peer support is limited. Self-directed interventions appear to benefit some gamblers; however, the involvement of therapist support, either in person or by telephone, may bolster these effects and such support need not be extensive. These self-directed options reduce the barriers associated with treatment-seeking, and may reach a wider range of gamblers than professionally delivered treatments alone. Brief and motivational approaches similarly may extend treatment options to more gamblers, namely at-risk and problem gamblers and those not seeking treatment. Of more extensive therapies, no consistent benefit of one approach emerges, although cognitive–behavioral interventions have been most often applied. Overall, several treatments have been developed for gambling disorder and results are promising, but variability in findings suggests a need for further systematic evaluation. Keywords: gambling treatment, cognitive behavioral treatment, brief interventions, pathological gambling, problem gambling, behavioral addictions

Effects of cognitive-behavioural therapy (CBT) and positive psychological intervention (PPI) on female offenders with psychological distress in Hong Kong.

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Mak, Vivian W M; Chan, Calais K Y

2018-04-01

Despite rapid growth in the female prison population, there is little research on effectiveness of psychological interventions for them. To test the hypotheses that (1) each of two psychological interventions administered separately - cognitive behavioural therapy (CBT) or positive psychology intervention (PPI) - would be more effective than 'treatment-as-usual' alone in reducing psychological distress and enhancing psychological well-being; (2) outcomes would differ according to intervention; and (3) combining the interventions would be more effective than delivering either alone. We recruited 40 women in a special Hong Kong prison unit for female offenders with psychological distress. Half of them received eight sessions of CBT followed by eight sessions of PPI; the other half received the same interventions in the reverse order. We recruited another 35 women who received only 'treatment as usual' (TAU) in the same unit. We used various clinical scales to assess the women's psychological distress or well-being before and after the interventions or at similar time points for the comparison women. All intervention group women showed a significant reduction in psychological distress and enhancement in psychological well-being after each intervention alone compared to the TAU women. There were no significant differences between CBT and PPI in this respect. Receiving both treatments, however, did yield significantly more improvement than either intervention alone in reducing depressive thoughts and enhancing global judgement of life satisfaction, self-perceived strengths and hopeful thinking style. Our findings provide preliminary empirical support for the effectiveness of psychological interventions with psychologically distressed women in prison. It would be important now to conduct a full, randomised trial to determine optimal length and combinations of treatment. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Male psychological adaptation to unsuccessful medically assisted reproduction treatments

DEFF Research Database (Denmark)

Martins, Mariana Veloso; Basto-Pereira, Miguel; Pedro, Juliana

2016-01-01

BACKGROUND: Similarly to women, men suffer from engaging in fertility treatments, both physically and psychologically. Although there is a vast body of evidence on the emotional adjustment of women to infertility, there are no systematic reviews focusing on men's psychological adaptation...... for psychological maladaptation?' SEARCH METHODS: A literature search was conducted from inception to September 2015 on five databases using combinations of MeSH terms and keywords. Eligible studies had to present quantitative prospective designs and samples including men who did not achieve pregnancy or parenthood...... at follow-up. A narrative synthesis approach was used to conduct the review. OUTCOMES: Twelve studies from three continents were eligible from 2534 records identified in the search. The results revealed that psychological symptoms of maladjustment significantly increased in men 1 year after the first...

Mobilization versus manipulations versus sustain apophyseal natural glide techniques and interaction with psychological factors for patients with chronic neck pain: randomized controlled trial.

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Lopez-Lopez, A; Alonso Perez, J L; González Gutierez, J L; La Touche, R; Lerma Lara, S; Izquierdo, H; Fernández-Carnero, J

2015-04-01

Three different types of manual therapy techniques for patients with neck pain and relationship with psychological factors has not been evaluated. To compare the effectiveness high velocity and low amplitude (HVLA) manipulation vs. posteroanterior mobilization (PA mob) vs. sustain appophyseal natural glide (SNAG) in the management of patients with neck pain and to evaluate the interaction with psychological factors. Randomized clinical trial. Primary Health Care Center. Patients with history of chronic neck pain over the last 3 months were recruited. Patients were randomly assigned to receive treatment with HVLA (N.=15), with PA mob (N.=16) or with SNAG (N.=17). One session was applied. Pain intensity of neck pain, pressure pain threshold over processus spinosus of C2 (PPT_C2) and cervical range of motion (CROM) were measured pre- and post-intervention. Pain catastrophizing, depression, anxiety and kinesiophobia were assessed in baseline. ANOVAs were performed, with main effects, two-way (treatment x time) and three-way interactions (treatment x psychological variable x time) were examined. Fourthy-eight patients (mean±SD age, 36.5±8.7 years; 87.5% female). A significant interaction treatment x time was observed for VAS-rest in HVLA and AP mob groups (Ptechniques have similar immediate effects over neck pain and while under high anxiety levels a better outcome is expected after mobilization intervention, under low anxiety levels a better prognosis is expected after manipulation and SNAG intervention.

Blended care vs. usual care in the treatment of depressive symptoms and disorders in general practice [BLENDING]: study protocol of a non-inferiority randomized trial.

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Massoudi, Btissame; Blanker, Marco H; van Valen, Evelien; Wouters, Hans; Bockting, Claudi L H; Burger, Huibert

2017-06-13

The majority of patients with depressive disorders are treated by general practitioners (GPs) and are prescribed antidepressant medication. Patients prefer psychological treatments but they are under-used, mainly due to time constraints and limited accessibility. A promising approach to deliver psychological treatment is blended care, i.e. guided online treatment. However, the cost-effectiveness of blended care formatted as an online psychological treatment supported by the patients' own GP or general practice mental health worker (MHW) in routine primary care is unknown. We aim to demonstrate non-inferiority of blended care compared with usual care in patients with depressive symptoms or a depressive disorder in general practice. Additionally, we will explore the real-time course over the day of emotions and affect, and events within individuals during treatment. This is a pragmatic non-inferiority trial including 300 patients with depressive symptoms, recruited by collaborating GPs and MHWs. After inclusion, participants are randomized to either blended care or usual care in routine general practice. Blended care consists of the 'Act and Feel' treatment: an eight-week web-based program based on behavioral activation with integrated monitoring of depressive symptomatology and automatized feedback. GPs or their MHWs coach the participants through regular face-to-face or telephonic consultations with at least three sessions. Depressive symptomatology, health status, functional impairment, treatment satisfaction, daily activities and resource use are assessed during a follow-up period of 12 months. During treatment, real-time fluctuations in emotions and affect, and daily events will be rated using ecological momentary assessment. The primary outcome is the reduction of depressive symptoms from baseline to three months follow-up. We will conduct intention-to-treat analyses and supplementary per-protocol analyses. This trial will show whether blended care might be an

A Randomized Controlled Trial of a Brief Intervention for Delayed Psychological Effects in Snakebite Victims.

Directory of Open Access Journals (Sweden)

Chamara A Wijesinghe

Full Text Available Snakebite results in delayed psychological morbidity and negative psycho-social impact. However, psychological support is rarely provided to victims.To assess the effectiveness of a brief intervention which can be provided by non-specialist doctors aimed at reducing psychological morbidity following snakebite envenoming.In a single blind, randomized controlled trial, snakebite victims with systemic envenoming [n = 225, 168 males, mean age 42.1 (SD 12.4 years] were randomized into three arms. One arm received no intervention (n = 68, Group A, the second received psychological first aid and psychoeducation (dispelling prevalent cultural beliefs related to snakebite which promote development of a sick role at discharge from hospital (n = 65, Group B, while the third received psychological first aid and psychoeducation at discharge and a second intervention one month later based on cognitive behavioural principles (n = 69, Group C. All patients were assessed six months after hospital discharge for the presence of psychological symptoms and level of functioning using standardized tools.At six months, there was a decreasing trend in the proportion of patients who were positive for psychiatric symptoms of depression and anxiety from Group A through Group B to Group C (Chi square test for trend = 7.901, p = 0.005. This was mainly due to a decreasing trend for symptoms of anxiety (chi-square for trend = 11.256, p = 0.001. There was also decreasing trend in the overall prevalence of disability from Group A through Group B to Group C (chi square for trend = 7.551, p = 0.006, predominantly in relation to disability in family life (p = 0.006 and social life (p = 0.005. However, there was no difference in the proportion of patients diagnosed with depression between the three groups (chi square for trend = 0.391, p = 0.532, and the intervention also had no effect on post-traumatic stress disorder.A brief psychological intervention, which included psychological

A Randomized Controlled Trial of a Brief Intervention for Delayed Psychological Effects in Snakebite Victims.

Science.gov (United States)

Wijesinghe, Chamara A; Williams, Shehan S; Kasturiratne, Anuradhani; Dolawaththa, Nishantha; Wimalaratne, Piyal; Wijewickrema, Buddhika; Jayamanne, Shaluka F; Isbister, Geoffrey K; Dawson, Andrew H; Lalloo, David G; de Silva, H Janaka

2015-01-01

Snakebite results in delayed psychological morbidity and negative psycho-social impact. However, psychological support is rarely provided to victims. To assess the effectiveness of a brief intervention which can be provided by non-specialist doctors aimed at reducing psychological morbidity following snakebite envenoming. In a single blind, randomized controlled trial, snakebite victims with systemic envenoming [n = 225, 168 males, mean age 42.1 (SD 12.4) years] were randomized into three arms. One arm received no intervention (n = 68, Group A), the second received psychological first aid and psychoeducation (dispelling prevalent cultural beliefs related to snakebite which promote development of a sick role) at discharge from hospital (n = 65, Group B), while the third received psychological first aid and psychoeducation at discharge and a second intervention one month later based on cognitive behavioural principles (n = 69, Group C). All patients were assessed six months after hospital discharge for the presence of psychological symptoms and level of functioning using standardized tools. At six months, there was a decreasing trend in the proportion of patients who were positive for psychiatric symptoms of depression and anxiety from Group A through Group B to Group C (Chi square test for trend = 7.901, p = 0.005). This was mainly due to a decreasing trend for symptoms of anxiety (chi-square for trend = 11.256, p = 0.001). There was also decreasing trend in the overall prevalence of disability from Group A through Group B to Group C (chi square for trend = 7.551, p = 0.006), predominantly in relation to disability in family life (p = 0.006) and social life (p = 0.005). However, there was no difference in the proportion of patients diagnosed with depression between the three groups (chi square for trend = 0.391, p = 0.532), and the intervention also had no effect on post-traumatic stress disorder. A brief psychological intervention, which included psychological

Do all psychological treatments really work the same in posttraumatic stress disorder?

OpenAIRE

Ehlers, Anke; Bisson, Jonathan; Clark, David M.; Creamer, Mark; Pilling, Steven; Richards, David; Schnurr, Paula P.; Turner, Stuart; Yule, William

2010-01-01

A recent meta-analysis by Benish, Imel, and Wampold (2008, Clinical Psychology Review, 28, 746–758) concluded that all bona fide treatments are equally effective in posttraumatic stress disorder (PTSD). In contrast, seven other meta-analyses or systematic reviews concluded that there is good evidence that trauma-focused psychological treatments (trauma-focused cognitive behavior therapy and eye movement desensitization and reprocessing) are effective in PTSD; but that treatments that do not f...

A Randomised Controlled Trial to Determine the Effectiveness of an Early Psychological Intervention with Children Involved in Road Traffic Accidents

Science.gov (United States)

Stallard, Paul; Velleman, Richard; Salter, Emma; Howse, Imogen; Yule, William; Taylor, Gordon

2006-01-01

Objective: To determine whether an early intervention using a psychological debriefing format is effective in preventing psychological distress in child road traffic accident survivors. Design: Randomised controlled trial. Setting: Accident and Emergency Department, Royal United Hospital, Bath. Subjects: 158 children aged 7-18. Follow-up…

Psychological Treatments for Binge Eating Disorder

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Gredysa, Dana M.; Altman, Myra; Wilfley, Denise E.

2012-01-01

Binge eating disorder (BED) is the most prevalent eating disorder in adults, and individuals with BED report greater general and specific psychopathology than non-eating disordered individuals. The current paper reviews research on psychological treatments for BED, including the rationale and empirical support for cognitive behavioral therapy (CBT), interpersonal psychotherapy (IPT), dialectical behavior therapy (DBT), behavioral weight loss (BWL), and other treatments warranting further study. Research supports the effectiveness of CBT and IPT for the treatment of BED, particularly for those with higher eating disorder and general psychopathology. Guided self-help CBT has shown efficacy for BED without additional pathology. DBT has shown some promise as a treatment for BED, but requires further study to determine its long-term efficacy. Predictors and moderators of treatment response, such as weight and shape concerns, are highlighted and a stepped-care model proposed. Future directions include expanding the adoption of efficacious treatments in clinical practice, testing adapted treatments in diverse samples (e.g., minorities and youth), improving treatment outcomes for nonresponders, and developing efficient and cost-effective stepped-care models. PMID:22707016

Mindfulness-Based Cognitive Therapy as a Treatment for Chronic Tinnitus: A Randomized Controlled Trial.

Science.gov (United States)

McKenna, Laurence; Marks, Elizabeth M; Hallsworth, Christopher A; Schaette, Roland

2017-01-01

Tinnitus is experienced by up to 15% of the population and can lead to significant disability and distress. There is rarely a medical or surgical target and psychological therapies are recommended. We investigated whether mindfulness-based cognitive therapy (MBCT) could offer an effective new therapy for tinnitus. This single-site randomized controlled trial compared MBCT to intensive relaxation training (RT) for chronic, distressing tinnitus in adults. Both treatments involved 8 weekly, 120-min sessions focused on either relaxation (RT) or mindfulness meditation (MBCT). Assessments were completed at baseline and at treatment commencement 8 weeks later. The primary outcomes were tinnitus severity (Tinnitus Questionnaire) and psychological distress (Clinical Outcomes in Routine Evaluation - Non-Risk, CORE-NR), 16 weeks after baseline. The analysis utilized a modified intention-to-treat approach. A total of 75 patients were randomly allocated to MBCT (n = 39) or RT (n = 36). Both groups showed significant reductions in tinnitus severity and loudness, psychological distress, anxiety, depression, and disability. MBCT led to a significantly greater reduction in tinnitus severity than RT, with a mean difference of 6.3 (95% CI 1.3-11.4, p = 0.016). Effects persisted 6 months later, with a mean difference of 7.2 (95% CI 2.1-2.3, p = 0.006) and a standardized effect size of 0.56 (95% CI 0.16-0.96). Treatment was effective regardless of initial tinnitus severity, duration, or hearing loss. MBCT is effective in reducing tinnitus severity in chronic tinnitus patients compared to intensive RT. It also reduces psychological distress and disability. Future studies should explore the generalizability of this approach and how outcome relates to different aspects of the intervention. © 2017 The Author(s) Published by S. Karger AG, Basel.

Cognitive enhancement treatments for bipolar disorder

DEFF Research Database (Denmark)

Miskowiak, Kamilla W; Carvalho, André F; Vieta, Eduard

2016-01-01

Cognitive dysfunction is an emerging treatment target in bipolar disorder (BD). Several trials have assessed the efficacy of novel pharmacological and psychological treatments on cognition in BD but the findings are contradictory and unclear. A systematic search following the PRISMA guidelines...... was conducted on PubMed and PsychInfo. Eligible articles reported randomized, controlled or open-label trials investigating pharmacological or psychological treatments targeting cognitive dysfunction in BD. The quality of the identified randomized controlled trials (RCTs) was evaluated with the Cochrane...... Collaboration's Risk of Bias tool. We identified 19 eligible studies of which 13 were RCTs and six were open-label or non-randomized studies. The findings regarding efficacy on cognition were overall disappointing or preliminary, possibly due to several methodological challenges. For the RCTs, the risk of bias...

Psychological interventions for people with cystic fibrosis and their families.

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Glasscoe, Claire A; Quittner, Alexandra L

2008-07-16

With increasing survival estimates for cystic fibrosis (CF) long-term management has become an important focus. Psychological interventions are largely concerned with adherence to treatment, emotional and social adjustments and quality of life. We are unaware of any relevant systematic reviews. Assess whether psychological interventions for CF provide significant psychosocial and physical benefits in addition to standard care. Trials were identified from two Cochrane trial registers (CF and Genetic Disorders Group; Depression, Anxiety and Neurosis Group), Ovid MEDLINE and PsychINFO; unpublished trials were located through professional networks and Listserves. Most recent search: September 2007. Randomised controlled trials of a broad range of psychological interventions in children and adults with CF and their immediate family. Two authors independently selected relevant trials and assessed their methodological quality. The review includes 13 studies (five new at this update) representing data from 529 participants. Studies mainly assessed behavioural and educational interventions:1. gene pre-test education counselling for relatives of those with CF;2. biofeedback, massage and music therapy to assist physiotherapy;3. behavioural and educational interventions to improve dietary intake and airway clearance;4. self-administration of medication and education to promote independence, knowledge and quality of life; and5. systemic interventions promoting psychosocial functioning.A substantial proportion of outcomes were educational or behavioural relating to issues of adherence, change in physical status or other specific treatment concerns during the chronic phase of the disease. Some evidence was found for relative's acceptance of a genetic test for carrier status when using home-based rather than clinic-based information leaflets and testing. There is some evidence that behavioural interventions improve emotional outcomes in people with CF and their carers, and that

Is weight gain really a catalyst for broader recovery?: The impact of weight gain on psychological symptoms in the treatment of adolescent anorexia nervosa.

Science.gov (United States)

Accurso, Erin C; Ciao, Anna C; Fitzsimmons-Craft, Ellen E; Lock, James D; Le Grange, Daniel

2014-05-01

The main aims of this study were to describe change in psychological outcomes for adolescents with anorexia nervosa across two treatments, and to explore predictors of change, including baseline demographic and clinical characteristics, as well as weight gain over time. Participants were 121 adolescents with anorexia nervosa from a two-site (Chicago and Stanford) randomized controlled trial who received either family-based treatment or individual adolescent supportive psychotherapy. Psychological symptoms (i.e., eating disorder psychopathology, depressive symptoms, and self-esteem) were assessed at baseline, end of treatment, 6-month, and 12-month follow-up. Conditional multilevel growth models were used to test for predictors of slope for each outcome. Most psychological symptoms improved significantly from baseline to 12 month follow-up, regardless of treatment type. Depressive symptoms and dietary restraint were most improved, weight and shape concerns were least improved, and self-esteem was not at all improved. Weight gain emerged as a significant predictor of improved eating disorder pathology, with earlier weight gain having a greater impact on symptom improvement than later weight gain. Adolescents who presented with more severe, complex, and enduring clinical presentations (i.e., longer duration of illness, greater eating disorder pathology, binge-eating/purging subtype) also appeared to benefit more psychologically from treatment. Copyright © 2014 Elsevier Ltd. All rights reserved.

The role of psychological correction in discogenic dorsopathies treatment

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N. Chuhraev

2017-02-01

  1. LLC «NMZ Мedintech», Kiev, Ukraine. Email: nv11111@mail.ru 2. Kazimierz Wielki University, Bydgoszcz, Poland 3. National Medical Academy of Postgraduate Education named P. L. Shupik, Department of neurology №1, Kiev, Ukraine 4. Private higher education institution «Interregional Academy of Personnel Management», Kiev, Ukraine     Summary   The article dials with the role of psychological correction in the treatment of discogenic dorsopathies based on zonal applicated ultraphonophoresis of analgesic drugs and psychological treatment of anxious depression (F41.2 Mixed anxiety and depressive disorder with the use of binaural rhythms and magnetofotostimulation.     Keywords: discogenic dorsopathy, anxious depression, binaural rhythms, magnetofotostimulation.

Psychological distress, quality of life, symptoms and unmet needs of colorectal cancer survivors near the end of treatment.

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Russell, Lahiru; Gough, Karla; Drosdowsky, Allison; Schofield, Penelope; Aranda, Sanchia; Butow, Phyllis N; Westwood, Jennifer A; Krishnasamy, Mei; Young, Jane M; Phipps-Nelson, Jo; King, Dorothy; Jefford, Michael

2015-09-01

This study investigated psychological morbidity, quality of life (QoL), colorectal cancer (CRC)-specific symptoms and supportive care needs in a CRC population at the end of treatment (EOT). CRC survivors (n = 152) completed a post-treatment baseline questionnaire as part of a multisite supportive care randomised controlled trial (SurvivorCare). CRC survivors had completed treatment with curative intent within 0 to 6 months. Measures are as follows: Brief Symptom Inventory 18 (BSI-18) (psychological morbidity), EORTC QLQ-C30 and QLQ-CR29 (QoL and CRC-specific symptoms and problems) and Cancer Survivors' Unmet Needs (CaSUN) measure with a simplified response format (unmet needs). Linear regression models were used to compare participants' QoL with a general population sample. Correlation analysis examined associations between psychological morbidity, QoL and CRC-specific symptoms and problems. Average participant age was 64 years, and 51% were male. The majority (68%) had stage 3 disease. In comparison to population norms, CRC survivors had lower depression and anxiety scores (47.4 and 45.6, respectively) but higher somatisation, and lower role, cognitive and social functioning (p < 0.001). CRC survivors had higher fatigue, nausea/vomiting, appetite loss, diarrhoea and financial problems (all p < 0.001), as well as pain (p = 0.002) and constipation (p = 0.019). CRC-specific psychological scores were positively correlated with all three BSI domain scores, and pain and fatigue symptom scores on the QLQ-C30 while negatively correlated with all five functional scales of the QLQ-C30. CRC survivors reported good mental health at EOT. Role and social functioning were impaired compared to population norms, possibly related to physical symptoms. Findings may help guide consultations with patients and inform the design of more tailored supportive care interventions. ACTRN12610000207011.

An open trial of individualized face-to-face cognitive behavior therapy for psychological distress in parents of children after end of treatment for childhood cancer including a cognitive behavioral conceptualization

OpenAIRE

Lisa Ljungman; Martin Cernvall; Ata Ghaderi; Gustaf Ljungman; Louise von Essen; Brjánn Ljótsson

2018-01-01

Objective A subgroup of parents of children who have been treated for childhood cancer report high levels of psychological distress. To date there is no empirically supported psychological treatment targeting cancer-related psychological distress in this population. The aim of the current study was to test the feasibility and preliminarily evaluate the effect of individualized face-to-face cognitive behavior therapy (CBT) for parents of children after the end of treatment for childhood cancer...

Pilot study of a social network intervention for heroin users in opiate substitution treatment: study protocol for a randomized controlled trial.

Science.gov (United States)

Day, Edward; Copello, Alex; Seddon, Jennifer L; Christie, Marilyn; Bamber, Deborah; Powell, Charlotte; George, Sanju; Ball, Andrew; Frew, Emma; Freemantle, Nicholas

2013-08-19

Research indicates that 3% of people receiving opiate substitution treatment (OST) in the UK manage to achieve abstinence from all prescribed and illicit drugs within 3 years of commencing treatment, and there is concern that treatment services have become skilled at engaging people but not at helping them to enter a stage of recovery and drug abstinence. The National Treatment Agency for Substance Misuse recommends the involvement of families and wider social networks in supporting drug users' psychological treatment, and this pilot randomized controlled trial aims to evaluate the impact of a social network-focused intervention for patients receiving OST. In this two-site, early phase, randomized controlled trial, a total of 120 patients receiving OST will be recruited and randomized to receive one of three treatments: 1) Brief Social Behavior and Network Therapy (B-SBNT), 2) Personal Goal Setting (PGS) or 3) treatment as usual. Randomization will take place following baseline assessment. Participants allocated to receive B-SBNT or PGS will continue to receive the same treatment that is routinely provided by drug treatment services, plus four additional sessions of either intervention. Outcomes will be assessed at baseline, 3 and 12 months. The primary outcome will be assessment of illicit heroin use, measured by both urinary analysis and self-report. Secondary outcomes involve assessment of dependence, psychological symptoms, social satisfaction, motivation to change, quality of life and therapeutic engagement. Family members (n = 120) of patients involved in the trial will also be assessed to measure the level of symptoms, coping and the impact of the addiction problem on the family member at baseline, 3 and 12 months. This study will provide experimental data regarding the feasibility and efficacy of implementing a social network intervention within routine drug treatment services in the UK National Health Service. The study will explore the impact of the

Enhancing Placebo Effects: Insights From Social Psychology

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SLIWINSKI, JIM; ELKINS, GARY R.

2012-01-01

Placebo effects are widely recognized as having a potent impact upon treatment outcomes in both medical and psychological interventions, including hypnosis. In research utilizing randomized clinical trials, there is usually an effort to minimize or control placebo effects. However, in clinical practice there may be significant benefits in enhancing placebo effects. Prior research from the field of social psychology has identified three factors that may enhance placebo effects, namely: priming, client perceptions, and the theory of planned behavior. These factors are reviewed and illustrated via a case example. The consideration of social-psychological factors to enhance positive expectancies and beliefs has implications for clinical practice as well as future research into hypnotic interventions. PMID:23488251

Psychological approaches in the treatment of specific phobias: A meta-analysis

NARCIS (Netherlands)

Wolitzky-Taylor, K.B.; Horowitz, J.D.; Powers, M.B.; Telch, M.J.

2008-01-01

Data from 33 randomized treatment studies were subjected to a meta-analysis to address questions surrounding the efficacy of psychological approaches in the treatment of specific phobia. As expected, exposure-based treatment produced large effects sizes relative to no treatment. They also

Effects of a Psychological Intervention in a Primary Health Care Center for Caregivers of Dependent Relatives: A Randomized Trial

Science.gov (United States)

Rodriguez-Sanchez, Emiliano; Patino-Alonso, Maria C.; Mora-Simon, Sara; Gomez-Marcos, Manuel A.; Perez-Penaranda, Anibal; Losada-Baltar, Andres; Garcia-Ortiz, Luis

2013-01-01

Purpose: To assess, in the context of Primary Health Care (PHC), the effect of a psychological intervention in mental health among caregivers (CGs) of dependent relatives. Design and Methods: Randomized multicenter, controlled clinical trial. The 125 CGs included in the trial were receiving health care in PHC. Inclusion criteria: Identifying…

Psychological determinants of life satisfaction in women undergoing infertility treatment

Directory of Open Access Journals (Sweden)

Aleksandra Anna Dembińska

2016-01-01

Full Text Available Background Infertility treatment is a long-term process, spread out over months, or even years, and carries no guarantee of success. It generates an incessant state of uncertainty which becomes a chronic state of psychological discomfort. Each stage of treatment may become a source of more trouble. Women deciding to undergo infertility treatment are exposed to many negative feelings concerning different aspects of their life. Participants and procedure The present study was an attempt to understand psychological determinants of life satisfaction in women undergoing infertility treatment. The study group included 470 women treated for infertility. Results Patients perceiving more social support in general, as well as more of the support types used in the study, i.e. emotional, instrumental, informational and institutional support, and support from family and friends, have better self-esteem, higher acceptance of their infertility, higher satisfaction with life, higher hope as an emotional state, and lower levels of anxiety and depression. Three negative emotional states, i.e. anxiety, depression and irritation, are predictors influencing (lowering life satisfaction of women struggling with infertility. The strongest of these predictors is depression, which is also a factor lowering the acceptance of one’s own infertility. The conducted analyses revealed that predictors influencing the life satisfaction of patients treated for infertility are self-esteem and acceptance of one’s own infertility (apart from the aforementioned emotional state – anxiety, depression, irritation. It was found that the higher the self-esteem and acceptance of one’s own infertility, the higher was the satisfaction with life. Conclusions Knowledge of these determinants is extremely valuable for medical personnel conducting treatments, because, according to many studies, the psychological state of women suffering from procreation problems is connected not only with

Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial.

Directory of Open Access Journals (Sweden)

Richard A Bryant

2017-08-01

Full Text Available Gender-based violence (GBV represents a major cause of psychological morbidity worldwide, and particularly in low- and middle-income countries (LMICs. Although there are effective treatments for common mental disorders associated with GBV, they typically require lengthy treatment programs that may limit scaling up in LMICs. The aim of this study was to test the effectiveness of a new 5-session behavioural treatment called Problem Management Plus (PM+ that lay community workers can be taught to deliver.In this single-blind, parallel, randomised controlled trial, adult women who had experienced GBV were identified through community screening for psychological distress and impaired functioning in Nairobi, Kenya. Participants were randomly allocated in a 1:1 ratio either to PM+ delivered in the community by lay community health workers provided with 8 days of training or to facility-based enhanced usual care (EUC provided by community nurses. Participants were aware of treatment allocation, but research assessors were blinded. The primary outcome was psychological distress as measured by the total score on the 12-item General Health Questionnaire (GHQ-12 assessed at 3 months after treatment. Secondary outcomes were impaired functioning (measured by the WHO Disability Adjustment Schedule [WHODAS], symptoms of posttraumatic stress (measured by the Posttraumatic Stress Disorder Checklist [PCL], personally identified problems (measured by Psychological Outcome Profiles [PSYCHLOPS], stressful life events (measured by the Life Events Checklist [LEC], and health service utilisation. Between 15 April 2015 and 20 August 2015, 1,393 women were screened for eligibility on the basis of psychological distress and impaired functioning. Of these, 518 women (37% screened positive, of whom 421 (81% were women who had experienced GBV. Of these 421 women, 209 were assigned to PM+ and 212 to EUC. Follow-up assessments were completed on 16 January 2016. The primary

Female Sexual Dysfunction-Medical and Psychological Treatments, Committee 14.

Science.gov (United States)

Kingsberg, Sheryl A; Althof, Stanley; Simon, James A; Bradford, Andrea; Bitzer, Johannes; Carvalho, Joana; Flynn, Kathryn E; Nappi, Rossella E; Reese, Jennifer B; Rezaee, Roya L; Schover, Leslie; Shifrin, Jan L

2017-12-01

Since the millennium we have witnessed significant strides in the science and treatment of female sexual dysfunction (FSD). This forward progress has included (i) the development of new theoretical models to describe healthy and dysfunctional sexual responses in women; (ii) alternative classification strategies of female sexual disorders; (iii) major advances in brain, hormonal, psychological, and interpersonal research focusing on etiologic factors and treatment approaches; (iv) strong and effective public advocacy for FSD; and (v) greater educational awareness of the impact of FSD on the woman and her partner. To review the literature and describe the best practices for assessing and treating women with hypoactive sexual desire disorder, female sexual arousal disorder, and female orgasmic disorders. The committee undertook a comprehensive review of the literature and discussion among themselves to determine the best assessment and treatment methods. Using a biopsychosocial lens, the committee presents recommendations (with levels of evidence) for assessment and treatment of hypoactive sexual desire disorder, female sexual arousal disorder, and female orgasmic disorders. The numerous significant strides in FSD that have occurred since the previous International Consultation of Sexual Medicine publications are reviewed in this article. Although evidence supports an integrated biopsychosocial approach to assessment and treatment of these disorders, the biological and psychological factors are artificially separated for review purposes. We recognize that best outcomes are achieved when all relevant factors are identified and addressed by the clinician and patient working together in concert (the sum is greater than the whole of its parts). Kingsberg SA, Althof S, Simon JA, et al. Female Sexual Dysfunction-Medical and Psychological Treatments, Committee 14. J Sex Med 2017;14:1463-1491. Copyright © 2017 International Society for Sexual Medicine. Published by

Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial.

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Van Gordon, William; Shonin, Edo; Dunn, Thomas J; Garcia-Campayo, Javier; Griffiths, Mark D

2017-02-01

The purpose of this study was to conduct the first randomized controlled trial (RCT) to evaluate the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating fibromyalgia syndrome (FMS). Compared to first-generation mindfulness-based interventions, SG-MBIs are more acknowledging of the spiritual aspect of mindfulness. A RCT employing intent-to-treat analysis. Adults with FMS received an 8-week SG-MBI known as meditation awareness training (MAT; n = 74) or an active control intervention known as cognitive behaviour theory for groups (n = 74). Assessments were performed at pre-, post-, and 6-month follow-up phases. Meditation awareness training participants demonstrated significant and sustained improvements over control group participants in FMS symptomatology, pain perception, sleep quality, psychological distress, non-attachment (to self, symptoms, and environment), and civic engagement. A mediation analysis found that (1) civic engagement partially mediated treatment effects for all outcome variables, (2) non-attachment partially mediated treatment effects for psychological distress and sleep quality, and (3) non-attachment almost fully mediated treatment effects for FMS symptomatology and pain perception. Average daily time spent in meditation was found to be a significant predictor of changes in all outcome variables. Meditation awareness training may be a suitable treatment for adults with FMS and appears to ameliorate FMS symptomatology and pain perception by reducing attachment to self. Statement of contribution What is already known on this subject? Designing interventions to treat fibromyalgia syndrome (FMS) continues to be a challenge. There is growing interest into the applications of mindfulness-based interventions for treating FMS. Second-generation mindfulness-based interventions (SG-MBIs) are a key new direction in mindfulness research. What does this study add? Meditation awareness training - an SG-MBI - resulted

Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention

DEFF Research Database (Denmark)

Krogsbøll, Lasse Theis; Hróbjartsson, Asbjørn; Gøtzsche, Peter C

2009-01-01

were psychological in 17 trials, physical in 15 trials, and pharmacological in 5 trials. Overall, across all conditions and interventions, there was a statistically significant change from baseline in all three arms. The standardized mean difference (SMD) for change from baseline was -0.24 (95...... uncertainty, as indicated by the confidence intervals for the three SMDs. The conditions that had the most pronounced spontaneous improvement were nausea (45%), smoking (40%), depression (35%), phobia (34%) and acute pain (25%). CONCLUSION: Spontaneous improvement and effect of placebo contributed importantly...

Social networking sites: an adjunctive treatment modality for psychological problems.

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Menon, Indu S; Sharma, Manoj Kumar; Chandra, Prabha S; Thennarasu, K

2014-07-01

Social networking is seen as a way to enhance social support and feeling of well-being. The present work explores the potentials of social networking sites as an adjunctive treatment modality for initiating treatment contact as well as for managing psychological problems. Interview schedule, Facebook intensity questionnaire were administered on 28 subjects with a combination of 18 males and 10 females. They were taken from the in-patient and out-patient psychiatry setting of the hospital. Facebook was the most popular sites and used to seek emotional support on the basis of the frequent updates of emotional content that users put in their profile; reconciliations, escape from the problems or to manage the loneliness; getting information about illness and its treatment and interaction with experts and also manifested as problematic use. It has implications for developing social networking based adjunctive treatment modality for psychological problems.

Psychological therapies (remotely delivered) for the management of chronic and recurrent pain in children and adolescents.

Science.gov (United States)

Fisher, Emma; Law, Emily; Palermo, Tonya M; Eccleston, Christopher

2015-03-23

Chronic pain is common during childhood and adolescence and is associated with negative outcomes such as increased severity of pain, reduced function (e.g. missing school), and low mood (e.g. high levels of depression and anxiety). Psychological therapies, traditionally delivered face-to-face with a therapist, are efficacious at reducing pain intensity and disability. However, new and innovative technology is being used to deliver these psychological therapies remotely, meaning barriers to access to treatment such as distance and cost can be removed or reduced. Therapies delivered with technological devices, such as the Internet, computer-based programmes, smartphone applications, or via the telephone, can be used to deliver treatment to children and adolescents with chronic pain. To determine the efficacy of psychological therapies delivered remotely compared to waiting-list, treatment-as-usual, or active control treatments, for the management of chronic pain in children and adolescents. We searched four databases (CENTRAL, MEDLINE, EMBASE, and PsycINFO) from inception to June 2014 for randomised controlled trials of remotely delivered psychological interventions for children and adolescents (0 to 18 years of age) with chronic pain. We searched for chronic pain conditions including, but not exclusive to, headache, recurrent abdominal pain, musculoskeletal pain, and neuropathic pain. We also searched online trial registries for potential trials. A citation and reference search for all included studies was conducted. All included studies were randomised controlled trials that investigated the efficacy of a psychological therapy delivered remotely via the Internet, smartphone device, computer-based programme, audiotapes, or over the phone in comparison to an active, treatment-as-usual, or waiting-list control. We considered blended treatments, which used a combination of technology and face-to-face interaction. We excluded interventions solely delivered face

Current treatment for anorexia nervosa: efficacy, safety, and adherence

Directory of Open Access Journals (Sweden)

Lindsay P Bodell

2010-10-01

Full Text Available Lindsay P Bodell, Pamela K KeelDepartment of Psychology, Florida State University, Tallahassee, FL, USAAbstract: Anorexia nervosa (AN is a serious psychiatric illness associated with significant medical and psychiatric morbidity, psychosocial impairment, increased risk of death, and chronicity. Given the severity of the disorder, the establishment of safe and effective treatments is necessary. Several treatments have been tried in AN, but few favorable results have emerged. This paper reviews randomized controlled trials in AN, and provides a synthesis of existing data regarding the efficacy, safety, and adherence associated with pharmacologic and psychological interventions. Randomized controlled trials for the treatment of AN published in peer-reviewed journals were identified by electronic and manual searches. Overall, pharmacotherapy has limited benefits in the treatment of AN, with some promising preliminary findings associated with olanzapine, an antipsychotic agent. No single psychological intervention has demonstrated clear superiority in treating adults with AN. In adolescents with AN, the evidence base is strongest for the use of family therapy over alternative individual psychotherapies. Results highlight challenges in both treating individuals with AN and in studying the effects of those treatments, and further emphasize the importance of continued efforts to develop novel interventions. Treatment trials currently underway and areas for future research are discussed.Keywords: anorexia nervosa, treatment, pharmacotherapy, psychotherapy, randomized controlled trials

[Psychological approaches in hypertension management].

Science.gov (United States)

Abgrall-Barbry, Gaëlle; Consoli, Silla M

2006-06-01

Stress factors, especially high levels of occupational stress, are associated with hypertension. Several so-called psychological techniques have been applied to hypertension: biofeedback, relaxation techniques (Schultz' autogenic training, Jacobson's progressive relaxation), transcendental meditation, and cognitive behavioral techniques for stress management. Randomized studies show that the best results come from cognitive behavioral methods, whether or not they include relaxation techniques. Other forms of psychotherapy (such as psychoanalysis) may be useful, although their benefits for blood pressure have not been tested in controlled trials. Patients should be informed about the personal benefits they may obtain from psychological treatment. Indications are hyperreactivity to stress, high levels of occupational stress, and difficulty in tolerating or complying with antihypertensive drugs.

Barriers to treatment for older adults seeking psychological therapy.

Science.gov (United States)

Wuthrich, Viviana M; Frei, Jacqueline

2015-07-01

Older adults with mental health disorders underutilize mental health services more than other adults. While there are well known general barriers to help seeking across the population, specific barriers for older adults include difficulties with transportation, beliefs that it is normal to be anxious and depressed in old age, and beliefs by referrers that psychological therapy is less likely to be effective. This study examined barriers related to identifying the need for help, seeking help and participating in therapy in a clinical population of older adults. Sixty older adults (aged 60-79 years) with comorbid anxiety and unipolar mood disorders completed barriers to treatment questionnaires before and after psychological group treatment, as well as measures of cognitive ability, anxiety, depression, and quality of life at baseline. The greatest barriers to help seeking related to difficulties identifying the need for help, with 50% of the sample reporting their belief that their symptoms were normal as a major barrier. Other major barriers identified were related to: self-reliance, cost of treatment, and fear of medication replicating previous findings. The main barriers reported for difficulties in continuing therapy included not finding therapy helpful, cost of treatment, and thinking that the therapist did not understand their issues. The main barriers identified related to issues with identifying the need to seek help. More attention is needed to educate older adults and professionals about the need for, and effectiveness of, psychological therapies for older adults with anxiety and depression to reduce this barrier to help seeking.

Psychological comorbidities and compliance to interventional treatment of patients with cutaneous vascular malformations.

Science.gov (United States)

Kenny, Stephanie A; Majeed, Nevin; Zhand, Naista; Glikstein, Rafael; Agid, Ronit; Dos Santos, Marlise P

2016-08-01

The aim of this study was to assess qualitatively the psychological stressors affecting patients with cutaneous vascular malformations and hemangiomas (CVM-H) and their impact on compliance to interventional treatment. A retrospective chart review was conducted of all patients with CVM-H treated by interventional neuroradiology at a single academic institution during a five-year period (2009-2014). Psychological complaints were documented during each clinic visit by a neuroradiologist. Compliance to interventional treatment was defined by adherence to the scheduled treatment sessions. Fisher's exact test was used to assess for associations between psychological complaints and compliance. Seventy-five patients were assessed, of whom 49 (65.3%) were female, with an age range of 2-78 years (mean age 30.2 years). All except one patient older than seven years of age (n = 71; 94.6%) had a psychological complaint, including fear of negative appearance (n = 53; 70.6%), dissatisfaction with appearance (n = 46; 61.3%), low self-esteem (n = 35; 46.6%), anxiety (n = 16; 21.3%), stress (n = 13; 17.3%), bullying (n = 5; 6.6%), and low mood (n = 4; 5.3%). Twenty-three (31%) patients were non-compliant. Low self-esteem was significantly associated with non-compliance (p = 0.0381). There is a high prevalence of psychological comorbidities among patients treated for CVM-H. This has potential implications for interventional treatment, as it was found that low self-esteem is significantly associated with non-compliance. These results suggest the need for early psychological support in these patients in order to maximize compliance to interventional treatment. © The Author(s) 2016.

Psychological and behavioral approaches to cancer pain management.

Science.gov (United States)

Syrjala, Karen L; Jensen, Mark P; Mendoza, M Elena; Yi, Jean C; Fisher, Hannah M; Keefe, Francis J

2014-06-01

This review examines evidence for psychological factors that affect pain across the cancer continuum from diagnosis through treatment and long-term survivorship or end of life. Evidence is convincing that emotional distress, depression, anxiety, uncertainty, and hopelessness interact with pain. Unrelieved pain can increase a desire for hastened death. Patients with cancer use many strategies to manage pain, with catastrophizing associated with increased pain and self-efficacy associated with lower pain reports. A variety of psychological and cognitive behavioral treatments can reduce pain severity and interference with function, as indicated in multiple meta-analyses and high-quality randomized controlled trials. Effective methods include education (with coping skills training), hypnosis, cognitive behavioral approaches, and relaxation with imagery. Exercise has been tested extensively in patients with cancer and long-term survivors, but few exercise studies have evaluated pain outcomes. In survivors post-treatment, yoga and hypnosis as well as exercise show promise for controlling pain. Although some of these treatments effectively reduce pain for patients with advanced disease, few have been tested in patients at the end of life. Given the clear indicators that psychological factors affect cancer pain and that psychological and behavioral treatments are effective in reducing varying types of pain for patients with active disease, these methods need further testing in cancer survivors post-treatment and in patients with end-stage disease. Multidisciplinary teams are essential in oncology settings to integrate analgesic care and expertise in psychological and behavioral interventions in standard care for symptom management, including pain. © 2014 by American Society of Clinical Oncology.

From neuroscience to evidence based psychological treatments - The promise and the challenge, ECNP March 2016, Nice, France.

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Goodwin, Guy M; Holmes, Emily A; Andersson, Erik; Browning, Michael; Jones, Andrew; Lass-Hennemann, Johanna; Månsson, Kristoffer Nt; Moessnang, Carolin; Salemink, Elske; Sanchez, Alvaro; van Zutphen, Linda; Visser, Renée M

2018-02-01

This ECNP meeting was designed to build bridges between different constituencies of mental illness treatment researchers from a range of backgrounds with a specific focus on enhancing the development of novel, evidence based, psychological treatments. In particular we wished to explore the potential for basic neuroscience to support the development of more effective psychological treatments, just as this approach is starting to illuminate the actions of drugs. To fulfil this aim, a selection of clinical psychologists, psychiatrists and neuroscientists were invited to sit at the same table. The starting point of the meeting was the proposition that we know certain psychological treatments work, but we have only an approximate understanding of why they work. The first task in developing a coherent mental health science would therefore be to uncover the mechanisms (at all levels of analysis) of effective psychological treatments. Delineating these mechanisms, a task that will require input from both the clinic and the laboratory, will provide a key foundation for the rational optimisation of psychological treatments. As reviewed in this paper, the speakers at the meeting reviewed recent advances in the understanding of clinical and cognitive psychology, neuroscience, experimental psychopathology, and treatment delivery technology focussed primarily on anxiety disorders and depression. We started by asking three rhetorical questions: What has psychology done for treatment? What has technology done for psychology? What has neuroscience done for psychology? We then addressed how research in five broad research areas could inform the future development of better treatments: Attention, Conditioning, Compulsions and addiction, Emotional Memory, and Reward and emotional bias. Research in all these areas (and more) can be harnessed to neuroscience since psychological therapies are a learning process with a biological basis in the brain. Because current treatment approaches

Cost-effectiveness of exercise as a therapy for behavioural and psychological symptoms of dementia within the EVIDEM-E randomised controlled trial.

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D'Amico, Francesco; Rehill, Amritpal; Knapp, Martin; Lowery, David; Cerga-Pashoja, Arlinda; Griffin, Mark; Iliffe, Steve; Warner, James

2016-06-01

Although available evidence is modest, exercise could be beneficial in reducing behavioural and psychological symptoms of dementia. We aim to evaluate the cost-effectiveness of a dyadic exercise regimen for individuals with dementia and their main carer as therapy for behavioural and psychological symptoms of dementia. Cost-effectiveness analysis within a two-arm, pragmatic, randomised, controlled, single-blind, parallel-group trial of a dyadic exercise regimen (individually tailored, for 20-30 min at least five times per week). The study randomised 131 community-dwelling individuals with dementia and clinically significant behavioural and psychological symptoms with a carer willing and able to participate in the exercise regimen; 52 dyads provided sufficient cost data for analyses. Mean intervention cost was £284 per dyad. For the subsample of 52 dyads, the intervention group had significantly higher mean cost from a societal perspective (mean difference £2728.60, p = 0.05), but costs were not significantly different from a health and social care perspective. The exercise intervention was more cost-effective than treatment as usual from both societal and health and social care perspectives for the measure of behavioural and psychological symptoms (Neuropsychiatric Inventory). It does not appear cost-effective in terms of cost per quality-adjusted life year gain. The exercise intervention has the potential to be seen as cost-effective when considering behavioural and psychological symptoms but did not appear cost-effective when considering quality-adjusted life year gains. Copyright © 2015 John Wiley & Sons, Ltd.

Questionable assumptions hampered interpretation of a network meta-analysis of primary care depression treatments.

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Linde, Klaus; Rücker, Gerta; Schneider, Antonius; Kriston, Levente

2016-03-01

We aimed to evaluate the underlying assumptions of a network meta-analysis investigating which depression treatment works best in primary care and to highlight challenges and pitfalls of interpretation under consideration of these assumptions. We reviewed 100 randomized trials investigating pharmacologic and psychological treatments for primary care patients with depression. Network meta-analysis was carried out within a frequentist framework using response to treatment as outcome measure. Transitivity was assessed by epidemiologic judgment based on theoretical and empirical investigation of the distribution of trial characteristics across comparisons. Homogeneity and consistency were investigated by decomposing the Q statistic. There were important clinical and statistically significant differences between "pure" drug trials comparing pharmacologic substances with each other or placebo (63 trials) and trials including a psychological treatment arm (37 trials). Overall network meta-analysis produced results well comparable with separate meta-analyses of drug trials and psychological trials. Although the homogeneity and consistency assumptions were mostly met, we considered the transitivity assumption unjustifiable. An exchange of experience between reviewers and, if possible, some guidance on how reviewers addressing important clinical questions can proceed in situations where important assumptions for valid network meta-analysis are not met would be desirable. Copyright © 2016 Elsevier Inc. All rights reserved.

Family-related opinions and stressful situations associated with psychological distress in women undergoing infertility treatment.

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Takaki, Jiro; Hibino, Yuri

2014-09-02

The purpose of this study is to investigate how family-related opinions and stressful situations are related to psychological distress in women undergoing infertility treatment. The subjects in this cross-sectional study were recruited from female patients undergoing infertility treatment (n = 2540) at 70 infertility treatment institutions in Japan. Because of non-participation or missing data, the number of subjects included in the analysis was 635 (response rate, 25.0%). The family-related opinions and stressful situations were evaluated using the original questions. Psychological distress was assessed using a self-report measure, the Kessler Six-question Psychological Distress Scale (K6). The K6 scores of the following participants were significantly (p women should devote themselves to their household duties" those who had considered stopping treatment, those without the opinion that "married life without children is favorable" and those who had experienced stressful situations such as inadequate explanation by doctors, frustration of multiple failed attempts, differences of opinion with the partner, and lack of knowledge regarding when to stop treatment. Family-related opinions and stressful situations associated with psychological distress in women undergoing infertility treatment are outlined. The results of this study may contribute to the prevention of and care for psychological distress in female patients undergoing infertility treatment.

Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 2. Psychological Treatments.

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Parikh, Sagar V; Quilty, Lena C; Ravitz, Paula; Rosenbluth, Michael; Pavlova, Barbara; Grigoriadis, Sophie; Velyvis, Vytas; Kennedy, Sidney H; Lam, Raymond W; MacQueen, Glenda M; Milev, Roumen V; Ravindran, Arun V; Uher, Rudolf

2016-09-01

The Canadian Network for Mood and Anxiety Treatments (CANMAT) has revised its 2009 guidelines for the management of major depressive disorder (MDD) in adults by updating the evidence and recommendations. The target audiences for these 2016 guidelines are psychiatrists and other mental health professionals. Using the question-answer format, we conducted a systematic literature search focusing on systematic reviews and meta-analyses. Evidence was graded using CANMAT-defined criteria for level of evidence. Recommendations for lines of treatment were based on the quality of evidence and clinical expert consensus. "Psychological Treatments" is the second of six sections of the 2016 guidelines. Evidence-informed responses were developed for 25 questions under 5 broad categories: 1) patient characteristics relevant to using psychological interventions; 2) therapist and health system characteristics associated with optimizing outcomes; 3) descriptions of major psychotherapies and their efficacy; 4) additional psychological interventions, such as peer interventions and computer- and technology-delivered interventions; and 5) combining and/or sequencing psychological and pharmacological interventions. First-line psychological treatment recommendations for acute MDD include cognitive-behavioural therapy (CBT), interpersonal therapy (IPT), and behavioural activation (BA). Second-line recommendations include computer-based and telephone-delivered psychotherapy. Where feasible, combining psychological treatment (CBT or IPT) with antidepressant treatment is recommended because combined treatment is superior to either treatment alone. First-line psychological treatments for maintenance include CBT and mindfulness-based cognitive therapy (MBCT). Patient preference, in combination with evidence-based treatments and clinician/system capacity, will yield the optimal treatment strategies for improving individual outcomes in MDD. © The Author(s) 2016.

Treatment Acceptability of Interventions Published in Six School Psychology Journals

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Villarreal, Victor; Ponce, Christopher; Gutierrez, Heveli

2015-01-01

Treatment acceptability (TA) is critical when selecting and implementing an intervention, as TA is associated with treatment outcomes. The significance of TA is reflected in school psychology models for services that state that school psychologists should address TA during development, implementation, and evaluation of interventions. However, the…

Therapist adherence in the strong without anorexia nervosa (SWAN) study: A randomized controlled trial of three treatments for adults with anorexia nervosa.

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Andony, Louise J; Tay, Elaine; Allen, Karina L; Wade, Tracey D; Hay, Phillipa; Touyz, Stephen; McIntosh, Virginia V W; Treasure, Janet; Schmidt, Ulrike H; Fairburn, Christopher G; Erceg-Hurn, David M; Fursland, Anthea; Crosby, Ross D; Byrne, Susan M

2015-12-01

To develop a psychotherapy rating scale to measure therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center randomized controlled trial comparing three different psychological treatments for adults with anorexia nervosa. The three treatments under investigation were Enhanced Cognitive Behavioural Therapy (CBT-E), the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), and Specialist Supportive Clinical Management (SSCM). The SWAN Psychotherapy Rating Scale (SWAN-PRS) was developed, after consultation with the developers of the treatments, and refined. Using the SWAN-PRS, two independent raters initially rated 48 audiotapes of treatment sessions to yield inter-rater reliability data. One rater proceeded to rate a total of 98 audiotapes from 64 trial participants. The SWAN-PRS demonstrated sound psychometric properties, and was considered a reliable measure of therapist adherence. The three treatments were highly distinguishable by independent raters, with therapists demonstrating significantly more behaviors consistent with the actual allocated treatment compared to the other two treatment modalities. There were no significant site differences in therapist adherence observed. The findings provide support for the internal validity of the SWAN study. The SWAN-PRS was deemed suitable for use in other trials involving CBT-E, MANTRA, or SSCM. The Authors. International Journal of Eating Disorders Published by Wiley Periodicals, Inc.

The effectiveness of simple psychological and exercise interventions for high prevalence mental health problems in young people: a factorial randomised controlled trial

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Moller Bridget

2011-03-01

Full Text Available Abstract Background The prevalence of mental illness in young people is the highest of any age group, with the onset of depression, anxiety and substance use peaking between 18 and 24 years. Effective treatments that target sub-threshold or mild to moderate levels of disorder in young people are required to reduce the risk of persistence and recurrence. The aims of this study are to evaluate whether treatments that are less intensive than cognitive-behaviour therapy, such as problem solving therapy and exercise treatments, are acceptable and effective in managing depression and anxiety symptoms in young people and to identify possible attributes in those who are likely to respond to these treatments. Methods/design This is a factorial randomised controlled trial conducted at a large, metropolitan youth mental health service. Participants are young help-seekers aged 15-25 years with sub-threshold or mild to moderate levels of depression and anxiety (with or without comorbid substance use. The interventions comprise 4 treatment combinations delivered by psychologists over 6 sessions on a weekly basis: a psychological intervention (problem solving therapy versus supportive counselling and an exercise intervention (behavioural exercise versus psychoeducation. Structured assessments occur at baseline, mid-point, end-point (6 weeks and at a 6- and 12-month follow-up. The primary outcomes are depression and anxiety symptoms as measured by the Beck Depression and Anxiety Inventories. Secondary outcomes include remission (defined as no longer meeting the diagnostic criteria for a disorder if threshold level was reached at baseline, or no longer scoring in the clinical range on scale scores if sub-threshold at baseline, substance use, and functioning. Discussion The effectiveness of less complex psychological and exercise interventions in young help-seekers with sub-threshold or mild to moderate presentations of high prevalence disorders is yet to be

Intergenerational and cross-cultural differences in emotional wellbeing, mental health service utilisation, treatment-seeking preferences and acceptability of psychological treatments for Arab Australians.

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Kayrouz, Rony; Dear, Blake F; Johnston, Luke; Keyrouz, Liliane; Nehme, Edmond; Laube, Roy; Titov, Nickolai

2015-08-01

Little is known about the intergenerational and cross-cultural differences in emotional wellbeing and acceptability of psychological treatments for Arab Australians. To contribute to the emerging data about the mental health status and needs of Arab Australians. An Internet survey examined psychological distress and functional impairment as measured by the Kessler 10 Item scale (K-10) and the Sheehan Disability Scale (SDS) among Arab Australians. Additional questions enquired about their help-seeking behaviours, barriers to accessing psychological treatments and preferences for delivery of psychological treatments. A total of 252 participants were recruited through public talks, media and online promotions. Forty-three percent of the respondents reported moderate-to-severe functional impairment (M = 9.5; standard deviation (SD) = 1.8), 32% reported high psychological distress (M = 28.5; SD = 5.4) and 30% were born overseas. First-generation Arab Australians experiencing high psychological distress (i.e. K-10 ≥ 22), reported a greater preference for Internet-delivered treatment when compared to their second-generation counterparts. Only 18% of the sample reported seeking help from a mental health professional in the past year. The significant barriers reported by respondents with high psychological distress were poor mental health literacy, lack of time and stigma. Respondents preferred face-to-face (90%) over Internet-delivered treatment (55%). Finally, Arab Australians experienced higher psychological distress and underutilised mental health services when compared to the Australian population. Targeted public health campaigns that make culturally relevant interventions such as modifying existing Internet-delivered treatment for Arab Australians may reduce barriers and increase treatment options for this population. © The Author(s) 2014.

Effectiveness of psychological interventions delivered by non-psychologists on low back pain and disability: a qualitative systematic review.

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Bostick, Geoff P

2017-11-01

Psychological treatments delivered by non-psychologists have been proposed as a way to increase access to care to address important psychological barriers to recovery in people with low back pain (LBP). This review aimed to synthesize randomized controlled trials (RCTs) that assess the effectiveness of psychological interventions delivered by non-psychologists in reducing pain intensity and disability in adults with LBP, compared with usual care. A systematic review without meta-analysis was carried out. Randomized controlled trials including adult patients with all types of musculoskeletal LBP were eligible. Interventions included those based on psychological principles and delivered by non-psychologists. The primary outcomes of interest were self-reported pain intensity and disability. Information sources included Medline, EMBASE, and the Cochrane Central Registrar for Controlled Trials. The Cochrane Collaboration's tool for assessing risk of bias was used for the evaluation of internal validity. There were 1,101 records identified, 159 were assessed for eligibility, 16 were critically appraised, and 11 studies were included. Mild to moderate risk of bias was present in the included studies, with personnel and patient blinding, treatment fidelity, and attrition being the most common sources of bias. Considerable heterogeneity existed for patient population, intervention components, and comparison groups. Although most studies demonstrated statistical and clinical improvements in pain and disability, few were statistically superior to the comparison group. Consistent with the broader psychological literature, psychological interventions delivered by non-psychologists have modest effects on low back pain and disability. Additional high quality research is needed to understand what patients are likely to respond to psychological interventions, the appropriate dose to achieve the desired outcome, the amount of training required to implement psychological

Efficacy of Acupuncture for Psychological Symptoms Associated with Opioid Addiction: A Systematic Review and Meta-Analysis

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Zhang Boyuan

2014-01-01

Full Text Available This review systematically assessed the clinical evidence for and against acupuncture as a treatment for psychological symptoms associated with opioid addiction. The database was accessed from MEDLINE and China Knowledge Resource Integrated Database. We included all randomized clinical trials published in Chinese and English regardless of their controls. Meta-analysis was performed using the RevMan software, version 5.2. We conducted a literature search of 16 databases from their inception to January 2014. Four studies from Western countries did not report any clinical gains in the treatment of psychological symptoms associated with opioid addiction. 10 of 12 studies from China have reported positive findings regarding the use of acupuncture to treat the psychological symptoms associated with opioid addiction. The methodological quality of the included studies was poor. The meta-analysis indicated that there was a significant difference between the treatment group and the control group for anxiety and depression associated with opioid addiction, although groups did not differ on opioid craving. This review and meta-analysis could not confirm that acupuncture was an effective treatment for psychological symptoms associated with opioid addiction. However, considering the potential of acupuncture demonstrated in the included studies, further rigorous randomized controlled trials with long followup are warranted.

Psychological therapy for psychogenic amnesia: Successful treatment in a single case study.

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Cassel, Anneli; Humphreys, Kate

2016-01-01

Psychogenic amnesia is widely understood to be a memory impairment of psychological origin that occurs as a response to severe stress. However, there is a paucity of evidence regarding the effectiveness of psychological therapy approaches in the treatment of this disorder. The current article describes a single case, "Ben", who was treated with formulation-driven psychological therapy using techniques drawn from cognitive behavioural therapy (CBT) and acceptance and commitment therapy (ACT) for psychogenic amnesia. Before treatment, Ben exhibited isolated retrograde and anterograde memory impairments. He received 12 therapy sessions that targeted experiential avoidance followed by two review sessions, six weeks and five months later. Ben's retrograde and anterograde memory impairments improved following therapy to return to within the "average" to "superior" ranges, which were maintained at follow-up. Further experimental single case study designs and larger group studies are required to advance the understanding of the effectiveness and efficacy of psychological therapy for psychogenic amnesia.

A systematic review of psychological interventions for adult and pediatric patients with vocal cord dysfunction.

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Guglani, Loveleen; Atkinson, Sarah; Hosanagar, Avinash; Guglani, Lokesh

2014-01-01

Vocal cord dysfunction (VCD) or paradoxical vocal-fold motion (PVFM) is a functional disorder of the vocal cords that requires multidisciplinary treatment. Besides relaxation techniques, the use of psychological interventions can help treat the underlying psychological co-morbidities. There is currently no literature that examines the effectiveness of psychological interventions for VCD/PVFM. To review the evidence for psychological interventions used for the treatment of patients with VCD/PVFM. We searched electronic databases for English medical literature using Pubmed (Medline), PsycInfo, Cochrane Database of Systematic Reviews, Cochrane Central Registry of Controlled Trials, and Clinicaltrials.gov. The date range for our search is from June 1964 to June 2014. We included studies that reported the use of psychological interventions in both adults and children diagnosed with VCD/PVFM. We included randomized controlled trials, case-control studies, retrospective chart reviews, prospective case series, and individual case reports. Most reported studies are small case series or individual case reports that have described the use of interventions such as psychotherapy, behavioral therapy, use of anti-anxiety and anti-depressant medications, and hypnotherapy in conjunction with breathing exercises taught by speech therapists for symptomatic relief. Among the various psychological interventions that have been reported, there is no data regarding effectiveness and/or superiority of one approach over another in either adult or pediatric patients. Psychological interventions have a role to play in the management of adult and pediatric patients with VCD/PVFM. Future prospective studies using uniform approaches for treatment of associated psychopathology may help address this question.

Incorporating Psychological Predictors of Treatment Response into Health Economic Simulation Models: A Case Study in Type 1 Diabetes.

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Kruger, Jen; Pollard, Daniel; Basarir, Hasan; Thokala, Praveen; Cooke, Debbie; Clark, Marie; Bond, Rod; Heller, Simon; Brennan, Alan

2015-10-01

. Health economic modeling has paid limited attention to the effects that patients' psychological characteristics have on the effectiveness of treatments. This case study tests 1) the feasibility of incorporating psychological prediction models of treatment response within an economic model of type 1 diabetes, 2) the potential value of providing treatment to a subgroup of patients, and 3) the cost-effectiveness of providing treatment to a subgroup of responders defined using 5 different algorithms. . Multiple linear regressions were used to investigate relationships between patients' psychological characteristics and treatment effectiveness. Two psychological prediction models were integrated with a patient-level simulation model of type 1 diabetes. Expected value of individualized care analysis was undertaken. Five different algorithms were used to provide treatment to a subgroup of predicted responders. A cost-effectiveness analysis compared using the algorithms to providing treatment to all patients. . The psychological prediction models had low predictive power for treatment effectiveness. Expected value of individualized care results suggested that targeting education at responders could be of value. The cost-effectiveness analysis suggested, for all 5 algorithms, that providing structured education to a subgroup of predicted responders would not be cost-effective. . The psychological prediction models tested did not have sufficient predictive power to make targeting treatment cost-effective. The psychological prediction models are simple linear models of psychological behavior. Collection of data on additional covariates could potentially increase statistical power. . By collecting data on psychological variables before an intervention, we can construct predictive models of treatment response to interventions. These predictive models can be incorporated into health economic models to investigate more complex service delivery and reimbursement strategies. �

Psychological interventions for antisocial personality disorder.

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Gibbon, Simon; Duggan, Conor; Stoffers, Jutta; Huband, Nick; Völlm, Birgit A; Ferriter, Michael; Lieb, Klaus

2010-06-16

Antisocial personality disorder (AsPD) is associated with a wide range of disturbance including persistent rule-breaking, criminality, substance use, unemployment, homelessness and relationship difficulties. To evaluate the potential beneficial and adverse effects of psychological interventions for people with AsPD. Our search included CENTRAL Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, PsycINFO, ASSIA, BIOSIS and COPAC. Prospective, controlled trials in which participants with AsPD were randomly allocated to a psychological intervention and a control condition (either treatment as usual, waiting list or no treatment). Three authors independently selected studies. Two authors independently extracted data. We calculated mean differences, with odds ratios for dichotomous data. Eleven studies involving 471 participants with AsPD met the inclusion criteria, although data were available from only five studies involving 276 participants with AsPD. Only two studies focused solely on an AsPD sample. Eleven different psychological interventions were examined. Only two studies reported on reconviction, and only one on aggression. Compared to the control condition, cognitive behaviour therapy (CBT) plus standard maintenance was superior for outpatients with cocaine dependence in one study, but CBT plus treatment as usual was not superior for male outpatients with recent verbal/physical violence in another. Contingency management plus standard maintenance was superior for drug misuse for outpatients with cocaine dependence in one study but not in another, possibly because of differences in the behavioural intervention. However, contingency management was superior in social functioning and counselling session attendance in the latter. A multi-component intervention utilising motivational interviewing principles, the 'Driving Whilst Intoxicated program', plus incarceration was superior to incarceration alone for imprisoned drink-driving offenders. Results suggest

Do all psychological treatments really work the same in posttraumatic stress disorder?

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Ehlers, Anke; Bisson, Jonathan; Clark, David M; Creamer, Mark; Pilling, Steven; Richards, David; Schnurr, Paula P; Turner, Stuart; Yule, William

2010-03-01

A recent meta-analysis by Benish, Imel, and Wampold (2008, Clinical Psychology Review, 28, 746-758) concluded that all bona fide treatments are equally effective in posttraumatic stress disorder (PTSD). In contrast, seven other meta-analyses or systematic reviews concluded that there is good evidence that trauma-focused psychological treatments (trauma-focused cognitive behavior therapy and eye movement desensitization and reprocessing) are effective in PTSD; but that treatments that do not focus on the patients' trauma memories or their meanings are either less effective or not yet sufficiently studied. International treatment guidelines therefore recommend trauma-focused psychological treatments as first-line treatments for PTSD. We examine possible reasons for the discrepant conclusions and argue that (1) the selection procedure of the available evidence used in Benish et al.'s (2008)meta-analysis introduces bias, and (2) the analysis and conclusions fail to take into account the need to demonstrate that treatments for PTSD are more effective than natural recovery. Furthermore, significant increases in effect sizes of trauma-focused cognitive behavior therapies over the past two decades contradict the conclusion that content of treatment does not matter. To advance understanding of the optimal treatment for PTSD, we recommend further research into the active mechanisms of therapeutic change, including treatment elements commonly considered to be non-specific. We also recommend transparency in reporting exclusions in meta-analyses and suggest that bona fide treatments should be defined on empirical and theoretical grounds rather than by judgments of the investigators' intent. Copyright 2009 Elsevier Ltd. All rights reserved.

Do all psychological treatments really work the same in posttraumatic stress disorder?

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Ehlers, Anke; Bisson, Jonathan; Clark, David M.; Creamer, Mark; Pilling, Steven; Richards, David; Schnurr, Paula P.; Turner, Stuart; Yule, William

2010-01-01

A recent meta-analysis by Benish, Imel, and Wampold (2008, Clinical Psychology Review, 28, 746–758) concluded that all bona fide treatments are equally effective in posttraumatic stress disorder (PTSD). In contrast, seven other meta-analyses or systematic reviews concluded that there is good evidence that trauma-focused psychological treatments (trauma-focused cognitive behavior therapy and eye movement desensitization and reprocessing) are effective in PTSD; but that treatments that do not focus on the patients' trauma memories or their meanings are either less effective or not yet sufficiently studied. International treatment guidelines therefore recommend trauma-focused psychological treatments as first-line treatments for PTSD. We examine possible reasons for the discrepant conclusions and argue that (1) the selection procedure of the available evidence used in Benish et al.'s (2008)meta-analysis introduces bias, and (2) the analysis and conclusions fail to take into account the need to demonstrate that treatments for PTSD are more effective than natural recovery. Furthermore, significant increases in effect sizes of trauma-focused cognitive behavior therapies over the past two decades contradict the conclusion that content of treatment does not matter. To advance understanding of the optimal treatment for PTSD, we recommend further research into the active mechanisms of therapeutic change, including treatment elements commonly considered to be non-specific. We also recommend transparency in reporting exclusions in meta-analyses and suggest that bona fide treatments should be defined on empirical and theoretical grounds rather than by judgments of the investigators' intent. PMID:20051310

Meseron Therapy: An African Approach To Psychological Treatment ...

African Journals Online (AJOL)

Meseron therapy is a psychological treatment approach of African origin that consists of a direct and holistic counter-attack on undesirable conditions. It derives from an African custom of rejecting the negative while accepting the positive circumstances of life. Based on the philosophy of “I can”, and the concept of man as a ...

Beating the blues after Cancer: randomised controlled trial of a tele-based psychological intervention for high distress patients and carers

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Hutchison Sandy

2009-06-01

Full Text Available Abstract Background The diagnosis and treatment of cancer is a major life stress such that approximately 35% of patients experience persistent clinically significant distress and carers often experience even higher distress than patients. This paper presents the design of a two arm randomised controlled trial with patients and carers who have elevated psychological distress comparing minimal contact self management vs. an individualised tele-based cognitive behavioural intervention. Methods/design 140 patients and 140 carers per condition (560 participants in total will been recruited after being identified as high distress through caller screening at two community-based cancer helplines and randomised to 1 a single 30-minute telephone support and education session with a nurse counsellor with self management materials 2 a tele-based psychologist delivered five session individualised cognitive behavioural intervention. Session components will include stress reduction, problem-solving, cognitive challenging and enhancing relationship support and will be delivered weekly. Participants will be assessed at baseline and 3, 6 and 12 months after recruitment. Outcome measures include: anxiety and depression, cancer specific distress, unmet psychological supportive care needs, positive adjustment, overall Quality of life. Discussion The study will provide recommendations about the efficacy and potential economic value of minimal contact self management vs. tele-based psychologist delivered cognitive behavioural intervention to facilitate better psychosocial adjustment and mental health for people with cancer and their carers. Trial Registration ACTRN12609000301268.

Psychological treatments for mental disorders in adults: A review of the evidence of leading international organizations.

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Moriana, Juan Antonio; Gálvez-Lara, Mario; Corpas, Jorge

2017-06-01

Most mental health services throughout the world currently regard evidence-based psychological treatments as best practice for the treatment of mental disorders. The aim of this study was to analyze evidence-based treatments drawn from RCTs, reviews, meta-analyses, guides, and lists provided by the National Institute for Health and Care Excellence (NICE), Division 12 (Clinical Psychology) of the American Psychological Association (APA), Cochrane and the Australian Psychological Society (APS) in relation to mental disorders in adults. A total of 135 treatments were analyzed for 23 mental disorders and compared to determine the level of agreement among the organizations. The results indicate that, in most cases, there is little agreement among organizations and that there are several discrepancies within certain disorders. These results require reflection on the meaning attributed to evidence-based practice with regard to psychological treatments. The possible reasons for these differences are discussed. Based on these findings, proposals to unify the criteria that reconcile the realities of clinical practice with a scientific perspective were analyzed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Review of the optic neuritis treatment trial

International Nuclear Information System (INIS)

Chuman, Hideki

2007-01-01

The Optic Neuritis Treatment Trial (ONTT) is a multicenter controlled clinical trial. The primary objective of this trial is to assess the efficacy of corticosteroids in the treatment of optic neuritis. Treatment with intravenous methylprednisolone resulted in a more rapid return of the visual function to normal. Oral prednisone alone was associated with a significantly increased risk of recurrent optic neuritis. The trial also provided invaluable information about the clinical profile of optic neuritis and its relationship to Multiple Sclerosis (MS). At 6 months after the initial optic neuritis attack, a 12-month follow-up of patients was begun and the data collected during this period indicated that visual acuity was more than 20/20 in 69%, 20/40 in 93%, and 20/200 or less in only 3% of the patients. The risk of MS within 10 years after the first episode of optic neuritis was 56% among patients who were found to have had one or more characteristic white-matter lesions at baseline, as compared to only 22% for patients who had no observable lesions at baseline. (author)

Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial.

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Wells, Adrian; McNicol, Kirsten; Reeves, David; Salmon, Peter; Davies, Linda; Heagerty, Anthony; Doherty, Patrick; McPhillips, Rebecca; Anderson, Rebecca; Faija, Cintia; Capobianco, Lora; Morley, Helen; Gaffney, Hannah; Shields, Gemma; Fisher, Peter

2018-04-03

Anxiety and depression are prevalent among cardiac rehabilitation patients but pharmacological and psychological treatments have limited effectiveness in this group. Furthermore, psychological interventions have not been systematically integrated into cardiac rehabilitation services despite being a strategic priority for the UK National Health Service. A promising new treatment, metacognitive therapy, may be well-suited to the needs of cardiac rehabilitation patients and has the potential to improve outcomes. It is based on the metacognitive model, which proposes that a thinking style dominated by rumination, worry and threat monitoring maintains emotional distress. Metacognitive therapy is highly effective at reducing this thinking style and alleviating anxiety and depression in mental health settings. This trial aims to evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy for cardiac rehabilitation patients with elevated anxiety and/or depressive symptoms. The PATHWAY Group-MCT trial is a multicentre, two-arm, single-blind, randomised controlled trial comparing the clinical- and cost-effectiveness of group-based metacognitive therapy plus usual cardiac rehabilitation to usual cardiac rehabilitation alone. Cardiac rehabilitation patients (target sample n = 332) with elevated anxiety and/or depressive symptoms will be recruited across five UK National Health Service Trusts. Participants randomised to the intervention arm will receive six weekly sessions of group-based metacognitive therapy delivered by either cardiac rehabilitation professionals or research nurses. The intervention and control groups will both be offered the usual cardiac rehabilitation programme within their Trust. The primary outcome is severity of anxiety and depressive symptoms at 4-month follow-up measured by the Hospital Anxiety and Depression Scale total score. Secondary outcomes are severity of anxiety/depression at 12-month follow-up, health

Multiple treatment comparisons in epilepsy monotherapy trials

Directory of Open Access Journals (Sweden)

Chadwick David W

2007-11-01

Full Text Available Abstract Background The choice of antiepileptic drug for an individual should be based upon the highest quality evidence regarding potential benefits and harms of the available treatments. Systematic reviews and meta-analysis of randomised controlled trials should be a major source of evidence supporting this decision making process. We summarise all available individual patient data evidence from randomised controlled trials that compared at least two out of eight antiepileptic drugs given as monotherapy. Methods Multiple treatment comparisons from epilepsy monotherapy trials were synthesized in a single stratified Cox regression model adjusted for treatment by epilepsy type interactions and making use of direct and indirect evidence. Primary outcomes were time to treatment failure and time to 12 month remission from seizures. A secondary outcome was time to first seizure. Results Individual patient data for 6418 patients from 20 randomised trials comparing eight antiepileptic drugs were synthesized. For partial onset seizures (4628 (72% patients, lamotrigine, carbamazepine and oxcarbazepine provide the best combination of seizure control and treatment failure. Lamotrigine is clinically superior to all other drugs for treatment failure but estimates suggest a disadvantage compared to carbamazepine for time to 12 month remission [Hazard Ratio (95% Confidence Interval = 0.87(0.73 to 1.04] and time to first seizure [1.29(1.13 to 1.48]. Phenobarbitone may delay time to first seizure [0.77(0.61 to 0.96] but at the expense of increased treatment failure [1.60(1.22 to 2.10]. For generalized onset tonic clonic seizures (1790 (28% patients estimates suggest valproate or phenytoin may provide the best combination of seizure control and treatment failure but some uncertainty remains about the relative effectiveness of other drugs. Conclusion For patients with partial onset seizures, results favour carbamazepine, oxcarbazepine and lamotrigine. For

Coping strategies as mediators of the effect of the START (strategies for RelaTives) intervention on psychological morbidity for family carers of people with dementia in a randomised controlled trial.

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Li, Ryan; Cooper, Claudia; Barber, Julie; Rapaport, Penny; Griffin, Mark; Livingston, Gill

2014-10-01

Family carers of people with dementia frequently become depressed or anxious. In observational studies, more emotion-focused and less dysfunctional coping predict fewer psychological symptoms, but no randomised controlled trial (RCT) has directly investigated emotion-focused coping as mediator of effectiveness of a successful psychological intervention. We hypothesised that emotion-focused coping would mediate the START psychological intervention׳s effects in an RCT. We tested whether mediated effects were moderated by severity of baseline symptoms. 260 family carers from NHS dementia services were randomised to START (manualised coping skills intervention), or treatment-as-usual (TAU). Blinded raters administered the Hospital Anxiety and Depression Scale (HADS-T) and Brief COPE inventory at baseline, 4 and 8 months. HADS-T improved in the intervention group when compared to TAU at all levels of psychological distress. We tested whether coping was a mediator and for moderated mediation, and (post-hoc) subgroup treatment effects on coping. Data were available for 187 carers (71.9%) for the mediation analysis. The reduced HADS-T score in the intervention group was mediated by increased emotion-focused coping only among carers with higher (16+) baseline HADS-T scores (mediated effect=-0.63 [-1.11, -0.15]; proportion of overall effect=33% [3%, 64%]). We did not measure plausible psychosocial treatment mechanisms other than coping. START benefited family carers both in preventing and treating psychological morbidity, through different mechanisms of action. The most psychologically distressed carers increased their emotion-focused coping and did not decrease their dysfunctional coping, while others benefited but not through this mechanism. Copyright © 2014 Elsevier B.V. All rights reserved.

Psychological determinants of life satisfaction in women undergoing infertility treatment

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Aleksandra Anna Dembińska

2016-01-01

Background Infertility treatment is a long-term process, spread out over months, or even years, and carries no guarantee of success. It generates an incessant state of uncertainty which becomes a chronic state of psychological discomfort. Each stage of treatment may become a source of more trouble. Women deciding to undergo infertility treatment are exposed to many negative feelings concerning different aspects of their life. Participants and procedure The present study wa...

Efficacy and tolerance of the topical application of potassium hydroxide (10% and 15% in the treatment of molluscum contagiosum: Randomized clinical trial: Research protocol

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Galindo Gisela

2011-10-01

Full Text Available Abstract Background Molluscum contagiosum is a non-severe pediatric viral infection. Because it is highly contagious and current treatments have negative aesthetic and psychological effects, we want to test an alternative treatment in the primary care setting, consisting of two different concentrations of potassium hydroxide solution. Methods/design The study design is a double-blind, randomized clinical trial, using three types of topical treatment. The treatment consist of daily applications of potassium hydroxide (KOH in aqueous solution at 10% and 15% concentration, and a placebo administered in the control group. Four follow-up visits (at 15, 30, 45 and 60 days are planned to evaluate treatment effectiveness and patient tolerance. The main outcome measure of the trial will be the healing rate, defined as lesion disappearance in the affected zones after the topic application of the experimental treatment. Secondary measures will be the principal characteristics and evolution of the affected zone (surface area, number of lesions, size and density of lesions, treatment tolerance (hyperpigmentation, itching, burning, pain, recurrence rate and the natural evolution of lesions in the control group. Discussion KOH can potentially be an effective and safe treatment for MC in primary care, and can also reduce referrals to dermatologists and hospital pediatric departments. In addition, KOH may be a valid and less expensive alternative to current invasive treatments (surgical excision. Trial Registration ClinicalTrials.gov: NCT01348386

Psychological treatment of social anxiety disorder improves body dysmorphic concerns.

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Fang, Angela; Sawyer, Alice T; Aderka, Idan M; Hofmann, Stefan G

2013-10-01

Social anxiety disorder and body dysmorphic disorder are considered nosologically distinct disorders. In contrast, some cognitive models suggest that social anxiety disorder and body dysmorphic disorder share similar cognitive maintenance factors. The aim of this study was to examine the effects of psychological treatments for social anxiety disorder on body dysmorphic disorder concerns. In Study 1, we found that 12 weekly group sessions of cognitive-behavioral therapy led to significant decreases in body dysmorphic symptom severity. In Study 2, we found that an attention retraining intervention for social anxiety disorder was associated with a reduction in body dysmorphic concerns, compared to a placebo control condition. These findings support the notion that psychological treatments for individuals with primary social anxiety disorder improve co-occurring body dysmorphic disorder symptoms. Copyright © 2013 Elsevier Ltd. All rights reserved.

PAHA study: psychological active and healthy aging: psychological wellbeing, proactive attitude and happiness effects of whole-body vibration versus Multicomponent Training in aged women: study protocol for a randomized controlled trial.

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Compare, Angelo; Zarbo, Cristina; Marín, Elena; Meloni, Alessia; Rubio-Arias, Jacobo A; Berengüí, Rosendo; Grossi, Enzo; Shonin, Edo; Martini, Gianmaria; Alcaraz, Pedro E

2014-05-20

Evidence demonstrates that physical exercise and psychological wellbeing are closely interlinked, particularly in older-aged women. However, research investigating how different forms of exercise influence mental health in older-aged women is underdeveloped. A randomized controlled trial (N = 300) will assess the relative effectiveness of two different exercise programs (whole-body vibration and Multicomponent Training) for improving psychological wellbeing in older-aged women. The following outcomes will be assessed at three time points (that is, pre, post, and follow-up): psychological wellbeing, proactive attitude, quality of life, and happiness. Results will have important implications for preventing psychological and physiological disease in older-aged women and for managing health-related costs for this population group. Number NCT01966562 on Clinical Gov database the 8 October 2013.

A Systematic Review of Psychological Interventions for Adult and Pediatric Patients with Vocal Cord Dysfunction

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Loveleen eGuglani

2014-08-01

Full Text Available Background: Vocal Cord Dysfunction (VCD or Paradoxical Vocal Fold Motion (PVFM is a functional disorder of the vocal cords that requires multidisciplinary treatment. Besides relaxation techniques, the use of psychological interventions can help treat the underlying psychological co-morbidities. There is currently no literature that examines the effectiveness of psychological interventions for VCD/PVFM. Objectives: To review the evidence for psychological interventions used for the treatment of patients with VCD/PVFM. Data Sources: We searched electronic databases for English medical literature using Pubmed (Medline, PsycInfo, Cochrane Database of Systematic Reviews, Cochrane Central Registry of Controlled Trials and Clinicaltrials.gov. The date range for our search is from July 1963 to July 2013. Study Eligibility Criteria, Participants and Interventions: We included studies that reported the use of psychological interventions in both adults and children diagnosed with VCD/PVFM. We included randomized controlled trials, case-control studies, retrospective chart reviews, prospective case series, and individual case reports. Results: Most reported studies are small case series or individual case reports that have described the use of interventions such as psychotherapy, behavioral therapy, use of anti-anxiety and anti-depressant medications, and hypnotherapy in conjunction with breathing exercises taught by speech therapists for symptomatic relief. Among the various psychological interventions that have been reported, there is no data regarding effectiveness and/or superiority of one approach over another in either adult or pediatric patients. Conclusions: Psychological interventions have a role to play in the management of adult and pediatric patients with VCD/PVFM. Future prospective studies using uniform approaches for treatment of associated psychopathology may help address this question. Systematic Review Registration Number: CRD42013004873

Attitudes and expectations of patients with neuromuscular diseases about their participation in a clinical trial.

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Gargiulo, M; Herson, A; Michon, C C; Hogrel, J Y; Doppler, V; Laloui, K; Herson, S; Payan, C; Eymard, B; Laforêt, P

2013-01-01

This study aimed to gain a better understanding of the psychological impact of participating in a clinical trial for patients with Pompe disease (Acid Maltase Deficiency). Attitudes and expectations of adult patients with neuromuscular diseases regarding medical trials are as yet unreported. In order to learn about the psychological consequences of participating in a clinical trial, we conducted a prospective assessment of patients with late-onset Pompe Disease, a rare genetic condition, for which no treatment had been available before. This psychological study was carried out as an ancillary study to the randomized double-blind placebo-controlled trial described elsewhere (van der Ploeg et al., 2010). We assessed patients (n=8) at inclusion, and at 12 and 18 months for six psychological dimensions: depression (Beck Depression Inventory, BDI), hopelessness (Beck Hopelessness Scale, BHS), anxiety (STAI A-B), quality of life (Whoqol-26), social adjustment (S.A.S-self-report) and locus of control (IPC Levenson). We produced a self-administered questionnaire in order to assess the attitudes, motivations and expectations of patients during the trial. At 12 months, mean social adjustment (SAS-SR, P=0.02) had improved, and at 18 months mean depression score had improved as well (BDI, P=0.03). The quality of life of patients (Whoqol-26) remained unchanged. Throughout the study, patients were more likely to have an internal locus of control than an external one (IPC Levenson). The self-administered questionnaire showed that patients' expectations were disproportionate compared to the medical information they had received starting the trial. For all patients, the first motivation for being enrolled in a clinical trial was "to help research", for half of them the motivation was to "improve their health". Whether patients believed to be part of one group or another (placebo or treatment) depended on their subjective perception of improvement during the trial. Given the small

Family-Related Opinions and Stressful Situations Associated with Psychological Distress in Women Undergoing Infertility Treatment

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Jiro Takaki

2014-09-01

Full Text Available The purpose of this study is to investigate how family-related opinions and stressful situations are related to psychological distress in women undergoing infertility treatment. The subjects in this cross-sectional study were recruited from female patients undergoing infertility treatment (n = 2540 at 70 infertility treatment institutions in Japan. Because of non-participation or missing data, the number of subjects included in the analysis was 635 (response rate, 25.0%. The family-related opinions and stressful situations were evaluated using the original questions. Psychological distress was assessed using a self-report measure, the Kessler Six-question Psychological Distress Scale (K6. The K6 scores of the following participants were significantly (p < 0.05 and independently high: those with more frequent miscarriage/stillbirth/abortions, those with repeated miscarriages as the cause of infertility, those with infertility of unknown causes, those living with no child, those having a low joint income with their partner, those with the opinion that “women should devote themselves to their household duties” those who had considered stopping treatment, those without the opinion that “married life without children is favorable” and those who had experienced stressful situations such as inadequate explanation by doctors, frustration of multiple failed attempts, differences of opinion with the partner, and lack of knowledge regarding when to stop treatment. Family-related opinions and stressful situations associated with psychological distress in women undergoing infertility treatment are outlined. The results of this study may contribute to the prevention of and care for psychological distress in female patients undergoing infertility treatment.

A Structured, Manual-Based Low-Level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents with Extreme Obesity - the STEREO Trial

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Yvonne Mühlig

2017-08-01

Full Text Available Background: To compare efficacy and safety of a manual-based low-level psychological intervention with treatment as usual (weight loss treatment. Methods: A two-armed randomized controlled trial without blinding and computer-based stratified block randomization included adolescents and young adults (14.0-24.9 years with a BMI ≥ 30 kg/m2 at five German university hospitals. Primary outcomes were adherence (participation rate ≥ 5/6 sessions and quality of life (DISABKIDS-37 6 months after randomization. Secondary outcomes included depression, self-esteem, and perceived stress scores. Results: Of 397 screened adolescents, 119 (mean BMI 40.4 ± 7.0 kg/m2, 49.6% female were randomized to the manual-based low-level intervention (n = 59 or treatment as usual (n = 60. We observed no group difference for adherence (absolute risk reduction 0.4%, 95% CI -14.7% to 15.5%; p = 1.0 or health-related quality of life (score difference 8.1, 95% CI -2.1 to 18.3; p = 0.11. Among all secondary outcomes, we detected explorative evidence for an effect on the DISABKIDS-37 ‘social exclusion' subscale (score difference 15.5; 95% CI 1.6-29.4; p = 0.03. 18/19 adverse events occurred in 26 participants, none were classified as serious. Conclusion: Adherence to a coping-oriented intervention was comparable to weight loss treatment, although it was weak in both interventions. Psychological interventions may help to overcome social isolation; further confirmation is required.

Healthcare utilization in general practice before and after psychological treatment: a follow-up data linkage study in primary care.

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Prins, Marijn A; Verhaak, Peter F M; Smit, Dineke; Verheij, Robert A

2014-09-01

Literature suggests that serious mental health problems increase the use of health services and psychological interventions can reduce this effect. This study investigates whether this effect is also found in primary care patients with less serious mental health problems. Routine electronic health records (EHR) from a representative sample of 128 general practices were linked to patient files from 150 primary care psychologists participating in the NIVEL Primary Care Database, using a trusted third party. Data were linked using the date of birth, gender, and postcode. This yielded 503 unique data pairs that were listed in one of the participating GP practices in 2008-2010, for people who had psychological treatment from a psychologist that ended in 2009. The number of contacts, health problems presented, and prescribed medication in general practice were analysed before and after the psychological treatment. Nearly all 503 patients consulted their GP during the six months preceding the psychological treatment (90.9%) and also in the six months after this treatment had ended (83.7%). The frequency of contacts was significantly higher before than after the psychological treatment (6.1 vs. 4.8). Fewer patients contacted their GPs specifically for psychological or social problems (46.3% vs. 38.8%) and fewer patients had anxiolytic drug prescriptions (15.5% vs. 7.6%) after psychological treatment. After psychological treatment, patients contact their GPs less often and present fewer psychological or social problems. Although contact rates seem to decrease, clients of psychologists are still frequent GP attenders.

Trial-Based Functional Analysis Informs Treatment for Vocal Scripting.

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Rispoli, Mandy; Brodhead, Matthew; Wolfe, Katie; Gregori, Emily

2018-05-01

Research on trial-based functional analysis has primarily focused on socially maintained challenging behaviors. However, procedural modifications may be necessary to clarify ambiguous assessment results. The purposes of this study were to evaluate the utility of iterative modifications to trial-based functional analysis on the identification of putative reinforcement and subsequent treatment for vocal scripting. For all participants, modifications to the trial-based functional analysis identified a primary function of automatic reinforcement. The structure of the trial-based format led to identification of social attention as an abolishing operation for vocal scripting. A noncontingent attention treatment was evaluated using withdrawal designs for each participant. This noncontingent attention treatment resulted in near zero levels of vocal scripting for all participants. Implications for research and practice are presented.

Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study.

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Carhart-Harris, Robin L; Bolstridge, Mark; Rucker, James; Day, Camilla M J; Erritzoe, David; Kaelen, Mendel; Bloomfield, Michael; Rickard, James A; Forbes, Ben; Feilding, Amanda; Taylor, David; Pilling, Steve; Curran, Valerie H; Nutt, David J

2016-07-01

Psilocybin is a serotonin receptor agonist that occurs naturally in some mushroom species. Recent studies have assessed the therapeutic potential of psilocybin for various conditions, including end-of-life anxiety, obsessive-compulsive disorder, and smoking and alcohol dependence, with promising preliminary results. Here, we aimed to investigate the feasibility, safety, and efficacy of psilocybin in patients with unipolar treatment-resistant depression. In this open-label feasibility trial, 12 patients (six men, six women) with moderate-to-severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (10 mg and 25 mg, 7 days apart) in a supportive setting. There was no control group. Psychological support was provided before, during, and after each session. The primary outcome measure for feasibility was patient-reported intensity of psilocybin's effects. Patients were monitored for adverse reactions during the dosing sessions and subsequent clinic and remote follow-up. Depressive symptoms were assessed with standard assessments from 1 week to 3 months after treatment, with the 16-item Quick Inventory of Depressive Symptoms (QIDS) serving as the primary efficacy outcome. This trial is registered with ISRCTN, number ISRCTN14426797. Psilocybin's acute psychedelic effects typically became detectable 30-60 min after dosing, peaked 2-3 h after dosing, and subsided to negligible levels at least 6 h after dosing. Mean self-rated intensity (on a 0-1 scale) was 0·51 (SD 0·36) for the low-dose session and 0·75 (SD 0·27) for the high-dose session. Psilocybin was well tolerated by all of the patients, and no serious or unexpected adverse events occurred. The adverse reactions we noted were transient anxiety during drug onset (all patients), transient confusion or thought disorder (nine patients), mild and transient nausea (four patients), and transient headache (four patients). Relative to baseline, depressive symptoms were markedly reduced 1

Psilocybin with psychological support for treatment-resistant depression: six-month follow-up.

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Carhart-Harris, R L; Bolstridge, M; Day, C M J; Rucker, J; Watts, R; Erritzoe, D E; Kaelen, M; Giribaldi, B; Bloomfield, M; Pilling, S; Rickard, J A; Forbes, B; Feilding, A; Taylor, D; Curran, H V; Nutt, D J

2018-02-01

Recent clinical trials are reporting marked improvements in mental health outcomes with psychedelic drug-assisted psychotherapy. Here, we report on safety and efficacy outcomes for up to 6 months in an open-label trial of psilocybin for treatment-resistant depression. Twenty patients (six females) with (mostly) severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (10 and 25 mg, 7 days apart) in a supportive setting. Depressive symptoms were assessed from 1 week to 6 months post-treatment, with the self-rated QIDS-SR16 as the primary outcome measure. Treatment was generally well tolerated. Relative to baseline, marked reductions in depressive symptoms were observed for the first 5 weeks post-treatment (Cohen's d = 2.2 at week 1 and 2.3 at week 5, both p psilocybin. Reductions in depressive symptoms at 5 weeks were predicted by the quality of the acute psychedelic experience. Although limited conclusions can be drawn about treatment efficacy from open-label trials, tolerability was good, effect sizes large and symptom improvements appeared rapidly after just two psilocybin treatment sessions and remained significant 6 months post-treatment in a treatment-resistant cohort. Psilocybin represents a promising paradigm for unresponsive depression that warrants further research in double-blind randomised control trials.

Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders

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Chicchi Giglioli, Irene Alice; Pedroli, Elisa

2015-01-01

Augmented Reality is a new technological system that allows introducing virtual contents in the real world in order to run in the same representation and, in real time, enhancing the user's sensory perception of reality. From another point of view, Augmented Reality can be defined as a set of techniques and tools that add information to the physical reality. To date, Augmented Reality has been used in many fields, such as medicine, entertainment, maintenance, architecture, education, and cognitive and motor rehabilitation but very few studies and applications of AR exist in clinical psychology. In the treatment of psychological disorders, Augmented Reality has given preliminary evidence to be a useful tool due to its adaptability to the patient needs and therapeutic purposes and interactivity. Another relevant factor is the quality of the user's experience in the Augmented Reality system determined from emotional engagement and sense of presence. This experience could increase the AR ecological validity in the treatment of psychological disorders. This paper reviews the recent studies on the use of Augmented Reality in the evaluation and treatment of psychological disorders, focusing on current uses of this technology and on the specific features that delineate Augmented Reality a new technique useful for psychology. PMID:26339283

Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders.

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Chicchi Giglioli, Irene Alice; Pallavicini, Federica; Pedroli, Elisa; Serino, Silvia; Riva, Giuseppe

2015-01-01

Augmented Reality is a new technological system that allows introducing virtual contents in the real world in order to run in the same representation and, in real time, enhancing the user's sensory perception of reality. From another point of view, Augmented Reality can be defined as a set of techniques and tools that add information to the physical reality. To date, Augmented Reality has been used in many fields, such as medicine, entertainment, maintenance, architecture, education, and cognitive and motor rehabilitation but very few studies and applications of AR exist in clinical psychology. In the treatment of psychological disorders, Augmented Reality has given preliminary evidence to be a useful tool due to its adaptability to the patient needs and therapeutic purposes and interactivity. Another relevant factor is the quality of the user's experience in the Augmented Reality system determined from emotional engagement and sense of presence. This experience could increase the AR ecological validity in the treatment of psychological disorders. This paper reviews the recent studies on the use of Augmented Reality in the evaluation and treatment of psychological disorders, focusing on current uses of this technology and on the specific features that delineate Augmented Reality a new technique useful for psychology.

Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders

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Irene Alice Chicchi Giglioli

2015-01-01

Full Text Available Augmented Reality is a new technological system that allows introducing virtual contents in the real world in order to run in the same representation and, in real time, enhancing the user’s sensory perception of reality. From another point of view, Augmented Reality can be defined as a set of techniques and tools that add information to the physical reality. To date, Augmented Reality has been used in many fields, such as medicine, entertainment, maintenance, architecture, education, and cognitive and motor rehabilitation but very few studies and applications of AR exist in clinical psychology. In the treatment of psychological disorders, Augmented Reality has given preliminary evidence to be a useful tool due to its adaptability to the patient needs and therapeutic purposes and interactivity. Another relevant factor is the quality of the user’s experience in the Augmented Reality system determined from emotional engagement and sense of presence. This experience could increase the AR ecological validity in the treatment of psychological disorders. This paper reviews the recent studies on the use of Augmented Reality in the evaluation and treatment of psychological disorders, focusing on current uses of this technology and on the specific features that delineate Augmented Reality a new technique useful for psychology.

Effects of Screening for Psychological Distress on Patient Outcomes in Cancer: a Systematic Review

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Meijer, Anna; Roseman, Michelle; Delisle, Vanessa C.; Milette, Katherine; Levis, Brooke; Syamchandra, Achyuth; Stefanek, Michael E.; Stewart, Donna E.; de Jonge, Peter; Coyne, James C.; Thombs, Brett D.

2013-01-01

Objective Several practice guidelines recommend routine screening for psychological distress in cancer care. The objective was to evaluate the effect of screening cancer patients for psychological distress by assessing the (1) effectiveness of interventions to reduce distress among patients identified as distressed; and (2) effects of screening for distress on distress outcomes. Methods CINAHL, Cochrane, EMBASE, ISI, MEDLINE, PsycINFO, and SCOPUS databases were searched through April 6, 2011 with manual searches of 45 relevant journals, reference list review, citation tracking of included articles, and trial registry reviews through June 30, 2012. Articles in any language on cancer patients were included if they (1) compared treatment for patients with psychological distress to placebo or usual care in a randomized controlled trial (RCT); or (2) assessed the effect of screening on psychological distress in a RCT. Results There were 14 eligible RCTs for treatment of distress, and 1 RCT on the effects of screening on patient distress. Pharmacological, psychotherapy and collaborative care interventions generally reduced distress with small to moderate effects. One study investigated effects of screening for distress on psychological outcomes, and it found no improvement. Conclusion Treatment studies reported modest improvement in distress symptoms, but only a single eligible study was found on the effects of screening cancer patients for distress, and distress did not improve in screened patients versus those receiving usual care. Because of the lack of evidence of beneficial effects of screening cancer patients for distress, it is premature to recommend or mandate implementation of routine screening. PMID:23751231

Association between objective and subjective binge eating and psychopathology during a psychological treatment trial for bulimic symptoms.

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Goldschmidt, Andrea B; Accurso, Erin C; Crosby, Ross D; Cao, Li; Ellison, Jo; Smith, Tracey L; Klein, Marjorie H; Mitchell, James E; Crow, Scott J; Wonderlich, Stephen A; Peterson, Carol B

2016-12-01

Although loss of control (LOC) while eating is a core construct of bulimia nervosa (BN), questions remain regarding its validity and prognostic significance independent of overeating. We examined trajectories of objective and subjective binge eating (OBE and SBE, respectively; i.e., LOC eating episodes involving an objectively or subjectively large amount of food) among adults participating in psychological treatments for BN-spectrum disorders (n = 80). We also explored whether changes in the frequency of these eating episodes differentially predicted changes in eating-related and general psychopathology and, conversely, whether changes in eating-related and general psychopathology predicted differential changes in the frequency of these eating episodes. Linear mixed models with repeated measures revealed that OBE decreased twice as rapidly as SBE throughout treatment and 4-month follow-up. Generalized linear models revealed that baseline to end-of-treatment reductions in SBE frequency predicted baseline to 4-month follow-up changes in eating-related psychopathology, depression, and anxiety, while changes in OBE frequency were not predictive of psychopathology at 4-month follow-up. Zero-inflation models indicated that baseline to end-of-treatment changes in eating-related psychopathology and depression symptoms predicted baseline to 4-month follow-up changes in OBE frequency, while changes in anxiety and self-esteem did not. Baseline to end-of-treatment changes in eating-related psychopathology, self-esteem, and anxiety predicted baseline to 4-month follow-up changes in SBE frequency, while baseline to end-of-treatment changes in depression did not. Based on these findings, LOC accompanied by objective overeating may reflect distress at having consumed an objectively large amount of food, whereas LOC accompanied by subjective overeating may reflect more generalized distress related to one's eating- and mood-related psychopathology. BN treatments should

Pilot Randomized Controlled Trial of Internet-Delivered Cognitive-Behavioral Treatment for Pediatric Headache.

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Law, Emily F; Beals-Erickson, Sarah E; Noel, Melanie; Claar, Robyn; Palermo, Tonya M

2015-01-01

To evaluate the feasibility and preliminary effectiveness of an Internet-delivered cognitive-behavioral therapy (CBT) intervention for adolescents with chronic headache. Headache is among the most common pain complaints of childhood. Cognitive-behavioral interventions are efficacious for improving pain among youth with headache. However, many youth do not receive psychological treatment for headache due to poor access, which has led to consideration of alternative delivery modalities such as the Internet. We used a parallel arm randomized controlled trial design to evaluate the feasibility and preliminary effectiveness of an Internet-delivered family-based CBT intervention, Web-based management of adolescent pain. Adolescents were eligible for the trial if they were a new patient being evaluated in a specialized headache clinic, between 11 and 17 years of age, and had recurrent headache for 3 months or more as diagnosed by a pediatric neurologist. Eighty-three youths were enrolled in the trial. An online random number generator was used to randomly assign participants to receive Internet CBT adjunctive to specialized headache treatment (n = 44) or specialized headache treatment alone (n = 39). The primary treatment outcome was headache days. Youth and parents in the Internet CBT group demonstrated high levels of engagement with the web program and reported satisfaction with the intervention. Multilevel modelling (MLM) was used to conduct hypothesis testing for continuous outcomes. For our primary treatment outcome of headache days, adolescents reported a statistically significant reduction in headache days from baseline to post-treatment and baseline to 3-month follow-up in both treatment conditions (main effect for time F(2, 136) = 19.70, P headache treatment group at post-treatment or follow-up (group × time interaction F(2, 134) = 0.94, P = .395). For our secondary treatment outcomes, findings from MLM showed that adolescents in both

Bridging the gap: Lessons we have learnt from the merging of psychology and psychiatry for the optimisation of treatments for emotional disorders.

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Graham, Bronwyn M; Callaghan, Bridget L; Richardson, Rick

2014-11-01

In recent years the gap between psychological and psychiatric research and practice has lessened. In turn, greater attention has been paid toward how psychological and pharmacological treatments interact. Unfortunately, the majority of research has indicated no additive effect of anxiolytics and antidepressants when combined with psychological treatments, and in many cases pharmacological treatments attenuate the effectiveness of psychological treatments. However, as psychology and psychiatry have come closer together, research has started to investigate the neural and molecular mechanisms underlying psychological treatments. Such research has utilised preclinical models of psychological treatments, such as fear extinction, in both rodents and humans to determine multiple neural and molecular changes that may be responsible for the long-term cognitive and behavioural changes that psychological treatments induce. Currently, researchers are attempting to identify pharmacological agents that directly augment these neural/molecular changes, and which may be more effective adjuncts to psychological treatments than traditional anxiolytics and antidepressants. In this review we describe the research that has led to this new wave of thinking about combined psychological/pharmacological treatments. We also argue that an increased emphasis on identifying individual difference factors that predict the effectiveness of pharmacological adjuncts is critical in facilitating the translation of this preclinical research into clinical practice. Copyright © 2014 Elsevier Ltd. All rights reserved.

Psychological interventions for antisocial personality disorder

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Gibbon, Simon; Duggan, Conor; Stoffers, Jutta; Huband, Nick; Völlm, Birgit A; Ferriter, Michael; Lieb, Klaus

2014-01-01

Background Antisocial personality disorder (AsPD) is associated with a wide range of disturbance including persistent rule-breaking, criminality, substance use, unemployment, homelessness and relationship difficulties. Objectives To evaluate the potential beneficial and adverse effects of psychological interventions for people with AsPD. Search methods Our search included CENTRAL Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, PsycINFO, ASSIA, BIOSIS and COPAC. Selection criteria Prospective, controlled trials in which participants with AsPD were randomly allocated to a psychological intervention and a control condition (either treatment as usual, waiting list or no treatment). Data collection and analysis Three authors independently selected studies. Two authors independently extracted data. We calculated mean differences, with odds ratios for dichotomous data. Main results Eleven studies involving 471 participants with AsPD met the inclusion criteria, although data were available from only five studies involving 276 participants with AsPD. Only two studies focused solely on an AsPD sample. Eleven different psychological interventions were examined. Only two studies reported on reconviction, and only one on aggression. Compared to the control condition, cognitive behaviour therapy (CBT) plus standard maintenance was superior for outpatients with cocaine dependence in one study, but CBT plus treatment as usual was not superior for male outpatients with recent verbal/physical violence in another. Contingency management plus standard maintenance was superior for drug misuse for outpatients with cocaine dependence in one study but not in another, possibly because of differences in the behavioural intervention. However, contingency management was superior in social functioning and counselling session attendance in the latter. A multi-component intervention utilising motivational interviewing principles, the ‘Driving Whilst Intoxicated program’, plus

Are patients at risk for psychological maladjustment during fertility treatment less willing to comply with treatment? Results from the Portuguese validation of the SCREENIVF

NARCIS (Netherlands)

Lopes, V.; Canavarro, M.C.; Verhaak, C.M.; Boivin, J.; Gameiro, S.

2014-01-01

STUDY QUESTION: Do patients at risk for psychological maladjustment during fertility treatment present lower intentions to comply with recommended treatment than patients not at risk? SUMMARY ANSWER: Patients at risk of psychological maladjustment present similar high intentions to comply with

Psychological Treatments for Mental Disorders in Children and Adolescents: A Review of the Evidence of Leading International Organizations.

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Gálvez-Lara, Mario; Corpas, Jorge; Moreno, Eliana; Venceslá, José F; Sánchez-Raya, Araceli; Moriana, Juan A

2018-04-02

In recent decades, the evidence on psychological treatments for children and adolescents has increased considerably. Several organizations have proposed different criteria to evaluate the evidence of psychological treatment in this age group. The aim of this study was to analyze evidence-based treatments drawn from RCTs, reviews, meta-analyses, guides and lists provided by four leading international organizations. The institutions reviewed were the National Institute for Health and Care Excellence, the Society of Clinical Child and Adolescent Psychology (Division 53) of the American Psychological Association, Cochrane Collaboration and the Australian Psychological Society in relation to mental disorders in children and adolescents. A total of 137 treatments were analyzed for 17 mental disorders and compared to determine the level of agreement among the organizations. The results indicate that, in most cases, there is little agreement among organizations and that there are several discrepancies within certain disorders. These results require reflection on the meaning attributed to evidence-based treatments with regard to psychological treatments in children and adolescents. The possible reasons for these differences could be explained by a combination of different issues: the procedures or committees may be biased, different studies were reviewed, different criteria are used by the organizations or the reviews of existing evidence were conducted in different time periods.

A Randomized Controlled Trial on Effects of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults

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Nidich, Sanford I.; Rainforth, Maxwell V.; Haaga, David A.F.; Hagelin, John; Salerno, John W.; Travis, Fred; Tanner, Melissa; Gaylord-King, Carolyn; Grosswald, Sarina; Schneider, Robert H.

2009-01-01

Background Psychological distress contributes to the development of hypertension in young adults. This trial assessed the effects of a mind–body intervention on blood pressure (BP), psychological distress, and coping in college students. Methods This was a randomized controlled trial (RCT) of 298 university students randomly allocated to either the Transcendental Meditation (TM) program or wait-list control. At baseline and after 3 months, BP, psychological distress, and coping ability were assessed. A subgroup of 159 subjects at risk for hypertension was analyzed similarly. Results Changes in systolic BP (SBP)/diastolic BP (DBP) for the overall sample were −2.0/−1.2 mm Hg for the TM group compared to +0.4/+0.5 mm Hg for controls (P = 0.15, P = 0.15, respectively). Changes in SBP/DBP for the hypertension risk subgroup were −5.0/−2.8 mm Hg for the TM group compared to +1.3/+1.2 mm Hg for controls (P = 0.014, P = 0.028, respectively). Significant improvements were found in total psychological distress, anxiety, depression, anger/hostility, and coping (P values < 0.05). Changes in psychological distress and coping correlated with changes in SBP (P values < 0.05) and DBP (P values < 0.08). Conclusions This is the first RCT to demonstrate that a selected mind–body intervention, the TM program, decreased BP in association with decreased psychological distress, and increased coping in young adults at risk for hypertension. This mind–body program may reduce the risk for future development of hypertension in young adults. PMID:19798037

Exercise addiction- diagnosis, bio-psychological mechanisms and treatment issues.

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Weinstein, Aviv; Weinstein, Yitzhak

2014-01-01

Exercise and sports activity are beneficial both physically and psychologically but excessive exercise may have adverse physiological and psychological effects. There are methodological issues in the definition, diagnosis and etiology of exercise addiction. Several questionnaires and diagnostic tools have been developed and validated and they show high validity and reliability. Exercise addiction has been suggested as having an obsessive-compulsive dimension as well as rewarding aspects that may include it among the behavioral addictions. Biological studies show that in rodents, exercise such as wheel running activates the dopamine reward system and thus contributing to stress reduction. Further evidence suggests that running is associated with endorphins and cannabinoids thus explaining the "runners high" or euphoric feelings that may lead to exercise addiction. Genetic studies suggest that genes which control preference for drugs also control the preference for naturally rewarding behaviors such as exercise. Psychological studies also explain exercise addiction in terms of reward, habituation, social support, stress-relief, avoidance of withdrawal and reduction of anxiety. It has been suggested that exercise addiction is a part of a continuum of sportive activity that develops in stages from the recreational exercise to at-risk exercise, problematic exercise and finally into exercise addiction. Assessment and treatment should take into account the various stages of exercise addiction development, its comorbidity with other psychiatric disorders such as eating disorders or substance use and alcohol disorders. Treatment approaches for exercise addiction are based on the cognitive-behavioral approach but little is known about their effectiveness. A single-case study shows promise of pharmacological treatment for exercise addiction and further studies are required. This review summarizes diagnostic and phenomenology of exercise addiction with emphasis on

Can psychobiotics intake modulate psychological profile and body composition of women affected by normal weight obese syndrome and obesity? A double blind randomized clinical trial.

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De Lorenzo, Antonino; Costacurta, Micaela; Merra, Giuseppe; Gualtieri, Paola; Cioccoloni, Giorgia; Marchetti, Massimiliano; Varvaras, Dimitrios; Docimo, Raffaella; Di Renzo, Laura

2017-06-10

Evidence of probiotics effects on gut function, brain activity and emotional behaviour were provided. Probiotics can have dramatic effects on behaviour through the microbiome-gut-brain axis, through vagus nerve. We investigated whether chronic probiotic intake could modulate psychological state, eating behaviour and body composition of normal weight obese (NWO) and preobese-obese (PreOB/OB) compared to normal weight lean women (NWL). 60 women were enrolled. At baseline and after a 3-week probiotic oral suspension (POS) intake, all subjects underwent evaluation of body composition by anthropometry and dual X-ray absorptiometry, and psychological profile assessment by self-report questionnaires (i.e. EDI-2, SCL90R and BUT). Statistical analysis was carried out using paired t test or a non-parametric Wilcoxon test to evaluate differences between baseline and after POS intake, one-way ANOVA to compare all three groups and, where applicable, Chi square or t test were used to assess symptoms. Of the 48 women that concluded the study, 24% were NWO, 26% were NWL and 50% were PreOB/OB. Significant differences in body composition were highlighted among groups both at baseline and after a POS (p women. At baseline and after POS intake, all subjects tested were negative to SCL90R_GSI scale, but after treatment subjects positive to BUT_GSI scale were significantly reduced (8.33%) (p women. Further research is needed on a larger population and for a longer period of treatment before definitive conclusions can be made. Trial registration ClinicalTrials.gov Id: NCT01890070.

The EVERT (effective verruca treatments trial protocol: a randomised controlled trial to evaluate cryotherapy versus salicylic acid for the treatment of verrucae

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Cockayne E Sarah

2010-02-01

Full Text Available Abstract Background Verrucae are a common, infectious and sometimes painful problem. The optimal treatment for verrucae is unclear due to a lack of high quality randomised controlled trials. The primary objective of this study is to compare the clinical effectiveness of two common treatments for verrucae: cryotherapy using liquid nitrogen versus salicylic acid. Secondary objectives include a comparison of the cost-effectiveness of the treatments, and an investigation of time to clearance of verrucae, recurrence/clearance of verrucae at six months, patient satisfaction with treatment, pain associated with treatment, and use of painkillers for the treatments. Methods/Design This is an open, pragmatic, multicentre, randomised controlled trial with two parallel groups: cryotherapy using liquid nitrogen delivered by a healthcare professional for a maximum of 4 treatments (treatments 2-3 weeks apart or daily self-treatment with 50% salicylic acid for a maximum of 8 weeks. Two hundred and sixty-six patients aged 12 years and over with a verruca are being enrolled into the study. The primary outcome is complete clearance of all verrucae as observed on digital photographs taken at 12 weeks compared with baseline and assessed by an independent healthcare professional. Secondary outcomes include self-reported time to clearance of verrucae, self-reported clearance of verrucae at 6 months, cost-effectiveness of the treatments compared to one another, and patient acceptability of both treatments including possible side effects such as pain. The primary analysis will be intention to treat. It is planned that recruitment will be completed by December 2009 and results will be available by June 2010. Trial registration Current Controlled Trials ISRCTN18994246.

Sampling bias in an internet treatment trial for depression.

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Donkin, L; Hickie, I B; Christensen, H; Naismith, S L; Neal, B; Cockayne, N L; Glozier, N

2012-10-23

Internet psychological interventions are efficacious and may reduce traditional access barriers. No studies have evaluated whether any sampling bias exists in these trials that may limit the translation of the results of these trials into real-world application. We identified 7999 potentially eligible trial participants from a community-based health cohort study and invited them to participate in a randomized controlled trial of an online cognitive behavioural therapy programme for people with depression. We compared those who consented to being assessed for trial inclusion with nonconsenters on demographic, clinical and behavioural indicators captured in the health study. Any potentially biasing factors were then assessed for their association with depression outcome among trial participants to evaluate the existence of sampling bias. Of the 35 health survey variables explored, only 4 were independently associated with higher likelihood of consenting-female sex (odds ratio (OR) 1.11, 95% confidence interval (CI) 1.05-1.19), speaking English at home (OR 1.48, 95% CI 1.15-1.90) higher education (OR 1.67, 95% CI 1.46-1.92) and a prior diagnosis of depression (OR 1.37, 95% CI 1.22-1.55). The multivariate model accounted for limited variance (C-statistic 0.6) in explaining participation. These four factors were not significantly associated with either the primary trial outcome measure or any differential impact by intervention arm. This demonstrates that, among eligible trial participants, few factors were associated with the consent to participate. There was no indication that such self-selection biased the trial results or would limit the generalizability and translation into a public or clinical setting.

Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial

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Drossaert, Constance HC; Pieterse, Marcel E; Walburg, Jan A; Bohlmeijer, Ernst T

2015-01-01

Background Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. Objective This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. Methods In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. Results The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. Conclusions This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. Trial

Are pre-treatment psychological characteristics influenced by pre-surgical orthodontics?

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Cunningham, S J; Gilthorpe, M S; Hunt, N P

2001-12-01

A number of investigations have looked at psychological changes occurring in association with orthognathic treatment. However, most of these studies have used a pre-surgery questionnaire as the baseline measurement. There is little data relating to the true baseline, i.e. that prior to any active treatment. Until this aspect is investigated, it is not possible to assume that pre-surgery is an acceptable baseline. This questionnaire based study aimed to assess changes in six psychological outcome measures between T1 (prior to any active treatment) and T2 (following pre-surgical orthodontics/prior to surgery). The outcome variables were: state anxiety, trait anxiety, depression, self-esteem, body image, and facial body image. Sixty-two patients (39 females and 23 males) completed both questionnaires. The results showed that intervention, in the form of orthodontic treatment, had a minimal effect on the chosen psychometric outcome variables. There was a significant reduction in satisfaction with body image amongst patients who initially reported mild to moderate dental/facial problems, whilst a moderate increase in satisfaction occurred in those patients reporting severe conditions initially. Also of note were significant increases in state anxiety amongst older patients whilst trait anxiety showed greater increases in females than males.

Influence of Baseline Psychological Health on Muscle Pain During Atorvastatin Treatment.

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Zaleski, Amanda L; Taylor, Beth A; Pescatello, Linda S; Dornelas, Ellen A; White, Charles Michael; Thompson, Paul D

3-hydroxy-3-methylglutaryl coenzyme A reductase reductase inhibitors (statins) are generally well tolerated, with statin-associated muscle symptoms (SAMS) the most common side effect (~10%) seen in statin users. However, studies and clinical observations indicate that many of the self-reported SAMS appear to be nonspecific (ie, potentially not attributable to statins). Mental health and well-being influence self-perception of pain, so we sought to assess the effect of baseline well-being and depression on the development of muscle pain with 6 months of atorvastatin 80 mg/d (ATORVA) or placebo in healthy, statin-naive adults. The Psychological General Well-being Index (n = 83) and Beck Depression Inventory (n = 55) questionnaires were administered at baseline in participants (aged 59.5 ± 1.2 years) from the effect of Statins on Skeletal Muscle Function and Performance (STOMP) trial (NCT00609063). Muscle pain (Short-Form McGill Pain Questionnaire [SF-MPQ]), pain that interferes with daily life (Brief Pain Inventory [BPI]), and pain severity (BPI) were then measured before, throughout, and after treatment. At baseline, there were no differences in well-being (Psychological General Well-being Index), depression (Beck Depression Inventory), or pain measures (SF-MPQ and BPI) (P values ≥ .05) between the placebo and ATORVA groups. Baseline well-being correlated negatively with baseline BPI pain severity (r = -0.290, P = .008). Baseline depression correlated with baseline pain (SF-MPQ; r = 0.314, P = .020). Baseline well-being and depression did not predict the change in pain severity or interference after 6 months among the total sample or between groups (P values ≥ .05). Baseline well-being and depression were not significant predictors of pain after 6 months of ATORVA (P values ≥ .05). Thus, they do not appear to increase the risk of SAMS in otherwise healthy adults.

Treatment of traumatized refugees with Sertraline versus Venlafaxine in combination with psychotherapy – study protocol for a randomized clinical trial

Science.gov (United States)

2013-01-01

Background Sufficient evidence is lacking to draw final conclusions on the efficiency of medical and psychological treatments of traumatized refugees with PTSD. The pharmacological treatments of choice today for post-traumatic stress disorder are antidepressants from the subgroup selective serotonin reuptake inhibitors, especially Sertraline. The evidence for the use of selective serotonin reuptake inhibitors in the treatment of complex post-traumatic stress disorder in traumatized refugees is very limited. Venlafaxine is a dual-action antidepressant that works on several pathways in the brain. It influences areas in the brain which are responsible for the enhanced anxiety and hyper-arousal experienced by traumatized refugees and which some studies have found to be enlarged among patients suffering from post-traumatic stress disorder. Design This study will include approximately 150 patients, randomized into two different groups treated with either Sertraline or Venlafaxine. Patients in both groups will receive the same manual-based cognitive behavioral therapy, which has been especially adapted to this group of patients. The treatment period will be 6 to 7 months. The trial endpoints will be post-traumatic stress disorder and depressive symptoms and social functioning, all measured on validated ratings scales. Furthermore the study will examine the relation between a psycho-social resources and treatment outcome based on 15 different possible outcome predictors. Discussion This study is expected to bring forward new knowledge on treatment and clinical evaluation of traumatized refugees and the results are expected to be used in reference programs and clinical guidelines. Trial registration ClinicalTrials.gov NCT01569685 PMID:23663588

Effect of psychological therapy on disease activity, psychological comorbidity, and quality of life in inflammatory bowel disease: a systematic review and meta-analysis.

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Gracie, David J; Irvine, Andrew J; Sood, Ruchit; Mikocka-Walus, Antonina; Hamlin, P John; Ford, Alexander C

2017-03-01

Inflammatory bowel disease is associated with psychological comorbidity and impaired quality of life. Psychological comorbidity could affect the natural history of inflammatory bowel disease. Psychological therapies might therefore have beneficial effects on disease activity, mood, and quality of life in patients with inflammatory bowel disease. We did a systematic review and meta-analysis examining these issues. In this systematic review and meta-analysis, we searched MEDLINE, Embase, Embase Classic, PsychINFO, and the Cochrane Central Register of Controlled Trials for articles published between 1947 and Sept 22, 2016. Randomised controlled trials (RCTs) recruiting patients with inflammatory bowel disease aged at least 16 years that compared psychological therapy with a control intervention or usual treatment were eligible. We pooled dichotomous data to obtain relative risks of induction of remission in active disease or prevention of relapse of quiescent disease, with 95% CIs. We pooled continuous data to estimate standardised mean differences in disease activity indices, anxiety, depression, perceived stress, and quality-of-life scores in patients dichotomised into those with clinically active or quiescent disease, with 95% CIs. We extracted data from published reports and contacted the original investigators of studies for which the required data were not available. We pooled all data using a random-effects model. The search identified 1824 studies, with 14 RCTs of 1196 patients eligible for inclusion. The relative risk of relapse of quiescent inflammatory bowel disease with psychological therapy versus control was 0·98 (95% CI 0·77-1·24; p=0·87; I 2 =50%; six trials; 518 patients). We observed a significant difference in depression scores (standardised mean difference -0·17 [-0·33 to -0·01]; p=0·04; I 2 =0%; seven trials; 605 patients) and quality of life (0·30 [0·07-0·52]; p=0·01; I 2 =42%; nine trials; 578 patients) with psychological therapy

Phase 2 Neoadjuvant Treatment Intensification Trials in Rectal Cancer

DEFF Research Database (Denmark)

Teo, Mark T W; McParland, Lucy; Appelt, Ane L

2018-01-01

PURPOSE: Multiple phase 2 trials of neoadjuvant treatment intensification in locally advanced rectal cancer have reported promising efficacy signals, but these have not translated into improved cancer outcomes in phase 3 trials. Improvements in phase 2 trial design are needed to reduce these fals...

Causal explanations affect judgments of the need for psychological treatment

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Nancy S. Kim

2009-02-01

Full Text Available Knowing what event precipitated a client's abnormal behaviors makes the client appear more normal than if the event is not known (Meehl, 1973. Does such knowledge also influence judgments of the need for psychological treatment, and if so, does it matter whether the precipitating event was inside or outside the client's control? We presented undergraduates with cases of hypothetical clients exhibiting abnormal behaviors and manipulated whether they were also told of a precipitating event explaining those behaviors. Knowing the precipitant significantly reduced perceptions of clients' need for treatment, but only when the precipitating event was outside the client's control. These findings call into question the notion that it need always be beneficial for an outside reasoner to uncover the root cause of a client's psychological problems, particularly when the root cause is still unknown to the client. The rationality of the effect and additional implications for decision-making are discussed.

Associations between psychological factors and the effect of home-based physical exercise in women with chronic neck and shoulder pain

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Linn Karlsson

2016-09-01

Full Text Available Background: Exercise is often used in the treatment of chronic neck and shoulder muscle pain. It is likely that psychological aspects have an impact on the results of exercise-based treatments. Objectives: (1 To examine the associations between psychological factors and the effect of a home-based physical exercise intervention. (2 To examine differences in psychological factors at baseline between (a subjects who continued in the trial and those who did not and (b subjects who completed the intervention and those who did not. Method: A total of 57 women with chronic neck and shoulder pain were included in a home-based exercise intervention trial. Pain intensity, disability, and psychological factors (anxiety and depression symptoms, catastrophizing, fear-avoidance beliefs, self-efficacy, and pain acceptance were measured at baseline, after 4–6 months, and after 1 year of exercise. Associations between the psychological factors and changes in pain intensity and disability were analysed, as well as differences in psychological factors at baseline between subjects who continued in and completed the intervention, and those who did not. Results: Associations between positive changes in pain intensity and disability were found for low fear-avoidance beliefs and low-pain self-efficacy at baseline. In addition, fear-avoidance beliefs at baseline were higher in the subjects who dropped out of the intervention than in those who continued. Pain acceptance at baseline was higher in the subjects who completed the intervention at the end of the trial. Conclusion: Particularly, fear-avoidance beliefs and pain self-efficacy should be taken into consideration when implementing home-based physical exercise as treatment for chronic neck pain. In addition, high pain acceptance might improve the adherence to prescribed exercise.

A longitudinal study investigating the role of decisional conflicts and regret and short-term psychological adjustment after IVF treatment failure.

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Chan, Celia Hoi Yan; Lau, Hi Po Bobo; Tam, Michelle Yi Jun; Ng, Ernest Hung Yu

2016-12-01

What is the relationship between decisional conflict, decisional regret and psychological well-being in women following unsuccessful IVF cycles? The mediating effect of decisional regret on the relationship between decisional conflict and fertility-related quality of life (FRQOL) has been found to be moderated by the availability (versus absence) of frozen embryos after an unsuccessful IVF cycle. Infertility treatment is marked by its open-ended nature. Stresses in treatment decision-making could be aggravated by a culture which honours families through procreation. While studies have investigated treatment-related decision-making among infertile women, little is known about the mental health consequences of decisional conflict and decisional regret following an unsuccessful IVF cycle. A study was conducted over a 3-month period with infertile women who had recently experienced a failed IVF cycle (T 0 ). Decisional conflict when they decided on terminating or continuing treatment (T 1 ) and decisional regret 3 months later (T 2 ) were measured. Participants reported their levels of depression, anxiety and FRQOL at three time points. A total of 151 participants completed all time points (attrition rate: 39%). The average age of participants was 37.2 years, and they had had 1.1 cycles (range: 0-8) on average at the time of study intake. The duration of the study was 2 years. Participants were infertile women who were not pregnant following an IVF cycle recruited from a university-affiliated assisted reproduction centre. Following the notification of a negative pregnancy result, patients were invited to complete measures of FRQOL, depression and anxiety across three time points and decisional conflict and decisional regret at T 1 and T 2 respectively. Decisional regret partially mediated the effect of decisional conflict on overall and treatment-specific FRQOL (P IVF cycle (P IVF cycle. Healthcare professionals should be aware of the psychological ramifications of

Intensive home treatment for patients in acute psychiatric crisis situations: a multicentre randomized controlled trial.

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Cornelis, Jurgen; Barakat, Ansam; Dekker, Jack; Schut, Tessy; Berk, Sandra; Nusselder, Hans; Ruhl, Nikander; Zoeteman, Jeroen; Van, Rien; Beekman, Aartjan; Blankers, Matthijs

2018-02-27

Hospitalization is a common method to intensify care for patients experiencing a psychiatric crisis. A short-term, specialised, out-patient crisis intervention by a Crisis Resolution Team (CRT) in the Netherlands, called Intensive Home Treatment (IHT), is a viable intervention which may help reduce hospital admission days. However, research on the (cost-)effectiveness of alternatives to hospitalisation such as IHT are scarce. In the study presented in this protocol, IHT will be compared to care-as-usual (CAU) in a randomized controlled trial (RCT). CAU comprises low-intensity outpatient care and hospitalisation if necessary. In this RCT it is hypothesized that IHT will reduce inpatient days by 33% compared to CAU while safety and clinical outcomes will be non-inferior. Secondary hypotheses are that treatment satisfaction of patients and their relatives are expected to be higher in the IHT condition compared to CAU. A 2-centre, 2-arm Zelen double consent RCT will be employed. Participants will be recruited in the Amsterdam area, the Netherlands. Clinical assessments will be carried out at baseline and at 6, 26 and 52 weeks post treatment allocation. The primary outcome measure is the number of admission days. Secondary outcomes include psychological well-being, safety and patients' and their relatives' treatment satisfaction. Alongside this RCT an economic evaluation will be carried out to assess the cost-effectiveness and cost-utility of IHT compared to CAU. RCTs on the effectiveness of crisis treatment in psychiatry are scarce and including patients in studies performed in acute psychiatric crisis care is a challenge due to the ethical and practical hurdles. The Zelen design may offer a feasible opportunity to carry out such an RCT. If our study finds that IHT is a safe and cost-effective alternative for CAU it may help support a further decrease of in-patient bed days and may foster the widespread implementation of IHT by mental health care organisations

Psychological Characteristics of Chronic Pain: a Review of Current Evidence and Assessment Tools to Enhance Treatment.

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Miller, Rhondene M; Kaiser, Ronald S

2018-03-14

The complicated nature of chronic pain involves an interplay between psychological and physical factors, often resulting in increased emotional distress and reduced quality of life. This review is designed to help the medical practitioner who is working with chronic pain patients to be aware of psychological assessment techniques that can add to comprehensive patient understanding and more effectively guide treatment. Enhanced ability to assess and understand the emotional life of the chronic pain patient provides a basis for intervening and treating more successfully. There are a broad range of assessment techniques, some of which require a background in psychology and some that do not, that can identify psychological differences in chronic pain patients and serve to guide intervention strategies. Chronic pain is often comorbid with depression, anxiety, catastrophizing, and various ineffective coping strategies. Some patients, however, have demonstrated more adaptive and effective strategies for cognitively and behaviorally coping with pain and normalizing their lives. Proper assessment enables the individualization of treatment to overcome and/or build upon each patient's psychological frame of mind to maximize the potential for effective functioning. The use of standardized and documented psychological assessment techniques can lead to a better understanding of chronic pain patients and contribute in ways that can enhance response to medical treatment and improve quality of life. It is recommended that certain psychological tools be included to supplement the medical assessment of patients who have chronic pain. A basic assessment can include a short psychological-based clinical interview along with brief measures of depression, anxiety, and coping strategies. It is also recommended that the pain physician have access to professional psychological practitioners as a resource for more complicated assessments and psychological intervention services.

Weight-based stigmatization, psychological distress, & binge eating behavior among obese treatment-seeking adults.

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Ashmore, Jamile A; Friedman, Kelli E; Reichmann, Simona K; Musante, Gerard J

2008-04-01

To evaluate the associations between weight-based stigmatization, psychological distress, and binge eating behavior in a treatment-seeking obese sample. Ninety-three obese adults completed three questionnaires: 1) Stigmatizing Situations Inventory, 2) Brief Symptoms Inventory, and 3) Binge Eating Questionnaire. Correlational analyses were used to evaluate the association between stigmatizing experiences, psychological distress and binge eating behavior. Stigmatizing experiences predicted both binge eating behavior (R(2)=.20, p<.001) and overall psychological distress (R(2)=.18, p<.001). A substantial amount of the variance in binge eating predicted by weight-based stigmatization was due to the effect of psychological distress. Specifically, of the 20% of the variance in binge eating accounted for by stigmatizing experiences, between 7% and 34% (p<.01) was due to the effects of various indicators of psychological distress. These data suggest that weight-based stigmatization predicts binge eating behavior and that psychological distress associated with stigmatizing experiences may be an important mediating factor.

Clinical outcomes in clinical trials of anti-HIV treatment

DEFF Research Database (Denmark)

Reekie, J; Mocroft, A; J, Neaton

2007-01-01

Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial

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Ly Kien

2012-05-01

Full Text Available Abstract Background The need for cost-effective interventions for people suffering from major depressive disorders is essential. Behavioral activation is an intervention that can largely benefit from the use of new mobile technologies (for example smartphones. Therefore, developing smartphone-based behavioral activation interventions might be a way to develop cost-effective treatments for people suffering from major depressive disorders. The aim of this study will be to test the effects of a smartphone-delivered behavioral activation treatment. Methods The study will be a randomized controlled trial with a sample size of 120 participants, with 60 patients in each group. The treatment group includes an 8-week smartphone-based behavioral activation intervention, with minimal therapist contact. The smartphone-based intervention consists of a web-based psychoeducation, and a smartphone application. There is also a back-end system where the therapist can see reports from the patients or activities being reported. In the attention control group, we will include brief online education and then recommend use of a smartphone application that is not directly aimed at depression (for example, ‘Effective meditation’. The duration of the control condition will also be 8 weeks. For ethical reasons we will give the participants in the control group access to the behavioral activation treatment following the 8-week treatment period. Discussions We believe that this trial has at least three important implications. First, we believe that smartphones can be integrated even further into society and therefore may serve an important role in health care. Second, while behavioral activation is a psychological treatment approach for which there is empirical support, the use of a smartphone application could serve as the therapist’s prolonged arm into the daily life of the patient. Third, as we have been doing trials on guided Internet treatment for more than 10�

A psychological treatment programme for traumatised ex military personnel in the UK

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Beatriz Sánchez España

2008-12-01

Full Text Available A large proportion of homeless people in the UK are former members of the armed services and suffer from a mental illness. In fact, homelessness itself can be considered a symptom or manifestation of other underlying psychological difficulties. For these reasons Community Housing and Therapy (CHT considers that providing psychological therapies to treat the homeless population is a more effective way of tackling the problem of homelessness, as it addresses the roots of the problem. This approach is one which is beginning to be recognised by leading agencies in the field. At the same time, the provision of psychological therapies for symptoms such as depression and anxiety has become accepted through the Department of Health’s (DoH Increased Access to Psychological Therapies ( IAPT initiative. Depression is the most common psychiatric disorder that homeless people suffer and it is well documented that psychological treatments for depression can be extremely effective. As well as approaching homelessness from the angle of psychological therapies, CHT in its work with the ex-service community has become increasingly aware that there are a large number of non statutory homeless that do not get the same attention as rough sleepers.

Weight Change over the Course of Binge Eating Disorder Treatment: Relationship to Binge Episodes and Psychological Factors.

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Pacanowski, Carly R; Mason, Tyler B; Crosby, Ross D; Mitchell, James E; Crow, Scott J; Wonderlich, Stephen A; Peterson, Carol B

2018-05-01

Treatment for binge eating disorder (BED), a condition associated with both excess adiposity and psychological distress, has not typically produced significant weight loss despite reducing binge eating. Characterizing factors that promote or inhibit weight loss in individuals with co-occurring BED and obesity may help explain overall nonsignificant weight changes during treatment. In this study, 189 adults with BED participated in a randomized clinical trial evaluating the efficacy of 5 months of cognitive behavioral therapy. Assessments included measured height and weight at baseline, midtreatment, end of treatment (EOT), and 6-month follow-up, the Eating Disorder Examination interview, and questionnaires. During treatment, there was a mean weight gain of 1.3 ± 12.0 lb. Twenty-two percent of the sample lost ≥ 5 lb, and 25% of the sample gained ≥ 8 lb. Results showed that baseline objective binge eating episodes predicted weight over treatment. Changes in weight were significantly positively related to concurrent changes in shape concern, weight concern, and disinhibition, but not binge eating episodes. Changes in objective binge eating episodes from baseline to EOT were associated with changes in weight from EOT to follow-up. Further investigation of eating behavior during BED treatment to understand the energy balance contributions to weight change or stability is warranted. © 2018 The Obesity Society.

History of the treatment of persons with psychological difficulties and the abuse of their civil rights

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Petrović Nikola M.

2013-01-01

Full Text Available Treatment of persons with psychological difficulties varied in different historical periods, but in its essence remained similar until today. It included an inhumane relationship towards these persons, involuntary treatment through torture, and isolation from society as a kind of punishment for their diversity. It was not until the late 19th century that the relationship of society towards these individuals started to improve gradually, but in the 21st century isolation of these individuals still remained the dominant form of acceptable social solution for the “problem”, with a somewhat more humane attitude towards them and less cruel treatment. Serbia has followed the trends of treatment of the persons with psychological difficulties from the rest of Europe for centuries, but is still lagging behind the world in the introduction of new methods of treatment. Indeed the first legal solution to regulate the human rights of these people is currently in the process of implementation. The subject of this paper is the treatment of persons with psychological difficulties and the violation of their civil rights. In a subject specific context the goal of the analysis was the historical review of the treatment towards persons with psychological difficulties by doctors, other practicioners and the community in general, with reference to the current situation regarding their treatment within the psychiatric institutions, as well as the legal regulations and the protection of their civil rights.

Brief psychosocial therapy for the treatment of agitation in Alzheimer disease (the CALM-AD trial).

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Ballard, Clive; Brown, Richard; Fossey, Jane; Douglas, Simon; Bradley, Paul; Hancock, Judith; James, Ian A; Juszczak, Edmund; Bentham, Peter; Burns, Alistair; Lindesay, James; Jacoby, Robin; O'Brien, John; Bullock, Roger; Johnson, Tony; Holmes, Clive; Howard, Robert

2009-09-01

Good practice guidelines state that a psychological intervention should usually precede pharmacotherapy, but there are no data evaluating the feasibility of psychological interventions used in this way. At the first stage of a randomized blinded placebo-controlled trial, 318 patients with Alzheimer disease (AD) with clinically significant agitated behavior were treated in an open design with a psychological intervention (brief psychosocial therapy [BPST]) for 4 weeks, preceding randomization to pharmacotherapy. The therapy involved social interaction, personalized music, or removal of environmental triggers. Overall, 318 patients with AD completed BPST with an improvement of 5.6 points on the total Cohen-Mansfield Agitation Inventory (CMAI; mean [SD], 63.3 [16.0] to 57.7 [18.4], t = 4.8, df = 317, p 95% of patients. More detailed evaluation of outcome was completed for the 198 patients with AD from these centers, who experienced a mean improvement of 6.6 points on the total CMAI (mean [SD], 62.2 [14.3] to 55.6 [15.8], t = 6.5, df = 197, p < 0.0001). Overall, 43% of participants achieved a 30% improvement in their level of agitation. The specific attributable benefits of BPST cannot be determined from an open trial. However, the BPST therapy was feasible and was successfully delivered according to an operationalized manual. The encouraging outcome indicates the need for a randomized controlled trial of BPST.

A Randomized Controlled Trial of Intensive Sleep Retraining (ISR): A Brief Conditioning Treatment for Chronic Insomnia

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Harris, Jodie; Lack, Leon; Kemp, Kristyn; Wright, Helen; Bootzin, Richard

2012-01-01

sleep, daytime functioning, and psychological variables. Adding ISR to traditional interventions seems to result in a superior treatment response. Citation: Harris J; Lack L; Kemp K; Wright H; Bootzin R. A randomized controlled trial of intensive sleep retraining (ISR): a brief conditioning treatment for chronic insomnia. SLEEP 2012;35(1):49-60. PMID:22215918

Treatment mechanism in the MRC preschool autism communication trial: implications for study design and parent-focussed therapy for children.

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Pickles, Andrew; Harris, Victoria; Green, Jonathan; Aldred, Catherine; McConachie, Helen; Slonims, Vicky; Le Couteur, Ann; Hudry, Kristelle; Charman, Tony

2015-02-01

The PACT randomised-controlled trial evaluated a parent-mediated communication-focused treatment for children with autism, intended to reduce symptom severity as measured by a modified Autism Diagnostic Observation Schedule-Generic (ADOS-G) algorithm score. The therapy targeted parental behaviour, with no direct interaction between therapist and child. While nonsignificant group differences were found on ADOS-G score, significant group differences were found for both parent and child intermediate outcomes. This study aimed to better understand the mechanism by which the PACT treatment influenced changes in child behaviour though the targeted parent behaviour. Mediation analysis was used to assess the direct and indirect effects of treatment via parent behaviour on child behaviour and via child behaviour on ADOS-G score. Alternative mediation was explored to study whether the treatment effect acted as hypothesised or via another plausible pathway. Mediation models typically assume no unobserved confounding between mediator and outcome and no measurement error in the mediator. We show how to better exploit the information often available within a trial to begin to address these issues, examining scope for instrumental variable and measurement error models. Estimates of mediation changed substantially when account was taken of the confounder effects of the baseline value of the mediator and of measurement error. Our best estimates that accounted for both suggested that the treatment effect on the ADOS-G score was very substantially mediated by parent synchrony and child initiations. The results highlighted the value of repeated measurement of mediators during trials. The theoretical model underlying the PACT treatment was supported. However, the substantial fall-off in treatment effect highlighted both the need for additional data and for additional target behaviours for therapy. © 2014 The Authors. Journal of Child Psychology and Psychiatry. © 2014 Association for

Specific attitudes which predict psychology students' intentions to seek help for psychological distress.

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Thomas, Susan J; Caputi, Peter; Wilson, Coralie J

2014-03-01

Although many postgraduate psychology programs address students' mental health, there are compelling indications that earlier, undergraduate, interventions may be optimal. We investigated specific attitudes that predict students' intentions to seek treatment for psychological distress to inform targeted interventions. Psychology students (N = 289; mean age = 19.75 years) were surveyed about attitudes and intentions to seek treatment for stress, anxiety, or depression. Less than one quarter of students reported that they would be likely to seek treatment should they develop psychological distress. Attitudes that predicted help-seeking intentions related to recognition of symptoms and the benefits of professional help, and openness to treatment for emotional problems. The current study identified specific attitudes which predict help-seeking intentions in psychology students. These attitudes could be strengthened in undergraduate educational interventions promoting well-being and appropriate treatment uptake among psychology students. © 2013 Wiley Periodicals, Inc.

Meta-analysis of the effectiveness of psychological and medical treatments for binge-eating disorder (MetaBED): study protocol.

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Hilbert, Anja; Petroff, David; Herpertz, Stephan; Kersting, Anette; Pietrowsky, Reinhard; Tuschen-Caffier, Brunna; Vocks, Silja; Schmidt, Ricarda

2017-03-29

Binge-eating disorder (BED) was included as its own diagnostic entity in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). An increasing number of treatment studies have been published, but an up-to-date comprehensive meta-analysis on diverse treatment approaches for BED is lacking. In an updated and extension of a previous meta-analysis, the goals of this study are to assess the short-term and long-term effectiveness of psychological and medical treatments for BED. We will search bibliographic databases and study registries, including manual searches for studies published before January 2016. The search strategy will include terms relating to binge eating and diverse forms of psychological and medical interventions. Language will be restricted to English. The studies included will be treatment studies, that is, randomised-controlled trials, and non-randomised and non-controlled studies, for individuals with BED (DSM-IV or DSM-5), and studies that provided a pre-treatment and at least one post-treatment or follow-up assessment of binge eating. The primary outcomes will be the number of binge-eating episodes, abstinence from binge eating and diagnosis of BED at post-treatment and/or follow-up(s), and changes from pre-treatment to post-treatment and/or follow-up(s). Likewise, as secondary outcomes, eating disorder and general psychopathology, quality of life, and body weight will be analysed and adverse events and treatment drop-out will be examined. Study search, selection and data extraction, including risk of bias assessment, will be independently performed by 2 reviewers and consensus will be sought. Moderator analyses will be conducted, and equity aspects will be considered. Sensitivity analyses will be conducted to determine the robustness of the results. Ethical approval is not required for this meta-analysis. Published in a peer-reviewed journal and disseminated electronically and in print, this meta-analysis will form

The effects of an oral multivatimin combination with calcium, magnesium, and zinc on psychological well-being in healthy young male volunteers: A double-blind placebo-controlled trial.

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Carroll, D.; Ring, C.; Suter, M.; Willemsen, A.H.M.

2000-01-01

Rationale: Vitamin and mineral supplements may be associated with improved psychological status. Objective: The present study tested the effects of a multivitamin and mineral supplement (Berocca®) on psychological well-being. Methods: In a double-blind randomised-control trial, 80 healthy male

Reporting methods of blinding in randomized trials assessing nonpharmacological treatments.

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Isabelle Boutron

2007-02-01

Full Text Available BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment, or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography, or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.

Psychological therapies for sickle cell disease and pain.

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Anie, Kofi A; Green, John

2015-05-08

Sickle cell disease comprises a group of genetic blood disorders. It occurs when the sickle haemoglobin gene is inherited from both parents. The effects of the condition are: varying degrees of anaemia which, if severe, can reduce mobility; a tendency for small blood capillaries to become blocked causing pain in muscle and bone commonly known as 'crises'; damage to major organs such as the spleen, liver, kidneys, and lungs; and increased vulnerability to severe infections. There are both medical and non-medical complications, and treatment is usually symptomatic and palliative in nature. Psychological interventions for individuals with sickle cell disease might complement current medical treatment, and studies of their efficacy have yielded encouraging results. This is an update of a previously published Cochrane Review. To examine the evidence that psychological interventions improve the ability of people with sickle cell disease to cope with their condition. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, which comprises references identified from comprehensive electronic database searches and the Internet, handsearches of relevant journals and abstract books of conference proceedings.Date of the most recent search of the Group's Haemoglobinopathies Trials Register: 17 February 2015. All randomised or quasi-randomised controlled trials comparing psychological interventions with no (psychological) intervention in people with sickle cell disease. Both authors independently extracted data and assessed the risk of bias of the included studies. Twelve studies were identified in the searches and seven of these were eligible for inclusion in the review. Five studies, involving 260 participants, provided data for analysis. One study showed that cognitive behaviour therapy significantly reduced the affective component of pain (feelings about pain), mean difference -0.99 (95% confidence interval -1.62 to -0.36), but

Psychological treatment and therapeutic change in incarcerated rapists

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Ana Martínez-Catena

2017-01-01

Full Text Available Abstract Most Spanish prisons provide specialised treatment for incarcerated sex offenders, both rapists and child molesters. This treatment is a cognitive-behavioural intervention that has shown relative effectiveness in previous research. With regard to offenders’ rehabilitation, recidivism assessments are necessary as a final measure of treatment effectiveness. However, the evaluation of recidivism by itself does not provide sufficient information on the treatment process and the specific effects that treated subjects could undergo. This paper aims to analyse the therapeutic effectiveness of psychological treatment provided to rapists (in general, males sentenced for committing a sexual offence against women. To this aim, a group of treated rapists (N=153 serving a sentence in prison was analysed. Using a specially designed scale (PASSO, the global therapeutic change and ten specific variables (including assertiveness, readiness to change, cognitive distortions, impulsivity, etc. were assessed. The within-subjects comparison showed that treated sex offenders improved, in therapeutic terms, globally as well as in most of the specific variables assessed (improvements not experimented by the control group. Also, different therapeutic subscales showed relevant associations between them. The findings regarding treatment effectiveness are discussed.

Psychological effects of belonging to a Facebook weight management group in overweight and obese adults: Results of a randomised controlled trial.

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Jane, Monica; Foster, Jonathan; Hagger, Martin; Ho, Suleen; Kane, Robert; Pal, Sebely

2018-05-18

This study was conducted to test whether the weight outcomes in an online social networking group were mediated by changes to psychological outcome measures in overweight and obese individuals, following a weight management programme delivered via Facebook. The data analysed in this study were collected during a three-armed, randomised, controlled clinical weight management trial conducted with overweight and obese adults over 24 weeks. Two intervention groups were given the same weight management programme: one within a Facebook group, along with peer support from other group members (the Facebook Group); the other group received the same programme in a pamphlet (the Pamphlet Group). A Control Group was given standard care. The primary outcome was weight; secondary outcomes included the following domains from self-reported questionnaires: energy intake and expenditure; psychological health, social relationships, physical health, quality of life, depression, anxiety, stress, health anxiety, happiness, as well as Facebook Group participants' opinion of this group. The Facebook Group experienced a reduction in their baseline weight measurement by week 24, significantly compared to the Control Group (p = .016). The Facebook Group recorded a significant increase in the psychological health domain during the trial (at week 12) relative to their baseline measurement, and significant compared to the Control Group (p = .022). Mediation analysis indicated a statistical trend, but not statistical significance, for psychological health as a mediator to weight loss in the Facebook Group. While both intervention groups showed significant changes in psychological outcome measures, the Facebook Group was the only group to experience statistically significant weight loss by the end of the 24 weeks. Therefore, an examination of other psychological and/or behavioural outcome measures undertaken in larger studies in the future may help to identify significant mediators to

Psychological interventions for parents of children and adolescents with chronic illness.

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Eccleston, Christopher; Palermo, Tonya M; Fisher, Emma; Law, Emily

2012-08-15

Psychological therapies have been developed for parents of children and adolescents with a chronic illness. Such therapies include parent only or parent and child/adolescent, and are designed to treat parent behaviour, parent mental health, child behaviour/disability, child mental health, child symptoms and/or family functioning. No comprehensive, meta-analytic reviews have been published in this area. To evaluate the effectiveness of psychological therapies that include coping strategies for parents of children/adolescents with chronic illnesses (painful conditions, cancer, diabetes mellitus, asthma, traumatic brain injury, inflammatory bowel diseases, skin diseases or gynaecological disorders). The therapy will aim to improve parent behaviour, parent mental health, child behaviour/disability, child mental health, child symptoms and family functioning. We searched CENTRAL, MEDLINE, EMBASE and PsycINFO for randomised controlled trials (RCTs) of psychological interventions that included parents of children and adolescents with a chronic illness. The initial search was from inception of these databases to June 2011 and we conducted a follow-up search from June 2011 to March 2012. We identified additional studies from the reference list of retrieved papers and from discussion with investigators. Included studies were RCTs of psychological interventions that delivered treatment to parents of children and adolescents (under 19 years of age) with a chronic illness compared to active control, wait list control or treatment as usual. We excluded studies if the parent component was a coaching intervention, the aim of the intervention was health prevention/promotion, the comparator was a pharmacological treatment, the child/adolescent had an illness not listed above or the study included children with more than one type of chronic illness. Further to this, we excluded studies when the sample size of either comparator group was fewer than 10 at post-treatment. We included 35

Psychology Student Opinion of Virtual Reality as a Tool to Educate about Schizophrenia

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Tichon, Jennifer; Loh, Jennifer; King, Robert

2004-01-01

Virtual Reality (VR) techniques are increasingly being used in e-health education, training and in trial clinical programs in the treatment of certain types of mental illness. Undergraduate psychology student opinion of the use of Virtual Reality (VR) to teach them about schizophrenia at the University of Queensland, was determined with reference…

Healing by Gentle Touch Ameliorates Stress and Other Symptoms in People Suffering with Mental Health Disorders or Psychological Stress

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Clare Weze

2007-01-01

Full Text Available Previous studies on healing by gentle touch in clients with various illnesses indicated substantial improvements in psychological well-being, suggesting that this form of treatment might be helpful for people with impaired quality of mental health. The purpose of this study was to evaluate the effectiveness and safety of healing by gentle touch in subjects with self-reported impairments in their psychological well-being or mental health. One hundred and forty-seven clients who identified themselves as having psychological problems received four treatment sessions. Pre- to post-treatment changes in psychological and physical functioning were assessed by self-completed questionnaires which included visual analogue scales (VAS and the EuroQoL (EQ-5D. Participants recorded reductions in stress, anxiety and depression scores and increases in relaxation and ability to cope scores (all P < 0.0004. Improvements were greatest in those with the most severe symptoms initially. This open study provides strong circumstantial evidence that healing by gentle touch is safe and effective in improving psychological well-being in participants with self-reported psychological problems, and also that it safely complements standard medical treatment. Controlled trials are warranted.

Combining Pharmacological and Psychological Treatments for Binge Eating Disorder: Current Status, Limitations, and Future Directions.

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Grilo, Carlos M; Reas, Deborah L; Mitchell, James E

2016-06-01

Binge eating disorder (BED) is characterized by recurrent binge eating and marked distress about binge eating without the extreme compensatory behaviors for weight control that characterize other eating disorders. BED is prevalent, associated strongly with obesity, and is associated with heightened levels of psychological, psychiatric, and medical concerns. This article provides an overview of randomized controlled treatments for combined psychological and pharmacological treatment of BED to inform current clinical practice and future treatment research. In contrast to the prevalence and significance of BED, to date, limited research has been performed on combining psychological and pharmacological treatments for BED to enhance outcomes. Our review here found that combining certain medications with cognitive behavioral therapy (CBT) or behavioral weight loss (BWL) interventions produces superior outcomes to pharmacotherapy only but does not substantially improve outcomes achieved with CBT/BWL only. One medication (orlistat) has improved weight losses with CBT/BWL albeit minimally, and only one medication (topiramate) has enhanced reductions achieved with CBT in both binge eating and weight. Implications for future research are discussed.

Comparative efficacy and acceptability of antidepressants, psychological interventions, and their combination for depressive disorder in children and adolescents: protocol for a network meta-analysis

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Zhou, Xinyu; Cipriani, Andrea; Zhang, Yuqing; Cuijpers, Pim; Hetrick, Sarah E; Weisz, John R; Pu, Juncai; Giovane, Cinzia Del; Furukawa, Toshiaki A; Barth, Jürgen; Coghill, David; Leucht, Stefan; Yang, Lining; Ravindran, Arun V; Xie, Peng

2017-01-01

Introduction Depressive disorder is common in children and adolescents, with important consequences and serious impairments in terms of personal and social functioning. While both pharmacological and psychological interventions have been shown to be effective, there is still uncertainty about the balance between these and what treatment strategy should be preferred in clinical practice. Therefore, we aim to compare and rank in a network meta-analysis (NMA) the commonly used psychological, pharmacological and combined interventions for depressive disorder in children and adolescents. Methods and analysis We will update the literature search of two previous NMAs for the identification of trials of antidepressant and psychotherapy alone for depressive disorder in children and adolescents. For identification of trials of combination interventions, seven databases (PubMed, EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), Web of Science, PsycINFO, CINAHL, LiLACS) will be searched from date of inception. We will also search ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform and check relevant reports on the US Food and Drug Administration website for unpublished data. Building on our previous findings in the field, we will include any commonly prescribed oral antidepressants and any manualised or structured psychotherapies, as well as their combinations. Randomised controlled trials assessing any active intervention against active comparator or pill placebo/psychological controls in acute treatment for depressive disorder in children and adolescents will be included. The primary outcomes will be efficacy (mean change in depressive symptoms), and acceptability of treatment (dropout rate due to any cause). The secondary outcomes will be remission rate, tolerability of treatment (dropouts for adverse events), as well as suicide-related outcomes (suicidal behaviour or ideation). We will perform Bayesian NMAs for all relative outcome

The Cardiff dental study: a 20-year critical evaluation of the psychological health gain from orthodontic treatment.

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Kenealy, Pamela M; Kingdon, Anne; Richmond, Stephen; Shaw, William C

2007-02-01

Despite the widespread belief that orthodontics improves psychological well-being and self-esteem, there is little objective evidence to support this (Kenealy et al., 1989a; Shaw, O'Brien, Richmond, & Brook, 1991). A 20 year follow-up study compared the dental and psychosocial status of individuals who received, or did not receive, orthodontics as teenagers. A prospective longitudinal cohort design with four studies of the effect of orthodontic treatment. Secondary analysis of outcome data incorporated orthodontic need at baseline and treatment received in a 2 x 2 factorial design. A multidisciplinary research programme studied a cohort of 1,018, 11-12 year old participants in 1981. Extensive assessment of dental health and psychosocial well-being was conducted; facial and dental photographs and plaster casts of dentition were obtained and rated for attractiveness and pre-treatment need. No recommendations about orthodontic treatment were made, and an observational approach was adopted. At the third follow-up 337 (30-31 year olds) were re-examined in 2001. Participants with a prior need for orthodontic treatment as children who obtained treatment demonstrated better tooth alignment and satisfaction. However when self-esteem at baseline was controlled for, orthodontics had little positive impact on psychological health and quality of life in adulthood. Lack of orthodontic treatment where there was a prior need did not lead to psychological difficulties in later life. Dental status alone was a weak predictor of self-esteem at outcome explaining 8% of the variance. Self-esteem in adulthood was more strongly predicted (65% of the variance) by psychological variables at outcome: perception of quality of life, life satisfaction, self-efficacy, depression, social anxiety, emotional health, and by self-perception of attractiveness. Longitudinal analysis revealed that the observed effect of orthodontic treatment on self esteem at outcome was accounted for by self esteem at

Specialist group therapy for psychological factors associated with firesetting: Evidence of a treatment effect from a non-randomized trial with male prisoners.

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Gannon, Theresa A; Alleyne, Emma; Butler, Helen; Danby, Harriet; Kapoor, Aparna; Lovell, Tamsin; Mozova, Katarina; Spruin, Elizabeth; Tostevin, Tracey; Tyler, Nichola; Ciardha, Caoilte Ó

2015-10-01

Despite huge societal costs associated with firesetting, no standardized therapy has been developed to address this hugely damaging behavior. This study reports the evaluation of the first standardized CBT group designed specifically to target deliberate firesetting in male prisoners (the Firesetting Intervention Programme for Prisoners; FIPP). Fifty-four male prisoners who had set a deliberate fire were referred for FIPP treatment by their prison establishment and psychologically assessed at baseline, immediately post treatment, and three-months post treatment. Prisoners who were treatment eligible yet resided at prison establishments not identified for FIPP treatment were recruited as Treatment as Usual controls and tested at equivalent time-points. Results showed that FIPP participants improved on one of three primary outcomes (i.e., problematic fire interest and associations with fire), and made some improvement on secondary outcomes (i.e., attitudes towards violence and antisocial attitudes) post treatment relative to controls. Most notable gains were made on the primary outcome of fire interest and associations with fire and individuals who gained in this area tended to self-report more serious firesetting behavior. FIPP participants maintained all key improvements at three-month follow up. These outcomes suggest that specialist CBT should be targeted at those holding the most serious firesetting history. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effects of cognitive-behavioral conjoint therapy for PTSD on partners' psychological functioning.

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Shnaider, Philippe; Pukay-Martin, Nicole D; Fredman, Steffany J; Macdonald, Alexandra; Monson, Candice M

2014-04-01

A number of studies have documented that posttraumatic stress disorder (PTSD) symptoms in "one" partner are negatively associated with their intimate partner's psychological functioning. The present study investigated intimate partners' mental health outcomes (i.e., depression, anxiety, and anger) in a sample of 40 partners of individuals with PTSD within a randomized waitlist controlled trial of cognitive-behavioral conjoint therapy for PTSD (Monson & Fredman, 2012). There were no significant differences between active treatment and waitlist in intimate partners' psychological functioning at posttreatment. Subgroup analyses, however, of partners exhibiting clinical levels of distress at pretreatment on several measures showed reliable and clinically significant improvements in their psychological functioning at posttreatment and no evidence of worsening. Results suggest that cognitive-behavioral conjoint therapy for PTSD may have additional benefits for partners presenting with psychological distress. Copyright © 2014 International Society for Traumatic Stress Studies.

Functional network architecture predicts psychologically mediated analgesia related to treatment in chronic knee pain patients.

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Hashmi, Javeria Ali; Kong, Jian; Spaeth, Rosa; Khan, Sheraz; Kaptchuk, Ted J; Gollub, Randy L

2014-03-12

Placebo analgesia is an indicator of how efficiently the brain translates psychological signals conveyed by a treatment procedure into pain relief. It has been demonstrated that functional connectivity between distributed brain regions predicts placebo analgesia in chronic back pain patients. Greater network efficiency in baseline brain networks may allow better information transfer and facilitate adaptive physiological responses to psychological aspects of treatment. Here, we theorized that topological network alignments in resting state scans predict psychologically conditioned analgesic responses to acupuncture treatment in chronic knee osteoarthritis pain patients (n = 45). Analgesia was induced by building positive expectations toward acupuncture treatment with verbal suggestion and heat pain conditioning on a test site of the arm. This procedure induced significantly more analgesia after sham or real acupuncture on the test site than in a control site. The psychologically conditioned analgesia was invariant to sham versus real treatment. Efficiency of information transfer within local networks calculated with graph-theoretic measures (local efficiency and clustering coefficients) significantly predicted conditioned analgesia. Clustering coefficients in regions associated with memory, motivation, and pain modulation were closely involved in predicting analgesia. Moreover, women showed higher clustering coefficients and marginally greater pain reduction than men. Overall, analgesic response to placebo cues can be predicted from a priori resting state data by observing local network topology. Such low-cost synchronizations may represent preparatory resources that facilitate subsequent performance of brain circuits in responding to adaptive environmental cues. This suggests a potential utility of network measures in predicting placebo response for clinical use.

Predictors of Psychological Well-Being during Behavioral Obesity Treatment in Women

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Paulo N. Vieira

2011-01-01

Full Text Available This study examined the association of autonomy-related variables, including exercise motivation, with psychological well-being and quality of life, during obesity treatment. Middle-aged overweight/obese women (n=239 participated in a 1-year behavioral program and completed questionnaires measuring need support, general self-determination, and exercise and treatment motivation. General and obesity-specific health-related quality of life (HRQOL, self-esteem, depression, and anxiety were also assessed. Results showed positive correlations of self-determination and perceived need support with HRQOL and self-esteem, and negative associations with depression and anxiety (P<.001. Treatment autonomous motivation correlated positively with physical (P=.004 and weight-related HRQOL (P<.001, and negatively with depression (P=.025 and anxiety (P=.001. Exercise autonomous motivation was positively correlated with physical HRQOL (P<.001, mental HRQOL (P=.003, weight-related HRQOL (P<.001, and self-esteem (P=.003, and negatively with anxiety (P=.016. Findings confirm that self-determination theory's predictions apply to this population and setting, showing that self-determination, perceived need support, and autonomous self-regulation positively predict HRQOL and psychological well-being.

The PED-t trial protocol: The effect of physical exercise -and dietary therapy compared with cognitive behavior therapy in treatment of bulimia nervosa and binge eating disorder.

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Mathisen, Therese Fostervold; Rosenvinge, Jan H; Pettersen, Gunn; Friborg, Oddgeir; Vrabel, KariAnne; Bratland-Sanda, Solfrid; Svendsen, Mette; Stensrud, Trine; Bakland, Maria; Wynn, Rolf; Sundgot-Borgen, Jorunn

2017-05-12

Sufferers from bulimia nervosa (BN) and binge eating disorder (BED) underestimate the severity risk of their illness and, therefore, postpone seeking professional help for years. Moreover, less than one in five actually seek professional help and only 50% respond to current treatments, such as cognitive behavioral therapy (CBT). The impetus for the present trial is to explore a novel combination treatment approach adapted from physical exercise- and dietary therapy (PED-t). The therapeutic underpinnings of these separate treatment components are well-known, but their combination to treat BN and BED have never been previously tested. The purpose of this paper is to provide the rationale for this new treatment approach and to outline the specific methods and procedures. The PED-t trial uses a prospective randomized controlled design. It allocates women between 18 and 40 years (BMI range 17.5-35.0) to groups consisting of 5-8 members who receive either CBT or PED-t for 16 weeks. Excess participants are allocated to a waiting list control group condition. All participants are assessed at baseline, post-treatment, 6, 12 and 24 months' post-follow-up, respectively, and monitored for changes in biological, psychological and therapy process variables. The primary outcome relates to the ED symptom severity, while secondary outcomes relates to treatment effects on physical health, treatment satisfaction, therapeutic alliance, and cost-effectiveness. We aim to disseminate the results in high-impact journals, preferable open access, and at international conferences. We expect that the new treatment will perform equal to CBT in terms of behavioral and psychological symptoms, but better in terms of reducing somatic symptoms and complications. We also expect that the new treatment will improve physical fitness and thereby, quality of life. Hence, the new treatment will add to the portfolio of evidence-based therapies and thereby provide a good treatment alternative for females

Effects of a psychological intervention on the quality of life of obese adolescents under a multidisciplinary treatment.

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Freitas, Camila R M; Gunnarsdottir, Thrudur; Fidelix, Yara L; Tenório, Thiago R S; Lofrano-Prado, Mara C; Hill, James O; Prado, Wagner L

To investigate the effects of multidisciplinary treatment with and without psychological counseling on obese adolescents' self-reported quality of life. Seventy-six obese adolescents (15.87±1.53 y) were allocated into psychological counseling group (PCG; n=36) or control group (CG; n=40) for 12 weeks. All participants received the same supervised exercise training, nutritional and clinical counseling. Participants in PCG also received psychological counseling. QOL was measured before and after 12 weeks of intervention by Generic Questionnaire for the Evaluation of Quality of Life (SF-36). The dropout rate was higher in GC (22.5%) when compared with PCG (0.0%) (p<0.001). After 12 weeks, participants from PCG presents lower body weight, relative fat mass and higher free fat mass (p<0.001 for all) compared to GC. QOL improved among adolescents from both groups (p<0.05), however, a better QOL was reported from those adolescents enrolled in PCG. The inclusion of a psychological counseling component in multidisciplinary treatment for adolescent obesity appears to provide benefits observed for improved QOL as compared with treatment without psychological counseling. Copyright © 2016 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

A pilot feasibility randomised controlled trial of an adjunct brief social network intervention in opiate substitution treatment services.

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Day, Ed; Copello, Alex; Seddon, Jennifer L; Christie, Marilyn; Bamber, Deborah; Powell, Charlotte; Bennett, Carmel; Akhtar, Shabana; George, Sanju; Ball, Andrew; Frew, Emma; Goranitis, Ilias; Freemantle, Nick

2018-01-15

Approximately 3% of people receiving opioid substitution therapy (OST) in the UK manage to achieve abstinence from prescribed and illicit drugs within three years of commencing treatment. Involvement of families and wider social networks in supporting psychological treatment may be an effective strategy in facilitating recovery, and this pilot study aimed to evaluate the impact of a social network-focused intervention for patients receiving OST. A two-site, open feasibility trial randomised patients receiving OST for at least 12 months but still reporting illicit opiate use in the past 28 days to one of three treatments: 1) treatment as usual (TAU), 2) Brief Social Behaviour and Network Therapy (B-SBNT) + TAU, or 3) Personal Goal Setting (PGS) + TAU. The two active interventions consisted of 4 sessions. There were 3 aims: 1) test the feasibility of recruiting OST patients to a trial of B-SBNT, and following them up over 12 months; 2) test the feasibility of training clinicians to deliver B-SBNT; 3) test whether B-SBNT reduces heroin use 3 and 12 months after treatment, and to explore potential mediating factors. The primary outcome for aim 3 was number of days of heroin use in the past month, and a range of secondary outcome measures were specified in advance (level of drug dependence, mental health, social satisfaction, therapist rapport, treatment satisfaction, social network size and support). A total of 83 participants were randomised, and 70 (84%) were followed-up at 12 months. Fidelity analysis of showed that B-SBNT sessions were clearly distinguishable from PGS and TAU sessions, suggesting it was possible to train clinical staff to an adequate level of competence. No significant differences were found between the 3 intervention arms in the primary or secondary outcome measures. Attendance at psychosocial treatment intervention sessions was low across all three arms (44% overall). Patients receiving OST can be recruited into a trial of a social

[Ethical principles of clinical trials in minors].

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Koch, H J; Raschka, C

2002-12-05

Clinical trials in volunteers and patients are essential to ensure rational treatment of patients. As a rule, drugs are routinely developed for adults, but children are excluded. A major reason for this restriction are ethical justifications, in particular the lack of autonomy on the part of children. The principle of fairness, however, requires that everyone should benefit from progress. Industry, science and society are therefore called upon to find ways of making available safe and adequate treatment for children as quickly as possible, by defining the required conditions for pediatric clinical trials. Important principles are minimal risk, minimal invasivity, rapid decision-making, and careful documentation of trial results. Dynamic ethical principles, such as autonomy and competence in adolescents must be considered on equal footing with existing international GCP guidelines. Aspects of child psychology indicate that the autonomy of adolescents should be respected. Where economic incentives for such trials are absent, for example, in the case of non-pharmacological problems, pediatric trials must be considered a task for society as a whole.

The Role of Positive Emotion and Contributions of Positive Psychology in Depression Treatment: Systematic Review

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Santos, Veruska; Paes, Flavia; Pereira, Valeska; Arias-Carrión, Oscar; Silva, Adriana Cardoso; Carta, Mauro Giovanni; Nardi, Antonio Egidio; Machado, Sergio

2013-01-01

The present study aims to conduct a systematic review of the literature by checking the impact of positive emotion in the treatment of depression and on the use of strategies of positive psychology which involves positive emotion to treat and reduce symptoms of depression. For this purpose, we conducted searches in databases ISI Web of Knowledge, PsycINFO and PubMed and found a total of 3400 studies. After inclusion application and exclusion criteria, 28 articles remained, presented and discussed in this study. The studies have important relations between humor and positive emotion as well as a significant improvement in signs and symptoms of depression using differents strategies of positive psychology. Another relevant aspect is the preventative character of the proposed interventions by positive psychology by the fact that increase well-being and produce elements such as resilience and coping resources that reduce the recurrent relapses in the treatment of depression. The strategies of positive psychology, such as increasing positive emotions, develop personal strengths: seeking direction, meaning and engagement for the day-to-day life of the patients, appear as potentially tools for the prophylaxis and treatment of depression, helping to reduce signs and symptoms as well as for prevention of relapses. PMID:24358052

Childhood obesity treatment and prevention. Psychological perspectives of clinical approaches

OpenAIRE

Maria Catena Quattropani; Teresa Buccheri

2013-01-01

Objective: This work focuses on clinical psychologist’ presence within childhood obesity prevention programmes in several countries. Method: The Authors collected articles considering psychological, biological and social aspects linked to childhood obesity. Results: Studies reveal that childhood obesity prevention programmes are based on biological, medical and educational aspects; clinical psychologists up until now have been engaged almost exclusively in the treatment of obesity. Conclusion...

Effectiveness of a single-session early psychological intervention for children after road traffic accidents: a randomised controlled trial

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Meuli Martin

2010-02-01

Full Text Available Abstract Background Road traffic accidents (RTAs are the leading health threat to children in Europe, resulting in 355 000 injuries annually. Because children can suffer significant and long-term mental health problems following RTAs, there is considerable interest in the development of early psychological interventions. To date, the research in this field is scarce, and currently no evidence-based recommendations can be made. Methods To evaluate the effectiveness of a single-session early psychological intervention, 99 children age 7-16 were randomly assigned to an intervention or control group. The manualised intervention was provided to the child and at least one parent around 10 days after the child's involvement in an RTA. It included reconstruction of the accident using drawings and accident-related toys, and psychoeducation. All of the children were interviewed at 10 days, 2 months and 6 months after the accident. Parents filled in questionnaires. Standardised instruments were used to assess acute stress disorder (ASD, posttraumatic stress disorder (PTSD, depressive symptoms and behavioural problems. Results The children of the two study groups showed no significant differences concerning posttraumatic symptoms and other outcome variables at 2 or at 6 months. Interestingly, analyses showed a significant intervention × age-group effect, indicating that for preadolescent children the intervention was effective in decreasing depressive symptoms and behavioural problems. Conclusions This study is the first to show a beneficial effect of a single-session early psychological intervention after RTA in preadolescent children. Therefore, an age-specific approach in an early stage after RTAs may be a promising way for further research. Younger children can benefit from the intervention evaluated here. However, these results have to be interpreted with caution, because of small subgroup sizes. Future studies are needed to examine specific

Hypnosis or cognitive behavioral training for the reduction of pain and nausea during cancer treatment: a controlled clinical trial.

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Syrjala, K L; Cummings, C; Donaldson, G W

1992-02-01

Few controlled clinical trials have tested the efficacy of psychological techniques for reducing cancer pain or post-chemotherapy nausea and emesis. In this study, 67 bone marrow transplant patients with hematological malignancies were randomly assigned to one of four groups prior to beginning transplantation conditioning: (1) hypnosis training (HYP); (2) cognitive behavioral coping skills training (CB); (3) therapist contact control (TC); or (4) treatment as usual (TAU; no treatment control). Patients completed measures of physical functioning (Sickness Impact Profile; SIP) and psychological functioning (Brief Symptom Inventory; BSI), which were used as covariates in the analyses. Biodemographic variables included gender, age and a risk variable based on diagnosis and number of remissions or relapses. Patients in the HYP, CB and TC groups met with a clinical psychologist for two pre-transplant training sessions and ten in-hospital "booster" sessions during the course of transplantation. Forty-five patients completed the study and provided all covariate data, and 80% of the time series outcome data. Analyses of the principal study variables indicated that hypnosis was effective in reducing reported oral pain for patients undergoing marrow transplantation. Risk, SIP, and BSI pre-transplant were found to be effective predictors of inpatient physical symptoms. Nausea, emesis and opioid use did not differ significantly between the treatment groups. The cognitive behavioral intervention, as applied in this study, was not effective in reducing the symptoms measured.

A randomized controlled trial of laser treatment among hirsute women with polycystic ovary syndrome.

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Clayton, W J; Lipton, M; Elford, J; Rustin, M; Sherr, L

2005-05-01

Facial hirsutism is one of the characteristic features of polycystic ovary syndrome (PCOS), and this can lead to high levels of depression and anxiety. To evaluate the impact of laser treatment on the severity of facial hirsutism and on psychological morbidity in women with PCOS. A randomized controlled trial of five high-fluence treatments (intervention) vs. five low-fluence treatments (control) was performed over 6 months in a National Health Service teaching hospital. Subjects were 88 women with facial hirsutism due to PCOS recruited from hospital outpatient clinics and a patient support group in 2001-2002. The main outcomes were self-reported severity of facial hair (measured on a scale of 1-10), depression, anxiety (measured on the Hospital Anxiety and Depression Scale) and quality of life (measured on the WHOQOL-BREF). Self-reported severity of facial hair in the intervention group (n = 51) fell from 7.3 to 3.6 over the 6-month study period; for the control group (n = 37) the corresponding scores were 7.1 and 6.1. The change was significantly greater in the intervention group [ancova F((1,83)) = 24.5, P hair removal declined from 112 to 21 min per week in the intervention group and from 92 to 56 min in the control group [F((1,80)) = 10.2, P Psychological quality of life also improved more in the intervention group, from 49.6 to 61.2 vs. 50.1 to 51.5 in the control group [F((1,84)) = 10.9, P facial hair and time spent on hair removal as well as alleviating depression and anxiety in women with PCOS. These findings suggest that ways of making this method of hair removal more widely available to women with facial hirsutism should be considered.

Design paper: The CapOpus trial: A randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

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Gluud Christian

2008-07-01

Full Text Available Abstract Background A number of studies indicate a link between cannabis-use and psychosis as well as more severe psychosis in those with existing psychotic disorders. There is currently insufficient evidence to decide the optimal way to treat cannabis abuse among patients with psychosis. Objectives The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. Design The trial is designed as a randomized, parallel-group, observer-blinded clinical trial. Patients are primarily recruited through early-psychosis detection teams, community mental health centers, and assertive community treatment teams. Patients are randomized to one of two treatment arms, both lasting six months: 1 specialized addiction treatment plus treatment as usual or 2 treatment as usual. The specialized addiction treatment is manualized and consists of both individual and group-based motivational interviewing and cognitive behavioral therapy, and incorporates both the family and the case manager of the patient. The primary outcome measure will be changes in amount of cannabis consumption over time. Other outcome measures will be psychosis symptoms, cognitive functioning, quality of life, social functioning, and cost-benefit analyses. Trial registration ClinicalTrials.gov NCT00484302.

Chronic Hepatitis C and Antiviral Treatment Regimens: Where Can Psychology Contribute?

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Evon, Donna M.; Golin, Carol E.; Fried, Michael W.; Keefe, Francis J.

2013-01-01

Objective: Our goal was to evaluate the existing literature on psychological, social, and behavioral aspects of chronic hepatitis C viral (HCV) infection and antiviral treatment; provide the state of the behavioral science in areas that presently hinder HCV-related health outcomes; and make recommendations for areas in which clinical psychology…

The limitations of using randomised controlled trials as a basis for developing treatment guidelines.

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Mulder, Roger; Singh, Ajeet B; Hamilton, Amber; Das, Pritha; Outhred, Tim; Morris, Grace; Bassett, Darryl; Baune, Bernhard T; Berk, Michael; Boyce, Philip; Lyndon, Bill; Parker, Gordon; Malhi, Gin S

2018-02-01

Randomised controlled trials (RCTs) are considered the 'gold standard' by which novel psychotropic medications and psychological interventions are evaluated and consequently adopted into widespread clinical practice. However, there are some limitations to using RCTs as the basis for developing treatment guidelines. While RCTs allow researchers to determine whether a given medication or intervention is effective in a specific patient sample, for practicing clinicians it is more important to know whether it will work for their particular patient in their particular setting. This information cannot be garnered from an RCT. These inherent limitations are exacerbated by biases in design, recruitment, sample populations and data analysis that are inevitable in real-world studies. While trial registration and CONSORT have been implemented to correct and improve these issues, it is worrying that many trials fail to achieve such standards and yet their findings are used to inform clinical decision making. This perspective piece questions the assumptions of RCTs and highlights the widespread distortion of findings that currently undermine the credibility of this powerful design. It is recommended that the clinical guidelines include advice as to what should be considered good and relevant evidence and that external bodies continue to monitor RCTs to ensure that the outcomes published indeed reflect reality. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Debriefing interventions for the prevention of psychological trauma in women following childbirth.

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Bastos, Maria Helena; Furuta, Marie; Small, Rhonda; McKenzie-McHarg, Kirstie; Bick, Debra

2015-04-10

-analysis was conducted where there were more than two trials examining the same outcomes. We included seven trials (eight articles) from three countries (UK, Australia and Sweden) that fulfilled the inclusion criteria. The number of women contributing data to each outcome varied from 102 to 1745. Methodological quality was variable and most of the studies were of low quality. The quality of evidence for the prevalence of psychological trauma (primary outcome) and the prevalence of depression symptoms was rated low or very low, based on few studies (ranging from a single study to three studies) with high risk of bias in main domains such as performance bias, random sequence generation, allocation concealment and incomplete outcome data. The quality of evidence for the remaining outcomes (that is prevalence of anxiety, prevalence of fear of childbirth, prevalence of general psychological morbidity, health service utilization and attrition from treatment) was not assessed as data were not available.Among women who had a high level of obstetric intervention during labour and birth, we found no difference between standard postnatal care with debriefing and standard postnatal care without debriefing on psychological trauma symptoms within three months postpartum (RR 0.61; 95% CI 0.28 to 1.31; n = 425) or at three to six months postpartum (RR 0.62; 95% CI 0.27 to 1.42; n = 246). The results were based on two trials, respectively. Among women who experienced a distressing or traumatic birth, there was no evidence of an effect of psychological debriefing on the prevention of PTSD (measured by the MINI-PTSD) at four to six weeks postpartum (RR 1.15; 95% CI 0.66 to 2.01; n = 102) or at six months (RR 0.35; 95% CI 0.10 to 1.23; n = 103). The results were based on one small trial. One trial involving low-risk women who delivered healthy infants at or near term reported no significant difference between the intervention group and the control group in the proportion of women who met the

Integrated psychological therapy for people with bipolar disorder and co-morbid alcohol use: A feasibility and acceptability randomised controlled trial

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Steven Jones

2018-06-01

Full Text Available Background: Co-morbid substance misuse, particularly alcohol, is common in bipolar disorder (BD and associated with worse treatment outcomes. Research into psychological interventions for substance misuse in BD is at an early stage and no studies have specifically targeted problematic alcohol use. This paper describes the context and protocol for a feasibility and acceptability randomised controlled trial (RCT evaluating a novel intervention combining motivational interviewing and cognitive behavioural therapy (MI-CBT for participants with BD and problematic alcohol use, developed in collaboration with people with lived experience of both issues. Methods and design: An RCT will assess the feasibility and acceptability of MI-CBT in addition to treatment as usual (TAU compared with TAU alone. Participants will be recruited from across the North West of England through NHS services and self-referral. The primary outcomes will be the feasibility and acceptability of the intervention assessed by recruitment to target, adherence to intervention, retention rate at follow-up, absence of adverse events and qualitative analysis of participants' reported experiences of intervention. The effect size of the impact of the intervention on alcohol use and mood outcomes will also be estimated. In addition, we will explore a number of potential process variables in therapy. Discussion: This is the first RCT evaluating MI-CBT for BD and problematic alcohol use. Given the prevalence and impact of alcohol problems in BD this novel integrated intervention may have potential to offer important improvements in clinical and functional outcomes. Keywords: Bipolar, Alcohol, Substance, Motivational interviewing, Trial registration number: ISRCTN14774583

Right on Post-trial Access to Investigational Treatment

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Dmytro Lurye

2018-03-01

On this base, the author offered to provide in the legislation of Ukraine requirements to inform in advance subjects about the presence or absence of post-trial access and to evaluate these provisions by ethics committees before and at the end of all trials in order to determine its real need in each individual case. The scope of the right on post-trial access to investigational treatment must be reasonably weighed in order to avoid, on the one hand, becoming an excessive stimulus for the subjects, and, on the other hand, not leading to a situation where on such regulation conducting of clinical trials in the country will no longer be appropriate.

Randomised clinical trials with clinician-preferred treatment.

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Korn, E L; Baumrind, S

1991-01-19

The standard design for randomised clinical trials may be inappropriate when the clinician believes that one of the treatments being tested is superior for the patient, or when the clinician has a preference for one of the treatments. For such instances the suggestion is that the patient is randomly allocated to treatment only when there is clinical disagreement about treatment of choice for that patient, and then the patient is assigned to a clinician who had thought that the regimen allocated is the one most appropriate for that patient.

Psychological trauma symptoms and Type 2 diabetes prevalence, glucose control, and treatment modality among American Indians in the Strong Heart Family Study.

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Jacob, Michelle M; Gonzales, Kelly L; Calhoun, Darren; Beals, Janette; Muller, Clemma Jacobsen; Goldberg, Jack; Nelson, Lonnie; Welty, Thomas K; Howard, Barbara V

2013-01-01

The aims of this paper are to examine the relationship between psychological trauma symptoms and Type 2 diabetes prevalence, glucose control, and treatment modality among 3776 American Indians in Phase V of the Strong Heart Family Study. This cross-sectional analysis measured psychological trauma symptoms using the National Anxiety Disorder Screening Day instrument, diabetes by American Diabetes Association criteria, and treatment modality by four categories: no medication, oral medication only, insulin only, or both oral medication and insulin. We used binary logistic regression to evaluate the association between psychological trauma symptoms and diabetes prevalence. We used ordinary least squares regression to evaluate the association between psychological trauma symptoms and glucose control. We used binary logistic regression to model the association of psychological trauma symptoms with treatment modality. Neither diabetes prevalence (22%-31%; p=0.19) nor control (8.0-8.6; p=0.25) varied significantly by psychological trauma symptoms categories. However, diabetes treatment modality was associated with psychological trauma symptoms categories, as people with greater burden used either no medication, or both oral and insulin medications (odds ratio=3.1, ppsychological trauma symptoms suggests future research investigate patient and provider treatment decision making. © 2013.

More ethical and more efficient clinical research: multiplex trial design.

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Keus, Frederik; van der Horst, Iwan C C; Nijsten, Maarten W

2014-08-14

Today's clinical research faces challenges such as a lack of clinical equipoise between treatment arms, reluctance in randomizing for multiple treatments simultaneously, inability to address interactions and increasingly restricted resources. Furthermore, many trials are biased by extensive exclusion criteria, relatively small sample size and less appropriate outcome measures. We propose a 'Multiplex' trial design that preserves clinical equipoise with a continuous and factorial trial design that will also result in more efficient use of resources. This multiplex design accommodates subtrials with appropriate choice of treatment arms within each subtrial. Clinical equipoise should increase consent rates while the factorial design is the best way to identify interactions. The multiplex design may evolve naturally from today's research limitations and challenges, while principal objections seem absent. However this new design poses important infrastructural, organisational and psychological challenges that need in depth consideration.

Quantifying the placebo effect in psychological outcomes of exercise training: a meta-analysis of randomized trials.

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Lindheimer, Jacob B; O'Connor, Patrick J; Dishman, Rod K

2015-05-01

The placebo effect could account for some or all of the psychological benefits attributed to exercise training. The magnitude of the placebo effect in psychological outcomes of randomized controlled exercise training trials has not been quantified. The aim of this investigation was to estimate the magnitude of the population placebo effect in psychological outcomes from placebo conditions used in exercise training studies and compare it to the observed effect of exercise training. Articles published before 1 July 2013 were located using Google Scholar, MEDLINE, PsycINFO, and The Cochrane Library. To be included in the analysis, studies were required to have (1) a design that randomly assigned participants to exercise training, placebo, and control conditions and (2) an assessment of a subjective (i.e., anxiety, depression, energy, fatigue) or an objective (i.e., cognitive) psychological outcome. Meta-analytic and multi-level modeling techniques were used to analyze effects from nine studies involving 661 participants. Hedges' d effect sizes were calculated, and random effects models were used to estimate the overall magnitude of the placebo and exercise training effects. After adjusting for nesting effects, the placebo mean effect size was 0.20 (95% confidence interval [CI] -0.02, 0.41) and the observed effect of exercise training was 0.37 (95% CI 0.11, 0.63). A small body of research suggests both that (1) the placebo effect is approximately half of the observed psychological benefits of exercise training and (2) there is an urgent need for creative research specifically aimed at better understanding the role of the placebo effect in the mental health consequences of exercise training.

Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial

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Vas, Jorge; Méndez, Camila; Perea-Milla, Emilio; Vega, Evelia; Panadero, María Dolores; León, José María; Borge, Miguel Ángel; Gaspar, Olga; Sánchez-Rodríguez, Francisco; Aguilar, Inmaculada; Jurado, Rosario

2004-01-01

Objectives To analyse the efficacy of acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee, with respect to pain relief, reduction of stiffness, and increased physical function during treatment; modifications in the consumption of diclofenac during treatment; and changes in the patient's quality of life. Design Randomised, controlled, single blind trial, with blinded evaluation and statistical analysis of results. Setting Pain management unit in a public primary care centre in southern Spain, over a period of two years. Participants 97 outpatients presenting with osteoarthritis of the knee. Interventions Patients were randomly separated into two groups, one receiving acupuncture plus diclofenac (n = 48) and the other placebo acupuncture plus diclofenac (n = 49). Main outcome measures The clinical variables examined included intensity of pain as measured by a visual analogue scale; pain, stiffness, and physical function subscales of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index; dosage of diclofenac taken during treatment; and the profile of quality of life in the chronically ill (PQLC) instrument, evaluated before and after the treatment programme. Results 88 patients completed the trial. In the intention to treat analysis, the WOMAC index presented a greater reduction in the intervention group than in the control group (mean difference 23.9, 95% confidence interval 15.0 to 32.8) The reduction was greater in the subscale of functional activity. The same result was observed in the pain visual analogue scale, with a reduction of 26.6 (18.5 to 34.8). The PQLC results indicate that acupuncture treatment produces significant changes in physical capability (P = 0.021) and psychological functioning (P = 0.046). Three patients reported bruising after the acupuncture sessions. Conclusions Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic

Interpreting treatment x environment interaction in agronomy trials

NARCIS (Netherlands)

Vargas, M.; Crossa, J.; Eeuwijk, van F.A.; Sayre, K.; Reynolds, M.P.

2001-01-01

Multienvironment trials are important in agronomy because the effects of agronomic treatments can change differentially in relation to environmental changes, producing a treatment × environment interaction (T × E). The aim of this study was to find a parsimonious description of the T × E existing in

Effects of adjunctive exercise on physiological and psychological parameters in depression: a randomized pilot trial.

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Kerling, Arno; Tegtbur, Uwe; Gützlaff, Elke; Kück, Momme; Borchert, Luise; Ates, Zeynep; von Bohlen, Anne; Frieling, Helge; Hüper, Katja; Hartung, Dagmar; Schweiger, Ulrich; Kahl, Kai G

2015-05-15

Major depressive disorder (MDD) is associated with decreased physical activity and increased rates of the metabolic syndrome (MetS), a risk factor for the development of type 2 diabetes and cardiovascular disorders. Exercise training has been shown to improve cardiorespiratory fitness and metabolic syndrome factors. Therefore, our study aimed at examining whether patients receiving an exercise program as an adjunct to inpatient treatment will benefit in terms of physiological and psychological factors. Fourty-two inpatients with moderate to severe depression were included. Twenty-two patients were randomized to additional 3x weekly exercise training (EXERCISE) and compared to treatment as usual (TAU). Exercise capacity was assessed as peak oxygen uptake (VO2peak), ventilatory anaerobic threshold (VAT) and workload expressed as Watts (W). Metabolic syndrome was defined according to NCEP ATPIII panel criteria. After 6 weeks of treatment, cardiorespiratory fitness (VO2peak, VAT, Watt), waist circumference and HDL cholesterol were significantly improved in EXERCISE participants. Treatment response expressed as ≥50% MADRS reduction was more frequent in the EXERCISE group. Adjunctive exercise training in depressed inpatients improves physical fitness, MetS factors, and psychological outcome. Given the association of depression with cardiometablic disorders, exercise training is recommended as an adjunct to standard antidepressant treatment. Copyright © 2015 Elsevier B.V. All rights reserved.

Evidence Map of Prevention and Treatment Interventions for Depression in Young People

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Patrick Callahan

2012-01-01

Full Text Available Introduction. Depression in adolescents and young people is associated with reduced social, occupational, and interpersonal functioning, increases in suicide and self-harm behaviours, and problematic substance use. Age-appropriate, evidence-based treatments are required to provide optimal care. Methods. “Evidence mapping” methodology was used to quantify the nature and distribution of the extant high-quality research into the prevention and treatment of depression in young people across psychological, medical, and other treatment domains. Results. Prevention research is dominated by cognitive-behavioral- (CBT- based interventions. Treatment studies predominantly consist of CBT and SSRI medication trials, with few trials of other psychological interventions or complementary/alternative treatments. Quality studies on relapse prevention and treatment for persistent depression are distinctly lacking. Conclusions. This map demonstrates opportunities for future research to address the numerous evidence gaps for interventions to prevent or treat depression in young people, which are of interest to clinical researchers, policy makers, and funding bodies.

Psychological interventions for mental health disorders in children with chronic physical illness: a systematic review.

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Bennett, Sophie; Shafran, Roz; Coughtrey, Anna; Walker, Susan; Heyman, Isobel

2015-04-01

Children with chronic physical illness are significantly more likely to develop common psychiatric symptoms than otherwise healthy children. These children therefore warrant effective integrated healthcare yet it is not established whether the known, effective, psychological treatments for symptoms of common childhood mental health disorders work in children with chronic physical illness. EMBASE, MEDLINE, PsycINFO and CINAHL databases were searched with predefined terms relating to evidence-based psychological interventions for psychiatric symptoms in children with chronic physical illness. We included all studies (randomised and non-randomised designs) investigating interventions aimed primarily at treating common psychiatric symptoms in children with a chronic physical illness in the review. Two reviewers independently assessed the relevance of abstracts identified, extracted data and undertook quality analysis. Ten studies (209 children, including 70 in control groups) met the criteria for inclusion in the review. All studies demonstrated some positive outcomes of cognitive behavioural therapy for the treatment of psychiatric symptoms in children with chronic physical illness. Only two randomised controlled trials, both investigating interventions for symptoms of depression, were found. There is preliminary evidence that cognitive behavioural therapy has positive effects in the treatment of symptoms of depression and anxiety in children with chronic physical illness. However, the current evidence base is weak and fully powered randomised controlled trials are needed to establish the efficacy of psychological treatments in this vulnerable population. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Efficacy and tolerance of the topical application of potassium hydroxide (10% and 15%) in the treatment of molluscum contagiosum: randomized clinical trial: research protocol.

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Marsal, Josep R; Cruz, Ines; Teixido, Concepcio; Diez, Olga; Martinez, Mireia; Galindo, Gisela; Real, Jordi; Schoenenberger, Joan A; Pera, Helena

2011-10-19

Molluscum contagiosum is a non-severe pediatric viral infection. Because it is highly contagious and current treatments have negative aesthetic and psychological effects, we want to test an alternative treatment in the primary care setting, consisting of two different concentrations of potassium hydroxide solution. The study design is a double-blind, randomized clinical trial, using three types of topical treatment. The treatment consist of daily applications of potassium hydroxide (KOH) in aqueous solution at 10% and 15% concentration, and a placebo administered in the control group. Four follow-up visits (at 15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and patient tolerance. The main outcome measure of the trial will be the healing rate, defined as lesion disappearance in the affected zones after the topic application of the experimental treatment. Secondary measures will be the principal characteristics and evolution of the affected zone (surface area, number of lesions, size and density of lesions), treatment tolerance (hyperpigmentation, itching, burning, pain), recurrence rate and the natural evolution of lesions in the control group. KOH can potentially be an effective and safe treatment for MC in primary care, and can also reduce referrals to dermatologists and hospital pediatric departments. In addition, KOH may be a valid and less expensive alternative to current invasive treatments (surgical excision).

Estimation of treatment preference effects in clinical trials when some participants are indifferent to treatment choice

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Stephen D. Walter

2017-02-01

Full Text Available Abstract Background In the two-stage randomised trial design, a randomly sampled subset of study participants are permitted to choose their own treatment, while the remaining participants are randomised to treatment in the usual way. Appropriate analysis of the data from both arms of the study allows investigators to estimate the impact on study outcomes of treatment preferences that patients may have, in addition to evaluating the usual direct effect of treatment. In earlier work, we showed how to optimise this design by making a suitable choice of the proportion of participants who should be assigned to the choice arm of the trial. However, we ignored the possibility of some participants being indifferent to the treatments under study. In this paper, we extend our earlier work to consider the analysis of two-stage randomised trials when some participants have no treatment preference, even if they are assigned to the choice arm and allowed to choose. Methods We compare alternative characterisations of the response profiles of the indifferent or undecided participants, and derive estimates of the treatment and preference effects on study outcomes. We also present corresponding test statistics for these parameters. The methods are illustrated with data from a clinical trial contrasting medical and surgical interventions. Results Expressions are obtained to estimate and test the impact of treatment choices on study outcomes, as well as the impact of the actual treatment received. Contrasts are defined between patients with stated treatment preferences and those with no preference. Alternative assumptions concerning the outcomes of undecided participants are described, and an approach leading to unbiased estimation and testing is identified. Conclusions Use of the two-stage design can provide important insights into determinants of study outcomes that are not identifiable with other designs. The design can remain attractive even in the presence of

Empirical Comparison of Two Psychological Therapies: Self Psychology and Cognitive Orientation in the Treatment of Anorexia and Bulimia

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Bachar, Eytan; Latzer, Yael; Kreitler, Shulamit; Berry, Elliot M.

1999-01-01

The authors investigated the applicability of self psychological treatment (SPT) and cognitive orientation treatment (COT) to the treatment of anorexia and bulimia. Thirty-three patients participated in this study. The bulimic patients (n = 25) were randomly assigned either to SPT, COT, or control/nutritional counseling only (C/NC). The anorexic patients (n = 8) were randomly assigned to either SPT or COT. Patients were administered a battery of outcome measures assessing eating disorders symptomatology, attitudes toward food, self structure, and general psychiatric symptoms. After SPT, significant improvement was observed. After COT, slight but nonsignificant improvement was observed. After C/NC, almost no changes could be detected.(The Journal of Psychotherapy Practice and Research 1999; 8:115–128) PMID:10079459

The mind-body connection in irritable bowel syndrome: A randomised controlled trial of hypnotherapy as a treatment.

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Phillips-Moore, Julie S; Talley, Nicholas J; Jones, Michael P

2015-01-01

Hypnotherapy has been reported as being beneficial in the treatment of irritable bowel syndrome (IBS). We aimed to test the hypothesis that patients with IBS treated 'holistically' by hypnosis (i.e. by combined psychological and physiological symptom imagery) would have greater improvement in their IBS symptoms than patients treated by hypnosis using standard 'gut-directed' hypnotherapy, and both would be superior to simple relaxation therapy. Patients ( n  = 51) with Rome II criteria were randomised to 'individualised' (holistic) hypnotherapy, standard 'gut-directed' hypnotherapy or relaxation therapy for a period of 11 weeks with two follow-up assessments at 2 weeks and at 3 months after the completion of the trial. The primary outcome was bowel symptom severity scale (BSSS). All the participants in this study improved their IBS symptoms (pain, bloating, constipation and diarrhoea) and physical functioning at the end of the treatment from baseline, but this was not significantly different across the treatment arms. Neither 'individualised' nor 'gut-directed' hypnotherapy is superior to relaxation therapy in IBS.

The mind–body connection in irritable bowel syndrome: A randomised controlled trial of hypnotherapy as a treatment

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Talley, Nicholas J; Jones, Michael P

2015-01-01

Background: Hypnotherapy has been reported as being beneficial in the treatment of irritable bowel syndrome (IBS). We aimed to test the hypothesis that patients with IBS treated ‘holistically’ by hypnosis (i.e. by combined psychological and physiological symptom imagery) would have greater improvement in their IBS symptoms than patients treated by hypnosis using standard ‘gut-directed’ hypnotherapy, and both would be superior to simple relaxation therapy. Methods: Patients (n = 51) with Rome II criteria were randomised to ‘individualised’ (holistic) hypnotherapy, standard ‘gut-directed’ hypnotherapy or relaxation therapy for a period of 11 weeks with two follow-up assessments at 2 weeks and at 3 months after the completion of the trial. The primary outcome was bowel symptom severity scale (BSSS). Results: All the participants in this study improved their IBS symptoms (pain, bloating, constipation and diarrhoea) and physical functioning at the end of the treatment from baseline, but this was not significantly different across the treatment arms. Conclusion: Neither ‘individualised’ nor ‘gut-directed’ hypnotherapy is superior to relaxation therapy in IBS. PMID:28070348

Design paper: The CapOpus trial: a randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

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Hjorthøj, Carsten; Fohlmann, Allan; Larsen, Anne-Mette

2008-01-01

: The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. DESIGN: The trial is designed as a randomized, parallel-group, observer-blinded clinical...

The effect of aromatherapy massage on the psychological symptoms of postmenopausal Iranian women.

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Taavoni, S; Darsareh, F; Joolaee, S; Haghani, H

2013-06-01

Menopausal symptoms experienced by women vary widely, and while many women transition through menopause with manageable symptoms, others experience severe symptoms, which may impair their quality of life. A randomized clinical trial was conducted to determine the effect of aromatherapy massage on psychological symptoms during menopause. The study population comprised 90 women. Each subject in the aromatherapy massage group received 30 min aromatherapy sessions with aroma oil, twice a week, for four weeks; each subject in the massage therapy group received the same treatment with odorless oil, while no treatment was provided to subjects in the control group. The outcome measures were psychological symptoms, as obtained through the psychological subscale of the Menopause Rating Scale. A total of 87 women were evaluated. A statistically significant difference was found between the participants' pre- and post-application psychological score in intervention groups, whereas the score in the control group did not differ significantly. Aromatherapy massage decreased the psychological score MD: -3.49 (95% Confidence Interval of Difference: -4.52 to -2.47). Massage therapy also decreased the psychological score MD: -1.20 (95% Confidence Interval of Difference: -2.19 to -0.08). To distinguish the effect of aromatherapy from massage separately, we compared the reduction in the psychological score. Aromatherapy massage decreased the psychological score more than massage therapy MD: -2.29 (95% Confidence Interval of Difference: -3.01 to -0.47). Both aromatherapy massage and massage were effective in reducing psychological symptoms, but, the effect of aromatherapy massage was higher than massage. Copyright © 2013 Elsevier Ltd. All rights reserved.

Comparative efficacy and acceptability of antidepressants, psychological interventions, and their combination for depressive disorder in children and adolescents: protocol for a network meta-analysis.

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Zhou, Xinyu; Cipriani, Andrea; Zhang, Yuqing; Cuijpers, Pim; Hetrick, Sarah E; Weisz, John R; Pu, Juncai; Giovane, Cinzia Del; Furukawa, Toshiaki A; Barth, Jürgen; Coghill, David; Leucht, Stefan; Yang, Lining; Ravindran, Arun V; Xie, Peng

2017-08-11

Depressive disorder is common in children and adolescents, with important consequences and serious impairments in terms of personal and social functioning. While both pharmacological and psychological interventions have been shown to be effective, there is still uncertainty about the balance between these and what treatment strategy should be preferred in clinical practice. Therefore, we aim to compare and rank in a network meta-analysis (NMA) the commonly used psychological, pharmacological and combined interventions for depressive disorder in children and adolescents. We will update the literature search of two previous NMAs for the identification of trials of antidepressant and psychotherapy alone for depressive disorder in children and adolescents. For identification of trials of combination interventions, seven databases (PubMed, EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), Web of Science, PsycINFO, CINAHL, LiLACS) will be searched from date of inception. We will also search ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform and check relevant reports on the US Food and Drug Administration website for unpublished data. Building on our previous findings in the field, we will include any commonly prescribed oral antidepressants and any manualised or structured psychotherapies, as well as their combinations. Randomised controlled trials assessing any active intervention against active comparator or pill placebo/psychological controls in acute treatment for depressive disorder in children and adolescents will be included. The primary outcomes will be efficacy (mean change in depressive symptoms), and acceptability of treatment (dropout rate due to any cause). The secondary outcomes will be remission rate, tolerability of treatment (dropouts for adverse events), as well as suicide-related outcomes (suicidal behaviour or ideation). We will perform Bayesian NMAs for all relative outcome measures. Subgroup analyses and

Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial

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Till Beiwinkel

2017-09-01

Full Text Available Mobile health (mHealth could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N = 186 smartphone users will be recruited, with an over-sampling of persons with moderate to high distress. Over a 4-week period, the intervention will be compared to a self-monitoring without intervention group and a passive control group. Telephone interviews will be conducted at baseline, post-intervention (4 weeks, and 12-week follow-up to assess study outcomes. The primary outcome will be improvement of mental health. Secondary outcomes will include well-being, intentions toward help-seeking and help-seeking behavior, user activation, attitudes toward mental-health services, perceived stigmatization, smartphone app quality, user satisfaction, engagement, and adherence with the intervention. Additionally, data from the user’s daily life as collected during self-monitoring will be used to investigate risk and protective factors of mental health in real-world settings. Therefore, this study will allow us to demonstrate the effectiveness of a smartphone application as a widely accessible and low-cost intervention to improve mental health on a population level. It also allows to identify new assessment approaches in the field of psychiatric epidemiology.

Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial

Science.gov (United States)

Beiwinkel, Till; Hey, Stefan; Bock, Olaf; Rössler, Wulf

2017-01-01

Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N = 186 smartphone users will be recruited, with an over-sampling of persons with moderate to high distress. Over a 4-week period, the intervention will be compared to a self-monitoring without intervention group and a passive control group. Telephone interviews will be conducted at baseline, post-intervention (4 weeks), and 12-week follow-up to assess study outcomes. The primary outcome will be improvement of mental health. Secondary outcomes will include well-being, intentions toward help-seeking and help-seeking behavior, user activation, attitudes toward mental-health services, perceived stigmatization, smartphone app quality, user satisfaction, engagement, and adherence with the intervention. Additionally, data from the user’s daily life as collected during self-monitoring will be used to investigate risk and protective factors of mental health in real-world settings. Therefore, this study will allow us to demonstrate the effectiveness of a smartphone application as a widely accessible and low-cost intervention to improve mental health on a population level. It also allows to identify new assessment approaches in the field of psychiatric epidemiology. PMID:28983477

Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial.

Science.gov (United States)

Beiwinkel, Till; Hey, Stefan; Bock, Olaf; Rössler, Wulf

2017-01-01

Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N  = 186 smartphone users will be recruited, with an over-sampling of persons with moderate to high distress. Over a 4-week period, the intervention will be compared to a self-monitoring without intervention group and a passive control group. Telephone interviews will be conducted at baseline, post-intervention (4 weeks), and 12-week follow-up to assess study outcomes. The primary outcome will be improvement of mental health. Secondary outcomes will include well-being, intentions toward help-seeking and help-seeking behavior, user activation, attitudes toward mental-health services, perceived stigmatization, smartphone app quality, user satisfaction, engagement, and adherence with the intervention. Additionally, data from the user's daily life as collected during self-monitoring will be used to investigate risk and protective factors of mental health in real-world settings. Therefore, this study will allow us to demonstrate the effectiveness of a smartphone application as a widely accessible and low-cost intervention to improve mental health on a population level. It also allows to identify new assessment approaches in the field of psychiatric epidemiology.

Chiropractic Treatment for Gastrointestinal Problems: A Systematic Review of Clinical Trials

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E Ernst

2011-01-01

Full Text Available Many chiropractors believe that chiropractic treatments are effective for gastrointestinal disorders. The aim of the present systematic review was to critically evaluate the evidence from controlled clinical trials supporting or not supporting this notion. Six electronic databases were searched for relevant studies. No limits were applied to language or publication date. Prospective, controlled, clinical trials of any type of chiropractic treatment for any type of gastrointestinal problem, except infant colic, were included. Only two trials were found – one was a pilot study, and the other had reached a positive conclusion; however, both had serious methodological flaws. There is no supportive evidence that chiropractic is an effective treatment for gastrointestinal disorders.

The effect of a mindfulness-based intervention in cognitive functions and psychological well-being applied as an early intervention in schizophrenia and high-risk mental state in a Chilean sample: study protocol for a randomized controlled trial.

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Langer, Álvaro I; Schmidt, Carlos; Mayol, Rocío; Díaz, Marcela; Lecaros, Javiera; Krogh, Edwin; Pardow, Aída; Vergara, Carolina; Vergara, Guillermo; Pérez-Herrera, Bernardita; Villar, María José; Maturana, Alejandro; Gaspar, Pablo A

2017-05-25

According to the projections of the World Health Organization, 15% of all disabilities will be associated with mental illnesses by 2020. One of the mental disorders with the largest social impacts due to high personal and family costs is psychosis. Among the most effective psychological approaches to treat schizophrenia and other psychotic disorders at the world level is cognitive behavioral therapy. Recently, cognitive behavioral therapy has introduced several tools and strategies that promote psychological processes based on acceptance and mindfulness. A large number of studies support the effectiveness of mindfulness in dealing with various mental health problems, including psychosis. This study is aimed at determining the efficiency of a mindfulness-based program in increasing cognitive function and psychological well-being in patients with a first episode of schizophrenia and a high risk mental state (those at risk of developing an episode of psychosis). This is an experimentally designed, multi-center randomized controlled trial, with a 3-month follow-up period. The study participants will be 48 patients diagnosed with schizophrenia (first episode) and 48 with a high-risk mental state, from Santiago, Chile, aged between 15 and 35 years. Participants will be submitted to a mindfulness-based intervention (MBI), which will involve taking part in eight mindfulness workshops adapted for people with psychosis. Workshops will last approximately 1.5 hours and take place once a week, over 8 weeks. The primary outcome will be the cognitive function through Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) and the secondary outcome will be psychological well-being measured by self-reporting questionnaires. The outcomes of this trial will add empirical evidence to the benefits and feasibility of MBIs for the psychotherapeutic treatment of patients with schizophrenia and high-risk mental states in reducing cognitive impairment in

Treatment of personality disorder.

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Bateman, Anthony W; Gunderson, John; Mulder, Roger

2015-02-21

The evidence base for the effective treatment of personality disorders is insufficient. Most of the existing evidence on personality disorder is for the treatment of borderline personality disorder, but even this is limited by the small sample sizes and short follow-up in clinical trials, the wide range of core outcome measures used by studies, and poor control of coexisting psychopathology. Psychological or psychosocial intervention is recommended as the primary treatment for borderline personality disorder and pharmacotherapy is only advised as an adjunctive treatment. The amount of research about the underlying, abnormal, psychological or biological processes leading to the manifestation of a disordered personality is increasing, which could lead to more effective interventions. The synergistic or antagonistic interaction of psychotherapies and drugs for treating personality disorder should be studied in conjunction with their mechanisms of change throughout the development of each. Copyright © 2015 Elsevier Ltd. All rights reserved.

A narrative review of binge eating disorder in adolescence: prevalence, impact, and psychological treatment strategies

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Marzilli E

2018-01-01

, especially in the internalizing area. Despite the evidence, to date, reviews on possible and effective psychological treatment for BED among young population are rare and focused primarily on adolescent females. Keywords: binge eating, adolescence, prevalence, impact, treatment

Effects of Positive Psychology Interventions on Risk Biomarkers in Coronary Patients: A Randomized, Wait-List Controlled Pilot Trial.

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Nikrahan, Gholam Reza; Laferton, Johannes A C; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C

2016-01-01

Among cardiac patients, positive psychologic factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychologic well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of 3 distinct PPIs on risk biomarkers in cardiac patients. In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to (1) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or (2) a wait-list control group. Risk biomarkers were assessed at baseline, postintervention (7 weeks), and at 15-week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Compared with the control group, participants randomized to the Seligman (B = -2.06; p = 0.02) and Fordyce PPI (B = -1.54; p = 0.04) had significantly lower high-sensitivity C-reactive protein levels at 7 weeks. Further, the Lyubomirsky PPI (B = -245.86; p = 0.04) was associated with a significantly lower cortisol awakening response at 7 weeks when compared with control participants. There were no other significant between-group differences. Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. All rights reserved.

Two-year follow-up of the MOSAIC trial: A multicenter randomized controlled trial comparing two psychological treatments in adult outpatients with broadly defined anorexia nervosa.

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Schmidt, Ulrike; Ryan, Elizabeth G; Bartholdy, Savani; Renwick, Bethany; Keyes, Alexandra; O'Hara, Caitlin; McClelland, Jessica; Lose, Anna; Kenyon, Martha; Dejong, Hannah; Broadbent, Hannah; Loomes, Rachel; Serpell, Lucy; Richards, Lorna; Johnson-Sabine, Eric; Boughton, Nicky; Whitehead, Linette; Bonin, Eva; Beecham, Jennifer; Landau, Sabine; Treasure, Janet

2016-08-01

This study reports follow-up data from a multicenter randomized controlled trial (n = 142) comparing the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with broadly defined anorexia nervosa (AN). At 12 months postrandomization, all patients had statistically significant improvements in body mass index (BMI), eating disorder (ED) symptomatology and other outcomes with no differences between groups. MANTRA was more acceptable to patients. The present study assessed whether gains were maintained at 24 months postrandomization. Follow-up data at 24 months were obtained from 73.2% of participants. Outcome measures included BMI, ED symptomatology, distress, impairment, and additional service utilization during the study period. Outcomes were analyzed using linear mixed models. There were few differences between groups. In both treatment groups, improvements in BMI, ED symptomatology, distress levels, and clinical impairment were maintained or increased further. Estimated mean BMI change from baseline to 24 months was 2.16 kg/m(2) for SSCM and 2.25 kg/m(2) for MANTRA (effect sizes of 1.75 and 1.83, respectively). Most participants (83%) did not require any additional intensive treatments (e.g., hospitalization). Two SSCM patients became overweight through binge-eating. Both treatments have value as outpatient interventions for patients with AN. © 2016 Crown copyright. International Journal of Eating Disorders. (Int J Eat Disord 2016; 49:793-800). © 2016 Crown copyright. International Journal of Eating Disorders.

Psychological interventions for parents of children and adolescents with chronic illness

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Eccleston, Christopher; Palermo, Tonya M; Fisher, Emma; Law, Emily

2012-01-01

Background Psychological therapies have been developed for parents of children and adolescents with a chronic illness. Such therapies include parent only or parent and child/adolescent, and are designed to treat parent behaviour, parent mental health, child behaviour/disability, child mental health, child symptoms and/or family functioning. No comprehensive, meta-analytic reviews have been published in this area. Objectives To evaluate the effectiveness of psychological therapies that include coping strategies for parents of children/adolescents with chronic illnesses (painful conditions, cancer, diabetes mellitus, asthma, traumatic brain injury, inflammatory bowel diseases, skin diseases or gynaecological disorders). The therapy will aim to improve parent behaviour, parent mental health, child behaviour/disability, child mental health, child symptoms and family functioning. Search methods We searched CENTRAL, MEDLINE, EMBASE and PsyclNFO for randomised controlled trials (RCTs) of psychological interventions that included parents of children and adolescents with a chronic illness. The initial search was from inception of these databases to June 2011 and we conducted a follow-up search from June 2011 to March 2012. We identified additional studies from the reference list of retrieved papers and from discussion with investigators. Selection criteria Included studies were RCTs of psychological interventions that delivered treatment to parents of children and adolescents (under 19 years of age) with a chronic illness compared to active control, wait list control or treatment as usual. We excluded studies if the parent component was a coaching intervention, the aim of the intervention was health prevention/promotion, the comparator was a pharmacological treatment, the child/adolescent had an illness not listed above or the study included children with more than one type of chronic illness. Further to this, we excluded studies when the sample size of either comparator

Mechanisms of action in mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in people with physical and/or psychological conditions: A systematic review.

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Alsubaie, Modi; Abbott, Rebecca; Dunn, Barnaby; Dickens, Chris; Keil, Tina Frieda; Henley, William; Kuyken, Willem

2017-07-01

Recently, there has been an increased interest in studying the effects of mindfulness-based interventions for people with psychological and physical problems. However, the mechanisms of action in these interventions that lead to beneficial physical and psychological outcomes have yet to be clearly identified. The aim of this paper is to review, systematically, the evidence to date on the mechanisms of action in mindfulness interventions in populations with physical and/or psychological conditions. Searches of seven databases (PsycINFO, Medline (Ovid), Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, AMED, ClinicalTrials.gov) were undertaken in June 2014 and July 2015. We evaluated to what extent the studies we identified met the criteria suggested by Kazdin for establishing mechanisms of action within a psychological treatment (2007, 2009). We identified four trials examining mechanisms of mindfulness interventions in those with comorbid psychological and physical health problems and 14 in those with psychological conditions. These studies examined a diverse range of potential mechanisms, including mindfulness and rumination. Of these candidate mechanisms, the most consistent finding was that greater self-reported change in mindfulness mediated superior clinical outcomes. However, very few studies fully met the Kazdin criteria for examining treatment mechanisms. There was evidence that global changes in mindfulness are linked to better outcomes. This evidence pertained more to interventions targeting psychological rather than physical health conditions. While there is promising evidence that MBCT/MBSR intervention effects are mediated by hypothesised mechanisms, there is a lack of methodological rigour in the field of testing mechanisms of action for both MBCT and MBSR, which precludes definitive conclusions. Copyright © 2017 Elsevier Ltd. All rights reserved.

Mental Fatigue Alters Cortical Activation and Psychological Responses, Impairing Performance in a Distance-Based Cycling Trial

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Flávio O. Pires

2018-03-01

Full Text Available Purpose: We sought to verify if alterations in prefrontal cortex (PFC activation and psychological responses would play along with impairments in pacing and performance of mentally fatigued cyclists.Materials and Methods: Eight recreational cyclists performed two preliminary sessions to familiarize them with the rapid visual information processing (RVP test, psychological scales and 20 km cycling time trial (TT20km (session 1, as well as to perform a VO2MAX test (session 2. Thereafter, they performed a TT20km either after a RVP test (30 min or a time-matched rest control session (session 3 and 4 in counterbalanced order. Performance and psychological responses were obtained throughout the TT20km while PFC electroencephalography (EEG was obtained at 10 and 20 km of the TT20km and throughout the RVP test. Increases in EEG theta band power indicated a mental fatigue condition. Repeated-measures mixed models design and post-hoc effect size (ES were used in comparisons.Results: Cyclists completed the trial ~2.7% slower in mental fatigue (34.3 ± 1.3 min than in control (33.4 ± 1.1 min, p = 0.02, very large ES, with a lower WMEAN (224.5 ± 17.9 W vs. 240.2 ± 20.9 W, respectively; p = 0.03; extremely large ES. There was a higher EEG theta band power during RVP test (p = 0.03; extremely large ES, which remained during the TT20km (p = 0.01; extremely large ES. RPE increased steeper in mental fatigue than in control, together with isolated reductions in motivation at 2th km (p = 0.04; extremely large ES, felt arousal at the 2nd and 4th km (p = 0.01; extremely large ES, and associative thoughts to exercise at the 6th and 16th km (p = 0.02; extremely large ES of the TT20km.Conclusions: Mentally fatigued recreational cyclists showed impaired performance, altered PFC activation and faster increase in RPE during a TT20km.

The implications of starvation induced psychological changes for the ethical treatment of hunger strikers.

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Fessler, D M T

2003-08-01

To evaluate existing ethical guidelines for the treatment of hunger strikers in light of findings on psychological changes that accompany the cessation of food intake. Electronic databases were searched for (a) editorials and ethical proclamations on hunger strikers and their treatment; (b) studies of voluntary and involuntary starvation, and (c) legal cases pertaining to hunger striking. Additional studies were gathered in a snowball fashion from the published material cited in these databases. Material was included if it (a) provided ethical or legal guidelines; (b) shed light on psychological changes accompanying starvation, or (c) illustrated the practice of hunger striking. Authors' observations, opinions, and conclusions were noted. Although the heterogeneous nature of the sources precluded statistical analysis, starvation appears to be accompanied by marked psychological changes. Some changes clearly impair competence, in which case physicians are advised to follow advance directives obtained early in the hunger strike. More problematic are increases in impulsivity and aggressivity, changes which, while not impairing competence, enhance the likelihood that patients will starve themselves to death.

Comparison of behavioural activation with guided self-help for treatment of depression in adults with intellectual disabilities: a randomised controlled trial.

Science.gov (United States)

Jahoda, Andrew; Hastings, Richard; Hatton, Chris; Cooper, Sally-Ann; Dagnan, Dave; Zhang, Ruiqi; McConnachie, Alex; McMeekin, Nicola; Appleton, Kim; Jones, Rob; Scott, Katie; Fulton, Lauren; Knight, Rosie; Knowles, Dawn; Williams, Chris; Briggs, Andrew; MacMahon, Ken; Lynn, Helen; Smith, Ian; Thomas, Gail; Melville, Craig

2017-12-01

Psychological therapies are first-line interventions for depression, but existing provision is not accessible for many adults with intellectual disabilities. We investigated the clinical and cost-effectiveness of a behavioural activation intervention (BeatIt) for people with intellectual disabilities and depression. BeatIt was compared with a guided self-help intervention (StepUp). We did a multicentre, single-blind, randomised, controlled trial with follow-up at 4 months and 12 months after randomisation. Participants aged 18 years or older, with mild to moderate intellectual disabilities and clinically significant depression were recruited from health and social care services in the UK. The primary outcome was the Glasgow Depression Scale for people with a Learning Disability (GDS-LD) score at 12 months. Analyses were done on an intention-to-treat basis. This trial is registered with ISCRTN, number ISRCTN09753005. Between Aug 8, 2013, and Sept 1, 2015, 161 participants were randomly assigned (84 to BeatIt; 77 to StepUp); 141 (88%) participants completed the trial. No group differences were found in the effects of BeatIt and StepUp based on GDS-LD scores at 12 months (12·03 [SD 7·99] GDS-LD points for BeatIt vs 12·43 [SD 7·64] GDS-LD points for StepUp; mean difference 0·26 GDS-LD points [95% CI -2·18 to 2·70]; p=0·833). Within-group improvements in GDS-LD scores occurred in both groups at 12 months (BeatIt, mean change -4·2 GDS-LD points [95% CI -6·0 to -2·4], peffect sizes (BeatIt, 0·590 [95% CI 0·337-0·844]; StepUp, 0·627 [0·380-0·873]). BeatIt was not cost-effective when compared with StepUp, although the economic analyses indicated substantial uncertainty. Treatment costs were only approximately 3·6-6·8% of participants' total support costs. No treatment-related or trial-related adverse events were reported. This study is, to our knowledge, the first large randomised controlled trial assessing individual psychological interventions for

Interrelation and independence of positive and negative psychological constructs in predicting general treatment adherence in coronary artery patients - Results from the THORESCI study.

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van Montfort, Eveline; Denollet, Johan; Widdershoven, Jos; Kupper, Nina

2016-09-01

In cardiac patients, positive psychological factors have been associated with improved medical and psychological outcomes. The current study examined the interrelation between and independence of multiple positive and negative psychological constructs. Furthermore, the potential added predictive value of positive psychological functioning regarding the prediction of patients' treatment adherence and participation in cardiac rehabilitation (CR) was investigated. 409 percutaneous coronary intervention (PCI) patients were included (mean age = 65.6 ± 9.5; 78% male). Self-report questionnaires were administered one month post-PCI. Positive psychological constructs included positive affect (GMS) and optimism (LOT-R); negative constructs were depression (PHQ-9, BDI), anxiety (GAD-7) and negative affect (GMS). Six months post-PCI self-reported general adherence (MOS) and CR participation were determined. Factor Analysis (Oblimin rotation) revealed two components (r = − 0.56), reflecting positive and negative psychological constructs. Linear regression analyses showed that in unadjusted analyses both optimism and positive affect were associated with better general treatment adherence at six months (p psychological constructs (i.e. optimism) may be of incremental value to negative psychological constructs in predicting patients' treatment adherence. A more complete view of a patients' psychological functioning will open new avenues for treatment. Additional research is needed to investigate the relationship between positive psychological factors and other cardiac outcomes, such as cardiac events and mortality.

Clinical outcomes in clinical trials of anti-HIV treatment

DEFF Research Database (Denmark)

Reekie, J; Mocroft, A; J, Neaton

2007-01-01

Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

Treatment of cannabis use among people with psychotic or depressive disorders: a systematic review.

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Baker, Amanda L; Hides, Leanne; Lubman, Dan I

2010-03-01

This article systematically reviews the evidence from randomized controlled trials (RCTs) for pharmacologic and psychological approaches to the treatment of cannabis use among individuals with psychotic or depressive disorders. A systematic literature search was conducted using the PubMed and PsychINFO databases from inception to December 2008. Individual searches in cannabis use (search terms: marijuana, cannabis, marijuana abuse, cannabis abuse, marijuana usage, cannabis usage), mental disorders (search terms: mood disorders, affective disorders, anxiety disorders, anxiety, depressive disorder, depression, psychotic disorders, psychosis, mental disorders), and pharmacotherapy (search terms: medication, drug therapy, pharmacotherapy, psychopharmacology, clinical trials, drug trial, treatment trial) were conducted and limited to humans, adolescents and adults. A search combining the individual cannabis use, mental disorder and pharmacotherapy searches produced 1,713 articles (PubMed = 1,398; PsychINFO = 315). Combining the cannabis use and mental disorder searches while limiting them to English articles and RCTs produced a total of 286 articles (PubMed = 228; PsychINFO = 58). From this literature, there were 7 RCTs conducted among mental health clients that reported cannabis use outcomes using pharmacologic or psychological interventions. While few RCTs have been conducted, there is evidence that pharmacologic and psychological interventions are effective for reducing cannabis use in the short-term among people with psychotic disorders or depression. Although it is difficult to make evidence-based treatment recommendations due to the paucity of research in this area, available studies indicate that effectively treating the mental health disorder with standard pharmacotherapy may be associated with a reduction in cannabis use and that longer or more intensive psychological interventions rather than brief interventions may be required, particularly among heavier

Meditation awareness training for the treatment of workaholism: A controlled trial.

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Van Gordon, William; Shonin, Edo; Dunn, Thomas J; Garcia-Campayo, Javier; Demarzo, Marcelo M P; Griffiths, Mark D

2017-06-01

Background and aims Workaholism is a form of behavioral addiction that can lead to reduced life and job satisfaction, anxiety, depression, burnout, work-family conflict, and impaired productivity. Given the number of people affected, there is a need for more targeted workaholism treatments. Findings from previous case studies successfully utilizing second-generation mindfulness-based interventions (SG-MBIs) for treating behavioral addiction suggest that SG-MBIs may be suitable for treating workaholism. This study conducted a controlled trial to investigate the effects of an SG-MBI known as meditation awareness training (MAT) on workaholism. Methods Male and female adults suffering from workaholism (n = 73) were allocated to MAT or a waiting-list control group. Assessments were performed at pre-, post-, and 3-month follow-up phases. Results MAT participants demonstrated significant and sustained improvements over control-group participants in workaholism symptomatology, job satisfaction, work engagement, work duration, and psychological distress. Furthermore, compared to the control group, MAT participants demonstrated a significant reduction in hours spent working but without a decline in job performance. Discussion and conclusions MAT may be a suitable intervention for treating workaholism. Further controlled intervention studies investigating the effects of SG-MBIs on workaholism are warranted.

Clinical trial or standard treatment? Shared decision making at the department of oncology

DEFF Research Database (Denmark)

Gregersen, Trine Ammentorp; Birkelund, Regner; Ammentorp, Jette

2016-01-01

Title: Clinical trial or standard treatment? Shared decision making at the department of oncology. Authors: Ph.d. student, Trine A. Gregersen. Trine.gregersen@rsyd.dk. Department of Oncology. Health Services Research Unit Lillebaelt Hospital / IRS University of Southern Denmark. Professor, Regner...... are involved in difficult treatment decisions including participation in clinical trials. The literature indicates that the decision is very often based on little knowledge about the treatment and that many patients who have consented to participate in a clinical trial are not always aware...... that they are participating in a trial. This place great demand on the healthcare providers’ ability to involve and advise patients in the decisions. The aim of this study is to investigate the characteristics of the communication when decisions about participation in clinical oncology trial are made and the patients...

Can Written Disclosure Reduce Psychological Distress and Increase Objectively Measured Injury Mobility of Student-Athletes? A Randomized Controlled Trial

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Duncan, Elaine; Gidron, Yori; Lavallee, David

2013-01-01

Injured students-athletes took part in a randomized controlled trial to test whether written disclosure could reduce psychological distress and improve injury mobility. Writing took place alongside prescribed physical rehabilitation and consisted of three 20-minute writing sessions, once a week for three consecutive weeks. Participants in the experimental injury-writing group followed a structured form of written disclosure, called the guided disclosure protocol (GDP). They firstly, wrote abo...

Hypoalgesic effects of three different manual therapy techniques on cervical spine and psychological interaction: A randomized clinical trial.

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Alonso-Perez, Jose Luis; Lopez-Lopez, Almudena; La Touche, Roy; Lerma-Lara, Sergio; Suarez, Emilio; Rojas, Javier; Bishop, Mark D; Villafañe, Jorge Hugo; Fernández-Carnero, Josué

2017-10-01

The purpose of this study was to evaluate the extent to which psychological factors interact with a particular manual therapy (MT) technique to induce hypoalgesia in healthy subjects. Seventy-five healthy volunteers (36 female, 39 males), were recruited in this double-blind, controlled and parallel study. Subjects were randomly assigned to receive: High velocity low amplitude technique (HVLA), joint mobilization, or Cervical Lateral glide mobilization (CLGM). Pressure pain threshold (PPT) over C7 unilaterally, trapezius muscle and lateral epicondyle bilaterally, were measured prior to single technique MT was applied and immediately after to applied MT. Pain catastrophizing, depression, anxiety and kinesiophobia were evaluated before treatment. The results indicate that hypoalgesia was observed in all groups after treatment in the neck and elbow region (P < 0.05), but mobilization induces more hypoalgesic effects. Catastrophizing interacted with change over time in PPT, for changes in C7 and in manipulation group. All the MT techniques studied produced local and segmental hypoalgesic effects, supporting the results of previous studies studying the individual interventions. Interaction between catastrophizing and HVLA technique suggest that whether catastrophizing level is low or medium, the chance of success is high, but high levels of catastrophizing may result in poor outcome after HVLA intervention. ClinicalTrials.gov Registration Number: NCT02782585. Copyright © 2016 Elsevier Ltd. All rights reserved.

Editorial: Trials and tribulations in child psychology and psychiatry: what is needed for evidence-based practice.

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Stringaris, Argyris

2014-11-01

If your child had leukaemia you would be distraught. Yet, there would also be hope. Most children with a diagnosis of leukaemia start their treatment as part of ongoing trials. The clinical teams looking after such children are motivated, knowledgeable and work in centres that specialise in the treatment of this lethal illness. The results speak for themselves. Not only have the trials helped oncologists learn more about which treatments work best. For years we have known that those who enter trials do better than those patients with similar characteristics who don't. We have recently also learnt that trials improve survival rates in those cancers population wide: the annual reduction between 1978-2005 in risk of death from childhood cancers ranged from 2.7% to 12.0%. This cancer trial culture is a splendid example of British health care delivery. What is happening in child psychiatry, though? If your child had, say, depression you would have every reason to be distraught too. The mortality rate is higher than in the general population and the burden of disease in the long run heavier than that of cardiovascular illness or cancer. Yet, your child would not have access to a trial. Instead, you would probably struggle to have your child's depression recognised in the first place. The care you would get would be determined by extreme regional variations and by what resources are available to local services and often the ideology or preferences of practitioners. © 2014 Association for Child and Adolescent Mental Health.

Psychological interventions for parents of children and adolescents with chronic illness.

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Eccleston, Christopher; Fisher, Emma; Law, Emily; Bartlett, Jess; Palermo, Tonya M

2015-04-15

Psychological therapies have been developed for parents of children and adolescents with a chronic illness. Such therapies include interventions directed at the parent only or at parent and child/adolescent, and are designed to improve parent, child, and family outcomes. This is an updated version of the original Cochrane review published in Issue 8, 2012, (Psychological interventions for parents of children and adolescents with chronic illness). To evaluate the efficacy of psychological therapies that include parents of children and adolescents with chronic illnesses including painful conditions, cancer, diabetes mellitus, asthma, traumatic brain injury (TBI), inflammatory bowel diseases (IBD), skin diseases, or gynaecological disorders. We also aimed to evaluate the adverse events related to implementation of psychological therapies for this population. Secondly, we aimed to evaluate the risk of bias of included studies and the quality of outcomes using the GRADE assessment. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and PsycINFO for randomised controlled trials (RCTs) of psychological interventions that included parents of children and adolescents with a chronic illness. Databases were searched to July 2014. Included studies were RCTs of psychological interventions that delivered treatment to parents of children and adolescents with a chronic illness compared to an active control, waiting list, or treatment as usual control group. Study characteristics and outcomes were extracted from included studies. We analysed data using two categories. First, we analysed data by each individual medical condition collapsing across all treatment classes at two time points. Second, we analysed data by each individual treatment class; cognitive behavioural therapy (CBT), family therapy (FT), problem solving therapy (PST) and multisystemic therapy (MST) collapsing across all medical conditions. For both sets of analyses we looked

Effects of Corporal Punishment and Psychological Treatment on Students' Learning and Behavior

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Arif, Muhammad Shahbaz; Rafi, Muhammad Shaban

2007-01-01

This paper aims to test the effects of corporal punishment and psychological treatment on students' learning and on their behavior. A pilot study, followed with experimental test, was framed in a demographically controlled environment on homogeneous variables at Punjab University Laboratory School, Pakistan over the period of six months.…

Factors associated with poor satisfaction with treatment and trial discontinuation in chronic schizophrenia.

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Schoemaker, Joep H; Vingerhoets, Ad J J M; Emsley, Robin A

2018-06-05

IntroductionDespite consistently high discontinuation rates due to withdrawal of consent (WOC) and insufficient therapeutic effect (ITE) in schizophrenia trials, insight into the underlying factors contributing to poor satisfaction with treatment and dropout is limited. A better understanding of these factors could help to improve trial design and completion rates. Using data from 1,136 trial participants with schizophrenia or schizoaffective disorder, we explored associations between predictor variables with (1) dropout due to WOC and ITE and (2) satisfaction with treatment among patients and investigators by means of hierarchic multiple regression analyses. ITE was associated with poor clinical improvement, poor investigator satisfaction with treatment, and poor patient insight into their own disease, whereas WOC only showed a meaningful association with poor patient satisfaction with treatment. Investigator satisfaction with treatment appeared most strongly associated with Positive and Negative Syndrome Scale (PANSS) positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor. The occurrence of severe side effects showed no meaningful association to satisfaction with treatment among investigators and patients, and neither did a patient's experienced psychopathology, nor their self-rating of functional impairment. Whereas trial discontinuation due to ITE is associated with poor treatment effectiveness, a patient's decision to withdraw from an antipsychotic trial remains unpredictable and may occur even when the investigator observes a global clinical improvement and is satisfied with the treatment.

Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes.

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Silver, Julie K; Baima, Jennifer

2013-08-01

Cancer prehabilitation, a process on the continuum of care that occurs between the time of cancer diagnosis and the beginning of acute treatment, includes physical and psychological assessments that establish a baseline functional level, identifies impairments, and provides targeted interventions that improve a patient's health to reduce the incidence and the severity of current and future impairments. There is a growing body of scientific evidence that supports preparing newly diagnosed cancer patients for and optimizing their health before starting acute treatments. This is the first review of cancer prehabilitation, and the purpose was to describe early studies in the noncancer population and then the historical focus in cancer patients on aerobic conditioning and building strength and stamina through an appropriate exercise regimen. More recent research shows that opportunities exist to use other unimodal or multimodal prehabilitation interventions to decrease morbidity, improve physical and psychological health outcomes, increase the number of potential treatment options, decrease hospital readmissions, and reduce both direct and indirect healthcare costs attributed to cancer. Future research may demonstrate increased compliance with acute cancer treatment protocols and, therefore, improved survival outcomes. New studies suggest that a multimodal approach that incorporates both physical and psychological prehabilitation interventions may be more effective than a unimodal approach that addresses just one or the other. In an impairment-driven cancer rehabilitation model, identifying current and anticipating future impairments are the critical first steps in improving healthcare outcomes and decreasing costs. More research is urgently needed to evaluate the most effective prehabilitation interventions, and combinations thereof, for survivors of all types of cancer.

Early Psychological Counseling for the Prevention of Posttraumatic Stress Induced by Acute Coronary Syndrome: The MI-SPRINT Randomized Controlled Trial.

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von Känel, Roland; Barth, Jürgen; Princip, Mary; Meister-Langraf, Rebecca E; Schmid, Jean-Paul; Znoj, Hansjörg; Herbert, Claudia; Schnyder, Ulrich

2018-01-01

Acute coronary syndrome (ACS)-induced posttraumatic stress disorder (PTSD) and clinically significant PTSD symptoms (PTSS) are found in 4 and 12% of patients, respectively. We hypothesized that trauma-focused counseling prevents the incidence of ACS-induced PTSS. Within 48 h of hospital admission, 190 patients with high distress during ACS were randomized to a single-session intervention of either trauma-focused counseling or an active control intervention targeting the general role of stress in patients with heart disease. Blind interviewer-rated PTSS (primary outcome) and additional health outcomes were assessed at 3 months of follow-up. Trial results about prevalence were compared with data from previous studies on the natural incidence of ACS-induced PTSS/PTSD. Intention-to-treat analyses revealed no difference in interviewer-rated PTSS between trauma-focused counseling (mean, 11.33; 95% Cl, 9.23-13.43) and stress counseling (9.88; 7.36-12.40; p = 0.40), depressive symptoms (6.01, 4.98-7.03, vs. 4.71, 3.65-5.77; p = 0.08), global psychological distress (5.15, 4.07-6.23, vs. 3.80, 2.60-5.00; p = 0.11), and the risk for cardiovascular-related hospitalization/all-cause mortality (OR, 0.67; 95% CI, 0.37-1.23). Self-rated PTSS indicated less beneficial effects with trauma-focused (6.54; 4.95-8.14) versus stress counseling (3.74; 2.39-5.08; p = 0.017). The completer analysis (154 cases) confirmed these findings. The prevalence rates of interviewer-rated PTSD (0.5%, 1/190) and self-rated PTSS were in this trial much lower than in meta-analyses and observation studies from the same cardiology department. Benefits were not seen for trauma-focused counseling when compared with an active control intervention. Nonetheless, in distressed ACS patients, individual, single-session, early psychological counseling shows potential as a means to prevent posttraumatic responses, but trauma-focused early treatments should probably be avoided. © 2018 S. Karger AG, Basel.

Community Trial of a Comprehensive Psychosocial Treatment for HFASDs

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Lopata, Christopher; Toomey, Jennifer A.; Thomeer, Marcus L.; McDonald, Christin A.; Fox, Jeffery D.; Smith, Rachael A.; Meichenbaum, David L.; Volker, Martin A.; Lee, Gloria K.; Lipinski, Alanna M.

2015-01-01

This community effectiveness trial examined the feasibility and efficacy of a comprehensive psychosocial treatment for 28 children, aged 7 to 10 years with high-functioning autism spectrum disorders (HFASDs). Treatment included instruction and therapeutic activities targeting social skills, face-emotion recognition skills, interest expansion, and…

Metric qualities of the cognitive behavioral assessment for outcome evaluation to estimate psychological treatment effects.

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Bertolotti, Giorgio; Michielin, Paolo; Vidotto, Giulio; Sanavio, Ezio; Bottesi, Gioia; Bettinardi, Ornella; Zotti, Anna Maria

2015-01-01

Cognitive behavioral assessment for outcome evaluation was developed to evaluate psychological treatment interventions, especially for counseling and psychotherapy. It is made up of 80 items and five scales: anxiety, well-being, perception of positive change, depression, and psychological distress. The aim of the study was to present the metric qualities and to show validity and reliability of the five constructs of the questionnaire both in nonclinical and clinical subjects. Four steps were completed to assess reliability and factor structure: criterion-related and concurrent validity, responsiveness, and convergent-divergent validity. A nonclinical group of 269 subjects was enrolled, as was a clinical group comprising 168 adults undergoing psychotherapy and psychological counseling provided by the Italian public health service. Cronbach's alphas were between 0.80 and 0.91 for the clinical sample and between 0.74 and 0.91 in the nonclinical one. We observed an excellent structural validity for the five interrelated dimensions. The clinical group showed higher scores in the anxiety, depression, and psychological distress scales, as well as lower scores in well-being and perception of positive change scales than those observed in the nonclinical group. Responsiveness was large for the anxiety, well-being, and depression scales; the psychological distress and perception of positive change scales showed a moderate effect. The questionnaire showed excellent psychometric properties, thus demonstrating that the questionnaire is a good evaluative instrument, with which to assess pre- and post-treatment outcomes.

Attitudes of psychology students to depression and its treatment: Implications for clinical practice.

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Economou, M; Peppou, L E; Geroulanou, K; Kontoangelos, K; Prokopi, A; Pantazi, A; Zervakaki, A; Stefanis, C N

2017-01-01

Stigma and mental health literacy affect access to and quality of treatment of major depression. Though mental health professionals seem better able to recognize major depression than the general public, they often hold similarly stigmatizing attitudes towards people suffering from the disorder. These attitudes are shaped jointly by the public stigma attached to mental illnesses as well as by the content and delivery of mental health professionals' undergraduate training. In line with this, the present study aimed to explore psychology students' ability to recognize major depression, their attitudes towards the disorder, and their views surrounding helpfulness of various interventions. A random sample of 167 undergraduate students was recruited from the psychology department of one public university in Athens. During one university hour, students were administered a vignette describing a woman fulfilling the DSM-IV criteria for major depression. A self-report questionnaire exploring students' recognition abilities, attitudes to depression and views on the helpfulness of various treatment modes was also administered. In total, 80.2% of students correctly recognized major depression from the vignette. Concerning their attitudes, students were unsure about the illness and ambivalent towards the person who suffers from it. With regard to available treatments for depression, students considered discussion with a friend to be the most helpful intervention. Counseling, cognitive behavioural therapy and psychoanalysis were also viewed in a positive light. On the contrary, antidepressants were not deemed helpful by most students. Finally, recognition of as well as attitudes towards depression and its treatments seemed to improve during the second year of undergraduate study; however they remained unchanged thereafter. Consistent with these, psychology students seem to have only a rudimentary knowledge on depression, that cannot not be qualified as mental health literacy

Prevalence and reporting of recruitment, randomisation and treatment errors in clinical trials: A systematic review.

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Yelland, Lisa N; Kahan, Brennan C; Dent, Elsa; Lee, Katherine J; Voysey, Merryn; Forbes, Andrew B; Cook, Jonathan A

2018-06-01

Background/aims In clinical trials, it is not unusual for errors to occur during the process of recruiting, randomising and providing treatment to participants. For example, an ineligible participant may inadvertently be randomised, a participant may be randomised in the incorrect stratum, a participant may be randomised multiple times when only a single randomisation is permitted or the incorrect treatment may inadvertently be issued to a participant at randomisation. Such errors have the potential to introduce bias into treatment effect estimates and affect the validity of the trial, yet there is little motivation for researchers to report these errors and it is unclear how often they occur. The aim of this study is to assess the prevalence of recruitment, randomisation and treatment errors and review current approaches for reporting these errors in trials published in leading medical journals. Methods We conducted a systematic review of individually randomised, phase III, randomised controlled trials published in New England Journal of Medicine, Lancet, Journal of the American Medical Association, Annals of Internal Medicine and British Medical Journal from January to March 2015. The number and type of recruitment, randomisation and treatment errors that were reported and how they were handled were recorded. The corresponding authors were contacted for a random sample of trials included in the review and asked to provide details on unreported errors that occurred during their trial. Results We identified 241 potentially eligible articles, of which 82 met the inclusion criteria and were included in the review. These trials involved a median of 24 centres and 650 participants, and 87% involved two treatment arms. Recruitment, randomisation or treatment errors were reported in 32 in 82 trials (39%) that had a median of eight errors. The most commonly reported error was ineligible participants inadvertently being randomised. No mention of recruitment, randomisation

Cognitive behavioural therapy versus multidisciplinary rehabilitation treatment for patients with chronic fatigue syndrome: study protocol for a randomised controlled trial (FatiGo

Directory of Open Access Journals (Sweden)

Vos-Vromans Desirée CWM

2012-05-01

Full Text Available Abstract Background Patients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to overcome their fatigue. Although there is no consensus, cognitive behavioural therapy is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment, a combination of cognitive behavioural therapy with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between multidisciplinary rehabilitation treatment and cognitive behavioural therapy is as yet unknown. The FatiGo (Fatigue-Go trial aims to compare the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life in patients with chronic fatigue syndrome. Methods One hundred twenty patients who meet the criteria of chronic fatigue syndrome, fulfil the inclusion criteria and sign the informed consent form will be recruited. Both treatments take 6 months to complete. The outcome will be assessed at 6 and 12 months after the start of treatment. Two weeks after the start of treatment, expectancy and credibility will be measured, and patients will be asked to write down their personal goals and score their current performance on these goals on a visual analogue scale. At 6 and 14 weeks after the start of treatment, the primary outcome and three potential mediators—self-efficacy, causal attributions and present-centred attention-awareness—will be measured. Primary outcomes are fatigue severity and quality of life. Secondary outcomes are physical activity, psychological symptoms, self-efficacy, causal attributions, impact of disease on emotional and physical functioning, present-centred attention-awareness, life

Generalized psychological distress among HIV-infected patients enrolled in antiretroviral treatment in Dilla University Hospital, Gedeo zone, Ethiopia

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Solomon H. Tesfaye

2014-05-01

Full Text Available Background: Psychological disorders like depression and anxiety are potentially dangerous conditions. In the context of HIV/AIDS, this can influence health-seeking behavior or uptake of diagnosis and treatment for HIV/AIDS, add to the burden of disease for HIV patients, create difficulty in adherence to treatment, and increase the risk of mortality and morbidity. The objective of this study was to assess the prevalence and correlates of generalized psychological distress among HIV-infected subjects on antiretroviral treatment (ART. Design: An institution-based cross-sectional study was conducted. Interviews were conducted with 500 patients initiating ART at Dilla Referral Hospital. Generalized psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS. A cutoff score ≥19 was used to identify possible cases of patients with generalized psychological distress. Multivariable logistic regression analysis using SPSS Version 20 was performed to identify factors associated with psychological distress. Results: The prevalence of generalized psychological distress among the population of this study was 11.2% (HADS≥19. Factors independently associated with generalized psychological distress were moderate stress (OR=6.87, 95% CI 2.27–20.81, low social support (OR=10.17, 95% CI 2.85–36.29, number of negative life events of six and above (OR=3.99, 95% CI 1.77–8.99, not disclosing HIV status (OR=5.24, 95% CI 1.33–20.62, and CD4 cell count of <200 cells/mm3 (OR=1.98, 95% CI 0.45–0.83 and 200–499 cells/mm3 (OR=3.53, 95% CI 1.62–7.73. Conclusions: This study provides prevalence of psychological distress lower than the prevalence of common mental disorders in Ethiopia and comparable to some other studies in sub-Saharan Africa. The findings are important in terms of their relevance to identifying high-risk groups for generalized psychological distress and preventing distress through integrating mental health

Psychological interventions for women with non-metastatic breast cancer.

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Jassim, Ghufran A; Whitford, David L; Hickey, Anne; Carter, Ben

2015-05-28

Breast cancer is the most common cancer affecting women worldwide. It is a distressing diagnosis and, as a result, considerable research has examined the psychological sequelae of being diagnosed and treated for breast cancer. Breast cancer is associated with increased rates of depression and anxiety and reduced quality of life. As a consequence, multiple studies have explored the impact of psychological interventions on the psychological distress experienced after a diagnosis of breast cancer. To assess the effects of psychological interventions on psychological morbidities, quality of life and survival among women with non-metastatic breast cancer. We searched the following databases up to 16 May 2013: the Cochrane Breast Cancer Group Specialised Register, CENTRAL, MEDLINE, EMBASE, CINAHL and PsycINFO; and reference lists of articles. We also searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) search portal and ClinicalTrials.gov for ongoing trials in addition to handsearching. Randomised controlled trials that assessed the effectiveness of psychological interventions for non-metastatic breast cancer in women. Two review authors independently appraised and extracted data from eligible trials. Any disagreement was resolved by discussion. Extracted data included information about participants, methods, the intervention and outcome. Twenty-eight randomised controlled trials comprising 3940 participants were included. The most frequent reasons for exclusion were non-randomised trials and the inclusion of women with metastatic disease. A wide range of interventions were evaluated, with 24 trials investigating a cognitive behavioural therapy and four trials investigating psychotherapy compared to control. Pooled standardised mean differences (SMD) from baseline indicated less depression (SMD -1.01, 95% confidence interval (CI) -1.83 to -0.18; P = 0.02; 7 studies, 637 participants, I(2) = 95%, low quality evidence), anxiety

Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT): modifying the CONSORT statement.

Science.gov (United States)

2014-10-01

Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which creates a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant after ≥20 weeks' gestation) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples

Predicting Treatment Response for Oppositional Defiant and Conduct Disorder Using Pre-treatment Adrenal and Gonadal Hormones.

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Shenk, Chad E; Dorn, Lorah D; Kolko, David J; Susman, Elizabeth J; Noll, Jennie G; Bukstein, Oscar G

2012-12-01

Variations in adrenal and gonadal hormone profiles have been linked to increased rates of oppositional defiant disorder (ODD) and conduct disorder (CD). These relationships suggest that certain hormone profiles may be related to how well children respond to psychological treatments for ODD and CD. The current study assessed whether pre-treatment profiles of adrenal and gonadal hormones predicted response to psychological treatment of ODD and CD. One hundred five children, 6 - 11 years old, participating in a randomized, clinical trial provided samples for cortisol, testosterone, dehydroepiandrosterone, and androstenedione. Diagnostic interviews of ODD and CD were administered up to three years post-treatment to track treatment response. Group-based trajectory modeling identified two trajectories of treatment response: 1) a High-response trajectory where children demonstrated lower rates of an ODD or CD diagnosis throughout follow-up, and 2) a Low-response trajectory where children demonstrated higher rates of an ODD or CD diagnosis throughout follow-up. Hierarchical logistic regression predicting treatment response demonstrated that children with higher pre-treatment concentrations of testosterone were four times more likely to be in the Low-response trajectory. No other significant relationship existed between pre-treatment hormone profiles and treatment response. These results suggest that higher concentrations of testosterone are related to how well children diagnosed with ODD or CD respond to psychological treatment over the course of three years.

Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety

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Teicher Martin H

2009-12-01

Full Text Available Abstract Background Many studies have reported beneficial effects from the application of near-infrared (NIR light photobiomodulation (PBM to the body, and one group has reported beneficial effects applying it to the brain in stroke patients. We have reported that the measurement of a patient's left and right hemispheric emotional valence (HEV may clarify data and guide lateralized treatments. We sought to test whether a NIR treatment could 1. improve the psychological status of patients, 2. show a relationship between immediate psychological improvements when HEV was taken into account, and 3. show an increase in frontal pole regional cerebral blood flow (rCBF, and 4. be applied without side effects. Methods We gave 10 patients, (5 M/5 F with major depression, including 9 with anxiety, 7 with a past history of substance abuse (6 with an opiate abuse and 1 with an alcohol abuse history, and 3 with post traumatic stress disorder, a baseline standard diagnostic interview, a Hamilton Depression Rating Scale (HAM-D, a Hamilton Anxiety Rating Scale (HAM-A, and a Positive and Negative Affect Scale (PANAS. We then gave four 4-minute treatments in a random order: NIR to left forehead at F3, to right forehead at F4, and placebo treatments (light off at the same sites. Immediately following each treatment we repeated the PANAS, and at 2-weeks and at 4-weeks post treatment we repeated all 3 rating scales. During all treatments we recorded total hemoglobin (cHb, as a measure of rCBF with a commercial NIR spectroscopy device over the left and the right frontal poles of the brain. Results At 2-weeks post treatment 6 of 10 patients had a remission (a score ≤ 10 on the HAM-D and 7 of 10 achieved this on the HAM-A. Patients experienced highly significant reductions in both HAM-D and HAM-A scores following treatment, with the greatest reductions occurring at 2 weeks. Mean rCBF across hemispheres increased from 0.011 units in the off condition to 0.043 units in

Psychological Treatments for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis

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Lackner, Jeffrey M.; Mesmer, Christina; Morley, Stephen; Dowzer, Clare; Hamilton, Simon

2004-01-01

This study conducted a systematic review to assess the quality of existing literature on psychological treatments for irritable bowel syndrome and to quantify the evidence for their efficacy. Three independent reviewers (2 from England, 1 from the United States) coded the quality of 32 studies, 17 of which provided data suitable for meta-analysis.…

A protocol for a trial of homeopathic treatment for irritable bowel syndrome

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Peckham Emily J

2012-11-01

Full Text Available Abstract Background Irritable bowel syndrome is a chronic condition with no known cure. Many sufferers seek complementary and alternative medicine including homeopathic treatment. However there is much controversy as to the effectiveness of homeopathic treatment. This three-armed study seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with irritable bowel syndrome. Methods/design This is a three-armed pragmatic randomised controlled trial using the cohort multiple randomised trial methodology. Patients are recruited to an irritable bowel syndrome cohort from primary and secondary care using GP databases and consultants lists respectively. From this cohort patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. The primary clinical outcome is the Irritable Bowel Syndrome Symptom Severity at 26 weeks. From a power calculation, it is estimated that 33 people will be needed for the homeopathic treatment arm and 132 for the usual care arm, to detect a minimal clinical difference at 80 percent power and 5 percent significance allowing for loss to follow up. An unequal group size has been used for reasons of cost. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis. Discussion This trial has received NHS approval and results are expected in 2013. Trial registration Current Controlled Trials ISRCTN90651143

Factors associated with psychological distress following colposcopy among women with low-grade abnormal cervical cytology: a prospective study within the Trial Of Management of Borderline and Other Low-grade Abnormal smears (TOMBOLA).

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Sharp, Linda; Cotton, Seonaidh; Carsin, Anne-Elie; Gray, Nicola; Thornton, Alison; Cruickshank, Margaret; Little, Julian

2013-02-01

Little is known about psychological after-effects of colposcopy and associated investigations and treatment in women with low-grade abnormal cervical cytology. We investigated psychological distress following colposcopy and related procedures. Nine hundred and eighty-nine women aged 20-59 years with routine cytology showing low-grade abnormalities were recruited to the Trial of Management of Borderline and other Low-grade Abnormal smears and attended colposcopy. If the cervical transformation zone (TZ) was colposcopically abnormal, women had immediate loop excision or diagnostic punch biopsies, with treatment if these showed cervical intraepithelial neoplasia grade 2/3 (CIN2/3). Women completed socio-demographic and psychosocial questionnaires at recruitment and before colposcopy. Six weeks after their last procedure, women completed the Impact of Event Scale (IES). Logistic regression was used to determine factors associated with significant psychological distress (IES ≥ 9). Analyses were stratified by colposcopic impression. The response rate was 74%. Six weeks after the last procedure, 86 (21%) of 391 women with a normal TZ had significant distress compared with 144 (42%) of 337 with an abnormal TZ. In both groups, significant distress was associated with anxiety pre-colposcopy and pain or discharge afterwards. Additional variables predicting distress in women with a normal TZ were worries about having sex and dissatisfaction with support from others. In women with an abnormal TZ, additional predictors of distress were younger age, CIN2/3, bleeding following colposcopy and worries about having cancer. Substantial proportions of women experience psychological distress after colposcopy and related procedures, even when the colposcopy is normal. This is an important cost of cervical screening. Interventions to alleviate these adverse psychological effects are required. Copyright © 2011 John Wiley & Sons, Ltd.

Treatment Algorithms Based on Tumor Molecular Profiling: The Essence of Precision Medicine Trials.

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Le Tourneau, Christophe; Kamal, Maud; Tsimberidou, Apostolia-Maria; Bedard, Philippe; Pierron, Gaëlle; Callens, Céline; Rouleau, Etienne; Vincent-Salomon, Anne; Servant, Nicolas; Alt, Marie; Rouzier, Roman; Paoletti, Xavier; Delattre, Olivier; Bièche, Ivan

2016-04-01

With the advent of high-throughput molecular technologies, several precision medicine (PM) studies are currently ongoing that include molecular screening programs and PM clinical trials. Molecular profiling programs establish the molecular profile of patients' tumors with the aim to guide therapy based on identified molecular alterations. The aim of prospective PM clinical trials is to assess the clinical utility of tumor molecular profiling and to determine whether treatment selection based on molecular alterations produces superior outcomes compared with unselected treatment. These trials use treatment algorithms to assign patients to specific targeted therapies based on tumor molecular alterations. These algorithms should be governed by fixed rules to ensure standardization and reproducibility. Here, we summarize key molecular, biological, and technical criteria that, in our view, should be addressed when establishing treatment algorithms based on tumor molecular profiling for PM trials. © The Author 2015. Published by Oxford University Press.

A randomised controlled multicentre trial of treatments for adolescent anorexia nervosa including assessment of cost-effectiveness and patient acceptability - the TOuCAN trial.

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Gowers, S G; Clark, A F; Roberts, C; Byford, S; Barrett, B; Griffiths, A; Edwards, V; Bryan, C; Smethurst, N; Rowlands, L; Roots, P

2010-03-01

to it), limits the assessment of the treatment effect of inpatient care. However, this study provides little support for lengthy inpatient psychiatric treatment on clinical or health economic grounds. These findings are broadly consistent with existing guidelines on the treatment of anorexia nervosa, which suggest that outpatient treatments should be offered to the majority, with inpatient treatment offered in rare cases, though our findings lend little support to a stepped-care approach in which inpatient care is offered to outpatient non-responders. Outpatient care, supported by brief (medical) inpatient management for correction of acute complications may be a preferable approach. The health economic analysis and user views both support NICE guidelines, which suggest that anorexia nervosa should be managed in specialist services that have experience and expertise in its management. Comprehensive general CAMHS might, however, be well placed to manage milder cases. Further research should focus on the specific components of outpatient psychological therapies. Although family-based treatments are well established, trials have not established their effectiveness compared with good-quality individual psychological therapies and the combination of individual and family approaches is untested. Further research is needed to establish which patients (if any) might respond to inpatient psychiatric treatment when unresponsive to outpatient care, the positive and negative components of it and the optimum length of stay. NRR number (National Research Register) N0484056615; Current Controlled Trials ISRCTN39345394.

Physical and psychologic effects of aromatherapy inhalation on pregnant women: a randomized controlled trial.

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Igarashi, Toshiko

2013-10-01

Stress reduction care is important for pregnant women to decrease obstetric complications and children's health problems after birth. The aim of this study is to clarify the physical and psychologic effects of inhalation aromatherapy on pregnant women. Essential oils with high linalool and linalyl acetate content that may be used during pregnancy were selected and among these, and the one preferred by the participant was used. This was a prospective, randomized, controlled trial. This trial was performed at a gynecology outpatient department in a hospital in Kyoto, Japan. The study included pregnant women in week 28 of a single pregnancy with a normal course. Participants were randomly assigned into an aromatherapy group and a control group. They were seated in the resting, seated position for 10 minutes. During the latter 5 minutes of each 10-minute session, aromatherapy inhalation was performed for the aromatherapy group. Before and after the intervention, the Profile of Mood States (POMS) was measured. During the trial, the heart-rate fluctuations were measured for the autonomic nervous system regulation. A total of 13 pregnant women participated in the trial. Seven (7) participants were assigned to the aromatherapy group and 6 participants to the control group. The results of the POMS were such that based on an intragroup comparison, significant differences were observed in the Tension-Anxiety score (paromatherapy. The results of the autonomic nervous system regulation were such that based on an intragroup comparison within the aromatherapy group, the parasympathetic nerve activity increased significantly (pAromatherapy inhalation using essential oils containing linalyl acetate and linalool was found to be effective for the POMS and parasympathetic nerve activity, based on an intragroup comparison. However, based on a comparison between the groups, no substantial difference was observed; hence, further study is necessary in the future.

The mind–body connection in irritable bowel syndrome: A randomised controlled trial of hypnotherapy as a treatment

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Julie S Phillips-Moore

2015-01-01

Full Text Available Background: Hypnotherapy has been reported as being beneficial in the treatment of irritable bowel syndrome (IBS. We aimed to test the hypothesis that patients with IBS treated ‘holistically’ by hypnosis (i.e. by combined psychological and physiological symptom imagery would have greater improvement in their IBS symptoms than patients treated by hypnosis using standard ‘gut-directed’ hypnotherapy, and both would be superior to simple relaxation therapy. Methods: Patients ( n  = 51 with Rome II criteria were randomised to ‘individualised’ (holistic hypnotherapy, standard ‘gut-directed’ hypnotherapy or relaxation therapy for a period of 11 weeks with two follow-up assessments at 2 weeks and at 3 months after the completion of the trial. The primary outcome was bowel symptom severity scale (BSSS. Results: All the participants in this study improved their IBS symptoms (pain, bloating, constipation and diarrhoea and physical functioning at the end of the treatment from baseline, but this was not significantly different across the treatment arms. Conclusion: Neither ‘individualised’ nor ‘gut-directed’ hypnotherapy is superior to relaxation therapy in IBS.

Internet-Delivered Exposure Therapy for Fibromyalgia: A Randomized Controlled Trial.

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Hedman-Lagerlöf, Maria; Hedman-Lagerlöf, Erik; Axelsson, Erland; Ljótsson, Brjánn; Engelbrektsson, Johanna; Hultkrantz, Sofia; Lundbäck, Karolina; Björkander, Daniel; Wicksell, Rikard K; Flink, Ida; Andersson, Erik

2018-06-01

Fibromyalgia (FM) is a common and disabling chronic pain disorder, for which existing pharmacological and psychological treatments have yet yielded insufficient effects. Previous literature has shown that exposure therapy may be an effective treatment for chronic pain. This study constitutes the first randomized controlled trial evaluating exposure therapy for FM. A total of 140 participants with diagnosed FM were randomized to a 10-week Internet-delivered exposure treatment (iExp; n=70) or a waitlist control condition (WLC; n=70). Primary outcome measure were FM symptoms and impact, and secondary outcome measures were fatigue, disability, quality of life, pain-related distress and avoidance behaviors, insomnia, depression, and anxiety. Data retention was high (100% data completion at posttreatment for primary outcome, 96% at 6-month follow-up and 94% at 12-month follow-up). Results showed that participants in the iExp group made large and superior improvements compared with WLC on FM symptoms and impact (B, -1.93; z, -10.14; P<0.001, between-group Cohen d=0.90), as well as all secondary outcomes (between-group Cohen d ranging from 0.44 to 1.38) with sustained results. We conclude that iExp seems to be an efficacious treatment for FM compared with no treatment, and the results also highlight the potential increase of accessibility by using the Internet format to deliver psychological treatments for these patients. Future trials with active control conditions are warranted.

Exploring patients' treatment journeys following randomisation in mental health trials to improve future trial conduct: a synthesis of multiple qualitative data sets.

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Turner, Katrina M; Percival, John; Kessler, David; Donovan, Jenny

2017-06-15

The way in which pragmatic trials are designed suggests that there are differences between the experiences of participants randomised to usual care and intervention arms. These potential differences relate not only to which treatment participants receive but also how they access and engage with their allocated treatment. Such differences could affect trial results. The aim of this study was to assess whether such differences exist and, if they do, to consider their implications for the design of future trials. Interview transcripts were sampled from data sets gathered during three qualitative studies, all of which had been nested within large, primary care depression trials. Each study had explored trial participants' views and experiences of treatments received following randomisation. Transcripts from 37 participants were purposefully sampled, 20 of which were from interviews held with individuals allocated to receive usual GP care. Data were analysed thematically. There was evidence of differences between trial arms across all three data sets. Intervention participants were willing and able to engage with the treatment to which they had been allocated. Randomisation had led to them embarking upon a clear treatment pathway and receiving care in a context where they felt comfortable discussing their mental health and had sufficient time to do so. Intervention participants also had continuity with and confidence in the practitioners they saw. A few usual-care participants talked about having continuity with and confidence in their GPs. However, most of the usual-care participants reported a reluctance to consult GPs about mental health, difficulties in securing treatment appointments, and little or no changes in care following randomisation. Additionally, most reported a lack of continuity of care and a lack confidence in the treatment available to them. There are important differences between usual-care and intervention arms that go beyond treatment received, and

The Virtual Anemia Trial: An Assessment of Model‐Based In Silico Clinical Trials of Anemia Treatment Algorithms in Patients With Hemodialysis

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Topping, Alice; Kappel, Franz; Thijssen, Stephan; Kotanko, Peter

2018-01-01

In silico approaches have been proposed as a novel strategy to increase the repertoire of clinical trial designs. Realistic simulations of clinical trials can provide valuable information regarding safety and limitations of treatment protocols and have been shown to assist in the cost‐effective planning of clinical studies. In this report, we present a blueprint for the stepwise integration of internal, external, and ecological validity considerations in virtual clinical trials (VCTs). We exemplify this approach in the context of a model‐based in silico clinical trial aimed at anemia treatment in patients undergoing hemodialysis (HD). Hemoglobin levels and subsequent anemia treatment were simulated on a per patient level over the course of a year and compared to real‐life clinical data of 79,426 patients undergoing HD. The novel strategies presented here, aimed to improve external and ecological validity of a VCT, significantly increased the predictive power of the discussed in silico trial. PMID:29368434

Psychological treatment of patients with chronic toxic encephalopathy: lessons from studies of chronic fatigue and whiplash

NARCIS (Netherlands)

van Hout, Moniek S. E.; Wekking, Ellie M.; Berg, Ina J.; Deelman, Betto G.

2003-01-01

Chronic toxic encephalopathy (CTE), which can result from long-term exposure to organic solvents, is characterized by problems of attention and memory, fatigue and affective symptoms. There is little experience with (neuro)psychological treatment in this patient group. We reviewed treatment outcome

Most Trial Eligibility Criteria and Patient Baseline Characteristics Do Not Modify Treatment Effect in Trials Using Targeted Therapies for Rheumatoid Arthritis

DEFF Research Database (Denmark)

Christensen, Anton Wulf; Tarp, Simon; Furst, Daniel E

2015-01-01

OBJECTIVE: To determine if variations in trial eligibility criteria and patient baseline characteristics could be considered effect modifiers of the treatment response when testing targeted therapies (biological agents and targeted synthetic disease modifying antirheumatic drugs (DMARDs....... Odds ratios (ORs) were calculated from the response rates and compared among the trial eligibility criteria/patient baseline characteristics of interest. Comparisons are presented as the Ratio of Odds Ratios (ROR). RESULTS: Sixty-two trials (19,923 RA patients) were included in the primary analyses...... using ACR20 response. Overall, targeted therapies constituted an effective treatment (OR 3.96 95% confidence interval (CI) 3.41 to 4.60). The majority of the trial eligibility criteria and patient baseline characteristics did not modify treatment effect. The added benefit of targeted therapies was lower...

Clinical trials as treatment option: bioethics and health care disparities in substance dependency.

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Timmermans, Stefan; McKay, Tara

2009-12-01

Bioethicists have warned against the dangers of mixing research with treatment. They are concerned that research priorities may take precedence over individual patient needs and that research subjects tend to misunderstand the purpose of research or overestimate the direct medical benefits of participating in studies. Yet, other work has questioned whether clinical research can always be separated from therapeutic benefit for participants. Using in-depth interviews with participants in two phase III randomized U.S. clinical trials for methamphetamine dependency, we examine the treatment options available to participants, their experiences with participating in the trials, and potential problems of trial participation. We find that while participants have experience with four alternative treatment modalities - quitting alone, support groups, in-patient treatment facilities, and consulting primary care physicians - the randomized clinical trials compare favorably to alternatives because they provide access to evidence-based behavioral treatments, specialized medical professionals, non-judgmental staff, and the possibility of receiving an experimental drug. We conclude that while randomized clinical trials are imperfect substitutes for clinical care, they constitute a fragile and sporadic therapeutic niche in a country with fundamental problems in access to health care, a mixed punitive-therapeutic drug addiction policy, and a profit-driven pharmaceutical development and approval process.

Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01] - study protocol and baseline practice and provider characteristics

Science.gov (United States)

2013-01-01

Background Inappropriate antibiotic prescribing for nonbacterial infections leads to increases in the costs of care, antibiotic resistance among bacteria, and adverse drug events. Acute respiratory infections (ARIs) are the most common reason for inappropriate antibiotic use. Most prior efforts to decrease inappropriate antibiotic prescribing for ARIs (e.g., educational or informational interventions) have relied on the implicit assumption that clinicians inappropriately prescribe antibiotics because they are unaware of guideline recommendations for ARIs. If lack of guideline awareness is not the reason for inappropriate prescribing, educational interventions may have limited impact on prescribing rates. Instead, interventions that apply social psychological and behavioral economic principles may be more effective in deterring inappropriate antibiotic prescribing for ARIs by well-informed clinicians. Methods/design The Application of Behavioral Economics to Improve the Treatment of Acute Respiratory Infections (BEARI) Trial is a multisite, cluster-randomized controlled trial with practice as the unit of randomization. The primary aim is to test the ability of three interventions based on behavioral economic principles to reduce the rate of inappropriate antibiotic prescribing for ARIs. We randomized practices in a 2 × 2 × 2 factorial design to receive up to three interventions for non-antibiotic-appropriate diagnoses: 1) Accountable Justifications: When prescribing an antibiotic for an ARI, clinicians are prompted to record an explicit justification that appears in the patient electronic health record; 2) Suggested Alternatives: Through computerized clinical decision support, clinicians prescribing an antibiotic for an ARI receive a list of non-antibiotic treatment choices (including prescription options) prior to completing the antibiotic prescription; and 3) Peer Comparison: Each provider’s rate of inappropriate antibiotic prescribing relative to top

The pharmacological and non-pharmacological treatment of attention deficit hyperactivity disorder in children and adolescents: A systematic review with network meta-analyses of randomised trials.

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Ferrán Catalá-López

Full Text Available Attention deficit hyperactivity disorder (ADHD is one of the most commonly diagnosed psychiatric disorders in childhood. A wide variety of treatments have been used for the management of ADHD. We aimed to compare the efficacy and safety of pharmacological, psychological and complementary and alternative medicine interventions for the treatment of ADHD in children and adolescents.We performed a systematic review with network meta-analyses. Randomised controlled trials (≥ 3 weeks follow-up were identified from published and unpublished sources through searches in PubMed and the Cochrane Library (up to April 7, 2016. Interventions of interest were pharmacological (stimulants, non-stimulants, antidepressants, antipsychotics, and other unlicensed drugs, psychological (behavioural, cognitive training and neurofeedback and complementary and alternative medicine (dietary therapy, fatty acids, amino acids, minerals, herbal therapy, homeopathy, and physical activity. The primary outcomes were efficacy (treatment response and acceptability (all-cause discontinuation. Secondary outcomes included discontinuation due to adverse events (tolerability, as well as serious adverse events and specific adverse events. Random-effects Bayesian network meta-analyses were conducted to obtain estimates as odds ratios (ORs with 95% credibility intervals. We analysed interventions by class and individually. 190 randomised trials (52 different interventions grouped in 32 therapeutic classes that enrolled 26114 participants with ADHD were included in complex networks. At the class level, behavioural therapy (alone or in combination with stimulants, stimulants, and non-stimulant seemed significantly more efficacious than placebo. Behavioural therapy in combination with stimulants seemed superior to stimulants or non-stimulants. Stimulants seemed superior to behavioural therapy, cognitive training and non-stimulants. Behavioural therapy, stimulants and their combination

Music therapy versus treatment as usual for refugees diagnosed with posttraumatic stress disorder (PTSD): study protocol for a randomized controlled trial

DEFF Research Database (Denmark)

Beck, Bolette Daniels; Lund, Steen; Søgaard, Ulf

2018-01-01

BACKGROUND: Meta-analyses of studies on psychological treatment of refugees describe highly varying outcomes, and research on multi-facetted and personalized treatment of refugees with post-traumatic stress disorder (PTSD) is needed. Music therapy has been found to affect arousal regulation...... session. DISCUSSION: The effect of music therapy can be explained by theories on affect regulation and social engagement, and the impact of music on brain regions affected by PTSD. The study will shed light on the role of therapy for the attainment of a safe attachment style, which recently has been shown...... and emotional processing, and a pilot study on the music therapy method Trauma-focused Music and Imagery (TMI) with traumatized refugees resulted in significant changes of trauma symptoms, well-being and sleep quality. The aim of the trial is to test the efficacy of TMI compared to verbal psychotherapy. METHODS...

Psychological impact of isotretinoin treatment in patients with moderate and severe acne.

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Simić, Dubravka; Situm, Mirna; Letica, Edita; Penavić, Jasna Zeljko; Zivković, Maja Vurnek; Tomić, Teo

2009-12-01

Acne patients are subject to different degree of psychosocial distress. The emotional impact of acne vulgaris due to disfigurement caused by the disease is undisputed. Most common reactions to the acne are depression and anxiety. The use of isotretinoin, one of the most effective options in acne treatment, increases depression symptoms. The aim of this study was to investigate the psychological status of the patients with moderate to severe acne and to compare patients treated with isotretinoin with patients treated with vitamin C. A total of 85 patients suffering from acne vulgaris were included in the study. The results of this study do not find a significant correlation between the use of isotretinoin and the psychological effects of the drug.

Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal

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Kent David M

2010-08-01

Full Text Available Abstract Mounting evidence suggests that there is frequently considerable variation in the risk of the outcome of interest in clinical trial populations. These differences in risk will often cause clinically important heterogeneity in treatment effects (HTE across the trial population, such that the balance between treatment risks and benefits may differ substantially between large identifiable patient subgroups; the "average" benefit observed in the summary result may even be non-representative of the treatment effect for a typical patient in the trial. Conventional subgroup analyses, which examine whether specific patient characteristics modify the effects of treatment, are usually unable to detect even large variations in treatment benefit (and harm across risk groups because they do not account for the fact that patients have multiple characteristics simultaneously that affect the likelihood of treatment benefit. Based upon recent evidence on optimal statistical approaches to assessing HTE, we propose a framework that prioritizes the analysis and reporting of multivariate risk-based HTE and suggests that other subgroup analyses should be explicitly labeled either as primary subgroup analyses (well-motivated by prior evidence and intended to produce clinically actionable results or secondary (exploratory subgroup analyses (performed to inform future research. A standardized and transparent approach to HTE assessment and reporting could substantially improve clinical trial utility and interpretability.

Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE).

Science.gov (United States)

2017-03-30

months. Conclusions  Both groups showed clinically relevant and long lasting decreases in HbA1c, rates of severe hypoglycaemia, and improved psychological measures, although few participants achieved glucose levels currently recommended by national and international guidelines. Adding pump treatment to structured training in flexible intensive insulin treatment did not substantially enhance educational benefits on glycaemic control, hypoglycaemia, or psychosocial outcomes in adults with type 1 diabetes. These results do not support a policy of providing insulin pumps to adults with poor glycaemic control until the effects of training on participants' level of engagement in intensive self management have been determined. Trial registration  Current Controlled Trials ISRCTN61215213. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Psychological workshops for children and adolescents suffering from malignant disease: The model of psychosocial support during hospitalization and treatment

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Klikovac Tamara

2014-01-01

Full Text Available Pediatric psycho-oncology within psycho-oncology is a highly developed scientific discipline in the world, both at the level of basic research and the development of theoretical concepts and at the practical level, which refers to the creation and implementation of various models of psychosocial support to children and young people who are suffering from various malignant diseases and their families during all stages of the demanding oncology treatment. One of the models of psychosocial support for children are workshops, as a form of group psychological treatment in which children and young people who are in distress, crisis, shock and even trauma, acquire a new positive experience and which provides new insights and knowledge to empower and boost the quality of life for overcoming severe malignant disease and treatment through meaningful games, all of which leads to overcoming the 'downtime' and regression and encouraging further psychological development. The outcome of workshop activities are various products (drawings, photographs, videos, posters, written material, but also positive feelings and behaviours in children and adolescents. The main objectives of introducing psychological workshops at the department of pediatric hematology-oncology in our community are, on the one hand, to provide professional counselling and support to children and young people during hospitalization and, on the other, to introduce a standard psychological procedure and quality psychological practice of group psychological counselling for sick children and young people in the hospital environment.

A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans with PTSD

Science.gov (United States)

2015-10-01

research on combined relapse prevention and exposure-based interventions in the treatment of AUD and PTSD. Presentation 4: Pharmacologic Therapies...psychological interviews to determine diagnostic eligibility [Structured Clinical Interview for DSM-IV (SCID) and the Clinician Administered PTSD Scale ...Psychology of Addictive Behaviors. PRESENTATION AT MOMRP SUSBSTANCE ABUSE IPR IN FT. DETRICK, MD: Presented overview & progress of study and pilot

Psychological skills training and a mindfulness-based intervention to enhance functional athletic performance: design of a randomized controlled trial using ambulatory assessment.

Science.gov (United States)

Röthlin, Philipp; Birrer, Daniel; Horvath, Stephan; Grosse Holtforth, Martin

2016-07-26

Struggling to deliver performance in competitions is one of the main reasons why athletes seek the advice of sport psychologists. Psychologists apply a variety of intervention techniques, many of which are not evidence-based. Evidence-based techniques promote quality management and could help athletes, for example, to increase and maintain functional athletic behavior in competitions/games (i.e., being focused on task relevant cues and executing movements and actions in high quality). However, well-designed trials investigating the effectiveness of sport psychological interventions for performance enhancement are scarce. The planed study is founded by the Swiss National Science Foundation and examines the effectiveness of two interventions with elite and sub-elite athletes. A psychological skills training (PST) and a mindfulness-based intervention (MI), administered as group-program, will be compared to a waiting-list control group concerning how they enhance functional athletic behavior - which is a prerequisite for optimal performance. Furthermore, we will investigate underlying mechanisms (mediators) and moderators (e.g., task difficulty, individual characteristics, intervention-expectancy and intervention-integrity). The presented trial uses a randomized controlled design with three groups, comparing PST, MI and a waiting list control condition. Both group interventions will last 5 weeks, consist of four 2 h sessions and will be administered by a trained sport psychologist. Primary outcome is functional athletic behavior assessed using ambulatory assessment in a competition/game. As secondary outcomes competition anxiety, cognitive interference and negative outcome expectations will be assessed. Assessments are held at pre- and post-intervention as well as at 2 months follow up. The study has been approved by the ethical committee of the Swiss Federal Institute of Sport. Both PST and MI are expected to help improve functional behavior in athletes. By

Speciality of psychological processes in relation to children testimony

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Brkić Snežana S.

2013-01-01

Full Text Available Witnesses are important and very frequent sources of evidence in criminal trial. The correct estimate the credibility of witneses is of great significance. Therefore the judge must obtain some psychological knowledge. He must know some essential things about psychological processes and psychological features which are in relation to witness testimony. The author brings into focus such processes as. Memory, thinking, speech and emphasizes the speciality of those psychological processes by children. The author also point to some psychological features of children witnesses as suggestibility.

Are patients at risk for psychological maladjustment during fertility treatment less willing to comply with treatment? Results from the Portuguese validation of the SCREENIVF.

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Lopes, V; Canavarro, M C; Verhaak, C M; Boivin, J; Gameiro, S

2014-02-01

Do patients at risk for psychological maladjustment during fertility treatment present lower intentions to comply with recommended treatment than patients not at risk? Patients at risk of psychological maladjustment present similar high intentions to comply with recommended fertility treatment to those not at risk but their intentions are conditioned by the degree of control they perceive over their fertility and its treatment and their capacity to accept a future without biological children. Infertile couples refer to the psychological burden of treatment as one of the most important reasons for withdrawal from recommended treatment. The SCREENIVF can be used before treatment to screen patients at risk for psychological maladjustment by assessing five risk factors: anxiety, depression, helplessness and lack of acceptance cognitions and social support. Cross-sectional study. First, we investigated the psychometric properties of the Portuguese version of the SCREENIVF. Secondly, we investigated associations between risk for psychological maladjustment and intentions to comply with treatment. Two hundred and ninety-one women and 92 men undergoing any stage of fertility treatment at Portuguese infertility clinics were recruited online or in the clinical setting (55% response rate). Participants completed questionnaires that assessed their emotional adjustment, quality of life and compliance intentions. The confirmatory factor analysis for the SCREENIVF indicated good fit [χ(2) = 188.50, P 0.05). Cognitive risk factors moderated negative associations found between distress and compliance intentions. Higher anxiety was associated with lower compliance intentions for patients with lower helplessness cognitions (β = -0.45, P = 0.01) and men with higher acceptance cognitions (β = -0.60; P = 0.03), but not for patients with higher helplessness cognitions (β = 0.25, P = 0.13) and men with lower acceptance cognitions (β = 0.38; P = 0.21). Higher depression was associated

Psychological Treatments for Borderline Personality Disorder: A Review of Cognitive-Behavioral Oriented Therapies

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Sofia Marques

2017-04-01

Conclusion: In summary, the available studies support cognitive-behavioral psychological treatments as an efficacious intervention in borderline personality disorder. However, the existing scientific literature on this topic is still scarce and there is need for more studies, with higher methodological rigor, that should validate these results.

Review of Randomized Controlled Trials on Psychological Interventions in Child Sexual Abuse: Current Status and Emerging Needs in the Indian Context.

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Choudhary, Vandana; Satapathy, Sujata; Sagar, Rajesh

2016-01-01

Child sexual abuse (CSA) is a critical, psychologically traumatic and sometimes life-threatening incident often associated with sequel of adverse physical, behavioral, and mental health consequences. Factors such as developmental age of the child, severity of abuse, closeness to the perpetrator, availability of medico-legal-social support network and family care, gender stereotypes in the community complicate the psychological trauma. Although the research on the effects of CSA as well as psychological intervention to reduce the victimization and promote the mental health of the child is in its infancy stage in India, the global research in the past three decades has progressed much ahead. A search was performed using MEDLINE, PubMed, PsycINFO, and Google Scholar from 1984 to 2015 and only 17 randomized controlled trials (RCTs) out of 96 potentially relevant studies were included. While nonspecific therapies covering a wide variety of outcome variables were prominent till 1999s, the trend changed to specific and focused forms of trauma-focused therapies in next one-and-half decades. Novel approaches to psychological interventions have also been witnessed. One intervention (non-RCT) study on effects on general counseling has been reported from India.

Quality of diets with fluidized bed combustion residue treatment: I. Rat trials

Energy Technology Data Exchange (ETDEWEB)

Cahill, N.J.; Reid, R.L.; Head, M.K.; Hern, J.L.; Bennett, O.L.

Feeding trials were conducted with rats (Rattus rattus) to examine effects of soil application, or dietary inclusion, of fluidized bed combustion residue (FBCR) on the composition and quality of foods. Four diets (vegetable protein, egg protein, chicken, chicken + dietary FBCR) prepared with either FBCR or lime (control) treatments, were fed to weanling, female rats in three growth and reproduction trials. Intake, growth rate, and composition of body and organs of rats were measured. Rats in one trial were bred, their litters maintained on dietary treatments, and the offspring rebred. Treatment (FBCR vs. lime) x diet interactions on food composition and animal responses generally were not significant. Treatment had little effect on element composition of diets; mineral concentrations were in normal ranges. Diet treatment with FBCR depressed (P<0.01) food intake and growth of rats in one trial, but not in others, and had no effect (P<0.05) on body water, protein, ether extract, or gross energy composition. Some differences in element concentrations in the carcass and organs of rats and pups resulted from FBCR treatment, but effects were small and inconsistent. Litters from the first reproductive cycle appeared normal, except for animals fed the chicken + dietary FBCR treatment, on which pups showed poor growth and anemia. Offspring from certain diets were rebred and litters showed a high mortality, although this was not associated specifically with FBCR treatment. Results indicated no major detrimental effects on food composition, or growth, tissue element accumulation, and reproduction in the rat relating to use of FBCR as a soil amendment. 20 refs., 9 tabs.

Cognitive behavioural therapy versus multidisciplinary rehabilitation treatment for patients with chronic fatigue syndrome: study protocol for a randomised controlled trial (FatiGo).

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Vos-Vromans, Desirée C W M; Smeets, Rob J E M; Rijnders, Leonie J M; Gorrissen, René R M; Pont, Menno; Köke, Albère J A; Hitters, Minou W M G C; Evers, Silvia M A A; Knottnerus, André J

2012-05-30

Patients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to overcome their fatigue. Although there is no consensus, cognitive behavioural therapy is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment, a combination of cognitive behavioural therapy with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between multidisciplinary rehabilitation treatment and cognitive behavioural therapy is as yet unknown. The FatiGo (Fatigue-Go) trial aims to compare the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life in patients with chronic fatigue syndrome. One hundred twenty patients who meet the criteria of chronic fatigue syndrome, fulfil the inclusion criteria and sign the informed consent form will be recruited. Both treatments take 6 months to complete. The outcome will be assessed at 6 and 12 months after the start of treatment. Two weeks after the start of treatment, expectancy and credibility will be measured, and patients will be asked to write down their personal goals and score their current performance on these goals on a visual analogue scale. At 6 and 14 weeks after the start of treatment, the primary outcome and three potential mediators-self-efficacy, causal attributions and present-centred attention-awareness-will be measured. Primary outcomes are fatigue severity and quality of life. Secondary outcomes are physical activity, psychological symptoms, self-efficacy, causal attributions, impact of disease on emotional and physical functioning, present-centred attention-awareness, life satisfaction, patient personal goals, self-rated improvement

A randomized trial comparing treatments for varicose veins.

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Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; Francis, Jill; Tassie, Emma; Scotland, Graham; Wileman, Samantha; Campbell, Marion K

2014-09-25

Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain. In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success. After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (Pdisease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

Suicidal Behavior Among People Living with HIV (PLHIV) in Medical Care in Estonia and Factors Associated with Receiving Psychological Treatment.

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Lemsalu, Liis; Rüütel, Kristi; Laisaar, Kaja-Triin; Lõhmus, Liilia; Raidvee, Aire; Uusküla, Anneli

2017-06-01

People living with HIV (PLHIV) have higher rates of suicidal behavior than the general population. This study assessed suicidal behavior (ideation and/or attempts, ever and in the past 12 months) among PLHIV receiving outpatient HIV medical care in Estonia and associations between suicidal behavior and psychological treatment. The cross-sectional study collected data from January to November 2013 using a self-report questionnaire. Eight hundred PLHIV participated, 39 % (n = 306) of whom had been suicidal. Lifetime prevalence was 36 % for suicidal ideation and 20 % for attempts. Younger age, incarceration, having ever abused alcohol and also injected drugs, having lived with HIV for more than 10 years, and being depressed were associated with lifetime suicidal behavior. Suicidal behavior within the past 12 months was reported by 20 % (n = 156) of respondents. Of these, 27 % received psychological treatment (counseling and/or psychotherapy), 20 % had taken antidepressants, and 49 % sedatives. Individuals perceiving a need for treatment were significantly more likely to receive psychological treatment when experiencing suicidal behavior (OR 25.65, 95 % CI 2.92-225.47). In conclusion, suicidal behavior is frequent among PLHIV but psychological treatment is not often received. One of the barriers to treatment is patients' lack of perceived need for help.

Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus.

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Chew, Boon How; Vos, Rimke C; Metzendorf, Maria-Inti; Scholten, Rob Jpm; Rutten, Guy Ehm

2017-09-27

Many adults with type 2 diabetes mellitus (T2DM) experience a psychosocial burden and mental health problems associated with the disease. Diabetes-related distress (DRD) has distinct effects on self-care behaviours and disease control. Improving DRD in adults with T2DM could enhance psychological well-being, health-related quality of life, self-care abilities and disease control, also reducing depressive symptoms. To assess the effects of psychological interventions for diabetes-related distress in adults with T2DM. We searched the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, BASE, WHO ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was December 2014 for BASE and 21 September 2016 for all other databases. We included randomised controlled trials (RCTs) on the effects of psychological interventions for DRD in adults (18 years and older) with T2DM. We included trials if they compared different psychological interventions or compared a psychological intervention with usual care. Primary outcomes were DRD, health-related quality of life (HRQoL) and adverse events. Secondary outcomes were self-efficacy, glycosylated haemoglobin A1c (HbA1c), blood pressure, diabetes-related complications, all-cause mortality and socioeconomic effects. Two review authors independently identified publications for inclusion and extracted data. We classified interventions according to their focus on emotion, cognition or emotion-cognition. We performed random-effects meta-analyses to compute overall estimates. We identified 30 RCTs with 9177 participants. Sixteen trials were parallel two-arm RCTs, and seven were three-arm parallel trials. There were also seven cluster-randomised trials: two had four arms, and the remaining five had two arms. The median duration of the intervention was six months (range 1 week to 24 months), and the median follow-up period was 12 months (range 0 to 12 months). The trials included a wide spectrum of interventions and were both

A comparison of two treatments for childhood apraxia of speech: methods and treatment protocol for a parallel group randomised control trial

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Murray Elizabeth

2012-08-01

Full Text Available Abstract Background Childhood Apraxia of Speech is an impairment of speech motor planning that manifests as difficulty producing the sounds (articulation and melody (prosody of speech. These difficulties may persist through life and are detrimental to academic, social, and vocational development. A number of published single subject and case series studies of speech treatments are available. There are currently no randomised control trials or other well designed group trials available to guide clinical practice. Methods/Design A parallel group, fixed size randomised control trial will be conducted in Sydney, Australia to determine the efficacy of two treatments for Childhood Apraxia of Speech: 1 Rapid Syllable Transition Treatment and the 2 Nuffield Dyspraxia Programme – Third edition. Eligible children will be English speaking, aged 4–12 years with a diagnosis of suspected CAS, normal or adjusted hearing and vision, and no comprehension difficulties or other developmental diagnoses. At least 20 children will be randomised to receive one of the two treatments in parallel. Treatments will be delivered by trained and supervised speech pathology clinicians using operationalised manuals. Treatment will be administered in 1-hour sessions, 4 times per week for 3 weeks. The primary outcomes are speech sound and prosodic accuracy on a customised 292 item probe and the Diagnostic Evaluation of Articulation and Phonology inconsistency subtest administered prior to treatment and 1 week, 1 month and 4 months post-treatment. All post assessments will be completed by blinded assessors. Our hypotheses are: 1 treatment effects at 1 week post will be similar for both treatments, 2 maintenance of treatment effects at 1 and 4 months post will be greater for Rapid Syllable Transition Treatment than Nuffield Dyspraxia Programme treatment, and 3 generalisation of treatment effects to untrained related speech behaviours will be greater for Rapid

Direct-to-consumer marketing of psychological treatments for anxiety disorders.

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Gallo, Kaitlin P; Comer, Jonathan S; Barlow, David H

2013-12-01

Progress disseminating and implementing evidence-based psychological treatments (EBPTs) for the anxiety disorders has been gradual. To date, the dominant approach for promoting the uptake of EBPTs in clinical settings has been to target the education and training of mental health providers, with many consumers remaining unaware of the potential benefits of EBPTs for anxiety disorders. Direct-to-consumer (DTC) marketing may be a promising vehicle for increasing EBPT utilization rates in the treatment of anxiety disorders. This paper provides an overview of the rationale and important considerations for applying DTC efforts to promote evidence-based care in the treatment of anxiety disorders, and reviews current DTC efforts in this area, including resources on the Internet and other media and in-person events. We conclude with recommendations for future efforts in the DTC marketing of EBPTs for the anxiety disorders, including the need for increased funding and grassroots efforts to inform consumers about anxiety disorders and their most effective treatments. Copyright © 2013 Elsevier Ltd. All rights reserved.

Psilocybin with psychological support improves emotional face recognition in treatment-resistant depression.

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Stroud, J B; Freeman, T P; Leech, R; Hindocha, C; Lawn, W; Nutt, D J; Curran, H V; Carhart-Harris, R L

2018-02-01

Depressed patients robustly exhibit affective biases in emotional processing which are altered by SSRIs and predict clinical outcome. The objective of this study is to investigate whether psilocybin, recently shown to rapidly improve mood in treatment-resistant depression (TRD), alters patients' emotional processing biases. Seventeen patients with treatment-resistant depression completed a dynamic emotional face recognition task at baseline and 1 month later after two doses of psilocybin with psychological support. Sixteen controls completed the emotional recognition task over the same time frame but did not receive psilocybin. We found evidence for a group × time interaction on speed of emotion recognition (p = .035). At baseline, patients were slower at recognising facial emotions compared with controls (p psilocybin, this difference was remediated (p = .208). Emotion recognition was faster at follow-up compared with baseline in patients (p = .004, d = .876) but not controls (p = .263, d = .302). In patients, this change was significantly correlated with a reduction in anhedonia over the same time period (r = .640, p = .010). Psilocybin with psychological support appears to improve processing of emotional faces in treatment-resistant depression, and this correlates with reduced anhedonia. Placebo-controlled studies are warranted to follow up these preliminary findings.

Recent Treatment Advances and New Trials in Adult Nephrotic Syndrome

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Eva Königshausen

2017-01-01

Full Text Available The etiology of nephrotic syndrome is complex and ranges from primary glomerulonephritis to secondary forms. Patients with nephrotic syndrome often need immunosuppressive treatment with its side effects and may progress to end stage renal disease. This review focuses on recent advances in the treatment of primary causes of nephrotic syndrome (idiopathic membranous nephropathy (iMN, minimal change disease (MCD, and focal segmental glomerulosclerosis (FSGS since the publication of the KDIGO guidelines in 2012. Current treatment recommendations are mostly based on randomized controlled trials (RCTs in children, small RCTs, or case series in adults. Recently, only a few new RCTs have been published, such as the Gemritux trial evaluating rituximab treatment versus supportive antiproteinuric and antihypertensive therapy in iMN. Many RCTs are ongoing for iMN, MCD, and FSGS that will provide further information on the effectiveness of different treatment options for the causative disease. In addition to reviewing recent clinical studies, we provide insight into potential new targets for the treatment of nephrotic syndrome from recent basic science publications.

Medicinal plants consumption by patients under psychological treatment in a municipality in Chile

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Rodrigo Ramírez-Tagle

2018-04-01

Full Text Available Context: High levels of mental illness are found today in the population of Chile and the consumption of medicinal herbs could be included in the scope of complementary therapies for the treatment of mental illnesses. In Chile there is no information respect to consumption of medicinal herbs in patients under psychological treatment. Aims: To characterize the consumption of medicinal herbs by patients treated in a mental health clinic. Methods: In this quantitative cross-sectional study (n = 100, patients were administered a closed-response survey to determine the frequency of medicinal plant consumption as complementary treatment and subsequently to characterize such consumption. Results: Among the patients surveyed, 36% consumed medicinal herbs to treat a psychological pathology as a complementary treatment. Among those who consumed medicinal herbs, 65% consumed Cannabis sativa (marijuana either exclusively (42% or in conjunction with other plants (23%, 80% reported that their therapist was aware of this behavior, and 35% consumed medicinal herbs once or twice a day. Conclusions: In the present study, there was significant use of medicinal plants by patients treated at the mental health clinic, especially marijuana consuming. This demonstrates the importance of recognizing citizens´ right to free and equal access to healthcare and acknowledging the responsibility of the state to ensure the safety and quality of the services offered to the population.

Internet-based self-help treatment for depression in multiple sclerosis: study protocol of a randomized controlled trial

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Boeschoten Rosa E

2012-09-01

Full Text Available Abstract Background Depression in MS patients is frequent but often not treated adequately. An important underlying factor may be physical limitations that preclude face-to-face contact. Internet-based treatment showed to be effective for depressive symptoms in general and could thus be a promising tool for treatment in MS. Methods/design Here, we present a study protocol to investigate the effectiveness of a 5 week Internet-based self-help problem solving treatment (PST for depressive symptoms in MS patients in a randomized controlled trial. We aim to include 166 MS patients with moderate to severe depressive symptoms who will be randomly assigned to an Internet-based intervention (with or without supportive text-messages or waiting list control group. The primary outcome is the change in depressive symptoms defined by a change in the sum score on the Beck Depression Inventory (BDI-II. Secondary outcomes will include measures of anxiety, fatigue, cognitive functioning, physical and psychological impact of MS, quality of life, problem solving skills, social support, mastery, satisfaction and compliance rate. Assessments will take place at baseline (T0, within a week after the intervention (T1, at four months (T2 and at ten months follow-up (T3: only the intervention group. The control group will be measured at the same moments in time. Analysis will be based on the intention-to-treat principle. Discussion If shown to be effective, Internet-based PST will offer new possibilities to reach and treat MS patients with depressive symptoms and to improve the quality of care. Trial Registration The Dutch Cochrane Center, NTR2772

The decade 1989-1998 in Spanish psychology: an analysis of research in personality, assessment, and psychological treatment (clinical and health psychology).

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Sanz, J

2001-11-01

The aim of this study is to analyze Spanish research published between 1989 and 1998 in clinical psychology and its most directly related psychological disciplines: personality psychology, psychopathology, differential psychology, health psychology, and psychological assessment. A search was performed in the various databases of the works published in that decade by Spanish university professors who investigate in these areas. Their localization was verified by direct correspondence with the professors, to whom was also sent a questionnaire to evaluate their research field and preferred theoretical approach. The 2,079 works located allowed me to identify 85 different research trends. These research trends are characterized by the predominance of applied studies over basic studies, of empirical research over theoretical research, and of the cognitive-behavioral approach over the rest of the theoretical orientations. In addition, various bibliometrical indicators of production, dissemination, and impact were calculated. They revealed that productivity and dissemination of Spanish research in these areas grew considerably during this 1989-98 period.

Power analysis to detect treatment effects in longitudinal clinical trials for Alzheimer's disease.

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Huang, Zhiyue; Muniz-Terrera, Graciela; Tom, Brian D M

2017-09-01

Assessing cognitive and functional changes at the early stage of Alzheimer's disease (AD) and detecting treatment effects in clinical trials for early AD are challenging. Under the assumption that transformed versions of the Mini-Mental State Examination, the Clinical Dementia Rating Scale-Sum of Boxes, and the Alzheimer's Disease Assessment Scale-Cognitive Subscale tests'/components' scores are from a multivariate linear mixed-effects model, we calculated the sample sizes required to detect treatment effects on the annual rates of change in these three components in clinical trials for participants with mild cognitive impairment. Our results suggest that a large number of participants would be required to detect a clinically meaningful treatment effect in a population with preclinical or prodromal Alzheimer's disease. We found that the transformed Mini-Mental State Examination is more sensitive for detecting treatment effects in early AD than the transformed Clinical Dementia Rating Scale-Sum of Boxes and Alzheimer's Disease Assessment Scale-Cognitive Subscale. The use of optimal weights to construct powerful test statistics or sensitive composite scores/endpoints can reduce the required sample sizes needed for clinical trials. Consideration of the multivariate/joint distribution of components' scores rather than the distribution of a single composite score when designing clinical trials can lead to an increase in power and reduced sample sizes for detecting treatment effects in clinical trials for early AD.

Psychological therapies for post-traumatic stress disorder and comorbid substance use disorder.

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Roberts, Neil P; Roberts, Pamela A; Jones, Neil; Bisson, Jonathan I

2016-04-04

Post-traumatic stress disorder (PTSD) is a debilitating mental health disorder that may develop after exposure to traumatic events. Substance use disorder (SUD) is a behavioural disorder in which the use of one or more substances is associated with heightened levels of distress, clinically significant impairment of functioning, or both. PTSD and SUD frequently occur together. The comorbidity is widely recognised as being difficult to treat and is associated with poorer treatment completion and poorer outcomes than for either condition alone. Several psychological therapies have been developed to treat the comorbidity, however there is no consensus about which therapies are most effective. To determine the efficacy of psychological therapies aimed at treating traumatic stress symptoms, substance misuse symptoms, or both in people with comorbid PTSD and SUD in comparison with control conditions (usual care, waiting-list conditions, and no treatment) and other psychological therapies. We searched the Cochrane Depression, Anxiety and Neurosis Group's Specialised Register (CCDANCTR) all years to 11 March 2015. This register contains relevant randomised controlled trials from the Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). We also searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov, contacted experts, searched bibliographies of included studies, and performed citation searches of identified articles. Randomised controlled trials of individual or group psychological therapies delivered to individuals with PTSD and comorbid substance use, compared with waiting-list conditions, usual care, or minimal intervention or to other psychological therapies. We used standard methodological procedures expected by Cochrane. We included 14 studies with 1506 participants, of which 13 studies were included in the quantitative synthesis. Most studies involved adult

The ADDITION-Cambridge trial protocol: a cluster – randomised controlled trial of screening for type 2 diabetes and intensive treatment for screen-detected patients

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Kinmonth Ann

2009-05-01

accessible through primary care. It addresses the feasibility of population-based screening for diabetes, as well as the benefits and costs of screening and intensive multifactorial treatment early in the disease trajectory. The intensive treatment algorithm is based on evidence from studies including individuals with clinically diagnosed diabetes and the education materials are informed by psychological theory. ADDITION-Cambridge will provide timely evidence concerning the benefits of early intensive treatment and will inform policy decisions concerning screening for type 2 diabetes. Trial registration Current Controlled trials ISRCTN86769081

Improving the reporting of clinical trials of infertility treatments (IMPRINT): modifying the CONSORT statement†‡.

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Legro, Richard S; Wu, Xiaoke; Barnhart, Kurt T; Farquhar, Cynthia; Fauser, Bart C J M; Mol, Ben

2014-10-10

Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and result in a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which create a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant ≥20 weeks gestations) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and during the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and

Effectiveness of chemotherapy counselling on self-esteem and psychological affects among cancer patients in Malaysia: Randomized controlled trial.

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Mohd-Sidik, Sherina; Akhtari-Zavare, Mehrnoosh; Periasamy, Ummavathy; Rampal, Lekhraj; Fadhilah, Siti Irma; Mahmud, Rozi

2018-05-01

The aim of this study was to implement and evaluate the outcomes of chemotherapy counselling based on the "Managing Patients on Chemotherapy" module on self-esteem and psychological affect (anxiety, depression) of cancer patients by pharmacists in ten selected government hospitals in Peninsular Malaysia. A randomized control trial was conducted among 2120 cancer patients from April 2016 to January 2017 in ten selected government hospitals in Peninsular Malaysia. Cancer patients were randomly assigned to intervention and control groups. The intervention group received chemotherapy counselling by pharmacists based on the "Managing Patients on Chemotherapy" module. The outcomes were assessed at baseline, 1st, 2nd and 3rd follow-ups after counselling. In the course of data analysis; independent sample t-test, chi-square and two-way repeated measures ANOVA were conducted. Mean scores of self-esteem in the intervention group had significant difference in comparison with those of the control group in the 1st, 2nd and 3rd follow-ups after counselling (P self-esteem and psychological affect of cancer patients undergoing chemotherapy in Peninsular Malaysia. This module can be used for all Malaysian cancer patients undergoing chemotherapy to improving self-esteem and psychological affect. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Sexual orientation and sexual behavior among Latino and Asian Americans: implications for unfair treatment and psychological distress.

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Chae, David H; Ayala, George

2010-09-01

Research on the sexuality of Asians and Latinos in the United States has been sparse, and the studies that have been done suffer from a number of limitations. Using data from the National Latino and Asian American Study (2002-2003), this study examined self-identified sexual orientation and self-reported sexual behavior among Latinos (n = 2,554; age: M = 38.1, SE = 0.5) and Asians (n = 2,095; age: M = 41.5, SE = 0.8). This study also investigated implications for unfair treatment and psychological distress among sexual minorities identified in the sample. Results indicated heterogeneity in responses to items assessing sexual orientation and sexual behavior including differences in the adoption of lesbian, gay, or bisexual (LGB) identity by gender, ethnicity, nativity, and socioeconomic status. LGB sexual minorities reported higher levels of unfair treatment and psychological distress compared to their non-LGB-identified sexual minority counterparts, and unfair treatment was positively associated with psychological distress. Results highlight the need to consider multiple demographic factors in assessing sexuality, and also suggest that measures of both self-identified sexual orientation and sexual behavior should be collected. In addition, findings provide support for the deleterious influence of unfair treatment among Asians and Latinos in the United States.

Effectiveness of jyoti meditation for patients with chronic neck pain and psychological distress--a randomized controlled clinical trial.

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Jeitler, Michael; Brunnhuber, Stefan; Meier, Larissa; Lüdtke, Rainer; Büssing, Arndt; Kessler, Christian; Michalsen, Andreas

2015-01-01

Chronic neck pain is a common medical complaint partly mediated by psychosocial distress and having a high socioeconomic impact. There is preliminary evidence that stress reduction by meditation might be beneficial in chronic pain syndromes. We aimed to evaluate the effectiveness of an 8-week meditation program (jyoti meditation) in patients with chronic neck pain by means of a randomized clinical trial. Eighty-nine patients (aged 49.7 ± 10.5 years, 73 female) with chronic neck pain who scored >40 mm on a 100-mm visual analog scale and had concomitant increased perceived stress were randomized to an 8-week meditation program (jyoti meditation) with weekly 90-minute classes (n = 45) or to a home-based exercise program (n = 44) with a wait list offer for meditation. Both groups were instructed to practice at home. Outcomes were assessed at baseline and after 8 weeks. Primary outcome measure was change of mean pain at rest (visual analog scale score) from baseline to week 8. Secondary outcomes included pain at motion, functional disability, pain-related bothersomeness, perceived stress, quality of life, and psychological outcomes. Patients had neck pain for a mean of 11 years. Eighteen patients in the meditation group and 16 patients in the exercise group were lost to follow-up. Meditation training significantly reduced pain when compared to the exercise group after 8 weeks (reduction of 45.5 ± 23.3 mm to 21.6 ± 17.2 mm in the meditation group, and 43.8 ± 22.0 mm to 37.7 ± 21.5 mm in the exercise group; mean difference: 13.2 mm [95% confidence interval: 2.1, 24.4; P = .02]). Pain-related bothersomeness decreased more in the meditation group (group difference 11.0 mm [95% confidence interval: 1.0, 21.0; P = .03]). No significant treatment effects were found for pain at motion, psychological scores, and quality of life, although the meditation group showed nonsignificant greater improvements compared to the exercise group. In conclusion

Faith-adapted psychological therapies for depression and anxiety: Systematic review and meta-analysis.

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Anderson, Naomi; Heywood-Everett, Suzanne; Siddiqi, Najma; Wright, Judy; Meredith, Jodi; McMillan, Dean

2015-05-01

Incorporating faith (religious or spiritual) perspectives into psychological treatments has attracted significant interest in recent years. However, previous suggestion that good psychiatric care should include spiritual components has provoked controversy. To try to address ongoing uncertainty in this field we present a systematic review and meta-analysis to assess the efficacy of faith-based adaptations of bona fide psychological therapies for depression or anxiety. A systematic review and meta-analysis of randomised controlled trials were performed. The literature search yielded 2274 citations of which 16 studies were eligible for inclusion. All studies used cognitive or cognitive behavioural models as the basis for their faith-adapted treatment (F-CBT). We identified statistically significant benefits of using F-CBT. However, quality assessment using the Cochrane risk of bias tool revealed methodological limitations that reduce the apparent strength of these findings. Whilst the effect sizes identified here were statistically significant, there were relatively a few relevant RCTs available, and those included were typically small and susceptible to significant biases. Biases associated with researcher or therapist allegiance were identified as a particular concern. Despite some suggestion that faith-adapted CBT may out-perform both standard CBT and control conditions (waiting list or "treatment as usual"), the effect sizes identified in this meta-analysis must be considered in the light of the substantial methodological limitations that affect the primary research data. Before firm recommendations about the value of faith-adapted treatments can be made, further large-scale, rigorously performed trials are required. Copyright © 2015 Elsevier B.V. All rights reserved.

The Virtual Anemia Trial: An Assessment of Model-Based In Silico Clinical Trials of Anemia Treatment Algorithms in Patients With Hemodialysis.

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Fuertinger, Doris H; Topping, Alice; Kappel, Franz; Thijssen, Stephan; Kotanko, Peter

2018-04-01

In silico approaches have been proposed as a novel strategy to increase the repertoire of clinical trial designs. Realistic simulations of clinical trials can provide valuable information regarding safety and limitations of treatment protocols and have been shown to assist in the cost-effective planning of clinical studies. In this report, we present a blueprint for the stepwise integration of internal, external, and ecological validity considerations in virtual clinical trials (VCTs). We exemplify this approach in the context of a model-based in silico clinical trial aimed at anemia treatment in patients undergoing hemodialysis (HD). Hemoglobin levels and subsequent anemia treatment were simulated on a per patient level over the course of a year and compared to real-life clinical data of 79,426 patients undergoing HD. The novel strategies presented here, aimed to improve external and ecological validity of a VCT, significantly increased the predictive power of the discussed in silico trial. © 2018 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Frequent attenders in general practice: problem solving treatment provided by nurses [ISRCTN51021015

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van Oppen P

2005-10-01

Full Text Available Abstract Background There is a need for assistance from primary care mental health workers in general practice in the Netherlands. General practitioners (GPs experience an overload of frequent attenders suffering from psychological problems. Problem Solving Treatment (PST is a brief psychological treatment tailored for use in a primary care setting. PST is provided by nurses, and earlier research has shown that it is a treatment at least as effective as usual care. However, research outcomes are not totally satisfying. This protocol describes a randomized clinical trial on the effectiveness of PST provided by nurses for patients in general practice. The results of this study, which currently being carried out, will be presented as soon as they are available. Methods/design This study protocol describes the design of a randomized controlled trial to investigate the effectiveness and cost-effectiveness of PST and usual care compared to usual care only. Patients, 18 years and older, who present psychological problems and are frequent attenders in general practice are recruited by the research assistant. The participants receive questionnaires at baseline, after the intervention, and again after 3 months and 9 months. Primary outcome is the reduction of symptoms, and other outcomes measured are improvement in problem solving skills, psychological and physical well being, daily functioning, social support, coping styles, problem evaluation and health care utilization. Discussion Our results may either confirm that PST in primary care is an effective way of dealing with emotional disorders and a promising addition to the primary care in the UK and USA, or may question this assumption. This trial will allow an evaluation of the effects of PST in practical circumstances and in a rather heterogeneous group of primary care patients. This study delivers scientific support for this use and therefore indications for optimal treatment and referral.

The ANKLE TRIAL (ANKLE treatment after injuries of the ankle ligaments: what is the benefit of external support devices in the functional treatment of acute ankle sprain? : a randomised controlled trial

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Witjes Suzanne

2012-02-01

Full Text Available Abstract Background Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises. Methods/design This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180 with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales, number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year. Discussion The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain. Trial registration Netherlands Trial Register (NTR: NTR2151

The ANKLE TRIAL (ANKLE treatment after injuries of the ankle ligaments): what is the benefit of external support devices in the functional treatment of acute ankle sprain? : a randomised controlled trial

Science.gov (United States)

2012-01-01

Background Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises. Methods/design This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180) with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales), number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year. Discussion The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain. Trial registration Netherlands Trial Register (NTR): NTR2151 PMID:22340371

Psychological correlates of sexual dysfunction in female rectal and anal cancer survivors: analysis of baseline intervention data.

Science.gov (United States)

Philip, Errol J; Nelson, Christian; Temple, Larissa; Carter, Jeanne; Schover, Leslie; Jennings, Sabrina; Jandorf, Lina; Starr, Tatiana; Baser, Ray; DuHamel, Katherine

2013-10-01

Sexual dysfunction represents a complex and multifactorial construct that can affect both men and women and has been noted to often deteriorate significantly after treatment for rectal and anal cancer. Despite this, it remains an understudied, underreported, and undertreated issue in the field of cancer survivorship. This study examined the characteristics of women enrolled in an intervention trial to treat sexual dysfunction, and explored the relationship between sexual functioning and psychological well-being. There were 70 female posttreatment anal or rectal cancer survivors assessed as part of the current study. Participants were enrolled in a randomized intervention trial to treat sexual dysfunction and completed outcome measures prior to randomization. The main outcome measures are quality of life (QOL) (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC-QLQ-C30] and Colorectal Cancer-Specific Module [QLQ-CR38]), sexual functioning (Female Sexual Functioning Index), and psychological well-being (Brief Symptom Inventory Depression/Anxiety, Impact of Events Scale-Revised, CR-38 Body Image). Women enrolled in the study intervention were on average 55 years old, predominantly Caucasian (79%), married (57%), and a median of 4 years postprimary treatment. For those reporting sexual activity at baseline (N=41), sexual dysfunction was associated with a range of specific measures of psychological well-being, all in the hypothesized direction. The Sexual/Relationship Satisfaction subscale was associated with all measures of psychological well-being (r=-0.45 to -0.70, all Psexual functioning, while a global QOL measure was largely unrelated. For sexually active female rectal and anal cancer survivors enrolled in a sexual health intervention, sexual dysfunction was significantly and consistently associated with specific measures of psychological well-being, most notably Sexual/Relationship Satisfaction. These results

Tai Chi on psychological well-being: systematic review and meta-analysis

Directory of Open Access Journals (Sweden)

Scott Tammy

2010-05-01

Full Text Available Abstract Background Physical activity and exercise appear to improve psychological health. However, the quantitative effects of Tai Chi on psychological well-being have rarely been examined. We systematically reviewed the effects of Tai Chi on stress, anxiety, depression and mood disturbance in eastern and western populations. Methods Eight English and 3 Chinese databases were searched through March 2009. Randomized controlled trials, non-randomized controlled studies and observational studies reporting at least 1 psychological health outcome were examined. Data were extracted and verified by 2 reviewers. The randomized trials in each subcategory of health outcomes were meta-analyzed using a random-effects model. The quality of each study was assessed. Results Forty studies totaling 3817 subjects were identified. Approximately 29 psychological measurements were assessed. Twenty-one of 33 randomized and nonrandomized trials reported that 1 hour to 1 year of regular Tai Chi significantly increased psychological well-being including reduction of stress (effect size [ES], 0.66; 95% confidence interval [CI], 0.23 to 1.09, anxiety (ES, 0.66; 95% CI, 0.29 to 1.03, and depression (ES, 0.56; 95% CI, 0.31 to 0.80, and enhanced mood (ES, 0.45; 95% CI, 0.20 to 0.69 in community-dwelling healthy participants and in patients with chronic conditions. Seven observational studies with relatively large sample sizes reinforced the beneficial association between Tai Chi practice and psychological health. Conclusions Tai Chi appears to be associated with improvements in psychological well-being including reduced stress, anxiety, depression and mood disturbance, and increased self-esteem. Definitive conclusions were limited due to variation in designs, comparisons, heterogeneous outcomes and inadequate controls. High-quality, well-controlled, longer randomized trials are needed to better inform clinical decisions.

Psychological interventions for acute pain after open heart surgery.

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Ziehm, Susanne; Rosendahl, Jenny; Barth, Jürgen; Strauss, Bernhard M; Mehnert, Anja; Koranyi, Susan

2017-07-12

This is an update of a Cochrane review previously published in 2014. Acute postoperative pain is one of the most disturbing complaints in open heart surgery, and is associated with a risk of negative consequences. Several trials investigated the effects of psychological interventions to reduce acute postoperative pain and improve the course of physical and psychological recovery of participants undergoing open heart surgery. To compare the efficacy of psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention control in adults undergoing open heart surgery for pain, pain medication, psychological distress, mobility, and time to extubation. For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and PsycINFO for eligible studies up to February 2017. We used the 'related articles' and 'cited by' options of eligible studies to identify additional relevant studies. We checked lists of references of relevant articles and previous reviews. We searched the ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and the WHO International Clinical Trials Registry Platform to identify any unpublished material or ongoing trials. We also contacted the authors of primary studies to identify any unpublished material. In addition, we wrote to all leading heart centres in Germany, Switzerland, and Austria to check whether they were aware of any ongoing trials. Randomised controlled trials comparing psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention in adults undergoing open heart surgery. Two review authors (SZ and SK) independently assessed trials for eligibility, estimated the risk of bias and extracted all data. We calculated effect sizes for each comparison (Hedges' g) and meta-analysed data using a random-effects model. We assessed the evidence using GRADE and created

The optimization of treatment and management of schizophrenia in Europe (OPTiMiSE) trial

DEFF Research Database (Denmark)

Leucht, Stefan; Winter-van Rossum, Inge; Heres, Stephan

2015-01-01

Commission sponsored "Optimization of Treatment and Management of Schizophrenia in Europe" (OPTiMiSE) trial which aims to provide a treatment algorithm for patients with a first episode of schizophrenia. METHODS: We searched Pubmed (October 29, 2014) for randomized controlled trials (RCTs) that examined...... switching the drug in nonresponders to another antipsychotic. We described important methodological choices of the OPTiMiSE trial. RESULTS: We found 10 RCTs on switching antipsychotic drugs. No trial was conclusive and none was concerned with first-episode schizophrenia. In OPTiMiSE, 500 first episode...

Psychological, pharmacological, and combined smoking cessation interventions for smokers with current depression: A systematic review and meta-analysis.

Directory of Open Access Journals (Sweden)

Roberto Secades-Villa

Full Text Available We conducted a systematic literature review and meta-analysis (ID: CRD42016051017 of smoking cessation interventions for patients with current depression. We examined the effectiveness of smoking cessation treatments in improving abstinence rates and depressive symptoms. The following electronic databases were used for potentially eligible studies: PUBMED, PSYCINFO, DIALNET and WEB OF KNOWLEDGE. The search terms used were: smoking cessation, depressive disorder, depression, mood, depressive, depressed, smoking, smokers, nicotine, nicotine dependence, and tobacco cigarette smoking. The methodological quality of included studies was assessed using the Effective Public Health Practice Project Quality assessment tool (EPHPP. Of the 6,584 studies identified, 20 were eligible and included in the review. Trial designs of studies were 16 randomized controlled trials and 4 secondary studies. Studies included three types of intervention: psychological (6/30%, pharmacological (6/30% or combined (8/40%. Four trials comprised special populations of smokers. Four studies received a strong methodological quality, 7 were scored as moderate and 9 studies received a weak methodological rating. Analyses of effectiveness showed that smoking cessation interventions appear to increase short-term and long-term smoking abstinence in individuals with current depression. Subgroup analyses revealed stronger effects among studies that provided pharmacological treatments than in studies using psychological treatments. However, the evidence is weak due to the small number of studies. Smoking abstinence appears to be associated with an improvement in depressive symptoms. Heterogeneity in protocols in similar types of treatment also prevent firm conclusions being drawn on the effectiveness of any particular treatment model to optimally manage abstinence among depressed smokers. Further research is required to strengthen the evidence base.

Prevention and treatment of long-term social disability amongst young people with emerging severe mental illness with social recovery therapy (The PRODIGY Trial): study protocol for a randomised controlled trial.

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Fowler, David; French, Paul; Banerjee, Robin; Barton, Garry; Berry, Clio; Byrne, Rory; Clarke, Timothy; Fraser, Rick; Gee, Brioney; Greenwood, Kathryn; Notley, Caitlin; Parker, Sophie; Shepstone, Lee; Wilson, Jon; Yung, Alison R; Hodgekins, Joanne

2017-07-11

Young people who have social disability associated with severe and complex mental health problems are an important group in need of early intervention. Their problems often date back to childhood and become chronic at an early age. Without intervention, the long-term prognosis is often poor and the economic costs very large. There is a major gap in the provision of evidence-based interventions for this group, and therefore new approaches to detection and intervention are needed. This trial provides a definitive evaluation of a new approach to early intervention with young people with social disability and severe and complex mental health problems using social recovery therapy (SRT) over a period of 9 months to improve mental health and social recovery outcomes. This is a pragmatic, multi-centre, single blind, superiority randomised controlled trial. It is conducted in three sites in the UK: Sussex, Manchester and East Anglia. Participants are aged 16 to 25 and have both persistent and severe social disability (defined as engaged in less than 30 hours per week of structured activity) and severe and complex mental health problems. The target sample size is 270 participants, providing 135 participants in each trial arm. Participants are randomised 1:1 using a web-based randomisation system and allocated to either SRT plus optimised treatment as usual (enhanced standard care) or enhanced standard care alone. The primary outcome is time use, namely hours spent in structured activity per week at 15 months post-randomisation. Secondary outcomes assess typical mental health problems of the group, including subthreshold psychotic symptoms, negative symptoms, depression and anxiety. Time use, secondary outcomes and health economic measures are assessed at 9, 15 and 24 months post-randomisation. This definitive trial will be the first to evaluate a novel psychological treatment for social disability and mental health problems in young people presenting with social

Time Course of Leptin in Patients with Anorexia Nervosa during Inpatient Treatment: Longitudinal Relationships to BMI and Psychological Factors.

Directory of Open Access Journals (Sweden)

Esther Stroe-Kunold

Full Text Available Leptin, a hormone secreted by adipose tissue, appears to play a major role in the homeostasis of body weight and psychobiological processes associated with anorexia nervosa (AN. However, there is scarce data on its exact influence on this disorder, in particular data over time.The present study addresses whether leptin changes during inpatient treatment play a role for treatment outcome and psychological factors in underweight AN patients.In order to understand whether leptin's role differs in relation to AN severity, data were assessed from 11 patients with a very low BMI and a higher chronicity (high severity group; HSS; mean BMI at the beginning of the study = 13.6; mean duration of illness = 5.1 years vs. nine with less severe symptoms (LSS; mean BMI = 16.2; mean duration of illness = 3.7 years. During the course of treatment, serum leptin concentrations were assessed weekly while weight (BMI was assessed twice per week. Concomitantly, psychological variables were obtained by means of electronic diaries. Unconditional linear growth models were calculated to evaluate the temporal course of leptin in relation to BMI. For HSS patients, two phases of treatment (BMI < 16 and BMI ≥ 16 kg/m2 were investigated.Leptin increased significantly with BMI in both groups of patients. For HSS patients, the increase of leptin in the first treatment phase did not predict later increases in BMI. Furthermore, the relationship of leptin and psychological factors was modulated by symptom severity. In HSS patients, higher leptin levels were associated with greater feelings of depression, anxiety, and stress whereas in LSS patients a higher leptin level showed the trend to be associated with lower psychological symptom burden.Our results suggest that leptin changes are differently associated with weight gain and psychological symptoms depending on the severity of starvation.

Psychological counselling in problematic diabetes

DEFF Research Database (Denmark)

Snoek, F. J.; Skinner, T. C.

2002-01-01

-destructive behaviour, but future research should substantiate these preliminary findings. Behaviour family therapy proved beneficial in terms of resolving family conflicts, but did not impact glycaemic control. Conclusions: Evidence to support the effect of psychological treatment in problematic diabetes is still......Background: In past decades clinicians have increasingly recognized the importance of psychological support for people with diabetes and their families, and many have recommended integrating psychological counselling into routine diabetes care. It is therefore important to consider whether...... psychological interventions in diabetes are effective in improving clinical outcomes. Methods: This review was limited to the literature reporting on the treatment of five common psychological problems known to complicate diabetes management: depression, eating disorders, anxiety/stress, self...

Psychological effects of nuclear warfare

International Nuclear Information System (INIS)

Mickley, G.A.

1987-01-01

This report is divided into five parts. (1) Discussion of the psychological milieu before a nuclear confrontation. (2) Acute psychological reactions to nuclear warfare (some of which may reflect, in part, direct radiogenic alteration of nervous system functions). (3) Chronic psychological effects of a nuclear confrontation. (4) Issues concerning treatment of these psychological changes. (5) Prevention of adverse psychological reactions to nuclear warfare

The Influence of Causal Explanations and Diagnostic Labeling on Psychology Students' Beliefs About Treatments, Prognosis, Dangerousness and Unpredictability in Schizophrenia.

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Magliano, Lorenza; Read, John; Rinaldi, Angela; Costanzo, Regina; De Leo, Renata; Schioppa, Giustina; Petrillo, Miriam

2016-04-01

This study explored views of 566 Italian psychology students about schizophrenia. The most frequently cited causes were psychological traumas (68 %) and heredity (54 %). Thirty-three percent of students firmly believed that people with the condition could recover. Reporting heredity among the causes, and identifying schizophrenia were both associated with prognostic pessimism, greater confidence in pharmacological treatments and lower confidence in psychological treatments. Schizophrenia labeling was also associated with higher perception of unpredictability and dangerousness. Compared to first year students, fourth/fifth year students more frequently reported heredity among the causes, and were more pessimistic about schizophrenia recovery. Stigma topics should be included in future psychologists' education.

One-stage individual participant data meta-analysis models: estimation of treatment-covariate interactions must avoid ecological bias by separating out within-trial and across-trial information.

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Hua, Hairui; Burke, Danielle L; Crowther, Michael J; Ensor, Joie; Tudur Smith, Catrin; Riley, Richard D

2017-02-28

Stratified medicine utilizes individual-level covariates that are associated with a differential treatment effect, also known as treatment-covariate interactions. When multiple trials are available, meta-analysis is used to help detect true treatment-covariate interactions by combining their data. Meta-regression of trial-level information is prone to low power and ecological bias, and therefore, individual participant data (IPD) meta-analyses are preferable to examine interactions utilizing individual-level information. However, one-stage IPD models are often wrongly specified, such that interactions are based on amalgamating within- and across-trial information. We compare, through simulations and an applied example, fixed-effect and random-effects models for a one-stage IPD meta-analysis of time-to-event data where the goal is to estimate a treatment-covariate interaction. We show that it is crucial to centre patient-level covariates by their mean value in each trial, in order to separate out within-trial and across-trial information. Otherwise, bias and coverage of interaction estimates may be adversely affected, leading to potentially erroneous conclusions driven by ecological bias. We revisit an IPD meta-analysis of five epilepsy trials and examine age as a treatment effect modifier. The interaction is -0.011 (95% CI: -0.019 to -0.003; p = 0.004), and thus highly significant, when amalgamating within-trial and across-trial information. However, when separating within-trial from across-trial information, the interaction is -0.007 (95% CI: -0.019 to 0.005; p = 0.22), and thus its magnitude and statistical significance are greatly reduced. We recommend that meta-analysts should only use within-trial information to examine individual predictors of treatment effect and that one-stage IPD models should separate within-trial from across-trial information to avoid ecological bias. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd

Effect of chemotherapy counseling by pharmacists on quality of life and psychological outcomes of oncology patients in Malaysia: a randomized control trial.

Science.gov (United States)

Periasamy, Ummavathy; Mohd Sidik, Sherina; Rampal, Lekhraj; Fadhilah, Siti Irma; Akhtari-Zavare, Mehrnoosh; Mahmud, Rozi

2017-05-15

Cancer is now becoming a leading cause of death. Chemotherapy is an important treatment for cancer patients. These patients also need consultation during their treatment to improve quality of life and decrease psychological disorders. The objectives of the study were to develop, implement and evaluate the effectiveness of a chemotherapy counseling module by pharmacists among oncology patients on their quality of life and psychological outcomes in Malaysia. A single-blind randomized controlled trial was carried out among 162 oncology patients undergoing chemotherapy from July 2013 to February 2014 in a government hospital with oncology facilities in Malaysia. Participants were randomized to either the intervention group or the control group. Chemotherapy counseling using the module on 'Managing Patients on Chemotherapy' by Pharmacists was delivered to the intervention group. The outcome measures were assessed at baseline, first follow-up and second follow-up and third follow-up post-intervention. Chi-square, independent samples t-test and two-way repeated measures ANOVA were conducted in the course of the data analyses. In assessing the impact of the chemotherapy counseling module, the study revealed that the module along with repetitive counseling showed significant improvement of quality of life in the intervention group as compared to the control group with a large effect size in physical health (p = 0.001, partial Ƞ 2  = 0.66), psychological (p = 0.001, partial Ƞ 2  = 0.65), social relationships (p = 0.001, partial Ƞ 2  = 0.30), and environment (p = 0.001, partial Ƞ 2  = 0.67) and decrease in the anxiety (p = 0.000; partial Ƞ 2  = 0.23), depression (p = 0.000; partial Ƞ 2  = 0.40). The module on 'Managing Patients on Chemotherapy' along with repetitive counseling by pharmacists has been shown to be effective in improving quality of life and decreasing anxiety and depression among oncology patients undergoing chemotherapy

Socioeconomic and psychological impact of treatment for unilateral intraocular retinoblastoma.

Science.gov (United States)

Soliman, S E; Dimaras, H; Souka, A A; Ashry, M H; Gallie, B L

2015-06-01

To identify the socioeconomic and psychosocial impacts of clinical treatment decisions for advanced unilateral intraocular retinoblastoma. Retrospective observational case series. institutional study at Alexandria Main University Hospital. records of 66 unilateral retinoblastoma cases treated from May 2005 to May 2013 were retrospectively reviewed. Sixty cases were eligible (International Intraocular Retinoblastoma Classification [IIRC] group C, D or E). two treatment groups were compared: enucleation vs. salvage treatment. Salvage treatment eyes were further subdivided based on IIRC group. Six socioeconomic parameters (financial burden, financial impact, psychological, social, medical and tumor impacts) were scored. Parameter scores ranged from 0 to 3, for overall score range 0 (no adverse impact) to 18 (severe adverse impact). derived Socioeconomic scores were correlated with treatment and outcomes. The enucleation group (28 eyes) had a median overall Socioeconomic score of 4/18, significantly lower than the salvage treatment group (32 eyes), median score 11/18 (PSocioeconomic score varied with IIRC group. Attempted eye salvage failed in 25 children, due to uncontrolled tumor (44%) and socioeconomic impact of cumulative therapies (56%). Treatment duration and Socioeconomic score were higher for the 5 children in the salvage treatment group who developed metastatic disease compared to those without metastasis (Psocioeconomic and psychosocial impacts of attempted ocular salvage for unilateral intraocular retinoblastoma are severe, in comparison to primary enucleation. Primary enucleation is a good treatment for unilateral retinoblastoma. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Drug trajectories among youth undergoing treatment: the influence of psychological problems and delinquency.

Science.gov (United States)

Brunelle, Natacha; Bertrand, Karine; Beaudoin, Isabelle; Ledoux, Cinthia; Gendron, Annie; Arseneault, Catherine

2013-08-01

Previous research has documented associations of addiction with delinquency and psychological problems. However, few studies have evaluated their influence on adolescent's drug use trajectories. The current study aims to examine the influence of these factors on the recovery trajectories of 199 youths aged 15.6 years on average admitted to inpatient and outpatient addiction treatment centers, followed up three and six months later. Results indicate that youth who show higher severity of drug abuse exhibit greater improvement than youth with a lower severity of drug abuse at the onset of treatment. Although psychological problems were associated with baseline drug use, they did not influence drug use trajectory over time. Only delinquency influenced the recovery trajectories of these youth. Results suggest that a high level of delinquency can have a significant effect on the drug recovery process of adolescents and that interventions should attempt to reduce both drug use and delinquency. Copyright © 2013 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

Smartphone-based ecological momentary assessment and intervention in a coping-focused intervention for hearing voices (SAVVy): study protocol for a pilot randomised controlled trial.

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Bell, Imogen H; Fielding-Smith, Sarah F; Hayward, Mark; Rossell, Susan L; Lim, Michelle H; Farhall, John; Thomas, Neil

2018-05-02

Smartphone-based ecological momentary assessment and intervention (EMA/I) show promise for enhancing psychological treatments for psychosis. EMA has the potential to improve assessment and formulation of experiences which fluctuate day-to-day, and EMI may be used to prompt use of therapeutic strategies in daily life. The current study is an examination of these capabilities in the context of a brief, coping-focused intervention for distressing voice hearing experiences. This is a rater-blinded, pilot randomised controlled trial comparing a four-session intervention in conjunction with use of smartphone EMA/I between sessions, versus treatment-as-usual. The recruitment target is 34 participants with persisting and distressing voice hearing experiences, recruited through a Voices Clinic based in Melbourne, Australia, and via wider advertising. Allocation will be made using minimisation procedure, balancing of the frequency of voices between groups. Assessments are completed at baseline and 8 weeks post-baseline. The primary outcomes of this trial will focus on feasibility and acceptability of the intervention and trial methodology, with secondary outcomes examining preliminary clinical effects related to overall voice severity, the emotional and functional impact of the voices, and emotional distress. This study offers a highly novel examination of specific smartphone capabilities and their integration with traditional psychological treatment for distressing voices. Such technology has potential to enhance psychological interventions and promote adaptation to distressing experiences. Australian New Zealand Clinical Trial Registry, ACTRN12617000348358 . Registered on 7 March 2017.

Diet and psychological health.

Science.gov (United States)

Miller, M

1996-09-01

This article reviews research that suggests a relationship between diet and psychological symptoms. Mind-body dualism (as it relates to clinical practice) and the limited role of nutrition in mainstream biomedical training and treatment are discussed as background issues. Two areas of inquiry that have generated relevant research findings in this area are reviewed: (1) orthomolecular theory and vitamin deficiencies, and (2) clinical ecology/environmental medicine theory and the impact of "food allergies." Although clinical case reports and promising research findings have been reported, the impact of diet on psychological health is neither widely accepted nor integrated into mental health treatment methods. Ongoing research findings in brain biochemistry and psychoneuroimmunology point to communication pathways that can provide a clearer understanding of the links between nutritional intake, central nervous system and immune function, and psychological health status. These findings may lead to greater acceptance of dietary treatment approaches among health practitioners addressing psychological disorders.

Efficacy of home-based non-pharmacological interventions for treating depression: a systematic review and network meta-analysis of randomised controlled trials.

Science.gov (United States)

Sukhato, Kanokporn; Lotrakul, Manote; Dellow, Alan; Ittasakul, Pichai; Thakkinstian, Ammarin; Anothaisintawee, Thunyarat

2017-07-12

To systematically review and compare the efficacy of all available home-based non-pharmacological treatments of depression. Systematic review and network meta-analysis of randomised controlled trials. Medline, Scopus and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases were searched since inceptions to 7 August 2016. Randomised controlled trials comparing the efficacy of home-based non-pharmacological interventions with usual care of patients with depression were included in the review. Depression symptom scores and disease remission rates at the end of treatment. Seventeen studies were included in the review. Home-based non-pharmacological interventions were categorised as (1) home-based psychological intervention, (2) home-based exercise intervention, (3) combined home-based psychological intervention with exercise intervention and (4) complementary medicine. Complementary medicine approaches were excluded from the meta-analysis due to heterogeneity. The standardised mean differences of post-treatment depression symptom scores between usual care groups and home-based psychological intervention, home-based exercise intervention and combined home-based psychological intervention with exercise intervention were âˆ'0.57 (95% CI âˆ'0.84 to âˆ'0.31), âˆ'1.03 (95% CI âˆ'2.89 to 0.82) and âˆ'0.78 (95% CI âˆ'1.09 to âˆ'0.47), respectively. These results suggest that only home-based psychological intervention and combined home-based psychological intervention with exercise intervention could significantly decrease depression scores. Compared with usual care groups, the disease remission rate was also significantly higher for home-based psychological intervention (pooled risk ratio=1.53; 95% CI 1.19 to 1.98) and combined home-based psychological intervention with exercise intervention (pooled risk ratio=3.47; 95% CI 2.11 to 5.70). Of all the studied interventions, combined home-based psychological intervention with

Potential psychological & neural mechanisms in binge eating disorder: Implications for treatment.

Science.gov (United States)

Kober, Hedy; Boswell, Rebecca G

2018-03-01

Binge Eating Disorder (BED) is a newly-established eating disorder diagnosis in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Although systematic research on BED is in its infancy and many studies feature small samples, several observations emerge. First, we review diagnostic, developmental, and socio-demographic features of BED. Next, although BED and obesity are linked and frequently co-occur, we review data suggesting that BED is a distinct phenotype. Importantly, we take a mechanism-focused approach and propose four psychological processes with neurobiological bases that may uniquely differentiate BED from obesity: emotion reactivity, food-cue reactivity, food craving, and cognitive control. Further, we propose that interactions between impairments in cognitive control and increased emotional reactivity, food-cue reactivity, and craving may underlie emotion dysregulation and promote binge eating. Consistently, neuroimaging studies point towards neural alterations in the response to rewards and to food specifically, and suggest preliminary links between impaired cognitive-control-related neural activity and binge eating. However, additional systematic work is required in this area. We conclude with a detailed review of treatment approaches to BED; specifically, we suggest that psychological and pharmacological treatments that target core mechanisms - including cognitive control and emotion/craving dysregulation - may be particularly effective. Copyright © 2018 Elsevier Ltd. All rights reserved.

The Mycotic Ulcer Treatment Trial

Science.gov (United States)

Prajna, N. Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Prajna, Lalitha; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E.; Ray, Kathryn J.; Zegans, Michael E.; McLeod, Stephen D.; Porco, Travis C.; Acharya, Nisha R.; Lietman, Thomas M.

2013-01-01

Objective To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. Methods This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. Results A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycin-treated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=−0.18 logMAR; 95% CI, −0.30 to −0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=−0.41 logMAR; 95% CI, −0.61 to −0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=−0.02 logMAR; 95% CI, −0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Conclusions Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Application to Clinical Practice Voriconazole should not be used as monotherapy in filamentous keratitis. Trial Registration

A topographical map approach to representing treatment efficacy: a focus on positive psychology interventions.

Science.gov (United States)

Gorlin, Eugenia I; Lee, Josephine; Otto, Michael W

2018-01-01

A recent meta-analysis by Bolier et al. indicated that positive psychology interventions have overall small to moderate effects on well-being, but results were quite heterogeneous across intervention trials. Such meta-analytic research helps condense information on the efficacy of a broad psychosocial intervention by averaging across many effects; however, such global averages may provide limited navigational guidance for selecting among specific interventions. Here, we introduce a novel method for displaying qualitative and quantitative information on the efficacy of interventions using a topographical map approach. As an initial prototype for demonstrating this method, we mapped 50 positive psychology interventions targeting well-being (as captured in the Bolier et al. [2013] meta-analysis, [Bolier, L., Haverman, M., Westerhof, G. J., Riper, H., Smit, F., & Bohlmeijer, E. (2013). Positive psychology interventions: A meta-analysis of randomized controlled studies. BMC Public Health, 13, 83]). Each intervention domain/subdomain was mapped according to its average effect size (indexed by vertical elevation), number of studies providing effect sizes (indexed by horizontal area), and therapist/client burden (indexed by shading). The geographical placement of intervention domains/subdomains was determined by their conceptual proximity, allowing viewers to gauge the general conceptual "direction" in which promising intervention effects can be found. The resulting graphical displays revealed several prominent features of the well-being intervention "landscape," such as more strongly and uniformly positive effects of future-focused interventions (including, goal-pursuit and optimism training) compared to past/present-focused ones.

Psychological causes of non-compliance with electronically monitored occlusion therapy for amblyopia.

Science.gov (United States)

Loudon, S E; Passchier, J; Chaker, L; de Vos, S; Fronius, M; Harrad, R A; Looman, C W N; Simonsz, B; Simonsz, H J

2009-11-01

To analyse psychological causes for low compliance with occlusion therapy for amblyopia. In a randomised trial, the effect of an educational programme on electronically measured compliance had been assessed. 149 families who participated in this trial completed a questionnaire based on the Protection Motivation Theory after 8 months of treatment. Families with compliance less than 20% of prescribed occlusion hours were interviewed to better understand their cause for non-compliance. Poor compliance was most strongly associated with a high degree of distress (p<0.001), followed by low perception of vulnerability (p = 0.014), increased stigma (p = 0.017) and logistical problems with treatment (p = 0.044). Of 44 families with electronically measured compliance less than 20%, 28 could be interviewed. The interviews confirmed that lack of knowledge, distress and logistical problems resulted in non-compliance. Poor parental knowledge, distress and difficulties implementing treatment seemed to be associated with non-compliance. For the same domains, the scores were more favourable for families who had received the educational programme than for those who had not.

A novel design for randomized immuno-oncology clinical trials with potentially delayed treatment effects

Directory of Open Access Journals (Sweden)

Pei He

2015-10-01

Full Text Available The semi-parametric proportional hazards model is widely adopted in randomized clinical trials with time-to-event outcomes, and the log-rank test is frequently used to detect a potential treatment effect. Immuno-oncology therapies pose unique challenges to the design of a trial as the treatment effect may be delayed, which violates the proportional hazards assumption, and the log-rank test has been shown to markedly lose power under the non-proportional hazards setting. A novel design and analysis approach for immuno-oncology trials is proposed through a piecewise treatment effect function, which is capable of detecting a potentially delayed treatment effect. The number of events required for the trial will be determined to ensure sufficient power for both the overall log-rank test without a delayed effect and the test beyond the delayed period when such a delay exists. The existence of a treatment delay is determined by a likelihood ratio test with resampling. Numerical results show that the proposed design adequately controls the Type I error rate, has a minimal loss in power under the proportional hazards setting and is markedly more powerful than the log-rank test with a delayed treatment effect.

[Role of physical, psychological and sexual abuse in functional digestive disorders. A case-controls trial.].

Science.gov (United States)

Remes-Troche, J M; Cid-Juárez, S; Campos-Ramos, I; Ramos-de la Medina, A; Galmiche, A; Schmulson-Wasserman, M; Roesch-Dietlen, F

2008-01-01

Abuse has been considered a significant factor on the development of functional gastrointestinal disorders (FGID), especially for severe and treatment-refractory patients. The aim of our study was to evaluate the presence of all FGID according to Rome II criteria, in a group of women with history of physical, psychological and/or sexual abuse. A cross sectional study was performed in 96 women (37 +/- 12 years of age) with history of physical, psychological and/or sexual abuse (cases); and 96 open population women (36 +/- 14 years of age) (controls). The following evaluations were administered: Rome II questionnaire, a self-administered instrument to evaluate history of physical (beating), psychological(insults, public humiliation) and/or sexual abuse (rape, coercion), and HAD questionnaire. Among 96 women with history of abuse,91 (95%) reported to have suffered psychological abuse, 72 (75%) physical abuse, and 24 (25%)sexual abuse. Women with history of abuse had a higher prevalence of rumination (6% vs. 0%, p= 0.02), functional heartburn (26% vs. 13%, p =0.04), aerofagia (17% vs. 5%, p = 0.019), irritable bowel syndrome (38% vs. 18%, p = 0.002), fecalin continence (16% vs. 4%, p = 0.01), elevator anisyndrome (5% vs. 0%, p = 0.05), and proctalgia fugax (29% vs. 15%, p = 0.02) compared to controls. There was a positive correlation between anxiety (r = 0.5, p = 0.001) and depression scores(r = 0.45, p = 0.001), and the number of FGID. We demonstrated a high prevalence of FGID among women with history of physical,psychological, and/or sexual abuse. In this association,concomitant anxiety and depression play a significant role.

The effects of a novel psychological attribution and emotional awareness and expression therapy for chronic musculoskeletal pain: A preliminary, uncontrolled trial.

Science.gov (United States)

Burger, Amanda J; Lumley, Mark A; Carty, Jennifer N; Latsch, Deborah V; Thakur, Elyse R; Hyde-Nolan, Maren E; Hijazi, Alaa M; Schubiner, Howard

2016-02-01

Current psychological and behavioral therapies for chronic musculoskeletal pain only modestly reduce pain, disability, and distress. These limited effects may be due to the failure of current therapies: a) to help patients learn that their pain is influenced primarily by central nervous system psychological processes; and b) to enhance awareness and expression of emotions related to psychological trauma or conflict. We developed and conducted a preliminary, uncontrolled test of a novel psychological attribution and emotional awareness and expression therapy that involves an initial individual consultation followed by 4 group sessions. A series of 72 patients with chronic musculoskeletal pain had the intervention and were assessed at baseline, post-treatment, and 6-month follow-up. Participation and satisfaction were high and attrition was low. Intent-to-treat analyses found significant improvements in hypothesized change processes: psychological attributions for pain, emotional awareness, emotional approach coping, and alexithymia. Pain, interference, depression, and distress showed large effect size improvements at post-treatment, which were maintained or even enhanced at 6 months. Approximately two-thirds of the patients improved at least 30% in pain and other outcomes, and one-third of the patients improved 70%. Changes in attribution and emotional processes predicted outcomes. Higher baseline depressive symptoms predicted greater improvements, and outcomes were comparable for patients with widespread vs. localized pain. This novel intervention may lead to greater benefits than available psychological interventions for patients with chronic musculoskeletal pain, but needs controlled testing. Copyright © 2015 Elsevier Inc. All rights reserved.

Forensic psychology and correctional psychology: Distinct but related subfields of psychological science and practice.

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Neal, Tess M S

2018-02-12

This article delineates 2 separate but related subfields of psychological science and practice applicable across all major areas of the field (e.g., clinical, counseling, developmental, social, cognitive, community). Forensic and correctional psychology are related by their historical roots, involvement in the justice system, and the shared population of people they study and serve. The practical and ethical contexts of these subfields is distinct from other areas of psychology-and from one another-with important implications for ecologically valid research and ethically sound practice. Forensic psychology is a subfield of psychology in which basic and applied psychological science or scientifically oriented professional practice is applied to the law to help resolve legal, contractual, or administrative matters. Correctional psychology is a subfield of psychology in which basic and applied psychological science or scientifically oriented professional practice is applied to the justice system to inform the classification, treatment, and management of offenders to reduce risk and improve public safety. There has been and continues to be great interest in both subfields-especially the potential for forensic and correctional psychological science to help resolve practical issues and questions in legal and justice settings. This article traces the shared and separate developmental histories of these subfields, outlines their important distinctions and implications, and provides a common understanding and shared language for psychologists interested in applying their knowledge in forensic or correctional contexts. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Cognitive-behavioral therapy for somatization and symptom syndromes: a critical review of controlled clinical trials.

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Kroenke, K; Swindle, R

2000-01-01

Few treatments for somatization have been proven effective. In the past decade, however, clinical trials of cognitive-behavioral therapy (CBT) have been promising. Our aim was to critically review and synthesize the evidence from these trials. A search of the Medline database from 1966 through July 1999 was conducted to identify controlled trials designed to evaluate the efficacy of CBT in patients with somatization or symptom syndromes. A total of 31 controlled trials (29 randomized and 2 nonrandomized) were identified. Twenty-five studies targeted a specific syndrome (e.g. chronic fatigue, irritable bowel, pain) while 6 focused on more general somatization or hypochondriasis. Primary outcome assessment included physical symptoms, psychological distress and functional status in 28, 26 and 19 studies, respectively. Physical symptoms appeared the most responsive: CBT-treated patients improved more than control subjects in 71% of the studies and showed possibly greater improvement (i.e., a trend) in another 11% of the studies. A definite or possible advantage of CBT for reducing psychological distress was demonstrated in only 38 and 8% of studies, and for improving functional status in 47 and 26%. Group therapy and interventions as brief as 5 sessions proved efficacious. Benefits were sustained for up to 12 months. CBT can be an effective treatment for patients with somatization or symptom syndromes. Benefits can occur whether or not psychological distress is ameliorated. Since chronic symptoms are exceptionally common and most studies were conducted in referral populations, the optimal sequencing of CBT in treating primary care patients and the identification of those most likely to accept and respond to therapy should be further evaluated. Copyright 2000 S. Karger AG, Basel.

A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

Science.gov (United States)

Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

2013-02-08

Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting

Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials

DEFF Research Database (Denmark)

Tulstrup, Morten; Larsen, Hanne Bækgaard; Castor, Anders

2015-01-01

compared to younger children in trials with different toxicity profiles. PROCEDURE: Age-dependent participation rates in three consecutive, randomized childhood leukemia trials conducted by the Nordic Society of Paediatric Haematology and Oncology were evaluated. The ALL2000 dexamethasone/vincristine (Dx...... prospectively registered by the treating physicians. RESULTS: Parents of young children favored treatment intensifications (Dx/VCR: 12% refusal; 6MP: 14%; ASP: 21%), whereas parents of adolescents favored treatment reductions (Dx/VCR: 52% refusal; 6MP: 30%; ASP: 8%). Adolescents were more likely to refuse...... intensification trials than young children (adjusted ORs 6.3; P treatment (adjusted OR for median consolidation length 0.15; P = 0...