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Sample records for psychological treatment trials

  1. Psychological Treatment

    Science.gov (United States)

    ... IBS Pain IBS Global Treatments IBS Diet Low FODMAP Diet Complimentary or Alt Treatments Medications Psychological Treatments ... IBS Pain IBS Global Treatments IBS Diet Low FODMAP Diet Complimentary or Alt Treatments Medications Psychological Treatments ...

  2. Psychological treatment of late-life depression:a meta-analysis of randomized controlled trials

    OpenAIRE

    2006-01-01

    SUMMARY Background Older meta-analyses of the effects of psychological treatments for depression in older adults have found that these treatments have large effects. However, these earlier meta-analyses also included non-randomized studies, and did not include newer high-quality randomized controlled trials. Methods We conducted a meta-analysis of randomized studies on psychological treatments for depression in older adults. Results Twenty-five studies were included, of which 17 compared a ps...

  3. Direct-to-consumer marketing of psychological treatments: A randomized controlled trial.

    Science.gov (United States)

    Gallo, Kaitlin P; Comer, Jonathan S; Barlow, David H; Clarke, Roberta N; Antony, Martin M

    2015-10-01

    Although direct-to-consumer (DTC) marketing of pharmacologic interventions is effective and common, similar approaches have yet to be evaluated in the promotion of psychological treatments (PTs). This is the first randomized controlled trial evaluating the potential of DTC marketing of PTs. Participants (N = 344; 75.0% female, mean age = 18.6 years, 48.5% non-Hispanic White) were randomly assigned to consume one of four extended commercial campaigns embedded within unrelated programming across 3 weeks. The four campaign conditions were a PT campaign, a PT informing about medication side effects campaign, a medication campaign, and a neutral campaign. Attitudes about and intention to seek psychological treatment were assessed prior to campaign exposure (T1), 1 week following the final week of campaign exposure (T2), and at a 3-month follow-up evaluation (T3). The percentage of participants who newly intended psychological treatment at T2 or T3 differed by condition, with those assigned to the PT campaign slightly more likely to have intended to receive psychological treatment at T2 or T3 than those in other conditions. Baseline reports of emotional symptoms moderated the effect of condition on attitudes toward PT and perceived likelihood of seeking treatment in the future. Findings support the preliminary utility of DTC marketing of psychological treatments. Increasing consumer knowledge of PTs may be a worthwhile complement to current dissemination and implementation efforts aimed at promoting the uptake of PTs in mental health care. (c) 2015 APA, all rights reserved).

  4. Baseline Psychological Treatment Reduces the Effect of Coaching in a Randomised Trial of a Depression Self-Care Intervention

    National Research Council Canada - National Science Library

    McCusker, Jane; Cole, Martin; Lambert, Sylvie; Yaffe, Mark; Ciampi, Antonio; Belzile, Eric

    2017-01-01

    Objective: To explore the effects of baseline psychological and antidepressant medication treatment in a trial of lay telephone coaching in a low-intensity, supported depression self-care intervention. Method...

  5. Scientific tools, fake treatments, or triggers for psychological healing: how clinical trial participants conceptualise placebos.

    Science.gov (United States)

    Bishop, Felicity L; Jacobson, Eric E; Shaw, Jessica R; Kaptchuk, Ted J

    2012-03-01

    Placebos are an essential tool in randomised clinical trials, where they are used to control for bias and contextual healing effects. Placebos and their effects are also studied from multiple diverse perspectives, but the perspectives of placebo recipients are seldom considered. Research shows that people form cognitive and affective representations of active treatments such as medicines, and that they use these representations to guide their behaviour; it seems reasonable to suggest that people might also think about and develop representations of placebos. We adopted a qualitative approach to examine in detail how participants in one RCT, conducted in the USA, conceptualised placebos. 12 people were interviewed 3 times each, at the start, middle, and end of a trial of placebo effects and acupuncture for Irritable Bowel Syndrome (IBS). The interview data were analysed inductively and we identified four ways in which the participants conceptualised placebos: placebos are necessary for research; placebo effects are fake; placebo acupuncture is not real acupuncture; placebos have real effects mediated by psychological mechanisms. Participants' conceptualisations of placebos were dynamic and situated in a broader psychological and socio-cultural context. Seeing placebo effects as legitimate seemed to be facilitated by having more holistic models of healing, viewing IBS as psychological, and seeing treatment as multifactorial. However, some participants maintained a negative view of placebo effects (e.g. as illusions) that was apparently inconsistent with their other beliefs (e.g. in mind-body healing mechanisms). This may indicate a dominance of negative discourses around placebos at a socio-cultural level. Negative views of placebos are inconsistent with evidence that placebo treatments can have positive effects on symptoms. RCT participants should be informed about potential benefits of placebo treatments to avoid misunderstandings and unease. Future work should

  6. Psychological treatment of late-life depression:a meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Cuijpers, P.; Straten, van A.; Smit, H.F.E.

    2006-01-01

    SUMMARY Background Older meta-analyses of the effects of psychological treatments for depression in older adults have found that these treatments have large effects. However, these earlier meta-analyses also included non-randomized studies, and did not include newer high-quality randomized controlle

  7. Psychological treatment of late-life depression:a meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Cuijpers, P.; Straten, van A.; Smit, H.F.E.

    2006-01-01

    SUMMARY Background Older meta-analyses of the effects of psychological treatments for depression in older adults have found that these treatments have large effects. However, these earlier meta-analyses also included non-randomized studies, and did not include newer high-quality randomized

  8. Effectiveness of the psychological and pharmacological treatment of catastrophization in patients with fibromyalgia: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Magallón Rosa

    2009-04-01

    Full Text Available Abstract Background Fibromyalgia is a prevalent and disabling disorder characterized by widespread pain and other symptoms such as insomnia, fatigue or depression. Catastrophization is considered a key clinical symptom in fibromyalgia; however, there are no studies on the pharmacological or psychological treatment of catastrophizing. The general aim of this study is to assess the effectiveness of cognitive-behaviour therapy and recommended pharmacological treatment for fibromyalgia (pregabalin, with duloxetine added where there is a comorbid depression, compared with usual treatment at primary care level. Method/design Design: A multi-centre, randomized controlled trial involving three groups: the control group, consisting of usual treatment at primary care level, and two intervention groups, one consisting of cognitive-behaviour therapy, and the other consisting of the recommended pharmacological treatment for fibromyalgia. Setting: 29 primary care health centres in the city of Zaragoza, Spain. Sample: 180 patients, aged 18–65 years, able to understand and read Spanish, who fulfil criteria for primary fibromyalgia, with no previous psychological treatment, and no pharmacological treatment or their acceptance to discontinue it two weeks before the onset of the study. Intervention: Psychological treatment is based on the manualized protocol developed by Prof. Escobar et al, from the University of New Jersey, for the treatment of somatoform disorders, which has been adapted by our group for the treatment of fibromyalgia. It includes 10 weekly sessions of cognitive-behaviour therapy. Pharmacological therapy consists of the recommended pharmacological treatment for fibromyalgia: pregabalin (300–600 mg/day, with duloxetine (60–120 mg/day added where there is a comorbid depression. Measurements: The following socio-demographic data will be collected: sex, age, marital status, education, occupation and social class. The diagnosis of psychiatric

  9. A Positive Psychology Intervention for Patients with an Acute Coronary Syndrome: Treatment Development and Proof-of-Concept Trial.

    Science.gov (United States)

    Huffman, Jeff C; Millstein, Rachel A; Mastromauro, Carol A; Moore, Shannon V; Celano, Christopher M; Bedoya, C Andres; Suarez, Laura; Boehm, Julia K; Januzzi, James L

    2016-10-01

    Positive psychological constructs are associated with superior outcomes in cardiac patients, but there has been minimal study of positive psychology (PP) interventions in this population. Our objective was to describe the intervention development and pilot testing of an 8-week phone-based PP intervention for patients following an acute coronary syndrome (ACS). Initial intervention development and single-arm proof-of-concept trial, plus comparison of the PP intervention to a subsequently-recruited treatment as usual (TAU) cohort. PP development utilized existing literature, expert input, and qualitative interview data in ACS patients. In the proof-of-concept trial, the primary outcomes were feasibility and acceptability, measured by rates of exercise completion and participant ratings of exercise ease/utility. Secondary outcomes were pre-post changes in psychological outcomes and TAU comparisons, measured using effect sizes (Cohen's d). The PP intervention and treatment manual were successfully created. In the proof-of-concept trial, 17/23 PP participants (74 %) completed at least 5 of 8 exercises. Participants rated the ease (M = 7.4/10; SD = 2.1) and utility (M = 8.1/10, SD = 1.6) of PP exercises highly. There were moderate pre-post improvements (ds = .46-.69) in positive affect, anxiety, and depression, but minimal effects on dispositional optimism (d = .08). Compared to TAU participants (n = 22), PP participants demonstrated greater improvements in positive affect, anxiety, and depression (ds = . 47-.71), but not optimism. A PP intervention was feasible, well-accepted, and associated with improvements in most psychological measures among cardiac patients. These results provide support for a larger trial focusing on behavioral outcomes.

  10. Improving quality of life in diverse rural older adults: a randomized trial of a psychological treatment.

    Science.gov (United States)

    Scogin, Forrest; Morthland, Martin; Kaufman, Allan; Burgio, Louis; Chaplin, William; Kong, Grace

    2007-12-01

    The efficacy of home-delivered cognitive-behavioral therapy (CBT) in improving quality of life and reducing psychological symptoms in older adults was examined in this study. One hundred thirty-four participants, predominately African American and characterized as primarily rural, low resource, and physically frail, were randomly assigned to either CBT or a minimal support control condition. Results indicate that CBT participants evidenced significantly greater improvements in quality of life and reductions in psychological symptoms. Mediation of treatment through cognitive and behavioral variables was not found despite the acceptable delivery of CBT by research therapists. These data suggest that treatment can be effective with a disadvantaged sample of older adults and extend efficacy findings to quality of life domains. Creating access to evidence-based treatments through nontraditional delivery is an important continuing goal for geriatric health care. PsycINFO Database Record (c) 2008 APA, all rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Messerli-Bürgy Nadine

    2012-12-01

    Full Text Available 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 treating depressive symptoms. Deprexis is a promising web-based psychological treatment which was devised for depressed patients. The aim of the study InterHerz is to examine if Deprexis is an effective psychological treatment to reduce stress and depression in cardiac patients. Methods/Design The sample will consist of 80 depressed patients randomized to an intervention group or a waitlist (10 weeks. Patients are recruited via cardiologists, cardiac rehabilitation units and the website of the Swiss Heart Foundation. Patients have access to a guided self-help program in which they work themselves through several modules and receive feedback from a clinical psychologist. Pre- and post-assessments, and a six-month follow-up, are conducted using online questionnaires and diagnostic interviews. Discussion Deprexis is a new web-based treatment which has the potential to help depressed cardiac patients with limited access to psychological treatment to increase their mental health. Trial registration Current Controlled Trials ISRCTN45945396

  12. Psychological treatments for depression in pre-adolescent children (12 years and younger): systematic review and meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Forti-Buratti, M Azul; Saikia, Rupalim; Wilkinson, Esther L; Ramchandani, Paul G

    2016-10-01

    The objective of this study was to evaluate the efficacy of psychological treatments for depression in pre-adolescent children, a disorder affecting 1-2 % of children in this age range. A systematic review of studies of psychological interventions to treat depressive disorder in pre-adolescent children (aged up to 12-years-old) was carried out. The primary outcome was level of depressive symptoms. Studies were found using Medline, PsycINFO, EMBASE and Web of Knowledge databases and selected on several criteria. Only randomised controlled trials were included. Where individual studies covered a broader age range (usually including adolescents up to age 18 years), authors of those studies were contacted and requested to provide individual patient level data for those aged 12 years and younger. 2822 abstracts were reviewed, and from these 124 full text articles were reviewed, yielding 7 studies for which we were able to access appropriate data for this review. 5 of these studies evaluated cognitive behaviour therapy (CBT). Combined results from these studies suggest that there is a lack of evidence that CBT is better than no treatment [standard mean difference -0.342 (95 % confidence interval -0.961, 0.278)], although the number of participants included in the trials was relatively small. The evidence for efficacy of family therapy and psychodynamic therapy is even more limited. The very limited number of participants in randomised controlled trials means that there is inconclusive evidence for the psychological treatment of depression in children aged 12 years and below. Given the prevalence and significant impact of this disorder, there is an urgent need to establish the effectiveness or otherwise of psychological intervention.

  13. A randomized controlled trial of a web-based psychological intervention for patients under treatment for chronic HIV infection

    Directory of Open Access Journals (Sweden)

    L Skeie

    2012-11-01

    Full Text Available Purpose of the study: One of the most prevalent mental conditions in people with HIV is depression as uniquely characterized by low positive affect. This study examined the effect of a web-based intervention (Avanti on overall mood and depressive symptoms among patients with HIV infection. Methods: Patients treated with effective antiretroviral treatment were included in a two-armed trial with substance abuse as an exclusion criterion and randomized to Avanti (n=36 or control (n=31. Patients were surveyed at baseline, as well as 1 and 3 months after the initiation of a 5-week intervention period. Outcomes were Center for Epidemiological Studies-Depression scale and the Positive and Negative Affect Schedule which was combined into an overall mood index. Changes within groups were tested by Wilcoxon matched pairs test and baseline differences between groups by chi-square and Mann-Whitney independent samples test. Summary of results: Baseline scores for both groups were similar. However, patients in the intervention group had an improvement in median (M overall mood from baseline (M=67.6 to 1 month (M=71, p=0.02 which was also maintained from 1 to 3 months (M=71.9. Moreover, these patients had a favorable reduction in negative affect from 1 (M=24 to 3 months (M=22, p=0.01 and a transient improvement in positive affect from baseline (M=31.7 to 1 month after intervention onset (M=35, p<0.01 which almost returned to baseline levels at month 3 (M=32, p=0.01. In contrast, no significant changes were observed within the control group, except for a reduction in negative affect from 1 (M=23 to 3 months (M=21.6, p=0.05. Notably, symptoms of depression at baseline were low in both the Avanti (M=13 and control (M=12 groups, possibly explaining why no further reduction in depression was observed from baseline to 3 months in either of the two groups. Conclusions: The results of this study lend support to the promise of a web-based psychological intervention

  14. Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial.

    Directory of Open Access Journals (Sweden)

    Habteyes Hailu Tola

    Full Text Available Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of non-adherence in resource limited countries based on theoretical models. This study aimed to evaluate the impact of psychological counseling and educational intervention on tuberculosis (TB treatment adherence based on Health Belief Model (HBM.A cluster randomized control trial was conducted in Addis Ababa from May to December, 2014. Patients were enrolled into study consecutively from 30 randomly selected Health Centers (HCs (14 HCs intervention and 16 HCs control groups. A total of 698 TB patients, who were on treatment for one month to two months were enrolled. A structured questionnaire was administered to both groups of patients at baseline and endpoint of study. Control participants received routine directly-observed anti-TB therapy and the intervention group additionally received combined psychological counseling and adherence education. Treatment non-adherence level was the main outcome of the study, and multilevel logistic regression was employed to assess the impact of intervention on treatment adherence.At enrollment, the level of non-adherence among intervention (19.4% and control (19.6% groups was almost the same. However, after intervention, non-adherence level decreased among intervention group from 19.4 (at baseline to 9.5% (at endpoint, while it increased among control group from 19.4% (baseline to 25.4% (endpoint. Psychological counseling and educational interventions resulted in significant difference with regard to non-adherence level between intervention and control groups (Adjusted OR = 0.31, 95% Confidence Interval (CI (0.18-0.53, p < 0.001.Psychological counseling and educational interventions, which were guided by HBM, significantly

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

    Directory of Open Access Journals (Sweden)

    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

  16. Types of Treatment: Clinical Trials

    Science.gov (United States)

    ... Disease Information Treatment Types of Treatment Clinical Trials Clinical Trials Clinical Trials SHARE: Print Glossary Taking part in a clinical ... for cancer are based on previous clinical trials. Clinical Trial Service: LLS provides personalized clinical trial navigation when ...

  17. Improving mood with psychoanalytic and cognitive therapies (IMPACT: a pragmatic effectiveness superiority trial to investigate whether specialised psychological treatment reduces the risk for relapse in adolescents with moderate to severe unipolar depression: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Suckling John

    2011-07-01

    Full Text Available Abstract Background Up to 70% of adolescents with moderate to severe unipolar major depression respond to psychological treatment plus Fluoxetine (20-50 mg with symptom reduction and improved social function reported by 24 weeks after beginning treatment. Around 20% of non responders appear treatment resistant and 30% of responders relapse within 2 years. The specific efficacy of different psychological therapies and the moderators and mediators that influence risk for relapse are unclear. The cost-effectiveness and safety of psychological treatments remain poorly evaluated. Methods/Design Improving Mood with Psychoanalytic and Cognitive Therapies, the IMPACT Study, will determine whether Cognitive Behavioural Therapy or Short Term Psychoanalytic Therapy is superior in reducing relapse compared with Specialist Clinical Care. The study is a multicentre pragmatic effectiveness superiority randomised clinical trial: Cognitive Behavioural Therapy consists of 20 sessions over 30 weeks, Short Term Psychoanalytic Psychotherapy 30 sessions over 30 weeks and Specialist Clinical Care 12 sessions over 20 weeks. We will recruit 540 patients with 180 randomised to each arm. Patients will be reassessed at 6, 12, 36, 52 and 86 weeks. Methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, research assessors independent of treatment team and blind to randomization, analysis by intention to treat, data management using remote data entry, measures of quality assurance, advanced statistical analysis, manualised treatment protocols, checks of adherence and competence of therapists and assessment of cost-effectiveness. We will also determine whether time to recovery and/or relapse are moderated by variations in brain structure and function and selected genetic and hormone biomarkers taken at entry. Discussion The objective of this clinical trial is to determine

  18. The neuroscience of psychological treatments.

    Science.gov (United States)

    Barlow, David H

    2014-11-01

    The series of articles in this issue of Behavior Research and Therapy presages a new field of translational research that could be called "the neuroscience of psychological treatments". After a brief retrospective on the origins and promise of this focus of study several cautions are adumbrated. As in any new field of scientific endeavor, close collaboration among stakeholders with interest in this field and the integration of a healthy scientific skepticism will best ensure the continued development of ever more powerful psychological treatments.

  19. Computer-based psychological treatment for comorbid depression and problematic alcohol and/or cannabis use: a randomized controlled trial of clinical efficacy.

    Science.gov (United States)

    Kay-Lambkin, Frances J; Baker, Amanda L; Lewin, Terry J; Carr, Vaughan J

    2009-03-01

    To evaluate computer- versus therapist-delivered psychological treatment for people with comorbid depression and alcohol/cannabis use problems. Randomized controlled trial. Community-based participants in the Hunter Region of New South Wales, Australia. Ninety-seven people with comorbid major depression and alcohol/cannabis misuse. All participants received a brief intervention (BI) for depressive symptoms and substance misuse, followed by random assignment to: no further treatment (BI alone); or nine sessions of motivational interviewing and cognitive behaviour therapy (intensive MI/CBT). Participants allocated to the intensive MI/CBT condition were selected at random to receive their treatment 'live' (i.e. delivered by a psychologist) or via a computer-based program (with brief weekly input from a psychologist). Depression, alcohol/cannabis use and hazardous substance use index scores measured at baseline, and 3, 6 and 12 months post-baseline assessment. (i) Depression responded better to intensive MI/CBT compared to BI alone, with 'live' treatment demonstrating a strong short-term beneficial effect which was matched by computer-based treatment at 12-month follow-up; (ii) problematic alcohol use responded well to BI alone and even better to the intensive MI/CBT intervention; (iii) intensive MI/CBT was significantly better than BI alone in reducing cannabis use and hazardous substance use, with computer-based therapy showing the largest treatment effect. Computer-based treatment, targeting both depression and substance use simultaneously, results in at least equivalent 12-month outcomes relative to a 'live' intervention. For clinicians treating people with comorbid depression and alcohol problems, BIs addressing both issues appear to be an appropriate and efficacious treatment option. Primary care of those with comorbid depression and cannabis use problems could involve computer-based integrated interventions for depression and cannabis use, with brief regular

  20. Trajectories of change during a randomized controlled trial of internet-delivered psychological treatment for adolescent chronic pain: how does change in pain and function relate?

    Science.gov (United States)

    Palermo, Tonya M; Law, Emily F; Zhou, Chuan; Holley, Amy Lewandowski; Logan, Deirdre; Tai, Gabrielle

    2015-04-01

    Although pain and function improve at immediate posttreatment for youth receiving cognitive behavioral therapy for chronic pain, limited data are available to understand changes that youth make during psychological treatment. We sought to characterize distinct trajectory patterns of change in pain and function to understand the temporal association of these changes during internet-delivered cognitive behavioral therapy (CBT). Weekly repeated assessments of pain and function were conducted during 8 weeks of treatment among 135 adolescents, aged 11 to 17 years, with chronic pain who were randomized to the cognitive behavioral intervention arm of an ongoing trial of internet-delivered CBT (Web-based management of adolescent pain; Web-MAP2). Using random-effects growth mixture models, we characterized pain and functional disability trajectories finding distinct trajectory groups indicating patterns of both linear and quadratic effects. Trajectories of change showed that some patients' pain and functional disability were improving, others worsened or changed minimally. Paired t tests compared the within-subject relative change rate in pain and function demonstrating similar change range for pain and function during the treatment period. There was no support for improvements in either pain or function to precede changes in the other domain. Findings may be useful in informing future studies of psychosocial treatments for pediatric chronic pain to consider how to target treatment strategies to distinct patient response profiles. This may lead to the development of intervention strategies that can both more effectively target children's pain and function during treatment and lead to sustained changes after treatment.

  1. Does Publication Bias Inflate the Apparent Efficacy of Psychological Treatment for Major Depressive Disorder? A Systematic Review and Meta-Analysis of US National Institutes of Health-Funded Trials.

    Directory of Open Access Journals (Sweden)

    Ellen Driessen

    Full Text Available The efficacy of antidepressant medication has been shown empirically to be overestimated due to publication bias, but this has only been inferred statistically with regard to psychological treatment for depression. We assessed directly the extent of study publication bias in trials examining the efficacy of psychological treatment for depression.We identified US National Institutes of Health grants awarded to fund randomized clinical trials comparing psychological treatment to control conditions or other treatments in patients diagnosed with major depressive disorder for the period 1972-2008, and we determined whether those grants led to publications. For studies that were not published, data were requested from investigators and included in the meta-analyses. Thirteen (23.6% of the 55 funded grants that began trials did not result in publications, and two others never started. Among comparisons to control conditions, adding unpublished studies (Hedges' g = 0.20; CI95% -0.11~0.51; k = 6 to published studies (g = 0.52; 0.37~0.68; k = 20 reduced the psychotherapy effect size point estimate (g = 0.39; 0.08~0.70 by 25%. Moreover, these findings may overestimate the "true" effect of psychological treatment for depression as outcome reporting bias could not be examined quantitatively.The efficacy of psychological interventions for depression has been overestimated in the published literature, just as it has been for pharmacotherapy. Both are efficacious but not to the extent that the published literature would suggest. Funding agencies and journals should archive both original protocols and raw data from treatment trials to allow the detection and correction of outcome reporting bias. Clinicians, guidelines developers, and decision makers should be aware that the published literature overestimates the effects of the predominant treatments for depression.

  2. Does Publication Bias Inflate the Apparent Efficacy of Psychological Treatment for Major Depressive Disorder? A Systematic Review and Meta-Analysis of US National Institutes of Health-Funded Trials

    Science.gov (United States)

    Driessen, Ellen; Hollon, Steven D.; Bockting, Claudi L. H.; Cuijpers, Pim; Turner, Erick H.

    2015-01-01

    Background The efficacy of antidepressant medication has been shown empirically to be overestimated due to publication bias, but this has only been inferred statistically with regard to psychological treatment for depression. We assessed directly the extent of study publication bias in trials examining the efficacy of psychological treatment for depression. Methods and Findings We identified US National Institutes of Health grants awarded to fund randomized clinical trials comparing psychological treatment to control conditions or other treatments in patients diagnosed with major depressive disorder for the period 1972–2008, and we determined whether those grants led to publications. For studies that were not published, data were requested from investigators and included in the meta-analyses. Thirteen (23.6%) of the 55 funded grants that began trials did not result in publications, and two others never started. Among comparisons to control conditions, adding unpublished studies (Hedges’ g = 0.20; CI95% -0.11~0.51; k = 6) to published studies (g = 0.52; 0.37~0.68; k = 20) reduced the psychotherapy effect size point estimate (g = 0.39; 0.08~0.70) by 25%. Moreover, these findings may overestimate the "true" effect of psychological treatment for depression as outcome reporting bias could not be examined quantitatively. Conclusion The efficacy of psychological interventions for depression has been overestimated in the published literature, just as it has been for pharmacotherapy. Both are efficacious but not to the extent that the published literature would suggest. Funding agencies and journals should archive both original protocols and raw data from treatment trials to allow the detection and correction of outcome reporting bias. Clinicians, guidelines developers, and decision makers should be aware that the published literature overestimates the effects of the predominant treatments for depression. PMID:26422604

  3. Psychological aspects of male fertility treatment

    DEFF Research Database (Denmark)

    Mikkelsen, Alice Toft; Madsen, Svend Aage; 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....

  4. Counselling for Alcohol Problems (CAP), a lay counsellor-delivered brief psychological treatment for harmful drinking in men, in primary care in India: a randomised controlled trial.

    Science.gov (United States)

    Nadkarni, Abhijit; Weobong, Benedict; Weiss, Helen A; McCambridge, Jim; Bhat, Bhargav; Katti, Basavaraj; Murthy, Pratima; King, Michael; McDaid, David; Park, A-La; Wilson, G Terence; Kirkwood, Betty; Fairburn, Christopher G; Velleman, Richard; Patel, Vikram

    2017-01-14

    Although structured psychological treatments are recommended as first-line interventions for harmful drinking, 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 Counselling for Alcohol Problems (CAP), a brief psychological treatment delivered by lay counsellors to patients with harmful drinking attending routine primary health-care settings. In this randomised controlled trial, we recruited male harmful drinkers defined by an Alcohol Use Disorders Identification Test (AUDIT) score of 12-19 who were aged 18-65 years from ten primary health centres in Goa, India. We excluded patients who needed emergency medical treatment or inpatient admission, who were unable to communicate clearly, and who were intoxicated at the time of screening. Participants were randomly allocated (1:1) by trained health assistants based at the primary health centres to enhanced usual care (EUC) alone or EUC combined with CAP, in randomly sized blocks of four to six, stratified by primary health centre, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC and those assessing outcomes were masked. Primary outcomes were remission (AUDIT score of CAP group and 190 [50%] to the EUC alone group [one of whom was subsequently excluded because of a protocol violation]), of whom 336 (89%) completed the 3 month primary outcome assessment (164 [87%] in the EUC plus CAP group and 172 [91%] in the EUC alone group). The proportion with remission (59 [36%] of 164 in the EUC plus CAP group vs 44 [26%] of 172 in the EUC alone group; adjusted prevalence ratio 1·50 [95% CI 1·09-2·07]; p=0·01) and the proportion abstinent in the past 14 days (68 [42%] vs 31 [18%]; adjusted odds ratio 3·00 [1·76-5·13]; pCAP group than in the EUC alone group, but we noted no effect on mean daily alcohol consumed in the past 14 days among those who reported

  5. 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

  6. Emotional Freedom Techniques in the Treatment of Unhealthy Eating Behaviors and Related Psychological Constructs in Adolescents: A Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Stapleton, Peta; Chatwin, Hannah; William, Mary; Hutton, Amanda; Pain, Amanda; Porter, Brett; Sheldon, Terri

    2016-01-01

    In Australia and throughout much of the world, rates of obesity continue to climb as do the prevalence of eating disorders, particularly in adolescents. Psychological consequences of childhood obesity include low self-esteem, depression, body dissatisfaction, and social maladjustment (Young-Hyman et al., 2012). This feasibility study sought to examine the impact of a six-week Emotional Freedom Techniques (EFT) group treatment program upon eating behaviours, self-esteem, compassion, and psychological symptoms. Forty-four students were randomly allocated to either the EFT group or the waitlist control group. Results revealed a delayed effect for both groups at post-intervention, with improved eating habits, self-esteem, and compassion at follow-up. Findings provide preliminary support for EFT as an effective treatment strategy for increasing healthy eating behaviours and improving associated weight-related psychopathology. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Comparative effectiveness of psychological treatments for depressive disorders in primary care: network meta-analysis

    OpenAIRE

    2015-01-01

    Background A variety of psychological interventions to treat depressive disorders have been developed and are used in primary care. In a systematic review, we compared the effectiveness of psychological treatments grouped by theoretical background, intensity of contact with the health care professional, and delivery mode for depressed patients in this setting. Methods Randomized trials comparing a psychological treatment with usual care, placebo, another psychological treatment, pharmacothera...

  8. Psychological Mechanisms of PTSD and Its Treatment.

    Science.gov (United States)

    Sripada, Rebecca K; Rauch, Sheila A M; Liberzon, Israel

    2016-11-01

    Psychological mechanisms can be defined as processes or events that are responsible for specific changes in psychological outcomes. In psychotherapy research, mechanisms are the factors through which interventions produce change. In this article, we explain the importance of identifying psychological mechanisms, describe methods for identifying them, and analyze recent literature on the psychological mechanisms underlying the development and treatment of posttraumatic stress disorder (PTSD). Based on the findings of recent investigations (from 2013 to present), we focus on four putative mechanisms: emotional engagement, extinction and contextualization, distress tolerance, and negative posttraumatic cognitions. Future directions for psychological mechanism research are also outlined, including possible opportunities for capitalizing on the most promising mechanisms identified to date.

  9. Mind/Body Psychological Treatments for Irritable Bowel Syndrome

    Directory of Open Access Journals (Sweden)

    Bruce D. Naliboff

    2008-01-01

    Full Text Available Currently, the goal of treatment for those with irritable bowel syndrome (IBS is to improve the quality of life through a reduction in symptoms. While the majority of treatment approaches involve the use of traditional medicine, more and more patients seek out a non-drug approach to managing their symptoms. Current forms of non-drug psychologic or mind/body treatment for IBS include hypnotherapy, cognitive behavioral therapy and brief psychodynamic psychotherapy, all of which have been proven efficacious in clinical trials. We propose that incorporating the constructs of mindfulness and acceptance into a mind/body psychologic treatment of IBS may be of added benefit due to the focus on changing awareness and acceptance of one's own state which is a strong component of traditional and Eastern healing philosophies.

  10. Psychological Neuromodulatory Treatments for Young People with Chronic Pain

    Directory of Open Access Journals (Sweden)

    Jordi Miró

    2016-12-01

    Full Text Available The treatment of young people with chronic pain is a complex endeavor. Many of these youth do not obtain adequate relief from available interventions. Psychological neuromodulatory treatments have been shown to have potential benefit for adults with chronic pain. Here, we review and summarize the available information about the efficacy of three promising psychological neuromodulatory treatments—neurofeedback, meditation and hypnosis—when provided to young people with chronic pain. A total of 16 articles were identified and reviewed. The findings from these studies show that hypnotic treatments are effective in reducing pain intensity for a variety of pediatric chronic pain problems, although research suggests variability in outcomes as a function of the specific pain problem treated. There are too few studies evaluating the efficacy of neurofeedback or meditation training in young people with chronic pain to draw firm conclusions regarding their efficacy. However, preliminary data indicate that these treatments could potentially have positive effects on a variety of outcomes (e.g., pain intensity, frequency of pain episodes, physical and psychological function, at least in the short term. Clinical trials are needed to evaluate the effects of neurofeedback and meditation training, and research is needed to identify the moderators of treatment benefits as well as better understand the mechanisms underlying the efficacy of all three of these treatments. The findings from such research could enhance overall treatment efficacy by: (1 providing an empirical basis for better patient-treatment matching; and (2 identifying specific mechanisms that could be targeted with treatment.

  11. Attraction, Discrepancy and Responses to Psychological Treatment.

    Science.gov (United States)

    Patton, Michael J.

    The responses of a laboratory subject (S) to a counselor-accomplice and to the psychological treatment situation are examined by manipulating experimentally interpersonal attraction and communication discrepancy. Four treatment conditions were set up: (1) topic similarity and positive attraction for counselor, (2) topic discrepancy and positive…

  12. 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

  13. Effectiveness of Psychological and Pharmacological Treatments for Nocturnal Enuresis.

    Science.gov (United States)

    Houts, Arthur C.; And Others

    1994-01-01

    Assesses overall effectiveness of psychological and pharmacological treatments, relative effectiveness of specific treatments, and moderators of treatment effectiveness for nocturnal enuretic children via quantitative integration of research. Findings confirm that more children benefit from psychological than from pharmacological interventions and…

  14. [Phantom limb pain. Psychological treatment strategies].

    Science.gov (United States)

    Diers, M; Flor, H

    2013-04-01

    Similar to other pain syndromes phantom limb pain is characterized by learning and memory processes that maintain the pain and increase maladaptive plastic changes of the brain: therefore, psychological interventions that change maladaptive memory processes are useful. In addition to traditional psychological interventions, such as pain management training and biofeedback, more recent developments that involve sensory discrimination training, mirror treatment, graded motor imagery, prosthesis training and training in virtual reality are interesting. These interventions not only reduce phantom limb pain but also reverse the associated maladaptive brain changes.

  15. Developing a Reporting Guideline for Social and Psychological Intervention Trials.

    Science.gov (United States)

    Grant, Sean; Montgomery, Paul; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Mayo-Wilson, Evan

    2013-11-01

    Social and psychological interventions are often complex. Understanding randomized controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them; however, RCT reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. In this article, we explain how reporting guidelines have improved the quality of reports in medicine and describe the ongoing development of a new reporting guideline for RCTs: Consolidated Standards of Reporting Trials-SPI (an extension for social and psychological interventions). We invite readers to participate in the project by visiting our website, in order to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/CONSORT-study).

  16. Psychological treatment of psychogenic idiopathic environmental intolerance.

    Science.gov (United States)

    Staudenmayer, H

    2000-01-01

    This chapter focuses on the psychotherapy of individuals who suffer distress from functional somatic syndromes; specifically, idiopathic environmental intolerance (IEI). While patients believe environmental intolerances cause their distress, its origin is treated as psychological, mediated through psychophysiological systems and mechanisms associated with the stress response. Factors considered include stress and trauma premorbid to the alleged onset of IEI; somatization and its expression through affective, anxiety, and somatoform disorders; personality disorders and associated psychological defenses; motivation for the sick role; and iatrogenic suggestion and reinforcement of unsubstantiated toxicogenic theories and treatments. Psychotherapies include behavioral desensitization, cognitive-behavioral therapy, cognitive therapy, and psychotropic medications. The greatest challenge in treatment is to overcome the patient's disabling belief in a toxicogenic explanation for his or her symptoms.

  17. Tackling sleeplessness: Psychological treatment options for insomnia

    Directory of Open Access Journals (Sweden)

    Natalie D Dautovich

    2010-03-01

    Full Text Available Natalie D Dautovich1, Joseph McNamara2, Jacob M Williams3, Natalie J Cross4, Christina S McCrae31Department of Psychology, 2Department of Psychiatry, 3Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA; 4Department of Veterans Affairs Community Based Outpatient Clinic, Greenville, NC, USAAbstract: The purpose of the present paper is to review and summarize the research supporting nonpharmacologic treatment options for insomnia. The different treatment approaches are described followed by a review of both original research articles and meta-analyses. Meta-analytic reviews suggest that common nonpharmacologic approaches exert, on average, medium to large effect sizes on SOL, WASO, NWAK, SQR, and SE while smaller effects are seen for TST. Stimulus control therapy, relaxation training, and CBT-I are considered standard treatments for insomnia by the American Academy of Sleep Medicine (AASM. Sleep restriction, multicomponent therapy without cognitive therapy, paradoxical intention, and biofeedback approaches have received some levels of support by the AASM. Sleep hygiene, imagery training, and cognitive therapy did not receive recommendation levels as single (standalone therapies by the AASM due to lack of empirical evidence. Less common approaches have been introduced (Internet-based interventions, bright light treatment, biofeedback, mindfulness, acupuncture, and intensive sleep retraining but require further research. Brief and group treatments have been shown to be as efficacious as longer and individually-administered treatments. Considerations are presented for special populations, including older adults, children and teens, individuals from diverse cultural backgrounds, insomnia comorbid with other disorders, and individuals who are taking hypnotics.Keywords: insomnia, nonpharmacologic, psychological, behavioral, treatments, sleep

  18. Psychological Treatment for Panic Disorder with Agoraphobia: A Randomized Controlled Trial to Examine the Role of Therapist-Guided Exposure in situ in CBT

    Science.gov (United States)

    Gloster, Andrew T.; Wittchen, Hans-Ulrich; Einsle, Franziska; Lang, Thomas; Helbig-Lang, Sylvia; Fydrich, Thomas; Fehm, Lydia; Hamm, Alfons O.; Richter, Jan; Alpers, George W.; Gerlach, Alexander L.; Strohle, Andreas; Kircher, Tilo; Deckert, Jurgen; Zwanzger, Peter; Hofler, Michael; Arolt, Volker

    2011-01-01

    Objective: Cognitive-behavioral therapy (CBT) is a first-line treatment for panic disorder with agoraphobia (PD/AG). Nevertheless, an understanding of its mechanisms and particularly the role of therapist-guided exposure is lacking. This study was aimed to evaluate whether therapist-guided exposure in situ is associated with more pervasive and…

  19. Psychological Treatment for Panic Disorder with Agoraphobia: A Randomized Controlled Trial to Examine the Role of Therapist-Guided Exposure in situ in CBT

    Science.gov (United States)

    Gloster, Andrew T.; Wittchen, Hans-Ulrich; Einsle, Franziska; Lang, Thomas; Helbig-Lang, Sylvia; Fydrich, Thomas; Fehm, Lydia; Hamm, Alfons O.; Richter, Jan; Alpers, George W.; Gerlach, Alexander L.; Strohle, Andreas; Kircher, Tilo; Deckert, Jurgen; Zwanzger, Peter; Hofler, Michael; Arolt, Volker

    2011-01-01

    Objective: Cognitive-behavioral therapy (CBT) is a first-line treatment for panic disorder with agoraphobia (PD/AG). Nevertheless, an understanding of its mechanisms and particularly the role of therapist-guided exposure is lacking. This study was aimed to evaluate whether therapist-guided exposure in situ is associated with more pervasive and…

  20. Neuroimaging correlates of pharmacological and psychological treatments for specific phobia.

    Science.gov (United States)

    Linares, Ila M; Chags, Marcos H N; Machado-de-Sousa, João P; Crippa, José A S; Hallak, Jaime E C

    2014-01-01

    Specific phobia is an anxiety disorder characterized by irrational fear and avoidance of specific things or situations, interfering significantly with the patients' daily life. Treatment for the disorder consists of both pharmacological and psychological approaches, mainly cognitive behavioral therapy (CBT). Neuroimaging techniques have been used in an attempt to improve our understanding of the neurobiology of SP and of the effects of treatment options available. This review describes the design and results of eight articles investigating the neuroimaging correlates of pharmacological and psychological treatments for SP. The studies show that CBT is effective in SP, leading to a reduction of anxiety symptoms that is accompanied by functional alterations in the brain. The results of pharmacological interventions for SP are less uniform, but suggest that the partial agonist of the NMDA (N-methyl D-aspartate) receptor DCS (D-cycloserine) can be used in combination with psychotherapy techniques for the achievement of quicker treatment response and that DCS modulates the function of structures implicated in the neurobiology of SP. Further research should explore the augmentation of CBT treatment with DCS in controlled trials.

  1. Placebo and other psychological interactions in headache treatment.

    Science.gov (United States)

    Autret, A; Valade, D; Debiais, S

    2012-04-01

    We present a theory according which a headache treatment acts through a specific biological effect (when it exists), a placebo effect linked to both expectancy and repetition of its administration (conditioning), and a non-specific psychological effect. The respective part of these components varies with the treatments and the clinical situations. During antiquity, suggestions and beliefs were the mainstays of headache treatment. The word placebo appeared at the beginning of the eighteenth century. Controversies about its effect came from an excessive interpretation due to methodological bias, inadequate consideration of the variation of the measure (regression to the mean) and of the natural course of the disease. Several powerful studies on placebo effect showed that the nature of the treatment, the associated announce, the patients' expectancy, and the repetition of the procedures are of paramount importance. The placebo expectancy is associated with an activation of pre-frontal, anterior cingular, accumbens, and periacqueducal grey opioidergic neurons possibly triggered by the dopaminergic meso-limbic system. In randomized control trials, several arms design could theoretically give information concerning the respective part of the different component of the outcome and control the natural course of the disease. However, for migraine and tension type headache attacks treatment, no three arm (verum, placebo, and natural course) trial is available in the literature. Indirect evidence of a placebo effect in migraine attack treatment, comes from the high amplitude of the improvement observed in the placebo arms (28% of the patients). This figure is lower (6%) when using the harder criterium of pain free at 2 h. But these data disregard the effect of the natural course. For prophylactic treatment with oral medication, the trials performed in the last decades report an improvement in 21% of the patients in the placebo arms. However, in these studies the duration of

  2. Psychological Treatments for Binge Eating Disorder

    Science.gov (United States)

    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

  3. 5HTT is associated with the phenotype psychological flexibility: results from a randomized clinical trial.

    Science.gov (United States)

    Gloster, Andrew T; Gerlach, Alexander L; Hamm, Alfons; Höfler, Michael; Alpers, Georg W; Kircher, Tilo; Ströhle, Andreas; Lang, Thomas; Wittchen, Hans-Ulrich; Deckert, Jürgen; Reif, Andreas

    2015-08-01

    Adaption to changing environments is evolutionarily advantageous. Studies that link genetic and phenotypic expression of flexible adjustment to one's context are largely lacking. In this study, we tested the importance of psychological flexibility, or goal-related context sensitivity, in an interaction between psychotherapy outcome for panic disorder with agoraphobia (PD/AG) and a genetic polymorphism. Given the established role of the 5HTT-LPR polymorphism in behavioral flexibility, we tested whether this polymorphism (short group vs. long group) impacted therapy response as a function of various endophenotypes (i.e., psychological flexibility, panic, agoraphobic avoidance, and anxiety sensitivity). Patients with PD/AG were recruited from a large multicenter randomized controlled clinical trial on cognitive-behavioral therapy. Pre- to post-treatment changes by 5HTT polymorphism were analyzed. 5HTT polymorphism status differentiated pre- to post-treatment changes in the endophenotype psychological flexibility (effect size difference d = 0.4, p < 0.05), but none of the specific symptom-related endophenotypes consistently for both the intent-to-treat sample (n = 228) and the treatment completers (n = 194). Based on the consistency of these findings with existing theory on behavioral flexibility, the specificity of the results across phenotypes, and the consistency of results across analyses (i.e., completer and intent to treat), we conclude that 5HTT polymorphism and the endophenotype psychological flexibility are important variables for the treatment of PD/AG. The endophenotype psychological flexibility may help bridge genetic and psychological literatures. Despite the limitation of the post hoc nature of these analyses, further study is clearly warranted.

  4. Reporting Quality of Social and Psychological Intervention Trials: A Systematic Review of Reporting Guidelines and Trial Publications

    OpenAIRE

    Grant, Sean P.; Evan Mayo-Wilson; Melendez-Torres, G. J.; Paul Montgomery

    2013-01-01

    BACKGROUND: Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. OBJECTIVE/DESIGN: We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. DATA SOURCES: (1) To identify reporting guidelines, we systematically searched multiple electronic databases and ...

  5. Treatment of Bulimia Nervosa: Psychological and Psychopharmacologic Considerations.

    Science.gov (United States)

    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…

  6. Treatment of Bulimia Nervosa: Psychological and Psychopharmacologic Considerations.

    Science.gov (United States)

    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…

  7. Does cognitive flexibility predict treatment gains in Internet-delivered psychological treatment of social anxiety disorder, depression, or tinnitus?

    Directory of Open Access Journals (Sweden)

    Philip Lindner

    2016-04-01

    Full Text Available Little is known about the individual factors that predict outcomes in Internet-administered psychological treatments. We hypothesized that greater cognitive flexibility (i.e. the ability to simultaneously consider several concepts and tasks and switch effortlessly between them in response to changes in environmental contingencies would provide a better foundation for learning and employing the cognitive restructuring techniques taught and exercised in therapy, leading to greater treatment gains. Participants in three trials featuring Internet-administered psychological treatments for depression (n = 36, social anxiety disorder (n = 115 and tinnitus (n = 53 completed the 64-card Wisconsin Card Sorting Test (WCST prior to treatment. We found no significant associations between perseverative errors on the WCST and treatment gains in any group. We also found low accuracy in the classification of treatment responders. We conclude that lower cognitive flexibility, as captured by perseverative errors on the WCST, should not impede successful outcomes in Internet-delivered psychological treatments.

  8. Identifying Effective Psychological Treatments of Insomnia: A Meta-Analysis.

    Science.gov (United States)

    Murtagh, Douglas R. R.; Greenwood, Kenneth M.

    1995-01-01

    Clarified efficacy of psychological treatments for insomnia through a meta-analysis of 66 outcome studies representing 139 treatment groups. Psychological treatments produced considerable enhancement of both sleep patterns and the subjective experience of sleep. Participants who were clinically referred and who did not regularly use sedatives…

  9. Mindful Walking in Psychologically Distressed Individuals: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    M. Teut

    2013-01-01

    Full Text Available Background. The aim of this randomized, controlled study was to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress. Methods. Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion or to no study intervention (waiting group. Primary outcome parameter was the difference to baseline on Cohen’s Perceived Stress Scale (CPSS after 4 weeks between intervention and control. Results. Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years to the control group. Adjusted CPSS differences after 4 weeks were −8.8 [95% CI: −10.8; −6.8] (mean 24.2 [22.2; 26.2] in the intervention group and −1.0 [−2.9; 0.9] (mean 32.0 [30.1; 33.9] in the control group, resulting in a highly significant group difference (. Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up.

  10. Reporting quality of social and psychological intervention trials: a systematic review of reporting guidelines and trial publications.

    Directory of Open Access Journals (Sweden)

    Sean P Grant

    Full Text Available BACKGROUND: Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. OBJECTIVE/DESIGN: We conducted a two-part study that reviewed (1 reporting guidelines for and (2 the reporting quality of social and psychological intervention trials. DATA SOURCES: (1 To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2 To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. ELIGIBILITY: (1 Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2 Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. RESULTS: (1 We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2 Our review of trials (n = 239 revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information and abstracts (55%; information about blinding (15%, sequence generation (23%, and allocation concealment (17%; and details about actual delivery of experimental (43% and control interventions (34%, participant uptake (25%, and service environment (28%. Only 11 of 40 journals referenced reporting guidelines in "Instructions to Authors." CONCLUSION: Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely

  11. The Psychology of Schizophrenia: Implications for Biological and Psychotherapeutic Treatments.

    Science.gov (United States)

    Dewan, Mantosh J

    2016-08-01

    The focus on recent advances in the neurobiology of schizophrenia has pushed aside the psychological understanding of the person with schizophrenia for several decades. However, a useful functional psychology of schizophrenia (in distinction to a psychological approach to symptoms) remains clinically important for several reasons: it is a core part of the bio-psycho-social formulation; it helps us understand and connect with persons with schizophrenia; and it provides a framework by which to organize our treatment efforts (both psychotherapeutic and particularly biological), which can improve adherence and outcomes. A coherent psychological model (the deficit model) based on object relations theory best explains all the biological, psychological, clinical, and sociocultural factors relevant to the understanding and treatment of persons with schizophrenia. A better understanding of a coherent psychology of persons with schizophrenia and provision of psychotherapies improves both the biological and psychotherapeutic treatment of persons with schizophrenia.

  12. Using Controversial Mock Trials in "Psychology and Law" Courses: Suggestions from Participants.

    Science.gov (United States)

    Werth, James L., Jr.; Harvey, James; McNamara, Rebecca; Svoboda, Andrea; Gulbrandson, Raina; Hendren, Jennifer; Greedy, Tiffany; Leybold, Christie

    2002-01-01

    Describes a mock trial focused on Jack Kevorkian and an euthanasia case that was included in a psychology and law course. Discusses the course format, provides the reactions to the mock trial by students and consultants, and includes suggestions for improving the mock trial. (CMK)

  13. Psychological adjustment of obese youth presenting for weight management treatment.

    Science.gov (United States)

    Zeller, Meg H; Saelens, Brian E; Roehrig, Helmut; Kirk, Shelley; Daniels, Stephen R

    2004-10-01

    To determine the prevalence of psychological maladjustment in clinic-based treatment-seeking obese children and adolescents (BMI > or = 95th percentile) and the degree to which maternal, demographic, and youth factors correlate to the youths' psychological adjustment. Anthropometrics, demographics (race, sex, insurance status), measures of youth psychological adjustment (self- and mother-report; Behavior Assessment System for Children), and maternal self-report of psychological distress (Symptom Checklist 90-Revised) were collected from 121 obese children and adolescents (55% white, 45% black) and their mothers. Approximately one-third of youths self-reported some psychological maladjustment, but two-thirds of youth were described by their mothers as experiencing some degree of psychological maladjustment. Adjustment difficulties were specific to social functioning, low self-esteem, and internalizing symptoms. Forty-one percent of mothers of child participants and 56% of mothers of adolescent participants reported clinically significant psychological distress. Youth self-report and mother-report of youths' psychological difficulties were often most strongly associated with mothers' level of psychological distress and/or family socioeconomic status rather than to youth characteristics (e.g., percent overweight, race). Psychological maladjustment levels among obese youth and their mothers were higher in this clinic-based sample than in treatment research-based samples. Present correlate findings extended to obese adolescents and reaffirm a potent association between youth self-report of their own psychological adjustment and their mother's level of psychological distress. Demographic characteristics and youth weight status were not consistent correlates of youths' psychological functioning. Findings have implications for the translation of empirically supported pediatric obesity interventions to clinic-based treatment samples.

  14. Is implementing screening for distress an efficient means to recruit patients to a psychological intervention trial?

    NARCIS (Netherlands)

    van Scheppingen, Corinne; Schroevers, Maya J.; Pool, Grieteke; Smink, Ans; Mul, Veronique E.; Coyne, James C.; Sanderman, Robbert

    2014-01-01

    ObjectivesPsychological interventions show greater efficacy when evaluated with distressed patients. We report on the feasibility of implementing screening for recruiting distressed cancer patients to a randomized controlled trial of problem-solving therapy (PST), characteristics associated with enr

  15. Is implementing screening for distress an efficient means to recruit patients to a psychological intervention trial?

    NARCIS (Netherlands)

    van Scheppingen, Corinne; Schroevers, Maya J.; Pool, Grieteke; Smink, Ans; Mul, Veronique E.; Coyne, James C.; Sanderman, Robbert

    2014-01-01

    ObjectivesPsychological interventions show greater efficacy when evaluated with distressed patients. We report on the feasibility of implementing screening for recruiting distressed cancer patients to a randomized controlled trial of problem-solving therapy (PST), characteristics associated with enr

  16. Do psychological interventions reduce depression in hemodialysis patients?: A meta-analysis of randomized controlled trials following PRISMA.

    Science.gov (United States)

    Xing, Lu; Chen, Ruiqi; Diao, Yongshu; Qian, Jiahui; You, Chao; Jiang, Xiaolian

    2016-08-01

    Depression is highly prevalent in hemodialysis patients and results in poor patient outcomes. Although psychological interventions are being developed and used for these patients, there is uncertainty regarding the effectiveness of these interventions. The purpose of this meta-analysis is to evaluate the effects of psychological interventions on depression treatment in hemodialysis patients. All randomized controlled trials (RCTs) relevant to the depression treatment of hemodialysis patients through psychological interventions were retrieved from the following databases: Embase, Pubmed, PsycINFO, the Cochrane Database of Systematic Reviews, and the Cochrane Central Register of Controlled Trials. The reference lists of identified RCTs were also screened. The Cochrane risk of bias tool was used to evaluate the quality of the studies, RevMan (5.3) was used to analyze the data, and the evidence quality of the combined results was evaluated using GRADE (3.6.1). Eight RCTs were included. The combined results showed that psychological interventions significantly reduced the scores of the Beck Depression Inventory (P<0.001) and interdialysis weight gain (P<0.001). However, due to the high heterogeneity, effect size combinations of sleep quality and quality of life were not performed. Psychological interventions may reduce the degree of depression and improve fluid intake restriction adherence. More rigorously designed research is needed.

  17. Childhood obesity treatment and prevention. Psychological perspectives of clinical approaches

    Directory of Open Access Journals (Sweden)

    Maria Catena Quattropani

    2013-05-01

    Full Text Available 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. Conclusions: There is a clear need to consider psychological aspects (emotional, cognitive and relational related to the childhood obesity’s causes and involve psychologists in its prevention projects. Keywords: childhood obesity, overweight, multidisciplinary approach, clinical psychology, prevention, treatment

  18. Avoiding Aging? Social Psychology's Treatment of Age

    Science.gov (United States)

    Barrett, Anne E.; Redmond, Rebecca; von Rohr, Carmen

    2012-01-01

    Population aging, in conjunction with social and cultural transformations of the life course, has profound implications for social systems--from large-scale structures to micro-level processes. However, much of sociology remains fairly quiet on issues of age and aging, including the subfield of social psychology that could illuminate the impact of…

  19. 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

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

    Science.gov (United States)

    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.

  1. Anesthesia awareness: narrative review of psychological sequelae, treatment, and incidence.

    Science.gov (United States)

    Bruchas, Robin R; Kent, Christopher D; Wilson, Hilary D; Domino, Karen B

    2011-09-01

    Awareness during general anesthesia occurs when patients recall events or sensations during their surgeries, although the patients should have been unconscious at the time. Anesthesiologists are cognizant of this phenomenon, but few discussions occur outside the discipline. This narrative review summarizes the patient recollections, psychological sequelae, treatment and follow-up of psychological consequences, as well as incidence and etiology of awareness during general anesthesia. Recalled memories include noises, conversations, images, mental processes, feelings of pain and/or paralysis. Psychological consequences include anxiety, flashbacks, and posttraumatic stress disorder diagnosis. Limited discussion for therapeutic treatment after an anesthesia awareness experience exists. The incidence of anesthesia awareness ranges from 0.1 to 0.2% (e.g., 1-2/1000 patients). Increased recognition of awareness during general anesthesia within the psychological/counseling community, with additional research focusing on optimal therapeutic treatment, will improve the care of these patients.

  2. Meta-analysis of psychological treatments for posttraumatic stress disorder in adult survivors of childhood abuse

    OpenAIRE

    Ehring, T.; Welboren, R; Morina, N; Wicherts, J.M.; J. Freitag; Emmelkamp, P.M.G.

    2014-01-01

    Posttraumatic stress disorder (PTSD) is highly prevalent in adult survivors of childhood sexual and/or physical abuse. However, intervention studies focusing on this group of patients are underrepresented in earlier meta-analyses on the efficacy of PTSD treatments. The current meta-analysis exclusively focused on studies evaluating the efficacy of psychological interventions for PTSD in adult survivors of childhood abuse. Sixteen randomized controlled trials meeting inclusion criteria could b...

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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…

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

    Science.gov (United States)

    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…

  7. Commentary on evidence-based psychological treatments for older adults.

    Science.gov (United States)

    Gatz, Margaret

    2007-03-01

    This article comments on the articles in the Special Section on Evidence-Based Psychological Treatments for Older Adults. The articles apply criteria developed by the Society of Clinical Psychology to evaluate treatments for late-life anxiety, insomnia, behavior disturbances in dementia, and caregiver distress. The articles document that there are evidence-based psychological treatments that can help older adults. However, there are 2 substantial hurdles: evidence and access. Gaps in the evidence, as mentioned by the authors of the articles in the special section, result from disproportionate research attention to some psychotherapies and some mental disorders, with corresponding lack of research about other treatments and disorders. The challenge for access is to ensure that older adults with treatable mental disorders will get connected to psychologists trained in these evidence-based therapies. ((c) 2007 APA, all rights reserved).

  8. PSYCHOLOGICAL COUNSELLING IN TREATMENT FOR IN VITRO FERTLIZATION

    Directory of Open Access Journals (Sweden)

    BELEVSKA J.

    2015-01-01

    Full Text Available Own family is the essence of person’s life. Forming family is the most important life event, for the couples. Often, it’s planned precisely in details, as education or career. Failure in this plan causes variety of negative psychological consequences. That’s why infertility of one or both of the partners is a serious problem. In the treatment of biologically supported fertilization, negative emotions may affect the successfulness of the IVF treatment. Intending to overcome negative emotional reaction, this study aims to identify the efficiency of psychological counseling of candidates for IFV in stress, anxiety and depression decreasing, and the impact of counseling over the successfulness of the treatment. Method: Random sample of 64 candidates for IVF treatment in total are divided in two groups: control group without psychological counseling (32 candidates and intervention group of 32 candidates included in psychological counseling. DASS scale is used to measure stress, anxiety and depression, semi structured interview is used to collect demographic and fertility data. Study results support the implementation of psychological counseling for candidates of IVF treatment.

  9. Psychological treatments for fibromyalgia: a meta-analysis.

    Science.gov (United States)

    Glombiewski, Julia A; Sawyer, Alice T; Gutermann, Jana; Koenig, Katharina; Rief, Winfried; Hofmann, Stefan G

    2010-11-01

    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 psychological treatment conditions and 1396 patients. Meta-analytic integration resulted in a significant but small effect size for short-term pain reduction (Hedges's g=0.37, 95% confidence interval (CI): 0.27-0.48) and a small-to-medium effect size for long-term pain reduction over an average follow-up phase of 7.4 months (Hedges's g=0.47, 95% CI: 0.3-0.65) for any psychological intervention. Psychological treatments also proved effective in reducing sleep problems (Hedges's g=0.46, 95% CI: 0.28-0.64), depression (Hedges's g=0.33, 95% CI: 0.20-0.45), functional status (Hedges's g=0.42, 95% CI: 0.25-0.58), and catastrophizing (Hedges's g=0.33, 95% CI: 0.17-0.49). These effects remained stable at follow-up. Moderator analyses revealed cognitive-behavioral treatment to be significantly better than other psychological treatments in short-term pain reduction (Hedges's g=0.60, 95% CI: 0.46-0.76). Higher treatment dose was associated with better outcome. Publication-bias analyses demonstrated that the effect sizes were robust. The results suggest that the effects of psychological treatments for fibromyalgia are relatively small but robust and comparable to those reported for other pain and drug treatments used for this disorder. Cognitive-behavioral therapy was associated with the greatest effect sizes. Copyright © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  10. Psychological treatment of social anxiety disorder: a meta-analysis.

    NARCIS (Netherlands)

    Acarturk, C.; Cuijpers, P.; Straten, van A.; Graaf, de R.

    2009-01-01

    Abstract Background Older meta-analyses of the effects of psychological treatments of social anxiety disorder have found that these treatments have moderate to large effects. However, these earlier meta-analyses also included non-randomized studies, and there are many featured studies in this area w

  11. Treatment Acceptability of Interventions Published in Six School Psychology Journals

    Science.gov (United States)

    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…

  12. Treatment Acceptability of Interventions Published in Six School Psychology Journals

    Science.gov (United States)

    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…

  13. Reflex sympathetic dystrophy: Early treatment and psychological aspects

    NARCIS (Netherlands)

    Geertzen, J.H.B.; De Bruijn, H.; De Bruijn-Kofman, A.T.; Arendzen, J.H.

    1994-01-01

    We report the results of two prospective studies of early treatment and psychological aspects in a series of 26 patients with sympathetic reflex dystrophy of the hand in which treatment was started within 3 months after diagnosis. Ismelin blocks is an often used therapy in sympathetic reflex dystrop

  14. The Psychological Impact of IVF Treatment

    NARCIS (Netherlands)

    C. de Klerk (Cora)

    2008-01-01

    textabstractIVF treatment requires the woman to undergo several invasive procedures, which are repeated in subsequent treatment cycles. In addition to the physical burden, the threat of treatment failure confronts the couple with the possibility that they have to give up hope to have a child of thei

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

    Science.gov (United States)

    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.

  16. 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...... 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...... statistical testing, we estimated the statistical significance of the differences between the compared groups using unpaired t tests. MAIN RESULTS: From 5099 retrieved abstracts, 16 studies were included. Diagnosis and treatment of CIN were associated with worse psychological outcomes than normal cytology...

  17. Cost-effectiveness of online positive psychology: Randomized controlled trial

    NARCIS (Netherlands)

    Bolier, Linda; Majo, Cristina; Smit, Filip; Westerhof, Gerben Johan; Haverman, Merel; Walburg, J.A.; Riper, Heleen; Bohlmeijer, Ernst Thomas

    2014-01-01

    As yet, no evidence is available about the cost-effectiveness of positive psychological interventions. When offered via the Internet, these interventions may be particularly cost-effective, because they are highly scalable and do not rely on scant resources such as therapists’ time. Alongside a rand

  18. Positive psychology group intervention for breast cancer patients: a randomised trial.

    Science.gov (United States)

    Victoria Cerezo, M; Ortiz-Tallo, Margarita; Cardenal, Violeta; De La Torre-Luque, Alejandro

    2014-08-01

    This study assessed the effects of a psychological group intervention based on positive psychology in women with breast cancer. 175 women were randomly assigned either to an experimental group, receiving the 14-session intervention (n = 87), or to a wait list group (n = 88) that did not receive any type of intervention. For treatment, a group intervention was applied, based on improving psychological strengths and enhancing positive psychology-based styles of coping. Strength-related outcomes, self-esteem, well-being, and happiness were assessed before and after the intervention. The experimental group showed higher scores on all of the study variables after the intervention. Participants reported improved self-esteem, emotional intelligence-related abilities, resilience, and optimism, as well as positive affectivity, well-being, and happiness. The results show a beneficial effect of this psychological intervention based on positive psychology on female breast cancer patients' psychological health.

  19. Placebo and other psychological interactions in headache treatment

    OpenAIRE

    Autret, A; Valade, D.; Debiais, S.

    2012-01-01

    We present a theory according which a headache treatment acts through a specific biological effect (when it exists), a placebo effect linked to both expectancy and repetition of its administration (conditioning), and a non-specific psychological effect. The respective part of these components varies with the treatments and the clinical situations. During antiquity, suggestions and beliefs were the mainstays of headache treatment. The word placebo appeared at the beginning of the eighteenth ce...

  20. Psychological treatment versus combined treatment of depression: A meta-analysis.

    NARCIS (Netherlands)

    Cuijpers, P.; Straten, van A.; Warmerdam, E.H.; Andersson, G.

    2009-01-01

    Background: A large number of studies have shown that psychological treatments have significant effects on depression. Although several studies have examined the relative effects of psychological and combined treatments, this has not been studied satisfactorily in recent statistical meta-analyses. M

  1. Psychological Therapy for People with Tinnitus: A Scoping Review of Treatment Components.

    Science.gov (United States)

    Thompson, Dean M; Hall, Deborah A; Walker, Dawn-Marie; Hoare, Derek J

    , habituation, hypnosis, or relaxation as necessary parts of the treatment. A total of 5043 records were retrieved of which 64 were retained. Twenty-five themes of components that have been included within a psychological therapy were identified, including tinnitus education, psychoeducation, evaluation treatment rationale, treatment planning, problem-solving behavioral intervention, thought identification, thought challenging, worry time, emotions, social comparison, interpersonal skills, self-concept, lifestyle advice, acceptance and defusion, mindfulness, attention, relaxation, sleep, sound enrichment, comorbidity, treatment reflection, relapse prevention, and common therapeutic skills. The most frequently reported psychological therapies were cognitive behavioral therapy, tinnitus education, and internet-delivered cognitive behavioral therapy. No records reported that an audiologist delivered any of these psychological therapies in the context of an empirical trial in which their role was clearly delineated from that of other clinicians. Scoping review methodology does not attempt to appraise the quality of evidence or synthesize the included records. Further research should therefore determine the relative importance of these different components of psychological therapies from the perspective of the patient and the clinician.

  2. Psychological Therapy for People with Tinnitus: A Scoping Review of Treatment Components

    Science.gov (United States)

    Hall, Deborah A.; Walker, Dawn-Marie; Hoare, Derek J.

    2017-01-01

    intervention included biofeedback, habituation, hypnosis, or relaxation as necessary parts of the treatment. Results: A total of 5043 records were retrieved of which 64 were retained. Twenty-five themes of components that have been included within a psychological therapy were identified, including tinnitus education, psychoeducation, evaluation treatment rationale, treatment planning, problem-solving behavioral intervention, thought identification, thought challenging, worry time, emotions, social comparison, interpersonal skills, self-concept, lifestyle advice, acceptance and defusion, mindfulness, attention, relaxation, sleep, sound enrichment, comorbidity, treatment reflection, relapse prevention, and common therapeutic skills. The most frequently reported psychological therapies were cognitive behavioral therapy, tinnitus education, and internet-delivered cognitive behavioral therapy. No records reported that an audiologist delivered any of these psychological therapies in the context of an empirical trial in which their role was clearly delineated from that of other clinicians. Conclusions: Scoping review methodology does not attempt to appraise the quality of evidence or synthesize the included records. Further research should therefore determine the relative importance of these different components of psychological therapies from the perspective of the patient and the clinician. PMID:27541331

  3. Web-based remote psychological intervention improves cancer treatment.

    Science.gov (United States)

    Wang, Ping; Yu, Tao; Yang, Lin

    2017-08-01

    Web-based-remote (WBR) intervention is a new approach that incorporates smart control technology and modern medicine to monitor patient compliance. It is based on computer control and communication technology. This study is to explore the benefits of WBR psychological intervention for cancer treatment. 128 patients diagnosed with cancer by Pathology Department of our hospital between 1 February 2013 and 1 August 2013 were included. Patients were randomly assigned to intervention and control group (n = 64). The Questionnaire-Core 30 (QLQ-C30) was used for the survey. Intervention group received WBR psychological intervention in addition to regular clinical follow-up care. Control group only received regular clinical follow-up care. The QLQ-C30 score was significantly better in the intervention group than the control group when the intervention and control groups were followed for three months. In conclusion, WBR psychological intervention substantially improves the quality of life in patients during cancer treatment.

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

    Science.gov (United States)

    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

  5. The psychology of own versus others’ treatment:

    NARCIS (Netherlands)

    Bos, K. van den; Lind, E. Allan

    2001-01-01

    This article focuses on how people interpret their own versus others’ treatment. Two experiments investigate how perceived procedural justice is affected by procedures that are experienced personally versus those seen to have been experienced by others. The studies show that, at least under some con

  6. Preferential treatment of women and psychological reactance theory: An experiment

    NARCIS (Netherlands)

    A.J. Vrugt

    1992-01-01

    187 male academic staff members read a low- or high-threat (freedom restricting) description of measures for the preferential treatment of women in job selection for academic staff functions. The high-threat condition evoked more psychological reactance than the low-threat condition. Ss with high se

  7. 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...

  8. 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 psychol

  9. Overview of Diagnosis and Treatment of Psychological Trauma in Children.

    Science.gov (United States)

    Munson, Carlton E.

    1995-01-01

    Provides comprehensive definition of psychological trauma and offers guidance to practitioners who are increasingly needed to treat traumatized children. Key therapy considerations are organized around the role of dissociation and repetition compulsion in trauma. Presents treatments in connection with aloneness of trauma experience, dream and…

  10. Research Forum on Psychological Treatment of Adults with ADHD

    Science.gov (United States)

    Weiss, Margaret; Safren, Steven A.; Solanto, Mary V.; Hechtman, Lily; Rostain, Anthony L.; Ramsay, J. Russell; Murray, Candice

    2008-01-01

    Background: A literature search found five empirical studies of psychological treatment for adults with ADHD, out of 1,419 articles on ADHD in adults. Practice guidelines to date all recommend multimodal intervention, given that a significant number of patients cannot tolerate, do not respond to, or fail to reach optimal outcomes with medication…

  11. Psychological treatment of depression in inpatients: A systematic review

    NARCIS (Netherlands)

    Cuijpers, Pim; Clignet, Frans; Meijel, Berno van; Straten, Annemieke van; Li, Juan; Andersson, Gerhard

    2011-01-01

    Research on psychological treatment of depression in inpatients is not conclusive,with some studies finding clear positive effects and other studies finding no significant benefit compared to usual care or structured pharmacotherapy. The results of a meta-analysis investigating how effective psychol

  12. 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

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

    Science.gov (United States)

    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.

  14. Psychological and Behavioral Treatments for Binge-Eating Disorder.

    Science.gov (United States)

    Grilo, Carlos M

    2017-01-01

    Several psychological and behavioral treatment options exist for patients who have been diagnosed with binge-eating disorder (BED). Cognitive-behavioral therapy and interpersonal psychotherapy are the most strongly supported interventions for BED, but they do not produce weight loss; behavioral weight loss therapy, a more widely available "generalist" intervention, achieves good outcomes for BED plus produces modest weight loss over the short-term. Relatively little is known about reliable predictors or moderators of treatment outcomes, but research has generally supported 2 significant predictors: (1) the presence of overvaluation of body shape and weight and (2) the occurrence of rapid response to treatment. Clinicians should train to provide patients with evidence-supported psychological and behavioral treatments and follow these intervention protocols faithfully to increase the chances of good outcomes. © Copyright 2017 Physicians Postgraduate Press, Inc.

  15. Meta-analysis of psychological treatments for posttraumatic stress disorder in adult survivors of childhood abuse.

    Science.gov (United States)

    Ehring, Thomas; Welboren, Renate; Morina, Nexhmedin; Wicherts, Jelte M; Freitag, Janina; Emmelkamp, Paul M G

    2014-12-01

    Posttraumatic stress disorder (PTSD) is highly prevalent in adult survivors of childhood sexual and/or physical abuse. However, intervention studies focusing on this group of patients are underrepresented in earlier meta-analyses on the efficacy of PTSD treatments. The current meta-analysis exclusively focused on studies evaluating the efficacy of psychological interventions for PTSD in adult survivors of childhood abuse. Sixteen randomized controlled trials meeting inclusion criteria could be identified that were subdivided into trauma-focused cognitive behavior therapy (CBT), non-trauma-focused CBT, eye movement desensitization and reprocessing, and other treatments (interpersonal, emotion-focused). Results showed that psychological interventions are efficacious for PTSD in adult survivors of childhood abuse, with an aggregated uncontrolled effect size of g=1.24 (pre- vs. post-treatment), and aggregated controlled effect sizes of g=0.72 (post-treatment, comparison to waitlist control conditions) and g=0.50 (post-treatment, comparison with TAU/placebo control conditions), respectively. Effect sizes remained stable at follow-up. As the heterogeneity between studies was large, we examined the influence of two a priori specified moderator variables on treatment efficacy. Results showed that trauma-focused treatments were more efficacious than non-trauma-focused interventions, and that treatments including individual sessions yielded larger effect sizes than pure group treatments. As a whole, the findings are in line with earlier meta-analyses showing that the best effects can be achieved with individual trauma-focused treatments.

  16. Minority Representation in Migraine Treatment Trials.

    Science.gov (United States)

    Robbins, Nathaniel M; Bernat, James L

    2017-03-01

    . No studies stratified efficacy or safety by ethnicity or gender. Men and non-Whites in the U.S. were statistically underrepresented. Most recent headache studies comply with the NIH mandate to include women and minorities in research trials, particularly U.S.-based and industry-funded studies. Whites are overrepresented compared to both the general population and the population of migraineurs. Future studies should strive to increase minority participation and investigate race-based differences in migraine expression, treatment response, and medication toxicity. © 2017 American Headache Society.

  17. [Obesity psychological treatment: beyond cognitive and behavioral therapy].

    Science.gov (United States)

    Volery, M; Bonnemain, A; Latino, A; Ourrad, N; Perroud, A

    2015-03-25

    The psychological assessment of the patient with obesity aims to identify the factors of maintenance of excess weight, such as eating disorders or anxio-depressive disorders. Psychotherapy helps a better weight management. Cognitive-behavioral therapy has shown its effectiveness in the treatment of obesity. New psychotherapeutic approaches are explored. The hypnosis and mindfulness are proposed for the management of emotions and stress. A targeted approach on the body image disorder decreases body dissatisfaction. When post-traumatic stress syndrome is involved, EMDR (Eye Movement Desensitization & Reprocessing) is better than other types of therapies. Family therapy is indicated when the entourage is impacted. Psychological difficulties should be the subject of specific care.

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

    Science.gov (United States)

    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

  19. Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study

    NARCIS (Netherlands)

    Schellekens, M.P.J.; Hurk, D.G.M. van den; Prins, J.B.; Molema, J.; Donders, A.R.T.; Woertman, W.H.; Drift, M.A. van der; Speckens, A.E.M.

    2014-01-01

    BACKGROUND: Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxie

  20. Study protocol of a multicenter randomized controlled trial comparing the effectiveness of group and individual internet-based Mindfulness-Based Cognitive Therapy with treatment as usual in reducing psychological distress in cancer patients: the BeMind study

    NARCIS (Netherlands)

    Compen, F.R.; Bisseling, E.M.; Lee, M.L. Van der; Adang, E.M.M.; Donders, A.R.T.; Speckens, A.E.M.

    2015-01-01

    BACKGROUND: Mindfulness-based interventions have shown to reduce psychological distress in cancer patients. The accessibility of mindfulness-based interventions for cancer patients could be further improved by providing mindfulness using an individual internet-based format. The aim of this study is

  1. The Psychological Development of the Terrorist Mind Set: Pertinence in the Sentencing Phase of Capital Trial

    Directory of Open Access Journals (Sweden)

    Leslie Dawn Culpepper

    2016-03-01

    Full Text Available This paper reviews past and current scholarly literature about the psychological development of the terrorist mind set with a special focus on how adverse life experiences early in one’s lifetime negatively impacts the normal psychological development. Information that pertains to childhood trauma, social psychological factors, psycho-social causes, and psycho-cultural foundations that play a role in the development of terrorist beliefs and behaviors are explored. This paper also reviews several theories that attempt to explain terrorism; a few from a social and cultural perspective, as a constellation of terrorism research scholars suggest that the development of terrorist behavior is in every way contextual. The lives of two known terrorists, Dzhokhar Tsarnaev and Ted Kaczynski, are analyzed to illustrate how the psychological, social, and cultural factors that make up their backgrounds were applied in the sentencing (mitigation phases of their trials resulting in the death penalty being replaced with a life sentence for both. 

  2. Male psychological adaptation to unsuccessful medically assisted reproduction treatments

    DEFF Research Database (Denmark)

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

    2016-01-01

    for psychological maladjustment. Protective factors were related to the use of coping strategies that involve seeking information and attribution of a positive meaning to infertility, having the support of others and of one's spouse, and engaging in open communication about the infertility problem. WIDER...... to infertility and related treatments. OBJECTIVE AND RATIONALE: The main research questions addressed in this review were 'Does male psychological adaptation to unsuccessful medically assisted reproduction (MAR) treatment vary over time?' and 'Which psychosocial variables act as protective or risk factors...... IMPLICATIONS: Our findings recommend an active involvement of men during the treatment process by health care professionals, and the inclusion of coping skills training and couple communication enhancement interventions in counselling. Further prospective large studies with high-quality design and power...

  3. Sustained effectiveness and cost-effectiveness of Counselling for Alcohol Problems, a brief psychological treatment for harmful drinking in men, delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Abhijit Nadkarni

    2017-09-01

    unable to work, or perpetration of intimate partner violence. Economic analyses indicated that CAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed a 99% chance of CAP being cost-effective per remission achieved from a health system perspective, using a willingness to pay threshold equivalent to 1 month's wages for an unskilled manual worker in Goa. Readiness to change level at 3 months mediated the effect of CAP on mean standard ethanol consumption at 12 months (indirect effect -6.014 [95% CI -13.99, -0.046]. Serious adverse events were infrequent, and prevalence was similar by arm. The methodological limitations of this trial are the susceptibility of self-reported drinking to social desirability bias, the modest participation rates of eligible patients, and the examination of mediation effects of only 1 mediator and in only half of our sample.CAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by readiness to change. CAP provides better outcomes at lower costs from a societal perspective.ISRCTN registry ISRCTN76465238.

  4. Psychological treatments for adults with posttraumatic stress disorder: A systematic review and meta-analysis.

    Science.gov (United States)

    Cusack, Karen; Jonas, Daniel E; Forneris, Catherine A; Wines, Candi; Sonis, Jeffrey; Middleton, Jennifer Cook; Feltner, Cynthia; Brownley, Kimberly A; Olmsted, Kristine Rae; Greenblatt, Amy; Weil, Amy; Gaynes, Bradley N

    2016-02-01

    Numerous guidelines have been developed over the past decade regarding treatments for Posttraumatic stress disorder (PTSD). However, given differences in guideline recommendations, some uncertainty exists regarding the selection of effective PTSD therapies. The current manuscript assessed the efficacy, comparative effectiveness, and adverse effects of psychological treatments for adults with PTSD. We searched MEDLINE, Cochrane Library, PILOTS, Embase, CINAHL, PsycINFO, and the Web of Science. Two reviewers independently selected trials. Two reviewers assessed risk of bias and graded strength of evidence (SOE). We included 64 trials; patients generally had severe PTSD. Evidence supports efficacy of exposure therapy (high SOE) including the manualized version Prolonged Exposure (PE); cognitive therapy (CT), cognitive processing therapy (CPT), cognitive behavioral therapy (CBT)-mixed therapies (moderate SOE); eye movement desensitization and reprocessing (EMDR) and narrative exposure therapy (low-moderate SOE). Effect sizes for reducing PTSD symptoms were large (e.g., Cohen's d ~-1.0 or more compared with controls). Numbers needed to treat (NNTs) were PTSD diagnosis for exposure therapy, CPT, CT, CBT-mixed, and EMDR. Several psychological treatments are effective for adults with PTSD. Head-to-head evidence was insufficient to determine these treatments' comparative effectiveness, and data regarding adverse events was absent from most studies.

  5. 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

  6. Causal explanations affect judgments of the need for psychological treatment

    Directory of Open Access Journals (Sweden)

    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.

  7. 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...... from baseline, and we aimed at quantifying these contributions. METHODS: Systematic review and meta-analysis, based on a Cochrane review of the effect of placebo interventions for all clinical conditions. We selected all trials that had randomised the patients to three arms: no treatment, placebo...

  8. Clinical Trials and Treatment of ATL

    Directory of Open Access Journals (Sweden)

    Kunihiro Tsukasaki

    2012-01-01

    Full Text Available ATL is a distinct peripheral T-lymphocytic malignancy associated with human T-cell lymphotropic virus type I (HTLV-1. The diversity in clinical features and prognosis of patients with this disease has led to its subtype-classification into four categories, acute, lymphoma, chronic, and smoldering types, defined by organ involvement, and LDH and calcium values. In case of acute, lymphoma, or unfavorable chronic subtypes (aggressive ATL, intensive chemotherapy like the LSG15 regimen (VCAP-AMP-VECP is usually recommended if outside of clinical trials, based on the results of a phase 3 trial. In case of favorable chronic or smoldering ATL (indolent ATL, watchful waiting until disease progression has been recommended, although the long-term prognosis was inferior to those of, for instance, chronic lymphoid leukemia. Retrospective analysis suggested that the combination of interferon alpha and zidovudine was apparently promising for the treatment of ATL, especially for types with leukemic manifestation. Allogeneic hematopoietic stem cell transplantation (allo-HSCT is also promising for the treatment of aggressive ATL possibly reflecting graft versus ATL effect. Several new agent trials for ATL are ongoing and in preparation, including a defucosylated humanized anti-CC chemokine receptor 4 monoclonal antibody, IL2-fused with diphtheria toxin, histone deacetylase inhibitors, a purine nucleoside phosphorylase inhibitor, a proteasome inhibitor, and lenalidomide.

  9. Psychological testing and treatment implications: we can say more.

    Science.gov (United States)

    Bram, Anthony D

    2013-01-01

    Psychologists invest considerable time and labor in psychological testing and report writing. Patients and families expose vulnerabilities and make a significant financial and time investment in the hope that testing will make a difference in treatment. Frequently, though, handling of treatment implications in reports is generic, which might not justify the time, expense, and emotional investment involved in the evaluation. As diagnosticians, we have the responsibility and potential to contribute more meaningfully to the work of our referring colleagues and the treatment of the patients we assess. I review the psychotherapy research literature to highlight evidence-based findings that can serve as guideposts in formulating treatment implications. Subsequently, I illustrate how we can use test data to make nuanced inferences about therapeutic alliance, potential resistances, likely transferences and countertransferences, and conceptualizing treatment on the supportive-expressive continuum.

  10. Music therapy to promote psychological and physiological relaxation in palliative care patients: protocol of a randomized controlled trial.

    Science.gov (United States)

    Warth, Marco; Kessler, Jens; Koenig, Julian; Wormit, Alexander F; Hillecke, Thomas K; Bardenheuer, Hubert J

    2014-01-01

    Music therapy is one of the most frequently used complementary therapies in different palliative care settings. Despite its long tradition and high acceptance by other health-care professionals, evidence on the effectiveness of music therapy interventions for terminally ill patients is rare. Recent reviews and health-care reports consistently point out the need of music therapists to provide an evidence-based rationale for their clinical treatments in this field. Therefore, the present study evaluates the psychological and physiological response of palliative care patients to a standardized music therapy relaxation intervention in a randomized controlled trial. A sample of 84 participants from a palliative care unit in Heidelberg is randomized to either two sessions of music therapy or two sessions of a verbal relaxation exercise, each lasting 30 minutes. The music therapy sessions consist of live played monochord music and a vocal improvisation, the control group uses a prerecorded excerpt from the mindfulness-based stress reduction program containing no musical elements. Outcome measures include self-report data on subjective relaxation, well-being, pain intensity, and quality of life, as well as continuous recording of heart rate variability and blood volume pulse as indicators of autonomous nervous system functioning. To our knowledge, this study is the first clinical trial in Europe and one of very few randomized controlled trials worldwide to systematically examine the effects of music therapy in palliative care. German Clinical Trials Register - DRKS00006137.

  11. 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…

  12. [Treatment of the psychological and behavioural disorders of Alzheimer's disease].

    Science.gov (United States)

    Pancrazi, M-P; Metais, P

    2005-05-14

    When psychological and behavioral disorders of Alzheimer's disease appear suddenly, somatic, iatrogenic and reactive or relational psychological causes must be ruled out or treated before concluding that the cause is lesional. Non-pharmacological interventions should be privileged for the prevention and management of behavioral manifestations of mild to moderate intensity: psychological support of the patient (short therapies), training the caregiver, work on daily habits, reorganization of the home, behavioral measures against apathy and especially agitation, rehabilitation strategies, and therapy involving music, light, aromas, etc. Pharmacological therapies are only moderately effective in these disorders. They must be targeted and follow a sequence of prescription that maximizes tolerance and distinguishes treatment of acute and chronic states. Anticholinesterase agents may be useful in this domain to prevent or ease some symptoms (especially apathy). The efficacy of memantine must be confirmed by additional data. Some selective serotonin reuptake inhibitors agents may be useful not only in depression but also anxiety, emotional disturbances, irritability and compulsiveness. Atypical neuroleptics are better tolerated than the classic ones. They are most effective in this context but must be reserved for specific indications and limited in time because of the increased risk of stroke. Other psychotropics (benzodiazepines, carbamates, antiepileptics) should be used cautiously in this context.

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

    Science.gov (United States)

    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

  14. Psychological distress among dancers seeking outpatient treatment for musculoskeletal injury.

    Science.gov (United States)

    Air, Mary Elizabeth

    2013-09-01

    The purpose of this study was to investigate the incidence and magnitude of clinically significant psychological symptoms among outpatient injured dancers presenting for musculoskeletal issues and to identify features of "at risk" dancer-patients who might require additional psychological support when injured. The Brief Symptom Inventory® (BSI), a highly reliable and valid screening tool for psychological distress, was administered to first- and last-visit injured dancers at an orthopedic clinic in the Netherlands from February to May 2008. In all, 153 BSI surveys were completed, including 82 among first-visit patients and 71 among end-treatment patients. Scores were examined for the influence of age, gender, dance level, style, pain, perceived level of artistic compromise, and anatomic location of injury. Dancers' scores were compared to normative values for adult non-psychiatric patient community members. Ninety-two dancers (60.1%) met requirements for clinical referral to a psychologist or psychiatrist, having scored two or more standard deviations (SD) above the norm in at least one of nine psychopathological symptoms. Across first- and last-visit groups, dancers met referral criteria for an average of four psychopathological symptoms. First-visit dancers demonstrated higher distress than the general population on 90% of BSI dimensional symptoms and last-visit dancers on 50%. On the Global Symptom Index, a summary score for overall distress and the best measure of psychological discomfort, 46.6% of dancers demonstrated "above average" distress (≥ 1 SD) compared to the general population, and 19.6% demonstrated "high" (≥ 2 SD) or "very high" (≥ 2.5 SD) distress. Compared to academy level pre-professional students, professionals showed reduction in BSI scores on somatic, cognitive, interpersonal sensitivity, anxious, hostile, phobic, and global scores following resolution of injury, particularly among those greater than 25 years of age. Students and

  15. Psychological influences on the timing of orthodontic treatment.

    Science.gov (United States)

    Tung, A W; Kiyak, H A

    1998-01-01

    Debates about the "ideal" timing of orthodontic treatment have focused on issues of biologic development and readiness. In this article we examine psychologic issues that should be considered in the decision to initiate orthodontics in the younger child or to wait until adolescence or later. Psychologic development during the preadolescent and adolescent stages may influence the child's motive for, understanding of, and adherence to treatment regimens. Results of a study of some personality characteristics, motives, and aesthetic values of young phase I patients are presented. Questionnaires were completed by 75 children (mean age 10.85 years, 52.1% female, 84% white) and their parents. Children's perceived reasons for treatment were consistent with their parents' reports (chi 2 = 76.08, p crowded teeth (56%) and overbite (17.3%). Although body image and self-concept scores were within the normal range, both children and their parents expected the most improvement in self-image and oral function, with greater expectations by parents on self-image (p crowded teeth (p < .02), overbite (p < .02), and diastema (p < .01) more negatively than did ethnic minorities. These results suggest that younger children are good candidates for Phase I orthodontics, have high self-esteem and body-image, and expect orthodontics to improve their lives. White children who have been referred for Phase I orthodontics appear to have a narrower range of aesthetic acceptability than minority children.

  16. From question-behaviour effects in trials to the social psychology of research participation.

    Science.gov (United States)

    McCambridge, Jim

    2015-01-01

    The 'question-behaviour effect' (QBE) has attracted much recent attention within health psychology, where it has also been referred to as the 'mere measurement' effect. There are other conceptualisations of similar phenomena in related disciplines. This paper explores the implications of the QBE for the safety of inferences about intervention effectiveness within the context of randomised controlled trials evaluating health behaviour change interventions. It draws attention to poorly understood mechanisms by which bias is introduced with conventional thinking about trial design and analysis. The threat to valid inference on intervention effectiveness posed by the QBE applies even when its effects are small and regardless of the specific content of the QBE. The nature of the resulting bias does not fit well within existing bias classification schemes, such as that proposed by the Cochrane Collaboration. The QBE is one possible consequence of research participation and it is suggested that the social psychology of research participation is very much underdeveloped. Possible future directions for health psychology research in this area are considered.

  17. The effects of centralised and specialised combined pharmacological and psychological intervention compared with decentralised and non-specialised treatment in the early course of severe unipolar and bipolar affective disorders--design of two randomised clinical trials

    DEFF Research Database (Denmark)

    Kessing, Lars Vedel; Hansen, Hanne Vibe; Christensen, Ellen Margrethe

    2011-01-01

    In unipolar, and bipolar affective disorders, there is a high risk of relapse that increases as the number of episodes increases. Naturalistic follow-up studies suggest that the progressive development of the diseases is not prevented with the present treatment modalities. It is not known whether...... centralised and specialised secondary care intervention initiated early after the onset of the diseases can prevent the progression and thereby improve the prognosis....

  18. Psychological treatment and therapeutic change in incarcerated rapists

    Directory of Open Access Journals (Sweden)

    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.

  19. Inter-reality in the evaluation and treatment of psychological stress disorders: the INTERSTRESS project.

    Science.gov (United States)

    Cipresso, Pietro; Gaggioli, Andrea; Serino, Silvia; Raspelli, Simona; Vigna, Cinzia; Pallavicini, Federica; Riva, Giuseppe

    2012-01-01

    "Psychological stress" occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. According to the Cochrane Database of Systematic Reviews, the best validated approach covering both stress management and stress treatment is the Cognitive Behavioral (CBT) approach. CBT has undergone a very large number of trials in research contexts. However, it has been less efficacious in clinical contexts and it has become obvious that CBT has some failings when applied in general practice. INTERSTRESS is a EU-funded project that aims to design, develop and test an advanced ICT-based solution for the assessment and treatment of psychological stress that is able to address three critical limitations of CBT: a) the therapist is less relevant than the specific protocol used. b) the protocol is not customized to the specific characteristics of the patient; c) the focus of the therapy is more on the top-down model of change (from cognitions to emotions) than on the bottom-up (from emotions to cognitions). To reach this goal the INTERSTRESS project applies an innovative paradigm for e-health - Interreality - that integrates assessment and treatment within a hybrid environment, bridging physical and virtual worlds. On one side, the patient is continuously assessed in the virtual and real worlds by tracking the behavioral and emotional status in the context of challenging tasks (customization of the therapy according to the characteristics of the patient). On the other side, feedback is continuously provided to improve both the appraisal and the coping skills of the patient through a conditioned association between effective performance state and task execution behaviors (improvement of self efficacy). Within this conceptual framework, it is possible to set up and test psychological treatments that could be extended also beyond the traditional research and clinical setting by using more and more emerging mobile technology to deliver real

  20. Psychoanalytic treatment of psychological addiction to alcohol (alcohol abuse).

    Science.gov (United States)

    Johnson, Brian

    2011-01-01

    The DSM-V Committee plans to abolish the distinction between Alcohol Abuse and Alcohol Dependence (dsm5.org). The author presents a case report as a proof of concept that this distinction should be retained. The author has asserted that Alcohol Abuse is a purely psychological addiction, while Alcohol Dependence involves capture of the ventral tegmental dopaminergic SEEKING system (Johnson, 2003). In psychological addiction the brain can be assumed to function normally, and ordinary psychoanalytic technique can be followed. For the patient described, transference interpretation was the fundamental key to recovery. Alcoholic drinking functioned to prevent this man from remembering overwhelming childhood events; events that were also lived out in his current relationships. Murders that occurred when he was a child were hidden in a screen memory. The patient had an obsessional style of relating where almost all feeling was left out of his associations. After he stopped drinking compulsively, he continued to work compulsively. The maternal transference had to be enacted and then interpreted in order for overwhelming memories to be allowed into conscious thought. After psychoanalysis, the patient resumed drinking and worked a normal schedule that allowed more fulfilling relationships. He had no further symptoms of distress from drinking over a 9-year followup. This case illustrates that Alcohol Abuse is a purely psychological illness, that it does not have the brain changes typical of Alcohol Dependence. Combining epidemiological, neurobiological, longitudinal, and psychoanalytic observations would allow multiple sources of information to be used in creating diagnostic categories. Losing details of human behavior by relying only on epidemiological studies is likely to cause errors in categorization of disorders. In turn, having faulty categories as the basis of further research is likely to impair identification of specific effective treatments.

  1. Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Benedict Weobong

    2017-09-01

    Full Text Available The Healthy Activity Programme (HAP, a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes.Primary care attendees aged 18-65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9 were randomised to either HAP plus enhanced usual care (EUC (n = 247 or EUC alone (n = 248, of whom 95% completed assessments at 3 months, and 91% at 12 months. Primary outcomes were severity on the Beck Depression Inventory-II (BDI-II and remission on the PHQ-9. HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up (difference in mean BDI-II score between 3 and 12 months = -0.34; 95% CI -2.37, 1.69; p = 0.74, with lower symptom severity scores than participants who received EUC alone (adjusted mean difference in BDI-II score = -4.45; 95% CI -7.26, -1.63; p = 0.002 and higher rates of remission (adjusted prevalence ratio [aPR] = 1.36; 95% CI 1.15, 1.61; p < 0.009. They also fared better on most secondary outcomes, including recovery (aPR = 1.98; 95% CI 1.29, 3.03; p = 0.002, any response over time (aPR = 1.45; 95% CI 1.27, 1.66; p < 0.001, higher likelihood of reporting a minimal clinically important difference (aPR = 1.42; 95% CI 1.17, 1.71; p < 0.001, and lower likelihood of reporting suicidal behaviour (aPR = 0.71; 95% CI 0.51, 1.01; p = 0.06. HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months (aPR = -1.58; 95% CI -3.33, 0.17; p = 0.08; other outcomes (days unable to work, intimate partner violence toward females did not statistically significantly differ between the two arms. Economic analyses

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

    Science.gov (United States)

    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.

  3. Stepped care targeting psychological distress in head and neck and lung cancer patients: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Krebber Anne-Marie H

    2012-05-01

    Full Text Available Abstract Background Psychological distress is common in cancer survivors. Although there is some evidence on effectiveness of psychosocial care in distressed cancer patients, referral rate is low. Lack of adequate screening instruments in oncology settings and insufficient availability of traditional models of psychosocial care are the main barriers. A stepped care approach has the potential to improve the efficiency of psychosocial care. The aim of the study described herein is to evaluate efficacy of a stepped care strategy targeting psychological distress in cancer survivors. Methods/design The study is designed as a randomized clinical trial with 2 treatment arms: a stepped care intervention programme versus care as usual. Patients treated for head and neck cancer (HNC or lung cancer (LC are screened for distress using OncoQuest, a computerized touchscreen system. After stratification for tumour (HNC vs. LC and stage (stage I/II vs. III/IV, 176 distressed patients are randomly assigned to the intervention or control group. Patients in the intervention group will follow a stepped care model with 4 evidence based steps: 1. Watchful waiting, 2. Guided self-help via Internet or a booklet, 3. Problem Solving Treatment administered by a specialized nurse, and 4. Specialized psychological intervention or antidepressant medication. In the control group, patients receive care as usual which most often is a single interview or referral to specialized intervention. Primary outcome is the Hospital Anxiety and Depression Scale (HADS. Secondary outcome measures are a clinical level of depression or anxiety (CIDI, quality of life (EQ-5D, EORTC QLQ-C30, QLQ-HN35, QLQ-LC13, patient satisfaction with care (EORTC QLQ-PATSAT, and costs (health care utilization and work loss (TIC-P and PRODISQ modules. Outcomes are evaluated before and after intervention and at 3, 6, 9 and 12 months after intervention. Discussion Stepped care is a system of delivering and

  4. Physical exercise in cancer patients during and after medical treatment: a systematic review of randomized and controlled clinical trials.

    NARCIS (Netherlands)

    Knols, R.H.; Aaronson, N.K.; Uebelhart, D.; Fransen, J.; Aufdemkampe, G.

    2005-01-01

    PURPOSE: To systematically review the methodologic quality of, and summarize the evidence from trials examining the effectiveness of physical exercise in improving the level of physical functioning and psychological well-being of cancer patients during and after medical treatment. METHODS: Thirty-fo

  5. The role of flumazenil in the treatment of benzodiazepine dependence: physiological and psychological profiles.

    Science.gov (United States)

    Hood, S; O'Neil, G; Hulse, G

    2009-06-01

    Two-related studies are presented here, detailing our early experience with benzodiazepine-dependent patients treated with a four-day flumazenil infusion using a novel delivery technique. Patients with long-term benzodiazepine dependence who attended the Australian Medical Procedures Research Foundation (AMPRF, Perth, Australia) for treatment were recruited for these studies. Self-reported psychological and physical symptoms, as well as objective vital signs data were collected at intervals before, during and 2 weeks postinfusion. Study A is a case series with cardiovascular measures; study B is an open trial that tracks the psychological profiles of 13 subjects. Withdrawal symptoms were tracked, however, the nature and severity of these symptoms differed between patients. No major complications or discomfort prompting study dropout was observed. Significant benzodiazepine abstinence occurred with this flumazenil infusion method despite high levels of initial dependence, comorbid substance use and comorbid psychiatric illness. Low-dose flumazenil infusion appears to be a safe and effective treatment resulting in withdrawal symptoms of lesser severity than any other cessation method currently available. Recommendations for future research are discussed.

  6. Review on clinical trials of targeted treatments in malignant mesothelioma

    DEFF Research Database (Denmark)

    Jakobsen, Jan Nyrop; Sørensen, Jens Benn

    2011-01-01

    Malignant mesothelioma (MM) is an aggressive tumor of the serosal surfaces with a poor prognosis. Advances in the understanding of tumor biology have led to the development of several targeted treatments, which have been evaluated in clinical trials. This article is a comprehensive review of all...... clinical trials evaluating the effect of targeted treatments in MM....

  7. The Treatment of Industrial/Organizational Psychology in Introductory Psychology Textbooks.

    Science.gov (United States)

    Carlson, Stephen; Millard, Richard J.

    1984-01-01

    An content analysis of introductory psychology textbooks revealed that only 25 percent of the texts include a section on industrial/organizational (I/O) psychology and that another 25 percent fail to even mention the area. Such limited coverage of the I/O field may limit career alternatives that students consider. (RM)

  8. Emerging treatments for the behavioral and psychological symptoms of dementia.

    Science.gov (United States)

    Anand, Abhinav; Khurana, Puneet; Chawla, Jasneet; Sharma, Neha; Khurana, Navneet

    2017-09-15

    Dementia is referred to a loss of memory and decline in other mental abilities at levels critical enough to hinder performance of daily activities. It can be of several types, depending on the underlying pathophysiology. The behavioral and psychological symptoms of dementia (BPSD) are various, but the most clinically significant are depression, apathy, and anxiety. Other BPSD include agitation, aberrant motor behavior, elation, hallucinations, and alterations in sleep and appetite. About 90% of sufferers of dementia are affected by BPSD during the course of the illness. These symptoms occur in demented patients irrespective of the dementia subtype. However, there has not been significant development in the areas of disease-modifying pharmacotherapeutics for dementia. Therefore, tackling BPSD has emerged as a research avenue in the recent past. Existing antidepressants, antipsychotics, and cholinergic agents have been extensively used in the treatment of BPSD, independently and in different combinations. However, these agents have not successful in completely alleviating such symptoms. Research in this field is going on globally, but it is still limited by various factors. There is a strong need to develop new entities and test them clinically. This review focuses on emerging treatments for the management of clinically significant BPSD.

  9. Psychological therapies for the treatment of anxiety disorders in chronic obstructive pulmonary disease.

    Science.gov (United States)

    Usmani, Zafar A; Carson, Kristin V; Heslop, Karen; Esterman, Adrian J; De Soyza, Anthony; Smith, Brian J

    2017-03-21

    Chronic obstructive pulmonary disease (COPD) (commonly referred to as chronic bronchitis and emphysema) is a chronic lung condition characterised by the inflammation of airways and irreversible destruction of pulmonary tissue leading to progressively worsening dyspnoea. It is a leading international cause of disability and death in adults. Evidence suggests that there is an increased prevalence of anxiety disorders in people with COPD. The severity of anxiety has been shown to correlate with the severity of COPD, however anxiety can occur with all stages of COPD severity. Coexisting anxiety and COPD contribute to poor health outcomes in terms of exercise tolerance, quality of life and COPD exacerbations. The evidence for treatment of anxiety disorders in this population is limited, with a paucity of evidence to support the efficacy of medication-only treatments. It is therefore important to evaluate psychological therapies for the alleviation of these symptoms in people with COPD. To assess the effects of psychological therapies for the treatment of anxiety disorders in people with chronic obstructive pulmonary disease. We searched the specialised registers of two Cochrane Review Groups: Cochrane Common Mental Disorders (CCMD) and Cochrane Airways (CAG) (to 14 August 2015). The specialised registers include reports of relevant randomised controlled trials from The Cochrane Library, MEDLINE, Embase, and PsycINFO. We carried out complementary searches on PsycINFO and CENTRAL to ensure no studies had been missed. We applied no date or language restrictions. We considered all randomised controlled trials (RCTs), cluster-randomised trials and cross-over trials of psychological therapies for people (aged over 40 years) with COPD and coexisting anxiety disorders (as confirmed by recognised diagnostic criteria or a validated measurement scale), where this was compared with either no intervention or education only. We included studies in which the psychological therapy was

  10. Using instrumental variables to disentangle treatment and placebo effects in blinded and unblinded randomized clinical trials influenced by unmeasured confounders

    Science.gov (United States)

    Chaibub Neto, Elias

    2016-11-01

    Clinical trials traditionally employ blinding as a design mechanism to reduce the influence of placebo effects. In practice, however, it can be difficult or impossible to blind study participants and unblinded trials are common in medical research. Here we show how instrumental variables can be used to quantify and disentangle treatment and placebo effects in randomized clinical trials comparing control and active treatments in the presence of confounders. The key idea is to use randomization to separately manipulate treatment assignment and psychological encouragement conversations/interactions that increase the participants’ desire for improved symptoms. The proposed approach is able to improve the estimation of treatment effects in blinded studies and, most importantly, opens the doors to account for placebo effects in unblinded trials.

  11. Assessing clinical trials of Internet addiction treatment: a systematic review and CONSORT evaluation.

    Science.gov (United States)

    King, Daniel L; Delfabbro, Paul H; Griffiths, Mark D; Gradisar, Michael

    2011-11-01

    Although there is ongoing debate concerning the clinical status of Internet addiction, and the quality of the extant literature in this emerging field is not optimal, several clinical trials of both pharmacological and psychological treatments for Internet addiction have been published in recent years. A systematic review investigating the reporting quality of eight treatment studies is presented. Reporting quality was defined according to the 2010 Consolidating Standards of Reporting Trials (CONSORT) statement. An evaluation of the reviewed studies highlighted several key limitations, including (a) inconsistencies in the definition and diagnosis of Internet addiction, (b) a lack of randomization and blinding techniques, (c) a lack of adequate controls or other comparison groups, and (d) insufficient information concerning recruitment dates, sample characteristics, and treatment effect sizes. It is concluded that improvements in future studies' design and reporting would be of significant benefit to both researchers and clinicians, and to the overall positioning of Internet addiction in the behavioral addiction field.

  12. 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.

    Science.gov (United States)

    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

  13. Psychological aspects in pre-transplantation assessments of patients prior to entering the first uterus transplantation trial.

    Science.gov (United States)

    Järvholm, Stina; Johannesson, Liza; Brännström, Mats

    2015-10-01

    Uterus transplantation is a treatment of uterine factor infertility. It raises questions of psychological aspects and well-being among the participants, which is of great importance as this is a new type of a major surgical procedure. This commentary focuses on the psychology surrounding this novel type of transplantation and the importance of patient selection. In addition, psychological aspects of events during the first postoperative year and the follow-up are discussed.

  14. Early psychological intervention in accidentally injured children ages 2–16: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Didier N. Kramer

    2014-06-01

    Full Text Available Background: Road traffic accidents (RTA and burns are frequent events in children. Although many children recover spontaneously, a considerable number develop long-term psychological sequelae. Evidence on early psychological interventions to prevent such long-term problems is still scarce for school-age children and completely lacking for pre-school children. Objectives: To evaluate the efficacy of an early two-session cognitive-behavioral intervention in 108 children ages 2–16 after RTAs and burns. Methods: Children assessed at risk for the development of posttraumatic stress disorder (PTSD were randomly assigned to either a control group offered treatment as usual or an intervention group. Primary outcomes were PTSD, behavioral problems, and depression symptoms. Baseline and blinded 3- and 6-month follow-up assessments were conducted. Results: In pre-school children, no intervention effects were found. School-age children in the intervention group exhibited significantly fewer internalizing problems at 3-month follow-up relative to controls and a borderline significant time-by-group effect for PTSD intrusion symptoms was found (p=0.06. Conclusions: This is the first study examining the efficacy of an indicated, early psychological intervention among both school-age and pre-school-age children. Because the intervention was ineffective for young children, no evidence-based practice can currently be suggested. Given that parents of pre-school children perceived the intervention as helpful, brief counseling of parents in terms of psychoeducation and training in coping skills still should be provided by clinicians, despite the current lack of evidence. To prevent trauma-related disorders in school-age children, the intervention might be used in a step-wise manner, where only children at risk for long-term psychological maladjustment are provided with psychological support.

  15. Psychology

    Science.gov (United States)

    Blackmore, Susan; Fouad, Nadya; Kagan, Jerome; Kosslyn, Stephen; Posner, Michael; Sternburg, Robert; Driscoll, Marcy; Ge, Xun; Parrish, Patrick

    2013-01-01

    Scholars representing the field of psychology were asked to identify what they considered to be the most exciting and imaginative work currently being done in their field, as well as how that work might change our understanding. The scholars included Susan Blackmore, Nadya Fouad, Jerome Kagan, Stephen Kosslyn, Michael Posner, and Robert Sternberg.…

  16. Psychology

    Science.gov (United States)

    Blackmore, Susan; Fouad, Nadya; Kagan, Jerome; Kosslyn, Stephen; Posner, Michael; Sternburg, Robert; Driscoll, Marcy; Ge, Xun; Parrish, Patrick

    2013-01-01

    Scholars representing the field of psychology were asked to identify what they considered to be the most exciting and imaginative work currently being done in their field, as well as how that work might change our understanding. The scholars included Susan Blackmore, Nadya Fouad, Jerome Kagan, Stephen Kosslyn, Michael Posner, and Robert Sternberg.…

  17. Data mining in psychological treatment research: a primer on classification and regression trees.

    Science.gov (United States)

    King, Matthew W; Resick, Patricia A

    2014-10-01

    Data mining of treatment study results can reveal unforeseen but critical insights, such as who receives the most benefit from treatment and under what circumstances. The usefulness and legitimacy of exploratory data analysis have received relatively little recognition, however, and analytic methods well suited to the task are not widely known in psychology. With roots in computer science and statistics, statistical learning approaches offer a credible option: These methods take a more inductive approach to building a model than is done in traditional regression, allowing the data greater role in suggesting the correct relationships between variables rather than imposing them a priori. Classification and regression trees are presented as a powerful, flexible exemplar of statistical learning methods. Trees allow researchers to efficiently identify useful predictors of an outcome and discover interactions between predictors without the need to anticipate and specify these in advance, making them ideal for revealing patterns that inform hypotheses about treatment effects. Trees can also provide a predictive model for forecasting outcomes as an aid to clinical decision making. This primer describes how tree models are constructed, how the results are interpreted and evaluated, and how trees overcome some of the complexities of traditional regression. Examples are drawn from randomized clinical trial data and highlight some interpretations of particular interest to treatment researchers. The limitations of tree models are discussed, and suggestions for further reading and choices in software are offered.

  18. Ethical considerations concerning treatment allocation in drug development trials.

    Science.gov (United States)

    Senn, S

    2002-10-01

    It is claimed that much of the opposition to placebos is based on the misunderstanding that their use implies the withholding of effective treatments. It is also argued that the ethical feasibility of a trial must be judged by comparing the likely prognosis of patients in the trial to their expectations outside the trial. Furthermore, a longer-term perspective of the patients needs is necessary; the ethical dilemmas involved cannot be resolved at the point of sickness. Some device such as the 'original position' of the philosopher John Rawls is needed. Finally, it is argued that placebo run-ins involve a violation of consent and should be eliminated from clinical trials.

  19. Hallucination focused integrative treatment : A randomized controlled trial

    NARCIS (Netherlands)

    Jenner, JA; Nienhuis, FJ; Wiersma, D; van de Willige, G

    2004-01-01

    Improvements in psychopathology, subjective burden, and coping with voices after hallucination focused integrative treatment (HIT) were studied in chronic schizophrenic patients with persistent (> 10 years), drug-refractory auditory hallucinations. In a randomized controlled trial, routine care was

  20. Adherence to treatment after coronary bypass surgery: Psychological aspects

    Directory of Open Access Journals (Sweden)

    Maria V. Iakovleva

    2016-01-01

    Full Text Available Poor adherence to treatment is a problem of great importance and striking magnitude. Its consequences are increased health care costs and poor health outcomes. It defined the objective of this research, which is the study of psychological characteristics of patients with different degrees of adherence to rehabilitation treatment after coronary bypass surgery. Ninety male and female patients with CHD, aged 46---71, were examined. The study was carried out using the questionnaire of ways of coping and the technique for diagnosing the types of attitude toward the disease, and the study of medical history. The analysis of the types of attitude toward the disease revealed that adherent patients show higher values on the harmonious type; patients with poor adherence show higher values on the apathetic, as well as the melancholic type of attitude toward illness. This study shows that wide range of psychological characteristics is significant for the definition of adherence to treatment. It is essential to consider the patient’s personality and his characteristics, such as attitude toward the disease, because they influence the adherence and, therefore, the effectiveness of therapy in the postoperative period. La escasa adherencia a la terapia es un problema de gran importancia ampliamente extendido. Sus consecuencias son el aumento de costes del tratamiento y su baja eficacia. El objetivo de la investigación fue el estudio de las características psicológicas de pacientes con diferentes grados de adherencia al tratamiento de rehabilitación después de la cirugía de derivación coronaria. Se recogieron datos clínicos de 90 pacientes de ambos sexos con cardiopatía coronaria, sometidos a cirugía de derivación coronaria, con edades comprendidas entre 46-71 a˜nos. Los cuestionarios administrados fueron el cuestionario de estilos de afrontamiento y la técnica de diagnóstico de tipos de actitud hacia la enfermedad. Además se realizó un estudio

  1. Randomized Trial of Drug Abuse Treatment-Linkage Strategies

    Science.gov (United States)

    Sorenson, James L.; Masson, Carmen L.; Delucchi, Kevin; Sporer, Karl; Barnett, Paul G.; Mitsuishi, Fumi; Lin, Christine; Song, Yong; Chen, TeChieh; Hall, Sharon M.

    2005-01-01

    A clinical trial contrasted 2 interventions designed to link opioid-dependent hospital patients to drug abuse treatment. The 126 out-of-treatment participants were randomly assigned to (a) case management, (b) voucher for free methadone maintenance treatment (MMT), (c) case management plus voucher, or (d) usual care. Services were provided for 6…

  2. Acupuncture Anxiolytic Effects on Physiological and Psychological Assessments for a Clinical Trial

    Directory of Open Access Journals (Sweden)

    Monir Shayestehfar

    2016-01-01

    Full Text Available In a randomized controlled trial we examined the effect of acupuncture on anxiety of the adolescent football players prior to the competition using psychological and physiological markers. A total of 45 athletes were equally allocated to either acupuncture group, sham group, or wait-list control group. Thereafter, all participants were asked to complete an anxiety questionnaire before and after the intervention. Their heart rate and skin conductance were also examined before and after the intervention. The results of ANOVA on posttest scores showed that acupuncture had a significant effect on cognitive anxiety (p=0.001 and somatic anxiety (p0.05. Furthermore, the results showed that acupuncture significantly decreased the skin conductance in acupuncture group compared to sham group (p=0.006 and wait-list control group (p<0.001. In conclusion, the results suggested that acupuncture has the capacity to decrease cognitive anxiety and somatic anxiety prior to competition in adolescent athletes, while this was accompanied by significant physiological changes. This trial is registered with IRCT138904074264N1 (IRCT is a Primary Registry in the WHO Registry Network.

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

    Directory of Open Access Journals (Sweden)

    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

  4. Psychological Interventions for the Management of Glycemic and Psychological Outcomes of Type 2 Diabetes Mellitus in China: A Systematic Review and Meta-Analyses of Randomized Controlled Trials.

    Science.gov (United States)

    Chapman, Anna; Liu, Shuo; Merkouris, Stephanie; Enticott, Joanne C; Yang, Hui; Browning, Colette J; Thomas, Shane A

    2015-01-01

    China has the largest number of type 2 diabetes mellitus (T2DM) cases globally, and T2DM management has become a critical public health issue in China. Individuals with T2DM have an increased risk of developing mental health disorders, psychological disturbances, and functional problems associated with living with their condition. Previous systematic reviews have demonstrated that, generally, psychological interventions are effective in the management of T2DM-related outcomes; however, these reviews have predominantly included studies conducted within English-speaking countries and have not determined the efficacy of the varying types of psychological interventions. As such, this paper aims to synthesize evidence and quantify the efficacy of psychological therapies for the management of glycemic and psychological outcomes of T2DM in China, relative to control conditions. A systematic search (MEDLINE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, and Wangfang Data) for all years to December 2014 identified all available literature. Eligibility criteria included: peer-reviewed journal articles, randomized controlled trials (RCTs) assessing the efficacy of a psychological therapy for the management of T2DM, adult participants (≥18 years) diagnosed with T2DM or non-insulin-dependent diabetes mellitus, and Chinese speaking participants only (in mainland China). Outcome measures were glycated hemoglobin, blood glucose concentration, depression, anxiety, and quality of life. Effect sizes were pooled using a random effects model. Negative effect sizes corresponded to positive outcomes favoring the intervention. Forty-five RCTs were eligible for the meta-analyses. Cognitive behavioral therapy (CBT) and motivational interviewing (MI) were more effective than the control condition in the reduction of glycated hemoglobin [CBT: -0.97 (95% CI -1.37 to -0.57); MI: -0.71 (95% CI -1.00 to -0.43)]. CBT and client

  5. The impact of digital technology on psychological treatments and their dissemination.

    Science.gov (United States)

    Fairburn, Christopher G; Patel, Vikram

    2017-01-01

    The psychological treatment of mental health problems is beginning to undergo a sea-change driven by the widespread availability of digital technology. In this paper we provide an overview of the developments to date and those in the pipeline. We describe the various uses of digital interventions and consider their likely impact on clinical practice, clinical services and the global dissemination of psychological treatments. We note the importance of online clinics, blended treatment, digital assessment and digital training.

  6. A randomized, open-label, controlled trial of gabapentin and phenobarbital in the treatment of alcohol withdrawal.

    Science.gov (United States)

    Mariani, John J; Rosenthal, Richard N; Tross, Susan; Singh, Prameet; Anand, Om P

    2006-01-01

    Gabapentin was compared with phenobarbital for the treatment of alcohol withdrawal in a randomized, open-label, controlled trial in 27 inpatients. There were no significant differences in the proportion of treatment completers between treatment groups or the proportion of patients in each group requiring rescue medication for breakthrough signs and symptoms of alcohol withdrawal. There were no significant treatment differences in withdrawal symptoms or psychological distress, nor were there serious adverse events. These findings suggest that gabapentin may be as effective as phenobarbital in the treatment of alcohol withdrawal. Given gabapentin's favorable pharmacokinetic profile, further study of its effectiveness in treating alcohol withdrawal is warranted.

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

    Science.gov (United States)

    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

  8. Treatment of Neurosensory Disorders Improves Psychological Well-Being in Children

    Science.gov (United States)

    Bohlander, Robert

    2009-01-01

    Psychological well-being is the ultimate "quality of life" measure. The presence of a neurosensory disorder (NSD) in a child, such as ADD, ADHD, Asperger's syndrome, or autism, can rob the child of psychological well-being, or hamper the growth of well-being as the child develops. Fortunately, treatment of NSDs can remove obstacles to the…

  9. Social Desirability, Psychological Distress, and Consumer Satisfaction With Mental Health Treatment.

    Science.gov (United States)

    Sabourin, Stephane; And Others

    1989-01-01

    Determined strength of relationship between social desirability, psychological distress, and consumer satisfaction with mental health treatment in 82 clients in therapy. Results indicated that both consumer satisfaction reports and psychological distress scores were contaminated by socially desirable responding. (Author/ABL)

  10. Treatment of Neurosensory Disorders Improves Psychological Well-Being in Children

    Science.gov (United States)

    Bohlander, Robert

    2009-01-01

    Psychological well-being is the ultimate "quality of life" measure. The presence of a neurosensory disorder (NSD) in a child, such as ADD, ADHD, Asperger's syndrome, or autism, can rob the child of psychological well-being, or hamper the growth of well-being as the child develops. Fortunately, treatment of NSDs can remove obstacles to the…

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

    Directory of Open Access Journals (Sweden)

    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.

  12. 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 outperform

  13. 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

  14. 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

  15. Community Trial of a Comprehensive Psychosocial Treatment for HFASDs

    Science.gov (United States)

    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…

  16. Improving access to psychological therapies (IAPT) and treatment outcomes: epistemological assumptions and controversies.

    Science.gov (United States)

    Williams, C H J

    2015-06-01

    Cognitive behaviour therapy (CBT) is recommended as a primary treatment choice in England, for anxiety and depression, by the National Institute for Health and Care Excellence (NICE). It has been argued that CBT has enjoyed political and cultural dominance and this has arguably led to maintained government investment in England for the cognitive and behavioural treatment of mental health problems. The government programme 'Improving Access to Psychological Therapies' (IAPT) aims to improve the availability of CBT. The criticism of the NICE evidence-based guidelines supporting the IAPT programme, has been the dominance of the gold standard randomized controlled trial methodology, with a focus on numerical outcome data, rather than a focus on a recovery narrative. RCT-based research is influenced by a philosophical paradigm called positivism. The IAPT culture is arguably influenced by one research paradigm and such an influence can skew services only towards numerical outcome data as the only truth of 'recovery'. An interpretative paradigm could assist in shaping service-based cultures, alter how services are evaluated and improve the richness of CBT research. This paper explores the theory of knowledge (epistemology) that underpins the evidence-based perspective of CBT and how this influences service delivery. The paper argues that the inclusion of service user narrative (qualitative data) can assist the evaluation of CBT from the user's perspective and can understand the context in which people live and how they access services. A qualitative perspective is discussed as a research strategy, capturing the lived experience of under-represented groups, such as sexual, gender and ethnic minorities. Cognitive behaviour therapy (CBT) has enjoyed political and cultural dominance within mental healthcare, with renewed government investment in England for the'Improving Access to Psychological Therapies' (IAPT) programme. The criticism of the evidence-based guidelines

  17. Family Therapy of Terroristic Trauma: Psychological Syndromes and Treatment Strategies.

    Science.gov (United States)

    Miller, Laurence

    2003-01-01

    Reviews pertinent literature on terroristic trauma and combines this information with the author's experience in treating adults, children, and family victims and survivors of recent terrorist attacks. Describes the psychological syndromes resulting from terrorism and discusses the relevant individual and family therapy modalities for treating…

  18. Psychological interventions for the management of glycemic and psychological outcomes of type 2 diabetes mellitus in China: A systematic review and meta-analyses of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Anna eChapman

    2015-11-01

    Full Text Available IntroductionChina has the largest number of type 2 diabetes mellitus (T2DM cases globally and T2DM management has become a critical public health issue in China. Individuals with T2DM have an increased risk of developing mental health disorders, psychological disturbances and functional problems associated with living with their condition. Previous systematic reviews have demonstrated that, generally, psychological interventions are effective in the management of T2DM related outcomes; however these reviews have predominantly included studies conducted within English speaking countries, and have not determined the efficacy of the varying types of psychological interventions. As such, this paper aims to synthesize evidence and quantify the efficacy of psychological therapies for the management of glycemic and psychological outcomes of T2DM in China, relative to control conditions. MethodsA systematic search (MEDLINE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, CNKI, Wangfang Data for all years to December 2014 identified all available literature. Eligibility criteria included: Peer reviewed journal articles; RCTs assessing the efficacy of a psychological therapy for the management of T2DM; adults diagnosed with T2DM or non-insulin dependent diabetes mellitus; Chinese speaking participants (in mainland China. Outcome measures were glycated hemoglobin, blood glucose concentration, depression, anxiety and quality of life. Effect sizes were pooled using a random effects model. Negative effect sizes corresponded to positive outcomes favoring the intervention. Results45 RCTs were eligible for the meta-analyses. Cognitive behavioral therapy (CBT and motivational interviewing (MI were more effective than the control condition in the reduction of glycated hemoglobin (CBT: -0·97 [95% CI -1·37 to -0·57]; MI -0·71 [95% CI -1·00 to -0·43]. CBT and client-centered therapy (CCT were also associated with reductions in depression and

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

    Science.gov (United States)

    Jonsson, Ulf; Bertilsson, Göran; Gyllensvärd, Harald; Söderlund, Anne; Tham, Anne; Andersson, Gerhard

    2016-01-01

    Objectives 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. Method 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). Results 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. Conclusion Psychological treatment is a feasible option for frail elderly with depressive symptoms

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

    Science.gov (United States)

    Jonsson, Ulf; Bertilsson, Göran; Allard, Per; Gyllensvärd, Harald; Söderlund, Anne; Tham, Anne; Andersson, Gerhard

    2016-01-01

    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 about

  1. Behavioral and Psychological Factors Associated with 12-Month Weight Change in a Physical Activity Trial

    Directory of Open Access Journals (Sweden)

    Melissa A. Napolitano

    2011-01-01

    Full Text Available Examining behavioral and psychological factors relating to weight stability over a 1-year period is of public health importance. We conducted a physical activity (PA intervention trial for women (N=247; mean age=47.5±10.7; mean BMI=28.6±5.3 in which participants were assigned to one of three groups (two PA and one contact-control. By Month 12, participants achieved 140.4±14.82 min of PA/week, with no group differences. Weight status change from baseline to Month 12 was categorized: no change (N=154; 62.4%; increase (N=34; 13.8%; decrease (N=59; 23.9%. Discriminant function analyses indentified two statistically significant dimensions associated with weight change. Dimension 1 was positively weighted by mood (0.73 and self-efficacy (0.79; dimension 2 was positively weighted to change in physical activity (0.58 and fat consumption (0.55. Results provide further evidence for the importance of behavior in long-term weight maintenance, particularly physical activity and dietary fat. These findings also provide evidence for the importance of addressing psychosocial variables, in particular depressed mood and self-efficacy.

  2. Estimating Statistical Power for Open Enrollment Group Treatment Trials

    Science.gov (United States)

    Morgan-Lopez, Antonio A.; Saavedra, Lissette M.; Hien, Denise A.; Fals-Stewart, William

    2010-01-01

    Modeling turnover in group membership has been identified as a key barrier contributing to a disconnect between the manner in which behavioral treatment is conducted (open enrollment groups) and the designs of substance abuse treatment trials (closed enrollment groups, individual therapy). Latent class pattern mixture models (LCPMM) are an emerging tool for modeling data from open enrollment groups with membership turnover in recently proposed treatment trials. The current article illustrates an approach to conducting power analyses for open enrollment designs based on Monte Carlo simulation of LCPMM models using parameters derived from published data from an RCT comparing Seeking Safety to a Community Care condition for women presenting with comorbid PTSD and substance use disorders. The example addresses discrepancies between the analysis framework assumed in power analyses of many recently-proposed open enrollment trials and the proposed use of LCPMM for data analysis. PMID:20832971

  3. Ischemic Stroke Treatment Trials: Neuroimaging Advancements and Implications.

    Science.gov (United States)

    Patel, Vivek P; Heit, Jeremy J

    2017-06-01

    There have been significant advancements in the treatment of acute ischemic stroke in the last 2 decades. Recent trials have placed a significant emphasis on minimizing the time from symptom onset to stroke treatment by reperfusion therapies, which decreases the cerebral infarct volume and improves clinical outcomes. These clinical advances have paralleled and been aided by advances in neuroimaging. However, controversy remains regarding how much time should be spent on neuroimaging evaluation versus expediting patient treatment. In this review article, we examine the key endovascular stroke trials published in the past 25 years, and we briefly highlight the failures and successes of endovascular stroke trials performed in the past 4 years. We also discuss the advantages and disadvantages of using time from symptom onset versus neuroimaging in determining endovascular stroke therapy candidacy.

  4. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments.

    Directory of Open Access Journals (Sweden)

    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.

  5. Insomnia: psychological and neurobiological aspects and non-pharmacological treatments.

    Science.gov (United States)

    Molen, Yara Fleury; Carvalho, Luciane Bizari Coin; Prado, Lucila Bizari Fernandes do; Prado, Gilmar Fernandes do

    2014-01-01

    Insomnia involves difficulty in falling asleep, maintaining sleep or having refreshing sleep. This review gathers the existing informations seeking to explain insomnia, including those that focus on psychological aspects and those considered neurobiological. Insomnia has been defined in psychological (cognitive components, such as worries and rumination, and behavioral aspects, such as classic conditioning) and physiological terms (increased metabolic rate, with increased muscle tone, heart rate and temperature). From the neurobiological point of view, there are two perspectives: one which proposes that insomnia occurs in association with a failure to inhibit wakefulness and another that considers hyperarousal as having an important role in the physiology of sleep. The non-pharmacological interventions developed to face different aspects of insomnia are presented.

  6. Insomnia: psychological and neurobiological aspects and non-pharmacological treatments

    Directory of Open Access Journals (Sweden)

    Yara Fleury Molen

    2014-01-01

    Full Text Available Insomnia involves difficulty in falling asleep, maintaining sleep or having refreshing sleep. This review gathers the existing informations seeking to explain insomnia, including those that focus on psychological aspects and those considered neurobiological. Insomnia has been defined in psychological (cognitive components, such as worries and rumination, and behavioral aspects, such as classic conditioning and physiological terms (increased metabolic rate, with increased muscle tone, heart rate and temperature. From the neurobiological point of view, there are two perspectives: one which proposes that insomnia occurs in association with a failure to inhibit wakefulness and another that considers hyperarousal as having an important role in the physiology of sleep. The non-pharmacological interventions developed to face different aspects of insomnia are presented.

  7. Brief problem-solving treatment in primary care (PST-PC) was not more effective than placebo for elderly patients screened positive of psychological problems

    OpenAIRE

    Lam, CLK; Fong, DYT; Chin, WY; Lo, YYC; Lee, PWH; Lam, ETP

    2010-01-01

    Objectives To evaluate whether screening followed by brief problem-solving treatment by primary care doctors (PST-PC) could improve health-related quality of life (HRQOL) and reduce consultation rates in the elderly. Design A single-blind randomized placebo controlled trial (RCT). Setting Two government funded primary care clinics in Hong Kong. Participants Two hundred and ninety nine Chinese patients aged 60 years or over, with positive screening scores for psychological problems by the Hosp...

  8. A psychological study of people who seek orthodontic treatment: Comparison with untreated controls

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    Hamidreza Jamilian

    2015-01-01

    Full Text Available Objective: Improvement in appearance is an important motivation for orthodontic treatment; nevertheless, not all patients with malocclusion seek treatment; therefore, the aim of this study was to compare the psychological state of patients with moderate to severe malocclusion who seek orthodontic treatment with patients who suffer from similar malocclusion but do not seek treatment. Materials and Methods: Minnesota multiphasic personality inventory-2 questionnaire which assesses psychological states of people were given to 100 subject with moderate to severe malocclusion who were undergoing orthodontic treatment and 100 subjects with similar malocclusion who did not request orthodontic treatment. All subjects had similar demographic variables. Clinical scales measured by the test included: Hypochondriasis, depression, hysteria, psychopathic deviate, paranoia, psychasthenia, schizophrenia, and hypomania. The questionnaire consisted of 71 questions, and the subjects had to mark "True" or "False" in response. The scores were transformed into T-scores by a trained psychologist. The results were evaluated by independent t-test. Results and Conclusion: The results of the test showed that both treated and untreated subjects were in similar psychological state and were psychologically normal; therefore, it is likely that other factors affect patients′ willingness for seeking orthodontic treatment rather than their psychological state.

  9. Selection and utilization of assessment instruments in substance abuse treatment trials: the National Drug Abuse Treatment Clinical Trials Network experience

    Directory of Open Access Journals (Sweden)

    Rosa C

    2012-07-01

    Full Text Available Carmen Rosa, Udi Ghitza, Betty TaiCenter for the Clinical Trials Network, National Institute on Drug Abuse, Bethesda, MD, USAAbstract: Based on recommendations from a US Institute of Medicine report, the National Institute on Drug Abuse established the National Drug Abuse Treatment Clinical Trials Network (CTN in 1999, to accelerate the translation of science-based addiction treatment research into community-based practice, and to improve the quality of addiction treatment, using science as the vehicle. One of the CTN's primary tasks is to serve as a platform to forge bi-directional communications and collaborations between providers and scientists, to enhance the relevance of research, which generates empirical results that impact practice. Among many obstacles in moving research into real-world settings, this commentary mainly describes challenges and iterative experiences in regard to how the CTN develops its research protocols, with focus on how the CTN study teams select and utilize assessment instruments, which can reasonably balance the interests of both research scientists and practicing providers when applied in CTN trials. This commentary also discusses the process by which the CTN further selects a core set of common assessment instruments that may be applied across all trials, to allow easier cross-study analyses of comparable data.Keywords: addiction, assessment, drug abuse treatment, drug dependence, NIDA Clinical Trials Network, substance use disorder

  10. Can a self-referral system help improve access to psychological treatments?

    Science.gov (United States)

    Brown, June S L; Boardman, Jed; Whittinger, Naureen; Ashworth, Mark

    2010-05-01

    Referrals for psychological treatment have been problematic for many years. Even though GPs have attempted to limit access into the small psychological treatment services, long waiting lists have developed which have deterred referrals and deferred psychological care. GPs have understandably been frustrated. In addition, the consultation rate for psychological problems is low when compared with the rate of identified mental health problems in population surveys. Possible reasons include patients' failure to recognise the problem as psychological and thus not consulting one's GP, and/or the problem not being detected by the GP. While a self-referral system may be seen as a way of trying to allow non-consulters to receive treatment, this has been viewed with some scepticism since it may allow the 'worried well' to access already limited services. However, a study has shown that those self-referring to advertised psychological workshops had high levels of psychological morbidity and also were more representative of the population, in terms of ethnicity, than GP referrals. The government has set up the Increasing Access to Psychological Therapies (IAPT) programme to address some of the service shortfalls by expanding the provision of psychological therapists. Notably, the IAPT programme is allowing self-referrals such that any member of the public can access the service directly, bypassing general practice. Although not available at all the sites, this represents a radical shift from the present system in which access to talking therapy is generally only available through direct referral by the GP. The implications of this new development are discussed.

  11. 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.

  12. Psychological distress and its effect on tuberculosis treatment outcomes in Ethiopia

    Directory of Open Access Journals (Sweden)

    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

  13. Psychological distress and its effect on tuberculosis treatment outcomes in Ethiopia.

    Science.gov (United States)

    Tola, Habteyes Hailu; Shojaeizadeh, Davoud; Garmaroudi, Gholamreza; Tol, Azar; Yekaninejad, Mir Saeed; Ejeta, Luche Tadesse; Kebede, Abebaw; Karimi, Mehrdad; Kassa, Desta

    2015-01-01

    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. This study aimed to determine the magnitude of psychological distress and its effect on treatment outcome among TB patients on treatment. 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. 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: 3.02; 95% CI: 1.17-7.75) and having low economic status (AOR: 3

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

    Science.gov (United States)

    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

  15. Randomised clinical trials with clinician-preferred treatment.

    Science.gov (United States)

    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.

  16. 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

  17. 躯体形式障碍病人的心理护理及心理治疗%Somatoform disorders the patient's psychological care and psychological treatment

    Institute of Scientific and Technical Information of China (English)

    杨晓兵

    2012-01-01

    目的:探讨心理护理及心理治疗对躯体形式障碍病人的影响.方法:对48例躯体形式障碍病人进行心理护理及心理治疗,采用90项症状自评量表(SCL-90)的测定和自我感觉的评定.结果:给予心理护理及心理治疗的病人与对照组的比较,经统计学分析,均p<0.05,差异具有统计学意义.结论:通过对躯体形式障碍病人的心理治疗及心理护理,使其好转、治愈出院的明显增加.%Objective To explore the impact of psychological care and psychological treatment of patients with somatoform disorders.Methods: 48 cases of patients with somatoform disorders, psychological care and psychological treatment, 90 symptoms of determination and self-assessment rating scale (scl-90). Results: The give psychological care and psychological treatment of patients with the control group comparison, statistical analysis, all p <0.05, statistically significant difference. Conclusion: The psychological treatment and psychological care of patients with somatoform disorders, making it better, cured significantly increased.

  18. 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…

  19. 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…

  20. Uncaria tomentosa—Adjuvant Treatment for Breast Cancer: Clinical Trial

    OpenAIRE

    Maria do Carmo Santos Araújo; Iria Luiza Farias; Jessie Gutierres; Dalmora, Sergio L.; Nélia Flores; Julia Farias; Ivana de Cruz; Juarez Chiesa; Vera Maria Morsch; Maria Rosa Chitolina Schetinger

    2012-01-01

    Breast cancer is the most frequent neoplasm affecting women worldwide. Some of the recommended treatments involve chemotherapy whose toxic effects include leukopenia and neutropenia. This study assessed the effectiveness of Uncaria tomentosa (Ut) in reducing the adverse effects of chemotherapy through a randomized clinical trial. Patients with Invasive Ductal Carcinoma—Stage II, who underwent a treatment regimen known as FAC (Fluorouracil, Doxorubicin, Cyclophosphamide), were divided into two...

  1. [Prospective therapeutic trial of masking treatment in patients with tinnitus].

    Science.gov (United States)

    Hernández Moñiz, F; Barrio, A; Pérez, A; Pertierra, M A; Salafranca, J M; González, M

    1998-01-01

    We report the results of a therapeutic trial of patients with tinnitus of different characteristics that was unresponsive to other medical or surgical treatments. Treatment was based on a combination of biofeedback training designed to reduce stress and either pure masking therapy or masking therapy consisting of a hearing aid and masker. The results showed an improvement in subjective perceptions and in the audiometric parameter of pitch in a significant percentage of patients.

  2. Predictors of outcomes of psychological treatments for disordered gambling: A systematic review.

    Science.gov (United States)

    Merkouris, S S; Thomas, S A; Browning, C J; Dowling, N A

    2016-08-01

    This systematic review aimed to synthesise the evidence relating to pre-treatment predictors of gambling outcomes following psychological treatment for disordered gambling across multiple time-points (i.e., post-treatment, short-term, medium-term, and long-term). A systematic search from 1990 to 2016 identified 50 articles, from which 11 socio-demographic, 16 gambling-related, 21 psychological/psychosocial, 12 treatment, and no therapist-related variables, were identified. Male gender and low depression levels were the most consistent predictors of successful treatment outcomes across multiple time-points. Likely predictors of successful treatment outcomes also included older age, lower gambling symptom severity, lower levels of gambling behaviours and alcohol use, and higher treatment session attendance. Significant associations, at a minimum of one time-point, were identified between successful treatment outcomes and being employed, ethnicity, no gambling debt, personality traits and being in the action stage of change. Mixed results were identified for treatment goal, while education, income, preferred gambling activity, problem gambling duration, anxiety, any psychiatric comorbidity, psychological distress, substance use, prior gambling treatment and medication use were not significantly associated with treatment outcomes at any time-point. Further research involving consistent treatment outcome frameworks, examination of treatment and therapist predictor variables, and evaluation of predictors across long-term follow-ups is warranted to advance this developing field of research.

  3. Perceptions of parental treatment styles and psychological well-being in Chinese adolescents.

    Science.gov (United States)

    Shek, D T

    1989-12-01

    Chinese secondary school students (N = 2,150) responded to instruments assessing their parent's treatment styles and their own psychological well-being. Results arising from bivariate and canonical correlation analyses showed that students' assessments of paternal (PT) and maternal (MT) treatment styles correlated significantly with measures of their general psychiatric morbidity, anxiety, depression, somatic symptoms, purpose in life, and ego strength. PT and MT were most strongly correlated with total scores on the Purpose in Life Questionnaire. These findings generally suggest that Chinese adolescents' recollections of their parents' treatment styles are significantly associated with their own psychological well-being, whether defined by active or passive mental health criteria.

  4. Asperger syndrome and anxiety disorders (PAsSA) treatment trial: a study protocol of a pilot, multicentre, single-blind, randomised crossover trial of group cognitive behavioural therapy

    Science.gov (United States)

    Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra

    2013-01-01

    Introduction A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. Methods and analysis This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. Ethics and dissemination The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. Trial Registration ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN

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

    Directory of Open Access Journals (Sweden)

    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.

  6. Psychoanalytic treatment of psychological addiction toalcohol (alcohol abuse

    Directory of Open Access Journals (Sweden)

    Brian eJohnson

    2011-12-01

    Full Text Available AbstractThe DSM-V Committee plans to abolish the distinction between Alcohol Abuse and Alcohol Dependence (DSM5.org. The author presents a case report as a proof of concept that this distinction should be retained. The author has asserted that Alcohol Abuse is a purely psychological addiction, while Alcohol Dependence involves capture of the ventral tegmental dopaminergic SEEKING system (Johnson 2003. In psychological addiction the brain can be assumed to function normally, and ordinary psychoanalytic technique can be followed. For the patient described, transference interpretation was the fundamental key to recovery.Alcoholic drinking functioned to prevent this man from remembering overwhelming childhood events; events that were also lived out in his current relationships. Murders that occurred when he was a child were hidden in a screen memory. The patient had an obsessional style of relating where almost all feeling was left out of his associations. After he stopped drinking compulsively, he continued to work compulsively. The maternal transference had to be enacted and then interpreted in order for overwhelming memories to be allowed into conscious thought. After psychoanalysis, the patient resumed drinking and worked a normal schedule that allowed more fulfilling relationships. He had no further symptoms of distress from drinking over a 9 year followup.

  7. The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Schakel, Lemmy; Veldhuijzen, Dieuwke S; van Middendorp, Henriët; Prins, Corine; Joosten, Simone A; Ottenhoff, Tom H M; Visser, Leo G; Evers, Andrea W M

    2017-05-26

    Previous research has provided evidence for the link between psychological processes and psychophysiological health outcomes. Psychological interventions, such as face-to-face or online cognitive behavioral therapy (CBT) and serious games aimed at improving health, have shown promising results in promoting health outcomes. Few studies so far, however, have examined whether Internet-based CBT combined with serious gaming elements is effective in modulating health outcomes. Moreover, studies often did not incorporate psychophysiological or immunological challenges in order to gain insight into physiological responses to real-life challenges after psychological interventions. The overall aim of this study is to investigate the effects of a psychological intervention on self-reported and physiological health outcomes in response to immune and psychophysiological challenges. In a randomized controlled trial, 60 healthy men are randomly assigned to either an experimental condition, receiving guided Internet-based (e-health) CBT combined with health-related serious gaming elements for 6 weeks, or a control condition receiving no intervention. After the psychological intervention, self-reported vitality is measured, and participants are given an immunological challenge in the form of a Mycobacterium bovis Bacillus Calmette-Guérin (BCG) vaccination. One day after the vaccination, participants are asked to perform several psychophysiological tasks in order to explore the effects of the psychological intervention on participants' stress response following the immune challenge. To assess the delayed effects of vaccination on self-reported and physiological health outcomes, a follow-up visit is planned 4 weeks later. Total study duration is approximately 14 weeks. The primary outcome measure is self-reported vitality measured directly after the intervention. Secondary outcome measures include inflammatory and endocrine markers, as well as psychophysiological measures of

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

    Science.gov (United States)

    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.

  9. Sudden Gains during Psychological Treatments of Anxiety and Depression: A Meta-Analysis

    Science.gov (United States)

    Aderka, Idan M.; Nickerson, Angela; Boe, Hans Jakob; Hofmann, Stefan G.

    2012-01-01

    Objective: The present study quantitatively reviewed the literature on sudden gains in psychological treatments for anxiety and depression. The authors examined the short- and long-term effects of sudden gains on treatment outcome as well as moderators of these effects. Method: The authors conducted a literature search using PubMed, PsycINFO, the…

  10. Sudden Gains during Psychological Treatments of Anxiety and Depression: A Meta-Analysis

    Science.gov (United States)

    Aderka, Idan M.; Nickerson, Angela; Boe, Hans Jakob; Hofmann, Stefan G.

    2012-01-01

    Objective: The present study quantitatively reviewed the literature on sudden gains in psychological treatments for anxiety and depression. The authors examined the short- and long-term effects of sudden gains on treatment outcome as well as moderators of these effects. Method: The authors conducted a literature search using PubMed, PsycINFO, the…

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

    Directory of Open Access Journals (Sweden)

    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.

  12. Internet-based acceptance and commitment therapy for psychological distress experienced by people with hearing problems: a pilot randomized controlled trial.

    Science.gov (United States)

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

    2017-09-12

    Psychological distress is common among people with hearing problems, but treatments that specifically target this aspect have been almost non-existent. In this pilot randomized controlled trial, an eight-week long Internet-based treatment, informed by Acceptance and Commitment Therapy, was administered to explore the feasibility and efficacy of such a treatment. Included participants were randomized to either treatment (n = 31) or wait-list control (n = 30) condition. All participants were measured prior to randomization and immediately after treatment ended using standardized self-report instruments measuring hearing-related emotional and social adjustment (Hearing Handicap Inventory for the Elderly - S, HHIE-S), quality of life (Quality of Life Inventory, QOLI), and symptoms of depression and anxiety (Patient health Questionnaire, PHQ-9 and Generalized Anxiety Disorder scale, GAD-7). Linear mixed effects regression analysis using the full intention-to-treat sample demonstrated that the treatment had superior outcomes on the main outcome measure as compared with the control group, Cohen's d = 0.93, 95% CI [0.24, 1.63]. The benefits of treatment over control were also evident in scores of depression, Cohen's d = 0.61, 95% CI [0.04, 1.19], and quality of life, Cohen's d = 0.88, 95% CI [0.14, 1.61]. The results provide preliminary support for Internet-delivered acceptance and commitment therapy as a potentially effective treatment of psychological symptoms associated with hearing problems.

  13. On-line randomized controlled trial of an internet based psychologically enhanced intervention for people with hazardous alcohol consumption.

    Directory of Open Access Journals (Sweden)

    Paul Wallace

    Full Text Available BACKGROUND: Interventions delivered via the Internet have the potential to address the problem of hazardous alcohol consumption at minimal incremental cost, with potentially major public health implications. It was hypothesised that providing access to a psychologically enhanced website would result in greater reductions in drinking and related problems than giving access to a typical alcohol website simply providing information on potential harms of alcohol. DYD-RCT Trial registration: ISRCTN 31070347. METHODOLOGY/PRINCIPAL FINDINGS: A two-arm randomised controlled trial was conducted entirely on-line through the Down Your Drink (DYD website. A total of 7935 individuals who screened positive for hazardous alcohol consumption were recruited and randomized. At entry to the trial, the geometric mean reported past week alcohol consumption was 46.0 (SD 31.2 units. Consumption levels reduced substantially in both groups at the principal 3 month assessment point to an average of 26.0 (SD 22.3 units. Similar changes were reported at 1 month and 12 months. There were no significant differences between the groups for either alcohol consumption at 3 months (intervention: control ratio of geometric means 1.03, 95% CI 0.97 to 1.10 or for this outcome and the main secondary outcomes at any of the assessments. The results were not materially changed following imputation of missing values, nor was there any evidence that the impact of the intervention varied with baseline measures or level of exposure to the intervention. CONCLUSIONS/SIGNIFICANCE: Findings did not provide support for the hypothesis that access to a psychologically enhanced website confers additional benefit over standard practice and indicate the need for further research to optimise the effectiveness of Internet-based behavioural interventions. The trial demonstrates a widespread and potentially sustainable demand for Internet based interventions for people with hazardous alcohol consumption

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

    OpenAIRE

    2015-01-01

    Objective 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). Method The SWAN Psychother...

  15. 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.

  16. Evaluation of a hospital-based day-structuring exercise programme on exacerbated behavioural and psychological symptoms in dementia - the exercise carrousel: study protocol for a randomised controlled trial

    OpenAIRE

    Fleiner, Tim; Zijlstra, Wiebren; Dauth, Hannah; Haussermann, Peter

    2015-01-01

    Background Conceptual reviews and observational studies describe a link between physical inactivity and behavioural disturbances in people with dementia. Consequently, treatment of these symptoms requires physical activation and pharmacological or physical immobilization should be avoided. The few trials that have been conducted in inpatient dementia care to investigate the effects of exercise on behavioural and psychological symptoms revealed inconsistent results. Due to a lack of evidence, ...

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

    Science.gov (United States)

    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

  18. 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.

  19. Childhood sexual abuse characteristics, intimate partner violence exposure, and psychological distress among women in methadone treatment.

    Science.gov (United States)

    Engstrom, Malitta; El-Bassel, Nabila; Gilbert, Louisa

    2012-10-01

    Traumatic experiences and their biopsychosocial sequelae present complex challenges in substance use treatment. For women with substance use problems, childhood sexual abuse (CSA), intimate partner violence exposure (IPV), posttraumatic stress disorder (PTSD), and overall psychological distress are often co-occurring concerns. To address gaps in knowledge and to strengthen practice regarding these critical issues in substance use treatment, we drew upon cross-sectional and longitudinal data from baseline and 12-month interviews with a random sample of 416 women in methadone treatment to examine relationships between CSA characteristics, particularly the presence of force and involvement of family, IPV, and mental health concerns. Although CSA involving force and family was not associated with IPV as hypothesized, it was associated with increased risk of PTSD and overall psychological distress. The multivariate findings underscore the psychological vulnerabilities associated with CSA involving force and family and suggest that drug use and financial circumstances may be important targets to reduce IPV risk.

  20. Feasibility of a Personal Health Technology-Based Psychological Intervention for Men with Stress and Mood Problems: Randomized Controlled Pilot Trial

    Science.gov (United States)

    Kaipainen, Kirsikka; Lappalainen, Raimo; Hoffrén, Henna; Myllymäki, Tero; Kinnunen, Marja-Liisa; Mattila, Elina; Happonen, Antti P; Rusko, Heikki; Korhonen, Ilkka

    2013-01-01

    Background Work-related stress is a significant problem for both people and organizations. It may lead to mental illnesses such as anxiety and depression, resulting in increased work absences and disabilities. Scalable interventions to prevent and manage harmful stress can be delivered with the help of technology tools to support self-observations and skills training. Objective The aim of this study was to assess the feasibility of the P4Well intervention in treatment of stress-related psychological problems. P4Well is a novel intervention which combines modern psychotherapy (the cognitive behavioral therapy and the acceptance and commitment therapy) with personal health technologies to deliver the intervention via multiple channels, includinggroup meetings, Internet/Web portal, mobile phone applications, and personal monitoring devices. Methods This pilot study design was a small-scale randomized controlled trial that compared the P4Well intervention with a waiting list control group. In addition to personal health technologies for self-assessment, the intervention consisted of 3 psychologist-assisted group meetings. Self-assessed psychological measures through questionnaires were collected offline pre- and post-intervention, and 6 months after the intervention for the intervention group. Acceptance and usage of technology tools were measured with user experience questionnaires and usage logs. Results A total of 24 subjects were randomized: 11 participants were followed up in the intervention group (1 was lost to follow-up) and 12 participants did not receive any intervention (control group). Depressive and psychological symptoms decreased and self-rated health and working ability increased. All participants reported they had benefited from the intervention. All technology tools had active users and 10/11 participants used at least 1 tool actively. Physiological measurements with personal feedback were considered the most useful intervention component. Conclusions

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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. PMID:26339283

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

    Directory of Open Access Journals (Sweden)

    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.

  5. Challenging factors for enuresis treatment: Psychological problems and non-adherence.

    Science.gov (United States)

    Van Herzeele, Charlotte; De Bruyne, Pauline; De Bruyne, Elke; Walle, Johan Vande

    2015-12-01

    The evidence for organic pathogenetic factors in enuresis and the discovery of effective therapies targeting the bladder and/or nocturnal diuresis have overwhelmed every potential role of psychological factors in pathogenesis and treatment. However, psychopathology is still important in enuresis because according to the document of the International Children's Continence Society (ICCS) 20-30% of the children with enuresis have at least one psychological/psychiatric disorder at rates two times higher than non-wetting children. The most common comorbid disorder with enuresis is attention deficit hyperactivity disorder. The aim of this review is to translate the existing evidence on the importance of a psychological screening into daily clinical practice of the medical practitioner. The use of the minimal psychological screening tool should be considered mandatory in each primary setting. If psychological problems are indicated, referral of the patient to a multidisciplinary setting should be considered, not only to allow psychological assessment to screen for a possible psychopathology, but also since therapy resistance might be expected. This review concentrates on two items from psychopathology/psychotherapy that might predict insufficient treatment response: the psychological comorbidities as described according to the DSM-5 criteria and the underestimated importance of therapy adherence. Adherence is a cornerstone of effective therapy in enuresis. It is a problem involving the doctor, the patient, and the parents. Increasing adherence takes effort and is time-consuming. But it is worthwhile knowing that several studies have demonstrated that high adherence is associated with high therapy success of enuresis. Eventually, this is the ultimate goal of treatment.

  6. Psychological effects of diagnosis and treatment of cervical intraepithelial neoplasia: a systematic review.

    Science.gov (United States)

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

    2015-06-01

    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. To investigate the psychological consequences of CIN diagnosis and treatment in a systematic review. We searched PubMed using Medical Subject Headings (MeSH) terms for articles published from January 1990 to February 2013. We also examined the reference lists of retrieved articles. Quantitative studies measuring psychological outcomes in women with a histological diagnosis or treatment of CIN, and in women having an outcome other than CIN at cervical screening. We abstracted the data using a pre-specified list of study characteristics and measured outcomes. For studies not reporting statistical testing, we estimated the statistical significance of the differences between the compared groups using unpaired t tests. From 5099 retrieved abstracts, 16 studies were included. Diagnosis and treatment of CIN were associated with worse psychological outcomes than normal cytology 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 diagnosis. The studies suggested that CIN diagnosis and treatment have a negative psychological impact. However, this conclusion should be viewed in the context of a paucity of rigorously designed studies. 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.

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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    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.

  9. Examining Emotion Regulation as an Outcome, Mechanism, or Target of Psychological Treatments

    Science.gov (United States)

    Gratz, Kim L.; Weiss, Nicole H.; Tull, Matthew T.

    2015-01-01

    This paper reviews the extant literature on emotion regulation (ER) in psychological interventions. First, we review current conceptualizations of ER, highlighting a model with established clinical utility (particularly with regard to the development of new interventions and modification of existing interventions). Next, we review the literature on the effects of psychological interventions on ER, from traditional cognitive-behavioral and acceptance-based behavioral interventions that do not target ER directly to treatments that directly target ER as one component of a larger or more comprehensive treatment, as well as the preliminary research examining ER as a mechanism of change in these treatments. Finally, extant data on three treatments developed specifically to address ER are reviewed, with an emphasis on the ER-specific treatment with the most empirical support to date (emotion regulation group therapy). PMID:25859561

  10. Radonexposure with the treatment of rheumatic diseases - randomized controlled trials

    Energy Technology Data Exchange (ETDEWEB)

    Falkenbach, A. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria)]|[Forschungsinstitut Gastein, Bad Gastein (Austria); Kovac, J.; Brandmaier, P. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria); Soto, J. [Dept. of Medical Physics, Univ. of Cantabria (Spain)

    2001-07-01

    The objective was to investigate whether there is evidence for the effectiveness of radon therapy in the treatment of rheumatic diseases. Method: Medline and MedKur databases were searched for randomised controlled clinical trials. Radon therapy centres and experts in the field were contacted, proceedings were hand-searched and bibliographies were checked for references of potential impact. Four clinical trials evaluating the effect of radon in patients suffering from rheumatic diseases with no or only a small number of drop-outs met the inclusion criteria. In patients with degenerative disease of the spine and large joints, two trials [1,2] reported less pain on pressure of painful paraspinal muscle points after a series of radon baths at a concentration of 0.8 kBq/L and 3 kBq/L, respectively. The alleviation of pain was most pronounced in the weeks following the treatment period. [3]. At six months follow-up serial immersion in combined radon and CO{sub 2} baths reduced pain and functional restrictions in patients with rheumatoid arthritis (n=60) more effectively than bathing in CO{sub 2} only. [4] In 130 patients with ankylosing spondylitis a complex rehabilitation program at a health resort (group 1 and 2) showed greater and longer-lasting differences to a control group staying at home (group 3), if speleotherapeutic radon exposure (group 1) was added (as compared to an added sauna treatment, group 2). Conclusion: The four trials meeting the inclusion criteria showed beneficial effects of radon therapy compared to interventions without radon exposure. Up to nine months after the treatment period significantly better results were observed, if radon therapy is added. (orig.)

  11. Early treatment of posterior crossbite - a randomised clinical trial

    Science.gov (United States)

    2013-01-01

    Background The aim of this randomised clinical trial was to assess the effect of early orthodontic treatment in contrast to normal growth effects for functional unilateral posterior crossbite in the late deciduous and early mixed dentition by means of three-dimensional digital model analysis. Methods This randomised clinical trial was assessed to analyse the orthodontic treatment effects for patients with functional unilateral posterior crossbite in the late deciduous and early mixed dentition using a two-step procedure: initial maxillary expansion followed by a U-bow activator therapy. In the treatment group 31 patients and in the control group 35 patients with a mean age of 7.3 years (SD 2.1) were monitored. The time between the initial assessment (T1) and the follow-up (T2) was one year. The orthodontic analysis was done by a three-dimensional digital model analysis. Using the ‘Digimodel’ software, the orthodontic measurements in the maxilla and mandible and for the midline deviation, the overjet and overbite were recorded. Results Significant differences between the control and the therapy group at T2 were detected for the anterior, median and posterior transversal dimensions of the maxilla, the palatal depth, the palatal base arch length, the maxillary arch length and inclination, the midline deviation, the overjet and the overbite. Conclusions Orthodontic treatment of a functional unilateral posterior crossbite with a bonded maxillary expansion device followed by U-bow activator therapy in the late deciduous and early mixed dentition is an effective therapeutic method, as evidenced by the results of this RCT. It leads to three-dimensional therapeutically induced maxillary growth effects. Dental occlusion is significantly improved, and the prognosis for normal craniofacial growth is enhanced. Trial registration Registration trial DRKS00003497 on DRKS PMID:23339736

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

    Directory of Open Access Journals (Sweden)

    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.

  13. Rapid response in psychological treatments for binge eating disorder.

    Science.gov (United States)

    Hilbert, Anja; Hildebrandt, Thomas; Agras, W Stewart; Wilfley, Denise E; Wilson, G Terence

    2015-06-01

    Analysis of short- and long-term effects of rapid response across 3 different treatments for binge eating disorder (BED). In a randomized clinical study comparing interpersonal psychotherapy (IPT), cognitive-behavioral therapy guided self-help (CBTgsh), and behavioral weight loss (BWL) treatment in 205 adults meeting Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV; APA, 1994) criteria for BED, the predictive value of rapid response, defined as ≥70% reduction in binge eating by Week 4, was determined for remission from binge eating and global eating disorder psychopathology at posttreatment, 6-, 12-, 18-, and 24-month follow-ups. Rapid responders in CBTgsh, but not in IPT or BWL, showed significantly greater rates of remission from binge eating than nonrapid responders, which was sustained over the long term. Rapid and nonrapid responders in IPT and rapid responders in CBTgsh showed a greater remission from binge eating than nonrapid responders in CBTgsh and BWL. Rapid responders in CBTgsh showed greater remission from binge eating than rapid responders in BWL. Although rapid responders in all treatments had lower global eating disorder psychopathology than nonrapid responders in the short term, rapid responders in CBTgsh and IPT were more improved than those in BWL and nonrapid responders in each treatment. Rapid responders in BWL did not differ from nonrapid responders in CBTgsh and IPT. Rapid response is a treatment-specific positive prognostic indicator of sustained remission from binge eating in CBTgsh. Regarding an evidence-based, stepped-care model, IPT, equally efficacious for rapid and nonrapid responders, could be investigated as a second-line treatment in case of nonrapid response to first-line CBTgsh. (c) 2015 APA, all rights reserved).

  14. Rapid Response in Psychological Treatments for Binge-Eating Disorder

    Science.gov (United States)

    Hilbert, Anja; Hildebrandt, Thomas; Agras, W. Stewart; Wilfley, Denise E.; Wilson, G. Terence

    2015-01-01

    Objective Analysis of short- and long-term effects of rapid response across three different treatments for binge-eating disorder (BED). Method In a randomized clinical study comparing interpersonal psychotherapy (IPT), cognitive-behavioral guided self-help (CBTgsh), and behavioral weight loss (BWL) treatment in 205 adults meeting DSM-IV criteria for BED, the predictive value of rapid response, defined as ≥ 70% reduction in binge-eating by week four, was determined for remission from binge-eating and global eating disorder psychopathology at posttreatment, 6-, 12-, 18-, and 24-month follow-up. Results Rapid responders in CBTgsh, but not in IPT or BWL, showed significantly greater rates of remission from binge-eating than non-rapid responders, which was sustained over the long term. Rapid and non-rapid responders in IPT and rapid responders in CBTgsh showed a greater remission from binge-eating than non-rapid responders in CBTgsh and BWL. Rapid responders in CBTgsh showed greater remission from binge-eating than rapid responders in BWL. Although rapid responders in all treatments had lower global eating disorder psychopathology than non-rapid responders in the short term, rapid responders in CBTgsh and IPT were more improved than those in BWL and non-rapid responders in each treatment. Rapid responders in BWL did not differ from non-rapid responders in CBTgsh and IPT. Conclusions Rapid response is a treatment-specific positive prognostic indicator of sustained remission from binge-eating in CBTgsh. Regarding an evidence-based stepped care model, IPT, equally efficacious for rapid and non-rapid responders, could be investigated as a second-line treatment in case of non-rapid response to first-line CBTgsh. PMID:25867446

  15. Magnesium treatment in alcoholics: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Poikolainen Kari

    2008-01-01

    Full Text Available Abstract Background Magnesium (Mg deficiency is common among alcoholics. Earlier research suggests that Mg treatment may help to normalize elevated enzyme activities and some other clinically relevant parameters among alcoholics but the evidence is weak. Methods The effect of Mg was studied in a randomized, parallel group, double-blind trial. The patients were first treated for alcohol withdrawal symptoms and then received for 8 weeks either 500 mg of Mg divided into two tablets or matching placebo. Measurements were made at the beginning and in the end of the Mg treatment period. The primary outcome was serum gamma-glutamyltransferase (S-GGT activity; secondary outcomes included aspartate-aminotransferase (S-AST and alanine-aminotransferase (S-ALT activity. Results The number of randomized patients (completers was 64 (27 in the treatment and 54 (31 in the control group. In intention-to-treat-analyses and in most analyses of study completers, there were no significant differences between the Mg-treated and placebo groups in the outcome variables. When baseline serum Mg level, coffee intake, and the number of unused Mg tablets were controlled for in a multivariate regression model, after-treatment serum Mg levels were found to be higher among the Mg-treated group than in the placebo group (t-test 3.334, df = 53, p = 0.002. After controlling for age, body weight, baseline alcohol intake, subsequent change in alcohol intake and baseline S-AST, the after-treatment S-AST levels were found to be lower among the Mg-treated group than in the placebo group (t-test 2.061, df = 49, p = 0.045. Conclusion Mg treatment may speed up the S-AST decrease in compliant patients. This might decrease the risk of death from alcoholic liver disease. Trial Registration ClinicalTrials.gov ID NCT00325299

  16. 氨磺必利治疗阿尔茨海默病行为和精神症状疗效与安全性对照研究%Efficacy and safety of amisulpride in treatment of Alzheimer's patients with behavioral and psychological symptoms:a randomized and comparative trial

    Institute of Scientific and Technical Information of China (English)

    秦文; 刘立恒; 易军

    2015-01-01

    目的:评估氨磺必利对阿尔茨海默病患者行为和精神症状的疗效及安全性。方法将88例伴有行为和精神症状的阿尔茨海默病患者随机分为氨磺必利组和奥氮平组,分别接受12周的氨磺必利或奥氮平系统治疗。在治疗前后分别采用阿尔茨海默病行为病理量表( BEHAVE-AD )、阳性和阴性综合征量表( PANSS )、简易精神状况检查量表( MMSE)、日常生活能力量表( ADL)、治疗中需处理的不良反应症状量表( TESS)评估疗效和安全性,在治疗前后分别测定空腹血糖、总胆固醇、高密度脂蛋白、低密度脂蛋白、甘油三酯及体质量指数。结果治疗后,两组有效率比较差异无统计学意义(P>0.05);两组治疗后ADL评分、BEHAVE-AD总分及各因子分、PANSS总分及各因子分均低于治疗前(P<0.05),治疗后PANSS阴性症状评分氨磺必利组低于奥氮平组(P<0.05);治疗后氨磺必利组的BMI、FBS、LDL、TC、TG均低于奥氮平组(P<0.05),治疗后氨磺必利组嗜睡、视物模糊、头晕、便秘及体质量增加发生率低于奥氮平组(P<0.05)。结论氨磺必利对阿尔茨海默病伴行为和精神症状的疗效与奥氮平相当,但氨磺必利不良反应发生率低,对患者血糖、血脂的影响较小。%Objective To explore the efficacy and safety of amisulpride in treatment of Alzheimer's patients with behavioral and psychological symptoms.Methods A total of 88 Alzheimer's Patients with behavioral and psychological symptoms were randomly divided into amisulpride group with amisulpride and olanzapine group with olanzapine for 12 weeks of treatment.They were assessed with the Behavioral Pathology in Alzheimer's Disease Rating Scale ( BEHAVE-AD ) , Positive and Negative Syndrome Scale( PANSS) , Mini-mental State Examination ( MMSE) , Activity of Daily Living Scale( ADL) , Treatment Emergent Symptom Scale (TESS

  17. Effectiveness of START psychological intervention in reducing abuse by dementia family carers: randomized controlled trial

    OpenAIRE

    Cooper, C.; Barber, J; Griffin, M.; Rapaport, P.; Livingston, G.

    2016-01-01

    BACKGROUND: Family carers of people with dementia frequently report acting abusively toward them and carer psychological morbidity predicts this. We investigated whether START (STrAtegies for RelaTives), a psychological intervention which reduces depression and anxiety in family carers also reduces abusive behavior in carers of people living in their own homes. We also explored the longitudinal course of carer abusive behavior over two year. METHODS: We included self-identified family carers ...

  18. [Anorexia nervosa and bulimia nervosa. Psychological considerations for its treatment].

    Science.gov (United States)

    Barriguete Meléndez, J Armando; Rojo, Luis; Emmelhainz, Marisa

    2004-11-01

    It is presented the current perspectives in the study and treatment of the eating disorders, in specific: anorexia nervosa and bulimia nervosa, epidemiology, and the interface among the different medical specialties, nutrition and sciences of the behavior, the diagnostic approaches, instruments and current therapeutic models.

  19. Psychological treatment of depression: A meta-analytic database of randomized studies

    NARCIS (Netherlands)

    Cuijpers, P.; Straten, van A.; Warmerdam, E.H.; Andersson, G.

    2008-01-01

    Abstract Background A large number of randomized controlled studies have clearly demonstrated that psychological interventions are effective in the treatment of depression. The number of studies in this area is increasing rapidly. In this paper, we present a database of controlled and comparative ou

  20. Psychological treatment of depressive symptoms in patients with medical disorders: a meta-analysis

    NARCIS (Netherlands)

    Straten, van A.; Geraedts, A.S.; Leeuw, de I.M.; Andersson, G.; Cuijpers, P.

    2010-01-01

    Objective It is widely acknowledged that the prevalence of depression in the general population is high, but that it is even higher for patients with medical disorders. Yet, the effectiveness of psychological treatments in these patient populations has not been firmly established. Methods We conduct

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

    Science.gov (United States)

    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.…

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

    Science.gov (United States)

    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…

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

    Science.gov (United States)

    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…

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

    Directory of Open Access Journals (Sweden)

    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.

  5. Propranolol treatment of infantile hemangioma is not associated with psychological problems at 7 years of age

    NARCIS (Netherlands)

    Moyakine, A.V.; Spillekom-van Koulil, S.; Vleuten, C.J.M. van der

    2017-01-01

    BACKGROUND: Concern has been raised about the potential long-term effects of propranolol treatment for infantile hemangioma (IH). OBJECTIVES: We sought to assess psychologic (social, emotional, behavioral, and executive) functioning in children treated with propranolol for IH. METHODS: Twenty-seven

  6. Nursing and psychological treatment during tension-free inguinal hernia repair under local nerve blocked anesthesia

    Institute of Scientific and Technical Information of China (English)

    ZHAO Li-hui

    2007-01-01

    Tension-free inguinal hernia repair under local nerve blocked anesthesia ia an up-to-date technology and is different from the traditional approach.The aim of this study isto evaluate the nursing and psychological treatment during operation under local nerve blocked anesthesia.

  7. Psychological treatment of depression in primary care: a meta-analysis

    NARCIS (Netherlands)

    Cuijpers, P.; Straten, van A.; Schaik, van D.J.F.; Andersson, G.

    2009-01-01

    Abstract: Background Although most depressive disorders are treated in primary care and several studies have examined the effects of psychological treatment in primary care, hardly any meta-analytic research has been conducted in which the results of these studies are integrated. Aim To integrate th

  8. Accuracy of effect size estimates from published psychological experiments involving multiple trials.

    Science.gov (United States)

    Brand, Andrew; Bradley, M T; Best, Lisa A; Stoica, George

    2011-01-01

    The reporting of exaggerated effect size estimates may occur either through researchers accepting statistically significant results when power is inadequate and/or from repeated measures approaches aggregating, averaging multiple items, or multiple trials. Monte-Carlo simulations with input of a small, medium, or large effect size were conducted on multiple items or trials that were either averaged or aggregated to create a single dependent measure. Alpha was set at the .05 level, and the trials were assessed over item or trial correlations ranging from 0 to 1. Simulations showed a large increase in observed effect size averages and the power to accept these estimates as statistically significant increased over numbers of trials or items. Overestimation effects were mitigated as correlations between trials increased but still remained substantial in some cases. The implications of these findings for meta-analyses and different research scenarios are discussed.

  9. [Psychological consequences and treatment of female victims of violence].

    Science.gov (United States)

    Lopez, Gérard

    2014-11-01

    Domestic violence often just reproduces the repeated violence suffered as a child. The treatment of a female victim depends a lot on her traumatic past, and the care is designed in coordination with various partners. By improving the identification and care of children who are so-called witnesses to family violence, but who are really co-victims, in other words abused, it is possible to avoid violence in all its forms being reproduced across the generations.

  10. PSYCHOLOGICAL TREATMENT OF DEPRESSION IN COLLEGE STUDENTS: A METAANALYSIS

    OpenAIRE

    2015-01-01

    Expanded efforts to detect and treat depression among college students, a peak period of onset, have the potential to bear high human capital value from a societal perspective because depression increases college withdrawal rates. However, it is not clear whether evidence-based depression therapies are as effective in college students as in other adult populations. The higher levels of cognitive functioning and IQ and higher proportions of first-onset cases might lead to treatment effects bei...

  11. Evidence-based psychological treatments for late-life anxiety.

    Science.gov (United States)

    Ayers, Catherine R; Sorrell, John T; Thorp, Steven R; Wetherell, Julie Loebach

    2007-03-01

    This project identified evidence-based psychotherapy treatments for anxiety disorders in older adults. The authors conducted a review of the geriatric anxiety treatment outcome literature by using specific coding criteria and identified 17 studies that met criteria for evidence-based treatments (EBTs). These studies reflected samples of adults with generalized anxiety disorder (GAD) or samples with mixed anxiety disorders or symptoms. Evidence was found for efficacy for 4 types of EBTs. Relaxation training, cognitive-behavioral therapy (CBT), and, to a lesser extent, supportive therapy and cognitive therapy have support for treating subjective anxiety symptoms and disorders. CBT for late-life GAD has garnered the most consistent support, and relaxation training represents an efficacious, relatively low-cost intervention. The authors provide a review of the strengths and limitations of this research literature, including a discussion of common assessment instruments. Continued investigation of EBTs is needed in clinical geriatric anxiety samples, given the small number of available studies. Future research should examine other therapy models and investigate the effects of psychotherapy on other anxiety disorders, such as phobias and posttraumatic stress disorder in older adults. ((c) 2007 APA, all rights reserved).

  12. Subject preferences for acne treatments containing adapalene gel 0.1%: results of the MORE trial.

    Science.gov (United States)

    Cook-Bolden, Fran

    2006-07-01

    Acne vulgaris can affect adolescents at a time of profound physical, social, and psychological change. The negative impact of acne on self-image and self-confidence can be severe, leading to potential psychiatric problems and limiting social interactions, even in adults. Adherence is necessary for successful treatment of acne, and patient satisfaction is crucial for adherence. The Measuring Acne Outcomes in a Real-World Experience (MORE) trial enrolled 1979 subjects who used combination acne treatments, all containing adapalene gel 0.1%. Among other measures, subjects were surveyed regarding their satisfaction with treatment. Adherence to treatment protocol was high throughout the study (94.5% and 88.0% at weeks 6 and 12, respectively, determined by self-report, and 93.7% and 80.3%, respectively, determined by filled prescriptions). Of the subjects who completed preference surveys, more than 70% rated adapalene gel 0.1% as much superior or superior to other acne treatments; more than 85% of subjects were very satisfied or satisfied with adapalene gel 0.1% to treat their acne; and more than 85% of subjects reported feeling more confident or positive after using this treatment. About 75% of subjects planned to continue using adapalene gel 0.1% and/or use it in the future if they needed acne treatment, and close to 75% of subjects indicated that they would recommend this treatment to a friend. The high level of patient satisfaction with adapalene gel 0.1% as an acne treatment is likely to translate into a high level of adherence to treatment, including maintenance treatment, and a major improvement in quality of life (QOL) for patients with acne.

  13. Does Pretreatment Severity Moderate the Efficacy of Psychological Treatment of Adult Outpatient Depression? A Meta-Analysis

    Science.gov (United States)

    Driessen, Ellen; Cuijpers, Pim; Hollon, Steven D.; Dekker, Jack J. M.

    2010-01-01

    Objective: It is widely believed that psychological treatment has little effect on more severely depressed patients. This study assessed whether pretreatment severity moderates psychological treatment outcome relative to controls by means of meta-analyses. Method: We included 132 studies (10,134 participants) from a database of studies…

  14. Does Pretreatment Severity Moderate the Efficacy of Psychological Treatment of Adult Outpatient Depression? A Meta-Analysis

    Science.gov (United States)

    Driessen, Ellen; Cuijpers, Pim; Hollon, Steven D.; Dekker, Jack J. M.

    2010-01-01

    Objective: It is widely believed that psychological treatment has little effect on more severely depressed patients. This study assessed whether pretreatment severity moderates psychological treatment outcome relative to controls by means of meta-analyses. Method: We included 132 studies (10,134 participants) from a database of studies…

  15. Psychological treatments to improve quality of life in cancer contexts: A meta-analysis

    OpenAIRE

    Alejandro de la Torre-Luque; Hilda Gambara; Escarlata López; Juan Antonio Cruzado

    2016-01-01

    This study aimed to analyze the effects of psychological treatments on quality of life among cancer patients and survivors. Additionally, it was explored the moderating influence of some medical- and treatment-related features on these effects. Scientific studies published between 1970 and 2012 were analyzed. Seventy-eight studies were included in a meta-analysis. Concerns related to samples, interventions, and standard of methodological evidence were explored across the studies. A signifi...

  16. Treatment of Chronic Phantom Limb Pain Using a Trauma-Focused Psychological Approach

    OpenAIRE

    Roos, C.; AC Veenstra; de Jongh, A.; ME den Hollander-Gijsman; NJA van der Wee; Zitman FG; YR van Rood

    2010-01-01

    BACKGROUND: Chronic phantom limb pain (PLP) is a disabling chronic pain syndrome for which regular pain treatment is seldom effective. Pain memories resulting from long-lasting preamputation pain or pain flashbacks, which are part of a traumatic memory, are reported to be powerful elicitors of PLP.OBJECTIVE: To investigate whether a psychological treatment directed at processing the emotional and somatosensory memories associated with amputation reduces PLP.METHODS: Ten consecutive participan...

  17. Behavioural treatments for sleep problems in children and adolescents with physical illness, psychological problems or intellectual disabilities.

    Science.gov (United States)

    Wiggs, Luci; France, Karyn

    2000-06-01

    Young people with physical, psychological or intellectual disabilities or disorders are reported to have more frequent and persistent problems with sleep than their peers without . Sleep disorders affecting the quantity or quality of sleep have effects on a child's daytime functioning and the functioning of their families. Many children with special needs have learning and behaviour problems and their parents (particularly mothers) have increased levels of stress and poorer mental health. This relationship between sleep disorders and learning, and behaviour and family functioning makes it particularly important that children with special needs receive appropriate intervention for their sleep disorders. This may be one way of mitigating these other problems. This review considers the case reports and experimental trials which have used behavioural treatments for sleep problems in children and adolescents with special needs. Behavioural treatments for sleep-wake cycle disorders, sleeplessness, parasomnias and excessive sleepiness are reported. These preliminary reports do suggest that behavioural approaches can be rapidly successful for treating sleep problems, even where the sleep problems are long-standing, severe and associated with physical, psychological or intellectual problems. The parent and the clinician should not be deterred from treating the sleep problem in isolation using behavioural treatments. Methodological issues, however, highlight the importance of further and better research. Not all children responded to the behavioural interventions and some needed re-implementation of therapy to maintain improvements; the use of heterogeneous groups make the findings and choice of treatment for individuals difficult to interpret. Finally, there are few studies overall, and the majority are case studies rather than controlled studies using multiple baseline designs or randomization and a control group. Careful studies are required in order to establish the

  18. Treatment via videoconferencing: a pilot study of delivery by clinical psychology trainees.

    Science.gov (United States)

    Dunstan, Debra A; Tooth, Susan M

    2012-04-01

    This pilot study explored the outcomes of clinical psychology trainees delivering treatments via videoconferencing. A noncurrent, multiple baseline across subjects and settings. University outpatient psychology clinic. Six clients (two men and four women) with an anxiety or depressive disorder were randomly assigned to received six sessions of individual therapy (either via videoconferencing or face to face) from a male or female clinical psychology trainee. Participants provided daily ratings (0-10) of subjective distress/well-being via text messaging, and at pre-, post-, and 1 month follow-up of treatment, completed the Depression Anxiety Stress Scales and the Outcome Questionnaire-45. Along with the trainees, participants also provided feedback on the therapy experience. The subjective well-being of all participants improved, and all videoconferencing participants showed a statistically and clinically significant reduction in symptomology and gains in general life functioning. Feedback comments were positive. This study suggests that there is value in clinical psychology trainees gaining experience in the delivery of treatments via videoconferencing. Further study is needed to demonstrate the potential for university clinics to deliver mental health services, via this modality, to rural and remote areas. © 2012 The Authors. Australian Journal of Rural Health © 2012 National Rural Health Alliance Inc.

  19. The role of positive emotion and contributions of positive psychology in depression treatment: systematic review.

    Science.gov (United States)

    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.

  20. Internet-Based and other computerized psychological treatments for adults depression: A meta-analysis

    NARCIS (Netherlands)

    Andersson, G.; Cuijpers, P.

    2009-01-01

    Computerized and, more recently, Internet-based treatments for depression have been developed and tested in controlled trials. The aim of this meta-analysis was to summarize the effects of these treatments and investigate characteristics of studies that may be related to the effects. In particular,

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

    Science.gov (United States)

    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.

  2. The effect of treatment history on therapeutic outcome: psychological and neurobiological underpinnings.

    Directory of Open Access Journals (Sweden)

    Simon Kessner

    Full Text Available It is increasingly recognized that the efficacy of medical treatments is determined in critical part by the therapeutic context in which it is delivered. An important characteristic of that context is treatment history. We recently reported first evidence for a carry-over of treatment experience to subsequent treatment response across different treatment approaches. Here we expand on these findings by exploring the psychological and neurobiological underpinnings of the effect of treatment experience on future treatment response in an experimental model of placebo analgesia with a conditioning procedure. In a combined behavioral and neuroimaging study we experimentally induced positive or negative experiences with an analgesic treatment in two groups of healthy human subjects. Subsequently we compared responses to a second, different analgesic treatment between both groups. We found that participants with an experimentally induced negative experience with the first treatment showed a substantially reduced response to a second analgesic treatment. Intriguingly, several psychological trait variables including anxiety, depression and locus of control modulate the susceptibility for the effects of prior treatment experiences on future treatment outcome. These behavioral effects were supported by neuroimaging data which showed significant differences in brain regions encoding pain and analgesia between groups. These differences in activation patterns were present not only during the pain phase, but also already prior to painful stimulation and scaled with the individual treatment response. Our data provide behavioral and neurobiological evidence showing that the influence of treatment history transfers over time and over therapeutic approaches. Our experimental findings emphasize the careful consideration of treatment history and a strictly systematic treatment approach to avoid negative carry-over effects.

  3. Effects of an Integrated Stress Management Program (ISMP) for Psychologically Distressed Students: A Randomized Controlled Trial.

    Science.gov (United States)

    Kim, Sunah; Lee, Hyangkyu; Kim, Hyunlye; Noh, Dabok; Lee, Hyunhwa

    2016-07-01

    This study aimed to evaluate the effects of an integrated stress management program (ISMP) on college life stress, stress coping, psychological distress, and cortisol among male college students. Out of 137 initially enrolled students, 99 participants were identified as distressed subjects and randomly assigned to either the ISMP or control group. Ultimately, 84 participants (43: experimental, 41: control) completed pretest-posttest. The experimental group received eight 2-hr sessions over 4 weeks. Stress and psychological distress decreased significantly, whereas stress coping and cortisol did not improve significantly. Further studies with longer follow-up periods and physiological interventions are required. © 2015 Wiley Periodicals, Inc.

  4. Uncaria tomentosa—Adjuvant Treatment for Breast Cancer: Clinical Trial

    Directory of Open Access Journals (Sweden)

    Maria do Carmo Santos Araújo

    2012-01-01

    Full Text Available Breast cancer is the most frequent neoplasm affecting women worldwide. Some of the recommended treatments involve chemotherapy whose toxic effects include leukopenia and neutropenia. This study assessed the effectiveness of Uncaria tomentosa (Ut in reducing the adverse effects of chemotherapy through a randomized clinical trial. Patients with Invasive Ductal Carcinoma—Stage II, who underwent a treatment regimen known as FAC (Fluorouracil, Doxorubicin, Cyclophosphamide, were divided into two groups: the UtCa received chemotherapy plus 300 mg dry Ut extract per day and the Ca group that only received chemotherapy and served as the control experiment. Blood samples were collected before each one of the six chemotherapy cycles and blood counts, immunological parameters, antioxidant enzymes, and oxidative stress were analyzed. Uncaria tomentosa reduced the neutropenia caused by chemotherapy and was also able to restore cellular DNA damage. We concluded that Ut is an effective adjuvant treatment for breast cancer.

  5. Uncaria tomentosa—Adjuvant Treatment for Breast Cancer: Clinical Trial

    Science.gov (United States)

    Santos Araújo, Maria do Carmo; Farias, Iria Luiza; Gutierres, Jessie; Dalmora, Sergio L.; Flores, Nélia; Farias, Julia; de Cruz, Ivana; Chiesa, Juarez; Morsch, Vera Maria; Chitolina Schetinger, Maria Rosa

    2012-01-01

    Breast cancer is the most frequent neoplasm affecting women worldwide. Some of the recommended treatments involve chemotherapy whose toxic effects include leukopenia and neutropenia. This study assessed the effectiveness of Uncaria tomentosa (Ut) in reducing the adverse effects of chemotherapy through a randomized clinical trial. Patients with Invasive Ductal Carcinoma—Stage II, who underwent a treatment regimen known as FAC (Fluorouracil, Doxorubicin, Cyclophosphamide), were divided into two groups: the UtCa received chemotherapy plus 300 mg dry Ut extract per day and the Ca group that only received chemotherapy and served as the control experiment. Blood samples were collected before each one of the six chemotherapy cycles and blood counts, immunological parameters, antioxidant enzymes, and oxidative stress were analyzed. Uncaria tomentosa reduced the neutropenia caused by chemotherapy and was also able to restore cellular DNA damage. We concluded that Ut is an effective adjuvant treatment for breast cancer. PMID:22811748

  6. Uncaria tomentosa-Adjuvant Treatment for Breast Cancer: Clinical Trial.

    Science.gov (United States)

    Santos Araújo, Maria do Carmo; Farias, Iria Luiza; Gutierres, Jessie; Dalmora, Sergio L; Flores, Nélia; Farias, Julia; de Cruz, Ivana; Chiesa, Juarez; Morsch, Vera Maria; Chitolina Schetinger, Maria Rosa

    2012-01-01

    Breast cancer is the most frequent neoplasm affecting women worldwide. Some of the recommended treatments involve chemotherapy whose toxic effects include leukopenia and neutropenia. This study assessed the effectiveness of Uncaria tomentosa (Ut) in reducing the adverse effects of chemotherapy through a randomized clinical trial. Patients with Invasive Ductal Carcinoma-Stage II, who underwent a treatment regimen known as FAC (Fluorouracil, Doxorubicin, Cyclophosphamide), were divided into two groups: the UtCa received chemotherapy plus 300 mg dry Ut extract per day and the Ca group that only received chemotherapy and served as the control experiment. Blood samples were collected before each one of the six chemotherapy cycles and blood counts, immunological parameters, antioxidant enzymes, and oxidative stress were analyzed. Uncaria tomentosa reduced the neutropenia caused by chemotherapy and was also able to restore cellular DNA damage. We concluded that Ut is an effective adjuvant treatment for breast cancer.

  7. DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative Treatment. A MULTICENTER RANDOMISED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    van de Wall Bryan JM

    2010-08-01

    Full Text Available Abstract Background Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses. Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management. We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. Methods/design The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management. Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used. The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years. Discussion Considering the high incidence and the

  8. Treatment of psychological co-morbidities in common gastrointestinal and hepatologic disorders

    Institute of Scientific and Technical Information of China (English)

    Antonina; A; Mikocka-Walus

    2010-01-01

    Anxiety and depressive disorders frequently coexist with gastrointestinal and hepatologic conditions.Despite their high prevalence,approach to treating these co-morbidities is not always straightforward.This paper aims to review the current literature into etiology of psychological comorbidities and their treatment in three conditions commonly encountered at gastroenterology outpatient clinics,namely inflammatory bowel disease(IBD),irritable bowel syndrome(IBS) and chronic hepatitis C(HepC).The paper demonstrates that although psychotherapy(and cognitive-behavioural therapy in particular) has been established as an effective treatment in IBS,more studies are needed in HepC and IBD.Antidepressants have been recognized as an effective treatment for psychological and somatic symptoms in IBS and for depression in HepC,but good quality studies in IBD are lacking despite the promising preliminary findings from animal models and case studies.Further studies in this area are needed.

  9. Pena Private Freedom with psychiatric treatment and psychological for Abused

    Directory of Open Access Journals (Sweden)

    Mirza Maria Pedrosa Porto de Mendonça

    2016-06-01

    Full Text Available The research aimed to investigate the opinion of professionals in law and health areas on the profile of the sexual abuser of children within the family and the effectiveness of the type of penalty he suffers. The offender is someone who probably does not enjoy enough sanity to control its inclination to unlawful and may or may not be classified as mentally ill. The research covers the incidence and effects of this event on intra-family life. Deals with this issue in order to establish a new legal paradigm in the context of the penalties in the most private sphere of criminal law. The work aims to demonstrate the social relevance of the topic and the need for an effective regulatory sweater for sexual abusers, especially the intra-family and makes a clear proposal for legislative changes with regard to this type of crime, arguing the need to adapt the law the objective reality. It argues that psychoanalytic treatment of offenders as a means of punishment is more important than the simple deprivation of liberty. It argues that the current legislation is incipient and inadequate for such cases and this opinion supported by a significant number of experts. This is not to defend this criminal who practice sexual abuse, but to seek solutions to impunity and respect for the principle of individualization of punishment.

  10. Evaluation of Exercise on Individuals with Behavioural and Psychological Symptoms of Dementia and Their Carers: A Randomized Controlled Trial

    OpenAIRE

    Cerga-Pashoja, A

    2016-01-01

    There are over 840,000 people in the UK with dementia, most of whom will experience Behavioural and Psychological Symptoms of Dementia (BPSD). Treatment options for BPSD are limited and often they have been managed with anti-psychotic medication, which increase mortality and the risk of stroke in people with dementia. Consequently, it is imperative to evaluate the impact that non-pharmacological interventions such as physical exercise have on BPSD. This research seeks to address this matter b...

  11. Comparison of the effectiveness of trauma-focused cognitive behavioral therapy and paroxetine treatment in PTSD patients: Design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Polak A

    2012-10-01

    Full Text Available Abstract Background The two most common interventions for Posttraumatic Stress Disorder (PTSD are pharmacological treatment with SSRIs such as paroxetine and psychological treatment such as Trauma-Focused Cognitive Behavioral Therapy (TF-CBT. International guidelines recommend trauma-focused psychological interventions for all PTSD patients as first-line treatment (NICE. However, no clear-cut evidence is available to support this recommendation. Methods/design In order to compare pharmacological treatment (paroxetine and psychological treatment (TF-CBT in (cost- effectiveness on the short and the long term, we will randomize 90 patients with chronic PTSD to either paroxetine (24 weeks or TF-CBT (10–12 weeks. We will assess symptom severity and costs before and after the intervention with the Clinician Administered PTSD Scale (CAPS, the Clinical Global Impression Scale (CGI and the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P. Discussion This study is unique for its direct comparison of the most commonly used psychological intervention (TF-CBT and pharmacological intervention (paroxetine on (cost- effectiveness on the short and the long term. The anticipated results will provide relevant evidence concerning long-term effects and relapse rates and will be beneficial in reducing societal costs. It may also provide information on who may benefit most from which type of intervention. Some methodological issues will be discussed. Trial Registration Dutch Trial registration: NTR2235

  12. Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme

    Directory of Open Access Journals (Sweden)

    Raftery James

    2011-05-01

    Full Text Available Abstract Background Previous research reviewed treatment success and whether the collective uncertainty principle is met in RCTs in the US National Cancer Institute portfolio. This paper classifies clinical trials funded by the UK HTA programme by results using the method applied to the US Cancer Institute trials, and compares the two portfolios. Methods Data on all completed randomised controlled trials funded by the HTA programme 1993-2008 were extracted. Each trial's primary results was classified into six categories; 1 statistically significant in favour of the new treatment, 2 statistically significant in favour of the control treatment 3 true negative, 4 truly inconclusive, 5 inconclusive in favour of new treatment or 6 inconclusive in favour of control treatment. Trials were classified by comparing the 95% confidence interval for the difference in primary outcome to the difference specified in the sample size calculation. The results were compared with Djulbegovic's analysis of NCI trials. Results Data from 51 superiority trials were included, involving over 48,000 participants and a range of diseases and interventions. 85 primary comparisons were available because some trials had more than two randomised arms or had several primary outcomes. The new treatment had superior results (whether significant or not in 61% of the comparisons (52/85 95% CI 49.9% to 71.6%. The results were conclusive in 46% of the comparisons (19% statistically significant in favour of the new treatment, 5% statistically significant in favour of the control and 22% true negative. The results were classified as truly inconclusive (i.e. failed to answer the question asked for 24% of comparisons (20/85. HTA trials included fewer truly inconclusive and statistically significant results and more results rated as true negative than NCI trials. Conclusions The pattern of results in HTA trials is similar to that of the National Cancer Institute portfolio. Differences that

  13. 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 recom

  14. Randomized controlled trial of modified Banxia Houpo decoction in treating functional dyspepsia patients with psychological factors

    Institute of Scientific and Technical Information of China (English)

    肖琳

    2013-01-01

    Objective To observe the therapeutic effect of Modified Banxia Houpo Decoction(MBHD)in treating patients with functional dyspepsia(FD)accompanied with psychological factors,and to compare it with Domperidone,Neurostan,and Domperidone+Neurostan.Methods Recruited were 89 FD patients

  15. Positive Psychology Intervention to Alleviate Child Depression and Increase Life Satisfaction: A Randomized Clinical Trial

    Science.gov (United States)

    Kwok, Sylvia Y. C. L.; Gu, Minmin; Kit, Katrina Tong Kai

    2016-01-01

    Purpose: The study aims to examine the effectiveness of a positive psychology group-based intervention program, incorporating elements of hope and gratitude, in decreasing depression and increasing life satisfaction among primary school students in Hong Kong. Method: A total of 68 children, with the Depression score of Chinese Hospital Anxiety and…

  16. Positive Psychology Intervention to Alleviate Child Depression and Increase Life Satisfaction: A Randomized Clinical Trial

    Science.gov (United States)

    Kwok, Sylvia Y. C. L.; Gu, Minmin; Kit, Katrina Tong Kai

    2016-01-01

    Purpose: The study aims to examine the effectiveness of a positive psychology group-based intervention program, incorporating elements of hope and gratitude, in decreasing depression and increasing life satisfaction among primary school students in Hong Kong. Method: A total of 68 children, with the Depression score of Chinese Hospital Anxiety and…

  17. Psychological distress because of asking about suicidal thoughts: a randomized controlled trial among students.

    NARCIS (Netherlands)

    Beurs, D.P. de; Ghoncheh, R.; Geraedts, A.S.; Kerkhof, A.J.F.M.

    2016-01-01

    The aim of this study was to investigate the effect of the questions from the Beck Scale for Suicide Ideation on psychological well-being among healthy participants. In a randomized controlled study, 301 participants completed the same 4 questionnaires on psychopathology. The experimental group addi

  18. Psychological distress because of asking about suicidal thoughts: a randomized controlled trial among students.

    NARCIS (Netherlands)

    Beurs, D.P. de; Ghoncheh, R.; Geraedts, A.S.; Kerkhof, A.J.F.M.

    2016-01-01

    The aim of this study was to investigate the effect of the questions from the Beck Scale for Suicide Ideation on psychological well-being among healthy participants. In a randomized controlled study, 301 participants completed the same 4 questionnaires on psychopathology. The experimental group addi

  19. Inability of positive phase II clinical trials of investigational treatments to subsequently predict positive phase III clinical trials in glioblastoma.

    Science.gov (United States)

    Mandel, Jacob J; Yust-Katz, Shlomit; Patel, Akash J; Cachia, David; Liu, Diane; Park, Minjeong; Yuan, Ying; A Kent, Thomas; de Groot, John F

    2017-07-31

    Glioblastoma is the most common primary malignant brain tumor in adults, but effective therapies are lacking. With the scarcity of positive phase III trials, which are increasing in cost, we examined the ability of positive phase II trials to predict statistically significant improvement in clinical outcomes of phase III trials. A PubMed search was conducted to identify phase III clinical trials performed in the past 25 years for patients with newly diagnosed or recurrent glioblastoma. Trials were excluded if they did not examine an investigational chemotherapy or agent, if they were stopped early owing to toxicity, if they lacked prior phase II studies, or if a prior phase II study was negative. Seven phase III clinical trials in newly diagnosed glioblastoma and 4 phase III clinical trials in recurrent glioblastoma met the inclusion criteria. Only 1 (9%) phase III study documented an improvement in overall survival and changed the standard of care. The high failure rate of phase III trials demonstrates the urgent need to increase the reliability of phase II trials of treatments for glioblastoma. Strategies such as the use of adaptive trial designs, Bayesian statistics, biomarkers, volumetric imaging, and mathematical modeling warrant testing. Additionally, it is critical to increase our expectations of phase II trials so that positive findings increase the probability that a phase III trial will be successful.

  20. Association of Psychological Characteristics and Functional Dyspepsia Treatment Outcome: A Case-Control Study

    Science.gov (United States)

    Wang, Caihua

    2016-01-01

    This study was to investigate the association of psychological characteristics and functional dyspepsia treatment outcome. 109 patients who met the criteria for FD were enrolled. Eysenck Personality Questionnaire (EPQ), Symptom Checklist 90 (SCL90), and the Pittsburgh Sleep Quality Index (PSQI) were used to measure personality, psychological symptoms, and sleep quality in our patients. Leeds Dyspepsia Questionnaire (LDQ) was used to assess dyspeptic symptoms at baseline and after eight weeks of treatment. The LDQ scores change after therapy, and the degraded rate of LDQ was used to assess the prognosis of patients. Logistic regression model was used to assess the effect of the personality, psychological symptoms, and sleep quality on the prognosis of patients. Our result revealed that poor sleep quality (OR = 7.68, 95% CI 1.83–32.25) and bad marriage status (OR = 1.22, 95% CI 1.10–1.36) had the negative effect on the prognosis of FD, while extroversion in personality traits (OR = 0.86, 95% CI 0.76–0.96) had positive effect on the prognosis of FD. We should pay attention to the sleep quality, the personality, and the marriage status of FD patients; psychological intervention may have benefit in refractory FD. PMID:27547220

  1. Design of Sequentially Randomized Trials for Testing Adaptive Treatment Strategies

    Science.gov (United States)

    Ogbagaber, Semhar B.; Karp, Jordan; Wahed, Abdus S.

    2016-01-01

    An adaptive treatment strategy (ATS) is an outcome-guided algorithm that allows personalized treatment of complex diseases based on patients’ disease status and treatment history. Conditions such as AIDS, depression, and cancer usually require several stages of treatment due to the chronic, multifactorial nature of illness progression and management. Sequential multiple assignment randomized (SMAR) designs permit simultaneous inference about multiple ATSs, where patients are sequentially randomized to treatments at different stages depending upon response status. The purpose of the article is to develop a sample size formula to ensure adequate power for comparing two or more ATSs. Based on a Wald-type statistic for comparing multiple ATSs with a continuous endpoint, we develop a sample size formula and test it through simulation studies. We show via simulation that the proposed sample size formula maintains the nominal power. The proposed sample size formula is not applicable to designs with time-to-event endpoints but the formula will be useful for practitioners while designing SMAR trials to compare adaptive treatment strategies. PMID:26412033

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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.

  4. Virtual reality in the psychological treatment for mental health problems: An systematic review of recent evidence.

    Science.gov (United States)

    Valmaggia, Lucia R; Latif, Leila; Kempton, Matthew J; Rus-Calafell, Maria

    2016-02-28

    The aim of this paper is to provide a review of controlled studies of the use of Virtual Reality in psychological treatment (VRT). Medline, PsychInfo, Embase and Web of Science were searched. Only studies comparing immersive virtual reality to a control condition were included. The search resulted in 1180 articles published between 2012 and 2015, of these, 24 were controlled studies. The reviewed studies confirm the effectiveness of VRT compared to treatment as usual, and show similar effectiveness when VRT is compared to conventional treatments. Current developments and future research are discussed.

  5. Improving clinical trial design for hepatocellular carcinoma treatments

    Directory of Open Access Journals (Sweden)

    Garrett Hisatake

    2011-12-01

    Full Text Available Despite its place as the third leading cause of cancer deaths worldwide, there are currently no approved chemotherapeutic agents, devices or techniques to treat hepatocellular carcinoma. Importantly, there have been no phase III studies demonstrating survival benefit, nor any randomized studies of treatment except for transarterial chemoembolization and most recently sorafenib. The importance of well-designed clinical trials of agents to treat HCC has never been greater. However, general clinical study design issues, combined with HCC-specific issues pose significant challenges in structuring such studies. HCC-related challenges include the heterogeneity of this cancer and the fact that it is frequently accompanied by significant comorbidities at diagnosis, such as active hepatitis B or C virus replication, substantial past or on-going alcohol use, and cirrhosis, itself often a fatal disease. The recently published comparison of a newer treatment, nolatrexed to doxorubicin, and comments about this study’s initial HCC diagnostic criteria, staging system, comparator therapy and choice of endpoints have provided a platform to discuss the challenges unique to the design of HCC clinical trials. The difficulty in accurately framing study results obtained from the constantly changing HCC clinical landscape and approaches to meet these challenges will be reviewed.

  6. Endpoints in adjuvant treatment trials: a systematic review of the literature in colon cancer and proposed definitions for future trials.

    NARCIS (Netherlands)

    Punt, C.J.A.; Buyse, M.; Kohne, C.H.; Hohenberger, P.; Labianca, R.; Schmoll, H.J.; Pahlman, L.; Sobrero, A.; Douillard, J.Y.

    2007-01-01

    Disease-free survival is increasingly being used as the primary endpoint of most trials testing adjuvant treatments in cancer. Other frequently used endpoints include overall survival, recurrence-free survival, and time to recurrence. These endpoints are often defined differently in different trials

  7. Electromagnetictherapy for Treatment of Insomnia: A clinical Trial Study

    Directory of Open Access Journals (Sweden)

    Fariba Sadeghi movahhed

    2012-04-01

    Full Text Available Background & Objectives: Insomnia is one of the most common sleep disorders in the world. It causes disruption in daily activities and increases the risk of major depression. Hence, clinically the appropriate and persistent treatment of insomnia is very important. Using of hypnotic drugs such as benzodiazepines is the common treatment for insomnia but they show several side effects and it seems that new medications should be used for treatment of sleep disorders. The aim of this study was comparison between the effects of electromagnetic therapy and conventional drug usage in the treatment of insomnia.   Methods: In a blind randomized clinical trial study, 60 people referred to the private office of the psychiatrist and experienced more than 3 months extended primary insomnia were selected. They were diagnosed by DSM-IV criteria and had no other underlying problems. The subjects were divided in two groups: 30 people in each and treated electromagnetically or with Alprazolam for 3 weeks. Before treatment, immediately and one month after treatment, quality of sleep and severity of the insomnia were evaluated by using the standard questionnaires and finally, the results were analyzed statistically.   Results : In this study, 60 individuals participated from whom 28 were male (46.7% and 32 patients were female (53.3%.The mean age was 37.3 years old in a range of 17- 65. The mean point of each questionnaire, before and immediately after treatment significantly didn't show any difference but one month after treatment, there was a significant difference in both groups.   Conclusion : To treat insomnia, electromagnetic therapy appears to be used as a replacement for sedative medicines. It also has more stability in comparison with other sedative medicines and no side effects have been reported yet.

  8. Empirically supported treatments for panic disorder with agoraphobia in a Spanish psychology clinic.

    Science.gov (United States)

    Ballesteros, Francisco; Labrador, Francisco J

    2014-10-27

    The aim of this work is to study the sociodemographic and clinical characteristics of patients diagnosed with Panic Disorder with Agoraphobia (PD/Ag), as well as the characteristics of the treatment and its results and cost in a University Psychology Clinic. Fifty patients demanded psychological assistance for PD/Ag; 80% were women, with an average age of 29.22 years (SD = 9.03). Mean number of evaluation sessions was 3.26 (SD = 1.03), and of treatment sessions, 13.39 (SD = 9.237). Of the patients, 83.33% were discharged (that is, questionnaire scores were below the cut-off point indicated by the authors, and no PD/Ag was observed at readministration of the semistructured interview), 5.5% refused treatment, and 11% were dropouts. The average number of treatment sessions of patients who achieved therapeutic success was 15.13 (SD = 8.98). Effect sizes (d) greater than 1 were obtained in all the scales. Changes in all scales were significant (p < .05). The estimated cost of treatment for patients who achieved therapeutic success was 945.12€. The treatment results are at least similar to those of studies of efficacy and effectiveness for PD/Ag. The utility of generalizing treatments developed in research settings to a welfare clinic is discussed.

  9. Effects of nutritional and psychological status in gastrointestinal cancer patients on tolerance of treatment

    Institute of Scientific and Technical Information of China (English)

    Jun Tian; Zhen-Chun Chen; Li-Fang Hang

    2007-01-01

    AIM: To assess the effects of poor nutritional and psychological status on tolerance of cancer treatment and the recovery of physical performance status in patients with gastrointestinal cancer.METHODS: An epidemiological survey with respect to nutritional and psychological status in patients with gastrointestinal cancer was conducted among 182 operated patients in four provincial-level hospitals from December 2005 to June 2006. The food frequency survey method, state-trait anxiety inventory (STAI) and depression status inventory (DSI) were used to obtain information about the diet and psychological status in the patients. Nutritional status in the participants was reflected by serum albumin (Alb), hemoglobin (HB) and body mass index (BMI).RESULTS: Alb, protein intake and anxiety were associated with the severity of side effects of treatment.The adjusted relative risk (RR) for Alb, protein intake and anxiety was 3.30 (95% CI: 1.08, 10.10, P = 0.03), 3.25(95% CI: 1.06, 9.90, P = 0.04) and 1.48 (95% CI: 1.29,1.70, P < 0.0001), respectively. Moreover, calorie intake,HB and depression were associated with the recovery of physical performance status in the patients. Adjusted relative risk was 2.12 (95% CI: 1.09, 4.03, P = 0.028),2.05 (95% CI: 1.08, 3.88, P =0.026) and 1.07 (95% CI:1.02, 1.12, P = 0.007), respectively.CONCLUSION: Both poor nutrition status and psychological status are independent risk factors for severe side effects of cancer treatment, and have impact on the recovery of physical performance status in patients after treatment.

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

    Science.gov (United States)

    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.

  11. A systematic review of randomized controlled trials examining the effectiveness of saffron (Crocus sativus L.) on psychological and behavioral outcomes

    Institute of Scientific and Technical Information of China (English)

    Heather Ann Hausenblas; Kacey Heekin; Heather Lee Mutchie; Stephen Anton

    2015-01-01

    BACKGROUND: Throughout the past three decades, increased scientiifc attention has been given to examining saffron’s (Crocus sativusL.) use as a potential therapeutic or preventive agent for a number of health conditions, including cancer, cardiovascular disease, and depression. OBJECTIVE: The purpose of this systematic review is to examine and categorize the current state of scientiifc evidence from randomized controled trials (RCTs) regarding the efifcacy of saffron on psychological/behavioral outcomes. SEARCH STRATEGY: Electronic and non-electronic systematic searches were conducted to identify al relevant human clinical research on saffron. The search strategy was extensive and was designed according to the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).” Reference lists of articles that met the inclusion criteria were searched. Only English language studies were reviewed. INCLUSION CRITERIA:Saffron trials in combination with other substances and saffron safety studies were considered, in accordance with the PRISMA statement. Included studies must have a control group. Included studies must measure a physiological and/or a behavioral outcome. DATA EXTRACTION AND ANALYSIS:The methodological quality of al included studies was independently evaluated by two reviewers using the Jadad score. Mean scores andP-values of measures were compared both inter- and intra-study for each parameter (i.e., depression). RESULTS:Twelve studies met our inclusion criteria. These studies examined the effects of saffron on psychological/behavioral outcomes of: major depressive disorder (n = 6), premenstrual syndrome (n = 1), sexual dysfunction and infertility (n = 4), and weight loss/snacking behaviors (n = 1). The data from these studies support the efifcacy of saffron as compared to placebo in improving the folowing conditions:depressive symptoms (compared to anti-depressants and placebo), premenstrual symptoms, and sexual dysfunction. In addition

  12. Physical exercise as a supplement to outpatient treatment of alcohol use disorders – design and preliminary results of a randomized controlled trial

    DEFF Research Database (Denmark)

    Sari, Sengül; Bilberg, Randi Marie; Roessler, Kirsten Kaya

    . The aim of this study is to investigate the effect of physical exercise on alcohol intake, cardio-respiratory fitness and socio-psychological outcomes. Methods and design The study is a randomized controlled trial with three arms: (A) Standard treatment alone, (B) Standard treatment and physical exercise...... the study and inform about the first preliminary results. Perspectives If this study detects a positive relationship between exercise as a supplement to alcohol treatment and patients’ alcohol intake, quality of life, fitness, well-being, anxiety, depression and interpersonal problems......Background and aim Alcohol use disorder is a widespread problem in Denmark and has severe impacts on health and quality of life of each individual. The clinical treatment of alcohol use disorder involves evidence-based knowledge on medical treatment, physical training, and psychological management...

  13. Effect of dignity therapy on end-of-life psychological distress in terminally ill Portuguese patients: A randomized controlled trial.

    Science.gov (United States)

    Julião, Miguel; Oliveira, Fátima; Nunes, Baltazar; Carneiro, António Vaz; Barbosa, António

    2017-02-07

    Dignity therapy (DT) is a brief form of psychotherapy developed for patients living with a life-limiting illness that has demonstrated efficacy in treating several dimensions of end-of-life psychological distress. Our aim was to determine the influence of DT on demoralization syndrome (DS), the desire for death (DfD), and a sense of dignity (SoD) in terminally ill inpatients experiencing a high level of distress in a palliative care unit. A nonblinded phase II randomized controlled trial was conducted with 80 patients who were randomly assigned to one of two groups: the intervention group (DT + standard palliative care [SPC]) or the control group (SPC alone). The main outcomes were DS, DfD, and SoD, as measured according to DS criteria, the Desire for Death Rating Scale, and the Patient Dignity Inventory (PDI), respectively. All scales were assessed at baseline (day 1) and at day 4 of follow-up. This study is registered with http://www.controlled-trials.com/ISRCTN34354086. Of the 80 participants, 41 were randomized to DT and 39 to SPC. Baseline characteristics were similar between the two groups. DT was associated with a significant decrease in DS compared with SPC (DT DS prevalence = 12.1%; SPC DS prevalence = 60.0%; p Dignity therapy had a beneficial effect on the psychological distress encountered by patients near the end of life. Our research suggests that DT is an important psychotherapeutic approach that should be included in clinical care programs, and it could help more patients to cope with their end-of-life experiences.

  14. Integrated psychological treatment for substance use and co-morbid anxiety or depression vs. treatment for substance use alone

    DEFF Research Database (Denmark)

    Hesse, Morten

    2009-01-01

    Background There is a growing consensus in favour of integrated treatment of substance use disorders and co-morbid conditions, such as depression or anxiety. However, up till now no systematic reviews have been published. Methods Based on a systematic search of MedLine and PsychInfo, 10 trials of...

  15. Integrated psychological treatment for substance use and co-morbid anxiety or depression vs. treatment for substance use alone

    DEFF Research Database (Denmark)

    Hesse, Morten

    2009-01-01

    and symptoms were non-significant, but favoured the experimental condition. For studies of integrated treatment for co-morbid anxiety disorders and substance use disorders, no meta-analysis could be carried out. Several studies of integrated treatment for anxiety and substance use disorders reported...... use disorders is not empirically supported. There is a need for more trials to replicate the findings from studies of integrated treatment for depression and substance use disorders, and for the development of new treatment options for co-morbid anxiety and substance use disorders....

  16. Controlled trials of antibiotic treatment in patients with post-treatment chronic Lyme disease.

    Science.gov (United States)

    Klempner, Mark S

    2002-01-01

    Some patients have persistence of profound fatigue, myalgias, arthralgias without arthritis, dysesthesia/paresthesia, and mood and memory disturbances after standard courses of antibiotic treatment for Lyme disease. This constellation of symptoms has been variously referred to as "chronic Lyme disease," "post-Lyme disease syndrome," and "post-treatment chronic Lyme disease." Persistent symptoms have been reported in patients who are seropositive for IgG antibodies against Borrelia burgdorferi as well as in patients who are seronegative. The cause or causes of persistent symptoms in these patients have not been clearly defined and are controversial. Because of the temporal association of these symptoms with infection with B. burgdorferi, some patients have been treated with prolonged courses of antibiotics. Case reports and uncontrolled trials have reported the efficacy of prolonged antibiotic therapy, often with relapse of the symptoms after discontinuation of therapy. To date, only one randomized, placebo-controlled, double-blind trial of antibiotic therapy for these patients has been published. An abstract of a second placebo-controlled trial of antibiotic therapy in a smaller cohort has also been presented. This paper will describe this patient population in detail and will review the clinical, microbiological, and selected biochemical and immunologic parameters and their responses to antibiotic treatment in the setting of a controlled trial.

  17. Psychological approaches in the treatment of specific phobias: a meta-analysis.

    Science.gov (United States)

    Wolitzky-Taylor, Kate B; Horowitz, Jonathan D; Powers, Mark B; Telch, Michael J

    2008-07-01

    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 outperformed placebo conditions and alternative active psychotherapeutic approaches. Treatments involving in vivo contact with the phobic target also outperformed alternative modes of exposure (e.g., imaginal exposure, virtual reality, etc.) at post-treatment but not at follow-up. Placebo treatments were significantly more effective than no treatment suggesting that specific phobia sufferers are moderately responsive to placebo interventions. Multi-session treatments marginally outperformed single-session treatments on domain-specific questionnaire measures of phobic dysfunction, and moderator analyses revealed that more sessions predicted more favorable outcomes. Contrary to expectation, effect sizes for the major comparisons of interest were not moderated by type of specific phobia. These findings provide the first quantitative summary evidence supporting the superiority of exposure-based treatments over alternative treatment approaches for those presenting with specific phobia. Recommendations for future research are also discussed.

  18. BREATH: Web-Based Self-Management for Psychological Adjustment After Primary Breast Cancer--Results of a Multicenter Randomized Controlled Trial

    NARCIS (Netherlands)

    Berg, S.W. van den; Gielissen, M.F.M.; Custers, J.A.E.; Graaf, W.T.A. van der; Ottevanger, P.B.; Prins, J.B.

    2015-01-01

    PURPOSE: Early breast cancer survivors (BCSs) report high unmet care needs, and easily accessible care is not routinely available for this growing population. The Breast Cancer E-Health (BREATH) trial is a Web-based self-management intervention to support the psychological adjustment of women after

  19. Counselors' Perspectives of Positive Psychology for the Treatment of Addiction: A Mixed Methods Pilot Study.

    Science.gov (United States)

    Krentzman, Amy R; Barker, Stacey L

    2016-01-01

    Little is known about the use of positive psychology interventions (PPI) in addictions treatment. Questionnaires and interviews with alcohol and substance use disorder counselors explored theories of how PPIs might work, the degree to which they are used, and downsides. Results suggested that positive and pathology-based themes were attended in equal proportion, that substance abuse treatment should help clients develop a good life in recovery; that counselors already use PPI; and that PPI might counter negative cognitions and affect. Reservations for using PPI included relying on PPI exclusively and employing PPI indiscriminately without regard to client characteristics.

  20. Using ApoE Genotyping to Promote Healthy Lifestyles in Finland - Psychological Impacts: Randomized Controlled Trial.

    Science.gov (United States)

    Hietaranta-Luoma, H-L; Luomala, H T; Puolijoki, H; Hopia, A

    2015-12-01

    Common health recommendations often incite very little public response, as people instead require individualized information. The purpose of this study was to assess the psychological effects of personal genetic information, provided by different apoE genotypes, as a tool to promote lifestyle changes. This study was a one-year intervention study using healthy adults, aged 20-67 years (n = 107). Their experiences of state anxiety, threat and stage of change were measured three times over a 12 months period. These psychological experiences were assessed, during the genetic information gathering, for three groups: a high-risk group (Ɛ4+, n = 16); a low-risk group (Ɛ4-, n = 35); and a control group (n = 56). The psychological effects of personal genetic risk information were shown to be short-term, although the levels of state anxiety and threat experiences in the high-risk group both remained at a slightly higher level than in the baseline. Threat experiences differed almost significantly (alpha = 0.017) between the Ɛ4+ and Ɛ4- groups (p = 0.034). Information on the apoE genotype impacted the experience of cardiovascular threat; this effect was most intense immediately after genetic feedback was received. However, fears of threat and anxiety may not be an obstacle for using gene information to motivate healthy, stable adults towards making lifestyle changes. Further studies should thus focus on how to utilize genetic screening in prevention of lifestyle-related diseases.

  1. Guidelines for trials of behavioral treatments for recurrent headache, first edition: American Headache Society Behavioral Clinical Trials Workgroup.

    Science.gov (United States)

    Penzien, Donald B; Andrasik, Frank; Freidenberg, Brian M; Houle, Timothy T; Lake, Alvin E; Lipchik, Gay L; Holroyd, Kenneth A; Lipton, Richard B; McCrory, Douglas C; Nash, Justin M; Nicholson, Robert A; Powers, Scott W; Rains, Jeanetta C; Wittrock, David A

    2005-05-01

    Guidelines for design of clinical trials evaluating behavioral headache treatments were developed to facilitate production of quality research evaluating behavioral therapies for management of primary headache disorders. These guidelines were produced by a Workgroup of headache researchers under auspices of the American Headache Society. The guidelines are complementary to and modeled after guidelines for pharmacological trials published by the International Headache Society, but they address methodologic considerations unique to behavioral and other nonpharmacological treatments. Explicit guidelines for evaluating behavioral headache therapies are needed as the optimal methodology for behavioral (and other nonpharmacologic) trials necessarily differs from the preferred methodology for drug trials. In addition, trials comparing and integrating drug and behavioral therapies present methodological challenges not addressed by guidelines for pharmacologic research. These guidelines address patient selection, trial design for behavioral treatments and for comparisons across multiple treatment modalities (eg, behavioral vs pharmacologic), evaluation of results, and research ethics. Although developed specifically for behavioral therapies, the guidelines may apply to the design of clinical trials evaluating many forms of nonpharmacologic therapies for headache.

  2. Initial Open Trial of a Computerized Behavioral Activation Treatment for Depression

    Science.gov (United States)

    Spates, C. Richard; Kalata, Alyssa H.; Ozeki, Satoshi; Stanton, Cory E.; Peters, Sofia

    2013-01-01

    This article presents preliminary findings from use of a novel computer program that implements an evidence-based psychological intervention to treat depression based on behavioral activation (BA) therapy. The program is titled “Building a Meaningful Life Through Behavioral Activation”. The findings derive from an open trial with moderate to…

  3. Initial Open Trial of a Computerized Behavioral Activation Treatment for Depression

    Science.gov (United States)

    Spates, C. Richard; Kalata, Alyssa H.; Ozeki, Satoshi; Stanton, Cory E.; Peters, Sofia

    2013-01-01

    This article presents preliminary findings from use of a novel computer program that implements an evidence-based psychological intervention to treat depression based on behavioral activation (BA) therapy. The program is titled “Building a Meaningful Life Through Behavioral Activation”. The findings derive from an open trial with moderate to…

  4. Bronchodilators for treatment of mild bronchiolitis: a factorial randomised trial.

    Science.gov (United States)

    Wang, E E; Milner, R; Allen, U; Maj, H

    1992-01-01

    A randomised double blind trial was conducted to determine the efficacy of inhaled bronchodilators, salbutamol and ipratropium bromide, compared with placebo in the treatment of bronchiolitis. Patients, who were 2 months to 2 years of age and without underlying cardiac or pulmonary disease, received drug 1 (salbutamol or saline placebo) followed one hour later by drug 2 (ipratropium bromide or placebo). Both agents were administered every four hours. The patients were allocated to one of four groups according to a factorial design. The four groups were similar in demographic characteristics, initial oxygenation, and clinical score. The change in oxygen saturation of recipients of both agents was significantly better than that of recipients of salbutamol alone or ipratropium bromide alone. This change, however, was not statistically different from that of the control group. No difference was observed in the clinical score or hospital duration. Inhaled bronchodilators did not improve the condition of hospitalised mild bronchiolitis. PMID:1533504

  5. Controlled trial of plasma exchange in treatment of Raynaud's syndrome.

    Science.gov (United States)

    O'Reilly, M J; Talpos, G; Roberts, V C; White, J M; Cotton, L T

    1979-01-01

    Twenty-seven patients with Raynaud's syndrome had their digital vessel patency assessed by Doppler ultrasound after different thermal stresses. Digital vessel patency rates differed significantly after stresses at 15 degrees C and 45 degrees C. In a randomised controlled trial placebo and heparin had no effect either on patients' symptoms or on the patency of their digital vessels. Plasma exchange improved both symptoms and vessel patency rates at 15 degrees C and 21 degrees C. Improvement in seven out of eight of these patients has been maintained for six months. Assessing digital vessel patency by Doppler techniques allow continuous, atraumatic, and safe evaluation of the effects of different methods of treatment on the patency of the digital vessels and has helped to indicate that plasma exchange is a useful adjunct in the management of patients with severe Raynaud's syndrome. PMID:376042

  6. Psychological intervention with working memory training increases basal ganglia volume: A VBM study of inpatient treatment for methamphetamine use

    Directory of Open Access Journals (Sweden)

    S.J. Brooks, PhD

    2016-01-01

    Conclusions: While psychological intervention is associated with larger volume in mesolimbic reward regions, the utilisation of additional working memory training as an adjunct to treatment may further normalize frontostriatal structure and function.

  7. Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial.

    Science.gov (United States)

    Nagai, Yoko; Cavanna, Andrea E; Critchley, Hugo D; Stern, Jeremy J; Robertson, Mary M; Joyce, Eileen M

    2014-03-01

    To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome. Despite advances in the pharmacologic treatment of patients with Tourette syndrome, many remain troubled by their tics, which may be resistant to multiple medications at tolerable doses. Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions. We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome. After training the patients for 3 sessions a week over 4 weeks, we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback (control) groups, but there was no difference between the groups in these measurements. Furthermore, the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback. Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo. The main confounding factor appeared to be the 30-minute duration of the training sessions, which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses. Despite a negative finding in this study, electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified.

  8. Treatment of psychological factors in a child with difficult asthma: a case report.

    Science.gov (United States)

    Anbar, Ran D; Sachdeva, Shagun

    2011-07-01

    Difficult asthma is defined as the persistence of asthma symptoms, abnormal pulmonary function showing airway obstruction, and continued requirement for short-acting bronchodilator therapy, despite adequate treatment with inhaled corticosteroids. It calls for a thorough evaluation of the patient to look into alternate and complicating diagnoses. The authors report a case of a 9-year-old patient with difficult asthma who failed to respond to conventional therapy. Although it was recognized that he had a number of potential medical complicating factors including allergies, chronic sinusitis, and gastroesophageal reflux, a psychological intervention using hypnosis ultimately appeared to help alleviate his symptoms completely. Thus, psychological evaluation and intervention should be considered early in the course of management of a patient with difficult asthma, because it may help avoid time-consuming and expensive investigations of potential complicating factors, and it may yield rapid improvement in the patient's clinical condition.

  9. [Psychological adjustment to invasive surgical and medicamentous tumor treatment of osteosarcoma patients with rotation-plasty].

    Science.gov (United States)

    Knahr, K; Kryspin-Exner, I

    1992-01-01

    Ten patients with osteosarcomas and rotation plasties made themselves available for a psychological survey. The time elapsed after their operations was between two and ten years, giving an average of six years. All patients were free of tumours at the time of the follow-up examination. Both in personal interviews and in psychological tests, it was possible to observe a very positive development of these patients' attitudes. Contributory factors in this context were discussions with the doctors administering treatment, the cheerful atmosphere of the hospital and the nursing staff, the physicotherapists and ergotherapists, and the excellent social support which all those interviewed also received from their relatives. Continuous positive motivation, a favourable social dialogue and patients' ability to control their own lives would appear to be the key factors in helping patients to come to terms with their illness.

  10. To resume a stalled psychotherapy? Psychological testing to understand an impasse and reevaluate treatment options.

    Science.gov (United States)

    Bram, Anthony D

    2015-01-01

    Clinical wisdom holds that psychological testing is a useful tool for consultation when there is a need to untangle and resolve a psychotherapeutic impasse. However, there has been a lack of empirical research in this area, and only a few cases have been published demonstrating how psychological testing can be used toward this end. In this article, the author offers a case illustration of the application of testing with a patient who sought to resume psychotherapy following a previous impasse and premature termination. Specific referral questions for the evaluation are explicated followed by discussion of the test data that answered each of them. The findings pointed not only to intrapsychic and object relational characteristics of the patient that contributed to the impasse but, importantly, alerted the author-therapist to his contributions as well. Treatment implications of the findings are also highlighted.

  11. The Citicoline Brain Injury Treatment (COBRIT) Trial: Design and Methods

    Science.gov (United States)

    Zafonte, Ross; Lee, Shing M.; Levin, Bruce; Diaz-Arrastia, Ramon; Ansel, Beth; Eisenberg, Howard; Timmons, Shelly D.; Temkin, Nancy; Novack, Thomas; Ricker, Joseph; Merchant, Randall; Jallo, Jack

    2009-01-01

    Abstract Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established. Citicoline, a naturally occurring endogenous compound, offers the potential of neuroprotection, neurorecovery, and neurofacilitation to enhance recovery after TBI. Citicoline has a favorable side-effect profile in humans and several meta-analyses suggest a benefit of citicoline treatment in stroke and dementia. COBRIT is a randomized, double-blind, placebo-controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate, and severe TBI. In all, 1292 patients will be recruited over an estimated 32 months from eight clinical sites with random assignment to citicoline (1000 mg twice a day) or placebo (twice a day), administered enterally or orally. Functional outcomes are assessed at 30, 90, and 180 days after the day of randomization. The primary outcome consists of a set of measures that will be analyzed as a composite measure using a global test procedure at 90 days. The measures comprise the following core battery: the California Verbal Learning Test II; the Controlled Oral Word Association Test; Digit Span; Extended Glasgow Outcome Scale; the Processing Speed Index; Stroop Test part 1 and Stroop Test part 2; and Trail Making Test parts A and B. Secondary outcomes include survival, toxicity, and rate of recovery. PMID:19803786

  12. The citicoline brain injury treatment (COBRIT) trial: design and methods.

    Science.gov (United States)

    Zafonte, Ross; Friedewald, William T; Lee, Shing M; Levin, Bruce; Diaz-Arrastia, Ramon; Ansel, Beth; Eisenberg, Howard; Timmons, Shelly D; Temkin, Nancy; Novack, Thomas; Ricker, Joseph; Merchant, Randall; Jallo, Jack

    2009-12-01

    Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established. Citicoline, a naturally occurring endogenous compound, offers the potential of neuroprotection, neurorecovery, and neurofacilitation to enhance recovery after TBI. Citicoline has a favorable side-effect profile in humans and several meta-analyses suggest a benefit of citicoline treatment in stroke and dementia. COBRIT is a randomized, double-blind, placebo-controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate, and severe TBI. In all, 1292 patients will be recruited over an estimated 32 months from eight clinical sites with random assignment to citicoline (1000 mg twice a day) or placebo (twice a day), administered enterally or orally. Functional outcomes are assessed at 30, 90, and 180 days after the day of randomization. The primary outcome consists of a set of measures that will be analyzed as a composite measure using a global test procedure at 90 days. The measures comprise the following core battery: the California Verbal Learning Test II; the Controlled Oral Word Association Test; Digit Span; Extended Glasgow Outcome Scale; the Processing Speed Index; Stroop Test part 1 and Stroop Test part 2; and Trail Making Test parts A and B. Secondary outcomes include survival, toxicity, and rate of recovery.

  13. 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.

  14. 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

  15. Accounting for Behavior in Treatment Effects: New Applications for Blind Trials.

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    Sylvain Chassang

    Full Text Available The double-blind randomized controlled trial (DBRCT is the gold standard of medical research. We show that DBRCTs fail to fully account for the efficacy of treatment if there are interactions between treatment and behavior, for example, if a treatment is more effective when patients change their exercise or diet. Since behavioral or placebo effects depend on patients' beliefs that they are receiving treatment, clinical trials with a single probability of treatment are poorly suited to estimate the additional treatment benefit that arises from such interactions. Here, we propose methods to identify interaction effects, and use those methods in a meta-analysis of data from blinded anti-depressant trials in which participant-level data was available. Out of six eligible studies, which included three for the selective serotonin re-uptake inhibitor paroxetine, and three for the tricyclic imipramine, three studies had a high (>65% probability of treatment. We found strong evidence that treatment probability affected the behavior of trial participants, specifically the decision to drop out of a trial. In the case of paroxetine, but not imipramine, there was an interaction between treatment and behavioral changes that enhanced the effectiveness of the drug. These data show that standard blind trials can fail to account for the full value added when there are interactions between a treatment and behavior. We therefore suggest that a new trial design, two-by-two blind trials, will better account for treatment efficacy when interaction effects may be important.

  16. Addiction treatment trials: how gender, race/ethnicity, and age relate to ongoing participation and retention in clinical trials

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    Korte JE

    2011-11-01

    Full Text Available Jeffrey E Korte1, Carmen L Rosa2, Paul G Wakim2, Harold I Perl21Division of Biostatistics and Epidemiology, Medical University of South Carolina, Charleston, SC, 2Center for the Clinical Trials Network, National Institute on Drug Abuse, Bethesda, MD, USAIntroduction: Historically, racial and ethnic minority populations have been underrepresented in clinical research, and the recruitment and retention of women and ethnic minorities in clinical trials has been a significant challenge for investigators. The National Drug Abuse Treatment Clinical Trials Network (CTN conducts clinical trials in real-life settings and regularly monitors a number of variables critical to clinical trial implementation, including the retention and demographics of participants.Purpose: The examination of gender, race/ethnicity, and age group differences with respect to retention characteristics in CTN trials.Methods: Reports for 24 completed trials that recruited over 11,000 participants were reviewed, and associations of gender, race/ethnicity, and age group characteristics were examined along with the rate of treatment exposure, the proportion of follow-up assessments obtained, and the availability of primary outcome measure(s.Results: Analysis of the CTN data did not indicate statistical differences in retention across gender or race/ethnicity groups; however, retention rates increased for older participants.Conclusion: These results are based on a large sample of patients with substance use disorders recruited from a treatment-seeking population. The findings demonstrate that younger participants are less likely than older adults to be retained in clinical trials.Keywords: addiction treatment, age, ethnic minorities, gender difference, substance use disorders, race, recruitment, retention, clinical trials

  17. [The role of psychological debriefing in the treatment of victims of trauma].

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    Devilly, Grant J; Wright, Renée; Gist, Richard

    2003-06-01

    The application of psychological debriefing has become an expected and widespread intervention following exposure to trauma. This article assesses the wisdom of such an approach and reports upon expert consensus regarding its use. Meta-analytic and narrative reviews are summarised and areas of agreement and disagreement are outlined. In sum, it was concluded that the majority of people do not become traumatised from stressful events; that generic psychological debriefing, when applied to individuals, appears to have little impact on functioning; that a specific form of debriefing called Critical Incident Stress Debriefing holds the possibility of noxious effects for some participants and that those most deleteriously affected by debriefing appear to be those most distressed by the initial trauma; that there is no randomised controlled trial evidence to support the validity of group debriefing approaches; and that early intervention using Cognitive Behavioural techniques for those with clinically significant presentations appears the most promising approach. A generic set of guidelines for intervention following trauma is provided.

  18. Treatment of Alzheimer's disease in Brazil: II. Behavioral and psychological symptoms of dementia

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    Francisco de Assis Carvalho do Vale

    Full Text Available Abstract This article reports the recommendations of the Scientific Department of Cognitive Neurology and Aging of the Brazilian Academy of Neurology for the treatment of Alzheimer's disease (AD in Brazil, with special focus on behavioral and psychological symptoms of dementia (BPSD. It constitutes a revision and broadening of the 2005 guidelines based on a consensus involving researchers (physicians and non-physicians in the field. The authors carried out a search of articles published since 2005 on the MEDLINE, LILACS and Cochrane Library databases. The search criteria were pharmacological and non-pharmacological treatment of the behavioral and psychological symptoms of AD. Studies retrieved were categorized into four classes, and evidence into four levels, based on the 2008 recommendations of the American Academy of Neurology. The recommendations on therapy are pertinent to the dementia phase of AD. Recommendations are proposed for the treatment of BPSD encompassing both pharmacological (including acetyl-cholinesterase inhibitors, memantine, neuroleptics, anti-depressives, benzodiazepines, anti-convulsants plus other drugs and substances and non-pharmacological (including education-based interventions, physiotherapy, occupational therapy, music therapy, therapy using light, massage and art therapy approaches. Recommendations for the treatment of cognitive disorders of AD symptoms are included in a separate article of this edition.

  19. Disseminating Self-Help: Positive Psychology Exercises in an Online Trial

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    Parks, Acacia C

    2012-01-01

    Background The recent growth of positive psychology has led to a proliferation in exercises to increase positive thoughts, behaviors, and emotions. Preliminary evidence suggests that these exercises hold promise as an approach for reducing depressive symptoms. These exercises are typically researched in isolation as single exercises. The current study examined the acceptability of several multi-exercise packages using online dissemination. Objective The purpose of this study was to investigate methods of dissemination that could increase the acceptability and effectiveness of positive psychology exercises. To achieve this goal, we compared the use of positive psychology exercises when delivered in packages of 2, 4, or 6 exercises. Methods Self-help–seeking participants enrolled in this study by visiting an online research portal. Consenting participants were randomly assigned to receive 2, 4, or 6 positive psychology exercises (or assessments only) over a 6-week period. These exercises drew from the content of group positive psychotherapy. Participants visited an automated website that distributed exercise instructions, provided email reminders, and contained the baseline and follow-up assessments. Following each exercise, participants rated their enjoyment of the exercise, answered how often they had used each technique, and completed outcome measures. Results In total, 1364 individuals consented to participate. Attrition rates across the 2-, 4-, and 6-exercise conditions were similar at 55.5% (181/326), 55.8% (203/364), and 52.7% (168/319) respectively but were significantly greater than the attrition rate of 42.5% (151/355) for the control condition (χ2 3 = 16.40, P < .001). Participants in the 6-exercise condition were significant more likely than participants in the 4-exercise condition to use both the third (F 1,312 = 5.61, P = .02) and fourth (F 1,313 = 6.03, P = .02) exercises. For 5 of the 6 exercises, enjoyment was related to continued use of the

  20. The B-VITAGE trial: A randomized trial of homocysteine lowering treatment of depression in later life

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    van Bockxmeer Frank

    2010-01-01

    Full Text Available Abstract Background Depression is a leading cause of disability worldwide and depressive symptoms are common in later life. Observational evidence suggests that depression is more prevalent among people with high plasma homocysteine (tHcy, but the results of randomized trials to date have been unable to show that lowering tHcy through the supplementation of vitamins B6, B12 and folate benefits depressive symptoms. We designed the B-VITAGE trial to determine whether adjunctive treatment with vitamins B6, B12 and folate increases the efficacy of standard antidepressant treatment. Methods/Design The B-VITAGE trial is a 12-month randomized, double-blind, placebo-controlled trial of daily citalopram (20 to 40 mg plus B12(0.4 mg, B6 (25 mg and folic acid (2 mg or citalopram (20 to 40 mg plus placebo for the treatment of depression in later life. The trial aims to recruit over 300 older adults with major depression (DSM-IV and has been powered to detect the impact of an intervention associated with moderate effect size. Depressive symptoms will be rated with the Montgomery-Åsberg Depression Rating Scale (MADRS. The trial has two main outcomes of interest: a reduction of 50% or more in the MADRS total score between baseline and week 12 and the remission of the depressive episode at weeks 12, 26 and 52 according to DSM-IV criteria. We hypothesize that subjects randomly allocated to the vitamin arm of the study will be more likely to show a clinically significant improvement and achieve and maintain remission of symptoms at 12, 26 and 52 weeks. Secondary outcomes of interest include compliance with treatment, reduction in the severity of depressive symptoms, switching to different antidepressants, the use of non-pharmacological antidepressant treatments, response to treatment according to MTHFRC677T genotype, and changes in cognitive function over 52 weeks. Conclusions The results of this trial will clarify whether the systematic use of B

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

    Science.gov (United States)

    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

  2. Psychological Treatments for Symptoms of Posttraumatic Stress Disorder in Children, Adolescents, and Young Adults: A Meta-Analysis.

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    Gutermann, Jana; Schreiber, Franziska; Matulis, Simone; Schwartzkopff, Laura; Deppe, Julia; Steil, Regina

    2016-06-01

    Meta-analyses of the treatment of posttraumatic stress disorder (PTSD) in childhood and adolescence are restricted to specific trauma, selected interventions, and methodologically rigorous studies. This large meta-analysis quantifies the effects of psychological treatments for PTSD symptoms in children and adolescents. An extensive literature search yielded a total of 13,040 articles; 135 studies with 150 treatment conditions (N = 9562 participants) met the inclusion criteria (psychological interventions with children and/or adolescents with PTSD symptoms that report quantitative measures of symptom change). The mean effect sizes (ESs) for PTSD symptoms ranged from large to small, depending on the control condition. Cognitive behavioral therapy (CBT) yielded the highest ESs. Age and caretaker involvement were identified as moderators. CBT, especially when conducted in individual treatment with the inclusion of parents, is a highly effective treatment for trauma symptoms. Psychological treatments need to be modified to address younger patients' specific needs.

  3. Looking at Infertility Treatment through The Lens of The Meaning of Life: The Effect of Group Logotherapy on Psychological Distress in Infertile Women

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    Anahita Khodabakshi Koolee

    2013-01-01

    Full Text Available Background: Women in particular suffer from psychological stress when diagnosed with infertility.Psychosocial interventions are known to not only prevent and lessen various mental problems,but also to play a positive role in physical health and pregnancy rates. The aim of this study isto determine the unique impact of spiritual psychotherapy on concerns about infertility and theirperceived psychological stresses.Materials and Methods: This study was a randomized clinical trial. The study population includednearly 800 infertile couples who attended the Maternity and Gynecology Clinic of Jahrom Universityof Medical Sciences, Jahrom, Iran. We enrolled65 people who were randomly divided into twogroups, experimental (n=33and control (n=32. The experimental group received spiritual grouppsychotherapy counseling for 12 sessions, 2 hours per week for a 3 months period. The controlgroup did not receive any intervention, but due to ethical considerations, we gave a presentation (onesession about infertility treatment for this group after the research process was completed. We usedtwo questionnaires to obtain data, the Penn State Worry Questionnaire (PSWQ and Perceived StressScale (PSS. Data analysis was done by descriptive and analytic statistics using SPSS 16 software.Results: Psychological intervention in the treatment group significantly decreased the PSWQ(p=0.004. There were significant differences in the mean score of the PSWQ in both groups asdetermined by analysis of covariance (ANCOVA; p=0.009. Psychological intervention in thetreatment group decreased the level of perceived stress, when compared with the control group.According to ANCOVA there were significant differences between the mean PSS scores of bothgroups (p=0.01.Conclusion: Logotherapy is related to stress reduction and can decrease psychiatric symptomsof worry and perceived stress. This approach tends to improve an infertile person's ability todeal with their problem of finding the

  4. Technology Addiction among Treatment Seekers for Psychological Problems: Implication for Screening in Mental Health Setting

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    Das, Aswathy; Sharma, Manoj Kumar; Thamilselvan, P.; Marimuthu, P.

    2017-01-01

    Background: Technology usage has seen an increase among users. The usage varies from social, personal, and psychological reasons. Users are frequently using to overcome mood states as well as to manage the other psychological states. This work is going to explore the information technology use among subjects with a psychiatric disorder. Materials and Methods: A total of 75 subjects were assessed using background data sheet, internet addiction impairment index, video game use pattern, pornography addiction screening tool and screening for mobile phone use, from in-patient and out-patient setting of tertiary mental health setting. Results: It showed the presence of addiction to mobile, internet, video game, and pornography. Age was found to be negatively correlated with this addiction. Average usage time had been associated with management of mood states. The addiction to information technology had been associated with a delay in initiation of sleep. Conclusion: This work has implication for screening technology addiction among subjects seeking treatment for psychological problems and motivate them to develop the healthy use of technology. PMID:28250554

  5. Technology Addiction among Treatment Seekers for Psychological Problems: Implication for Screening in Mental Health Setting.

    Science.gov (United States)

    Das, Aswathy; Sharma, Manoj Kumar; Thamilselvan, P; Marimuthu, P

    2017-01-01

    Technology usage has seen an increase among users. The usage varies from social, personal, and psychological reasons. Users are frequently using to overcome mood states as well as to manage the other psychological states. This work is going to explore the information technology use among subjects with a psychiatric disorder. A total of 75 subjects were assessed using background data sheet, internet addiction impairment index, video game use pattern, pornography addiction screening tool and screening for mobile phone use, from in-patient and out-patient setting of tertiary mental health setting. It showed the presence of addiction to mobile, internet, video game, and pornography. Age was found to be negatively correlated with this addiction. Average usage time had been associated with management of mood states. The addiction to information technology had been associated with a delay in initiation of sleep. This work has implication for screening technology addiction among subjects seeking treatment for psychological problems and motivate them to develop the healthy use of technology.

  6. Contributions of functional magnetic resonance in the field of psychological treatments with virtual reality.

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    Clemente, Miriam; Rey, Beatriz; Alcañiz, Mariano; Bretón-López, Juani; Moragrega, Inés; Baños, Rosa M; Botella, Cristina; Avila, César

    2010-01-01

    Many studies have been developed using brain imaging methods to investigate psychological disorders. On the other hand, there are many studies that make use of virtual reality (VR) to simulate a real condition during psychological treatments. In this research, we plan to analyze brain activity during the exposure to a virtual environment related to phobias. Our first goal is to study the possibility of activating brain areas related to phobias, specifically phobias to small animals (spiders and cockroaches), using virtual reality as stimulus, while the patient is inside a functional magnetic resonance imaging (fMRI) machine. The second goal of the research is to analyze if there are differences in the activated areas after patients have followed a psychological treatment for this specific phobia. That is why two different sessions with fMRI will be performed, before and after an intensive treatment for the phobia. In the fMRI room, participants will wear special glasses to visualize the VR environments in which they have to navigate (using also a joystick adapted to fMRI). They will have to perform some tasks while being exposed to the phobic stimuli. The VR environment used in the fMRI sessions has three different conditions: first, a clean room without spiders or cockroaches; second, the same room, but dirty and disordered (giving the sensation of having small animals, although actually there are none); third, the same dirty room but having spiders and cockroaches. It is our hypothesis that the patients will get anxious in the situation in which it is possible that the animal appears and the patterns of brain activation will be different in this condition.

  7. Evidence-based psychological treatments for distress in family caregivers of older adults.

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    Gallagher-Thompson, Dolores; Coon, David W

    2007-03-01

    This review identifies evidence-based psychological treatments (EBTs) for reducing distress, and improving well-being, of family members caring for an older relative with significant cognitive and/or physical impairment. Three categories of psychologically derived treatments met EBT criteria: psychoeducational programs (N = 14 studies), psychotherapy (N = 3 studies), and multicomponent interventions (N = 2 studies). Specifically, support within the psychoeducational category was found for skill-training programs focused on behavior management, depression management, and anger management and for the progressively lowered threshold model. Within the psychotherapy category, cognitive-behavioral therapy enjoys strong empirical support. Within the multicomponent category, programs using a combination of at least 2 distinct theoretical approaches (e.g., individual counseling and support group attendance) were also found to be effective. Suggestions for future research include the development of more well-integrated multicomponent approaches, greater inclusion of ethnically diverse family caregivers in research protocols, and greater incorporation of new technologies for treatment delivery. ((c) 2007 APA, all rights reserved).

  8. Effectiveness of Tai Chi on Physical and Psychological Health of College Students: Results of a Randomized Controlled Trial.

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    Guohua Zheng

    Full Text Available To investigate the effectiveness and safety of Tai Chi Chuan (TCC on physical and psychological health of college students.Two hundred six college students were recruited and randomly allocated to a control group or a TCC exercise group in an equal ratio. Participants in the control group were instructed to maintain their original activity level and those in the TCC exercise group received 12 weeks of TCC exercise training based on their original activity level. Physical and psychological outcomes were evaluated at baseline, 13 weeks and 25 weeks. Intention-to-treat analysis was performed for the above outcomes.Compared with the control group, the TCC exercise group showed significant improvements at the end of the 12-week intervention period for flexibility (length of Sit and Reach (cm: TCC group 14.09±7.40 versus control 12.88±6.57, P = 0.039 adjusted for its baseline measures using a general linear model and balance ability (open eyes perimeter: TCC group 235.6(191~314 versus control 261(216~300; closed eyes perimeter: TCC group 370.5 (284~454 versus control 367 (293~483; P = 0.0414, 0.008, respectively, adjusted for corresponding baseline measures using a general linear model. No significant changes in other physical and mental outcomes were found between the two groups. No adverse events were reported during the study period.TCC exercise was beneficial in college students for improving flexibility and balance capability to some extent, compared with usual exercise.Chinese Clinical Trial Registry ChiCTR-TRC-13003328.

  9. Treatment duration of febrile urinary tract infection (FUTIRST trial: a randomized placebo-controlled multicenter trial comparing short (7 days antibiotic treatment with conventional treatment (14 days

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    Kuijper Ed J

    2009-08-01

    Full Text Available Abstract Background Current guidelines on the management of urinary tract infection recommend treating febrile urinary tract infection or acute pyelonephritis with antimicrobials for at least 14 days. Few randomized trials showed the effectiveness of treatment durations of 5 to 7 days but this has only been studied in young previously healthy women. Methods/Design A randomized placebo-controlled double-blind multicenter non-inferiority trial in which 400 patients with community acquired febrile urinary tract infection will be randomly allocated to a short treatment arm (7 days of ciprofloxacin or 7 days of empirical β-lactams ± gentamicin intravenously with early switch to oral ciprofloxacin followed by 7 days of blinded placebo or standard treatment arm (7 days of ciprofloxacin or 7 days of empirical β-lactams ± gentamicin intravenously with early switch to oral ciprofloxacin followed by 7 days of blinded ciprofloxacin. The study is performed in the Leiden region in which one university hospital, 6 general hospitals and 32 primary health care centers are clustered. Patients eligible for randomization are competent patients aged 18 years or above with a presumptive diagnosis of acute pyelonephritis as defined by the combination of fever, one or more symptoms of urinary tract infection and a positive urine nitrate test and/or the presence of leucocyturia. Exclusion criteria are known allergy to fluoroquinolones, female patients who are pregnant or lactating, polycystic kidney disease, permanent renal replacement therapy, kidney transplantation, isolation of ciprofloxacin-resistant causal uropathogen, renal abscess, underlying chronic bacterial prostatitis, metastatic infectious foci and inability to obtain follow-up. The primary endpoint is the clinical cure rate through the 10- to 18-day post-treatment visit. Secondary endpoints are the microbiological cure rate 10- to 18-day post-treatment, the 30- and 90-day overall mortality rate, the

  10. Prevention of the development of psychological distress following a motor vehicle crash: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Guest, Rebecca; Tran, Yvonne; Gopinath, Bamini; Cameron, Ian D; Craig, Ashley

    2016-07-16

    It is estimated that up to 50 % of motor vehicle crash survivors develop significant psychological distress, such as depressive mood and anxiety, within 6 months of the crash. Associated impacts include loss of employment, delayed return to work, financial and familial stress, and increased medical and compensation costs. The major aim of this research is to investigate the efficacy of interventions for preventing the development of psychological distress following a motor vehicle crash. The efficacy of two brief interventions will be examined: a cognitive behaviour therapy (CBT) programme, targeting mood and anxiety, and a lifestyle programme, targeting sleep, diet and physical activity. This is a randomized, controlled multisite study. Participants include at least 180 adults injured in a motor vehicle crash who have entered a compensation process. Research will compare outcomes in three groups randomly assigned to: one group of 60 adults, who receive a brief email-delivered CBT programme, with one session every 2 weeks for 10 weeks and telephone contact every 2 weeks; a second group of 60 adults, who receive a brief email-delivered lifestyle intervention involving one session every 2 weeks for 10 weeks with telephone contact; and an active waiting-list control group of 60 adults who are provided claims processing-related reading material along with telephone contact every 2 weeks for 10 weeks. Participants will be recruited within 12 weeks of the motor vehicle crash, and will be comprehensively assessed before and after treatment, and 6 and 12 months post-injury. Assuming an α probability level of 0.05 and a power of 80 %, at least 180 participants will be recruited. The primary outcome measure is the presence and severity of psychological distress or disorder. Secondary outcome measures include assessment of self-efficacy, resilience employment status, social activity and support, lifestyle and physical health factors, along with process outcome

  11. Psychological factors and treatment effectiveness in resistant anxiety disorders in highly comorbid inpatients

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    Ociskova M

    2016-06-01

    Full Text Available Marie Ociskova, Jan Prasko, Klara Latalova, Dana Kamaradova, Ales Grambal Department of Psychiatry, Olomouc University Hospital, Faculty of Medicine and Dentistry, Palacký University Olomouc, Czech Republic Background: Anxiety disorders are a group of various mental syndromes that have been related with generally poor treatment response. Several psychological factors may improve or hinder treatment effectiveness. Hope has a direct impact on the effectiveness of psychotherapy. Also, dissociation is a significant factor influencing treatment efficiency in this group of disorders. Development of self-stigma could decrease treatment effectiveness, as well as several temperamental and character traits. The aim of this study was to explore a relationship between selected psychological factors and treatment efficacy in anxiety disorders. Subjects and methods: A total of 109 inpatients suffering from anxiety disorders with high frequency of comorbidity with depression and/or personality disorder were evaluated at the start of the treatment by the following scales: the Mini-International Neuropsychiatric Interview, the Internalized Stigma of Mental Illness scale, the Adult Dispositional Hope Scale, and the Temperament and Character Inventory – revised. The participants, who sought treatment for anxiety disorders, completed the following scales at the beginning and end of an inpatient-therapy program: Clinical Global Impression (objective and subjective the Beck Depression Inventory – second edition, the Beck Anxiety Inventory, and the Dissociative Experiences Scale. The treatment consisted of 25 group sessions and five individual sessions of cognitive behavioral therapy or psychodynamic therapy in combination with pharmacotherapy. There was no randomization to the type of group-therapy program. Results: Greater improvement in psychopathology, assessed by relative change in objective Clinical Global Impression score, was connected with low initial

  12. 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.

  13. 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.

    Science.gov (United States)

    Mühlig, Yvonne; Scherag, André; Bickenbach, Annika; Giesen, Ulrike; Holl, Reinhard; Holle, Rolf; Kiess, Wieland; Lennerz, Belinda; Lütke Brintrup, Diana; Moss, Anja; Neef, Madlen; Ose, Claudia; Reinehr, Thomas; Teuner, Christina M; Wiegand, Susanna; Wolters, Barbara; Wabitsch, Martin; Hebebrand, Johannes

    2017-01-01

    To compare efficacy and safety of a manual-based low-level psychological intervention with treatment as usual (weight loss treatment). 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. 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. 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. © 2017 The Author(s) Published by S. Karger GmbH, Freiburg.

  14. Yoga Practice for Reducing the Male Obesity and Weight Related Psychological Difficulties-A Randomized Controlled Trial.

    Science.gov (United States)

    Rshikesan, P B; Subramanya, Pailoor; Nidhi, Ram

    2016-11-01

    Obesity is a health disorder and increasing all over the world. It is also a cause for many non-communicable diseases. Yoga practice reduces the stress level which may improve the eating habits and help in weight reduction. To assess the final outcome of the effects after 3 months of the 14 weeks yoga training on obesity of adult male in an urban setting. This was a randomized controlled trial with parallel groups (Yoga and Control groups) on male obese. Total 80 subjects with Body Mass Index (BMI) between 25 to 35 kg/cm(2) were enrolled and randomized into two equal groups in which 72 subjects (yoga n = 37 and control n=35) completed the trial. Yoga group mean age ± SD was 40.03±8.74 and Control group mean age±SD was 42.20±12.06. A 14 weeks special IAYT (Integrated Approach of Yoga Therapy) yoga training was given to the Yoga group and no specific activity was given to Control group. The interim results of this study at 14 weeks were covered in another article which is under process. After the 14 weeks of yoga training the Yoga group was asked to continue the yoga practice for the next 3 months and the Control group was not given any physical activity. The final outcome is covered in this paper. The assessments were anthropometric parameters of body weight (Wt), BMI (Body Mass Index), MAC (Mid-upper Arm Circumferences of left and right arm), WC (Waist Circumference), HC (Hip Circumference), WHR (Waist Hip Ratio), SKF (Skin Fold Thickness) of biceps, triceps, sub scapular, suprailiac and cumulative skin fold thickness value), Percentage body fat based on SKF and Psychological questionnaires of PSS (Perceived Stress Scale) and AAQW (Acceptance and Action Questionnaire for Weight related difficulty). Assessments were taken after 3 months of yoga training, for both Yoga and Control groups. Within group, between group and correlation analyses were carried out using SPSS 21. Improvement in anthropometric and psychological parameters such as Wt, Percentage body fat

  15. Intense pulsed light in treatment of nevus spilus: brief report of a clinical trial

    Directory of Open Access Journals (Sweden)

    Amir Houshang Ehsani

    2014-10-01

    Conclusion: Intense pulsed light is seemed an effective and safe treatment for nevus spilus Treatment; however randomized control trials with longer follow-up periods are required to evaluate the efficacy and safety.

  16. Arthrocentesis as initial treatment for temporomandibular joint arthropathy : A randomized controlled trial

    NARCIS (Netherlands)

    Vos, L. M.; Huddleston Slater, J. J. R.; Stegenga, B.

    2014-01-01

    Objective: To determine the effectiveness of arthrocentesis compared to conservative treatment as initial treatment with regard to temporomandibular joint pain and mandibular movement. Patients and methods: In this randomized controlled trial, 80 patients with arthralgia of the TMJ (classified accor

  17. Inference on treatment effects from a randomized clinical trial in the presence of premature treatment discontinuation: the SYNERGY trial.

    Science.gov (United States)

    Zhang, Min; Tsiatis, Anastasios A; Davidian, Marie; Pieper, Karen S; Mahaffey, Kenneth W

    2011-04-01

    The Superior Yield of the New Strategy of Enoxaparin, Revascularization, and GlYcoprotein IIb/IIIa inhibitors (SYNERGY) was a randomized, open-label, multicenter clinical trial comparing 2 anticoagulant drugs on the basis of time-to-event endpoints. In contrast to other studies of these agents, the primary, intent-to-treat analysis did not find evidence of a difference, leading to speculation that premature discontinuation of the study agents by some subjects may have attenuated the apparent treatment effect and thus to interest in inference on the difference in survival distributions were all subjects in the population to follow the assigned regimens, with no discontinuation. Such inference is often attempted via ad hoc analyses that are not based on a formal definition of this treatment effect. We use SYNERGY as a context in which to describe how this effect may be conceptualized and to present a statistical framework in which it may be precisely identified, which leads naturally to inferential methods based on inverse probability weighting.

  18. Effectiveness of a minimal psychological intervention to reduce mild to moderate depression and chronic fatigue in a working population: the design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Aelfers Ed

    2013-02-01

    workers being anxious to be detected as having psychological problems. Additionally, long-term follow-up in a working population is time-consuming and continuously engages occupational health staff and administrative personnel to control the process of data gathering. However, if the intervention proves to be effective, occupational medicine will have a manageable option for treatment of workers who are at risk of loss of productivity or sickness absence. Trial registration Nederlands Trialregister NTR3162

  19. Psychological factors and treatment effectiveness in resistant anxiety disorders in highly comorbid inpatients.

    Science.gov (United States)

    Ociskova, Marie; Prasko, Jan; Latalova, Klara; Kamaradova, Dana; Grambal, Ales

    2016-01-01

    Anxiety disorders are a group of various mental syndromes that have been related with generally poor treatment response. Several psychological factors may improve or hinder treatment effectiveness. Hope has a direct impact on the effectiveness of psychotherapy. Also, dissociation is a significant factor influencing treatment efficiency in this group of disorders. Development of self-stigma could decrease treatment effectiveness, as well as several temperamental and character traits. The aim of this study was to explore a relationship between selected psychological factors and treatment efficacy in anxiety disorders. A total of 109 inpatients suffering from anxiety disorders with high frequency of comorbidity with depression and/or personality disorder were evaluated at the start of the treatment by the following scales: the Mini-International Neuropsychiatric Interview, the Internalized Stigma of Mental Illness scale, the Adult Dispositional Hope Scale, and the Temperament and Character Inventory - revised. The participants, who sought treatment for anxiety disorders, completed the following scales at the beginning and end of an inpatient-therapy program: Clinical Global Impression (objective and subjective) the Beck Depression Inventory - second edition, the Beck Anxiety Inventory, and the Dissociative Experiences Scale. The treatment consisted of 25 group sessions and five individual sessions of cognitive behavioral therapy or psychodynamic therapy in combination with pharmacotherapy. There was no randomization to the type of group-therapy program. Greater improvement in psychopathology, assessed by relative change in objective Clinical Global Impression score, was connected with low initial dissociation level, harm avoidance, and self-stigma, and higher amounts of hope and self-directedness. Also, individuals without a comorbid personality disorder improved considerably more than comorbid patients. According to backward-stepwise multiple regression, the best

  20. The role of psychological flexibility in a self-help acceptance and commitment therapy intervention for psychological distress in a randomized controlled trial.

    Science.gov (United States)

    Fledderus, Martine; Bohlmeijer, Ernst T; Fox, Jean-Paul; Schreurs, Karlein M G; Spinhoven, Philip

    2013-03-01

    This study examined the role of psychological flexibility, as a risk factor and as a process of change, in a self-help Acceptance and Commitment Therapy (ACT) intervention for adults with mild to moderate depression and anxiety. Participants were randomized to the self-help programme with e-mail support (n=250), or to a waiting list control group (n=126). All participants completed measures before and after the intervention to assess depression, anxiety and psychological flexibility. Participants in the experimental condition also completed these measures during the intervention (after three and six weeks) and at a three-month follow-up. With multilevel modelling, it was shown that the effects of the intervention on psychological distress were stronger for participants with higher levels of psychological flexibility. Furthermore, our study showed that improved psychological flexibility mediated the effects of the ACT intervention. With a cross-lagged panel design, it was shown that especially improvements in psychological flexibility in the last three sessions of the intervention were important for further reductions in anxiety. To conclude, our study showed the importance of targeting psychological flexibility during an ACT intervention for a reduction in depressive and anxiety symptoms. Copyright © 2012 Elsevier Ltd. All rights reserved.

  1. Effects of aerobic training, resistance training, or both on psychological health in adolescents with obesity: The HEARTY randomized controlled trial.

    Science.gov (United States)

    Goldfield, Gary S; Kenny, Glen P; Alberga, Angela S; Prud'homme, Denis; Hadjiyannakis, Stasia; Gougeon, Réjeanne; Phillips, Penny; Tulloch, Heather; Malcolm, Janine; Doucette, Steve; Wells, George A; Ma, Jinhui; Cameron, Jameason D; Sigal, Ronald J

    2015-12-01

    To determine the effects of aerobic training, resistance training, and combined training on mood, body image, and self-esteem in adolescents with obesity. After a 4-week prerandomization treatment, 304 postpubertal adolescents (91 males, 213 females) with obesity ages 14-18 years were randomized to 1 of 4 groups for 22 weeks: aerobic training (n = 75), resistance training (n = 78), combined aerobic and resistance training (n = 75), or nonexercising control (n = 76). All participants received dietary counseling, with a daily energy deficit of 250 kcal. Mood was measured using the Brunel Mood Scale. Body image was assessed using the Multiple Body Self-Relations Questionnaire, and physical self-perceptions and global self-esteem were measured using the Harter Physical Self-Perceptions Questionnaire. Median adherence was 62%, 56%, and 64% in aerobic, resistance, and combined training, respectively. Resistance and combined training produced greater improvements than control on vigor, and resistance training reduced depressive symptoms. All groups improved on body image and physical self-perceptions, but combined showed greater increases than control on perceived physical conditioning, while only resistance training showed greater increases than controls on global self-esteem. Both combined and resistance training demonstrated greater increases in perceived strength than control. Psychological benefits were more related to better adherence and reductions in body fat than changes in strength or fitness. Resistance training, alone or in combination with aerobic training, may provide psychological benefits in adolescents with overweight or obesity, and therefore could be an alternative to aerobic training for some individuals in the biological and psychological management of adolescent obesity. (c) 2015 APA, all rights reserved).

  2. A Chinese Herbal Formula to Improve General Psychological Status in Posttraumatic Stress Disorder: A Randomized Placebo-Controlled Trial on Sichuan Earthquake Survivors

    Directory of Open Access Journals (Sweden)

    Xian-Ze Meng

    2012-01-01

    Full Text Available Introduction. Posttraumatic stress disorder (PTSD is accompanied by poor general psychological status (GPS. In the present study, we investigated the effects of a Chinese herbal formula on GPS in earthquake survivors with PTSD. Methods. A randomized, double-blind, placebo-controlled trial compared a Chinese herbal formula, Xiao-Tan-Jie-Yu-Fang (XTJYF, to placebo in 2008 Sichuan earthquake survivors with PTSD. Patients were randomized into XTJYF (n=123 and placebo (n=122 groups. Baseline-to-end-point score changes in the three global indices of the Symptom Checklist-90-Revised (SCL-90-R and rates of response in the SCL global severity index (GSI were the primary endpoints. A subanalysis of the nine SCL factors and the sleep quality score were secondary endpoints. Results and Discussion. Compared to placebo, the XTJYF group was significantly improved in all three SCL global indices (P = 0.001~0.028. More patients in the XTJYF group reported “much improved” than the placebo group (P = 0.001. The XTJYF group performed significantly better than control in five out of nine SCL factors (somatization, obsessive-compulsive behavior, depression, anxiety, and hostility (P = 0.001~0.036, and in sleep quality score (P<0.001. XTJYF produced no serious adverse events. These findings suggest that XTJYF may be an effective and safe treatment option for improving GPS in patients with PTSD.

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

    Directory of Open Access Journals (Sweden)

    Filip K Arnberg

    Full Text Available BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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

  4. 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

  5. Treatment Programs in the National Drug Abuse Treatment Clinical Trials Network

    Science.gov (United States)

    McCarty, Dennis; Fuller, Bret; Kaskutas, Lee Ann; Wendt, William W.; Nunes, Edward V.; Miller, Michael; Forman, Robert; Magruder, Kathryn M.; Arfken, Cynthia; Copersino, Marc; Floyd, Anthony; Sindelar, Jody; Edmundson, Eldon

    2008-01-01

    Drug abuse treatment programs and university-based research centers collaborate to test emerging therapies for alcohol and drug disorders in the National Drug Abuse Treatment Clinical Trials Network (CTN). Programs participating in the CTN completed organizational (n = 106 of 112; 95% response rate) and treatment unit surveys (n = 348 of 384; 91% response rate) to describe the levels of care, ancillary services, patient demographics, patient drug use and co-occurring conditions. Analyses describe the corporations participating in the CTN and provide an exploratory assessment of variation in treatment philosophies. A diversity of treatment centers participate in the CTN; not for profit organizations with a primary mission of treating alcohol and drug disorders dominate. Compared to N-SSATS (National Survey of Substance Abuse Treatment Services), programs located in medical settings are over-represented and centers that are mental health clinics are under-represented. Outpatient, methadone, long-term residential and inpatient treatment units differed on patients served and services proved. Larger programs with higher counselor caseloads in residential settings reported more social model characteristics. Programs with higher social model scores were more likely to offer self-help meetings, vocational services and specialized services for women. Conversely, programs with accreditation had less social model influence. The CTN is an ambitious effort to engage community-based treatment organizations into research and more fully integrate research and practice. PMID:17875368

  6. Treatment programs in the National Drug Abuse Treatment Clinical Trials Network.

    Science.gov (United States)

    McCarty, Dennis; Fuller, Bret; Kaskutas, Lee Ann; Wendt, William W; Nunes, Edward V; Miller, Michael; Forman, Robert; Magruder, Kathryn M; Arfken, Cynthia; Copersino, Marc; Floyd, Anthony; Sindelar, Jody; Edmundson, Eldon

    2008-01-01

    Drug abuse treatment programs and university-based research centers collaborate to test emerging therapies for alcohol and drug disorders in the National Drug Abuse Treatment Clinical Trials Network (CTN). Programs participating in the CTN completed Organizational Surveys (n=106 of 112; 95% response rate) and Treatment Unit Surveys (n=348 of 384; 91% response rate) to describe the levels of care, ancillary services, patient demographics, patient drug use and co-occurring conditions. Analyses describe the corporations participating in the CTN and provide an exploratory assessment of variation in treatment philosophies. A diversity of treatment centers participate in the CTN; not for profit organizations with a primary mission of treating alcohol and drug disorders dominate. Compared to National Survey of Substance Abuse Treatment Services (N-SSATS), programs located in medical settings are over-represented and centers that are mental health clinics are under-represented. Outpatient, methadone, long-term residential and inpatient treatment units differed on patients served and services provided. Larger programs with higher counselor caseloads in residential settings reported more social model characteristics. Programs with higher social model scores were more likely to offer self-help meetings, vocational services and specialized services for women. Conversely, programs with accreditation had less social model influence. The CTN is an ambitious effort to engage community-based treatment organizations into research and more fully integrate research and practice.

  7. Treatment success in cancer: industry compared to publicly sponsored randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Benjamin Djulbegovic

    Full Text Available OBJECTIVE: To assess if commercially sponsored trials are associated with higher success rates than publicly-sponsored trials. STUDY DESIGN AND SETTINGS: We undertook a systematic review of all consecutive, published and unpublished phase III cancer randomized controlled trials (RCTs conducted by GlaxoSmithKline (GSK and the NCIC Clinical Trials Group (CTG. We included all phase III cancer RCTs assessing treatment superiority from 1980 to 2010. Three metrics were assessed to determine treatment successes: (1 the proportion of statistically significant trials favouring the experimental treatment, (2 the proportion of the trials in which new treatments were considered superior according to the investigators, and (3 quantitative synthesis of data for primary outcomes as defined in each trial. RESULTS: GSK conducted 40 cancer RCTs accruing 19,889 patients and CTG conducted 77 trials enrolling 33,260 patients. 42% (99%CI 24 to 60 of the results were statistically significant favouring experimental treatments in GSK compared to 25% (99%CI 13 to 37 in the CTG cohort (RR = 1.68; p = 0.04. Investigators concluded that new treatments were superior to standard treatments in 80% of GSK compared to 44% of CTG trials (RR = 1.81; p<0.001. Meta-analysis of the primary outcome indicated larger effects in GSK trials (odds ratio = 0.61 [99%CI 0.47-0.78] compared to 0.86 [0.74-1.00]; p = 0.003. However, testing for the effect of treatment over time indicated that treatment success has become comparable in the last decade. CONCLUSIONS: While overall industry sponsorship is associated with higher success rates than publicly-sponsored trials, the difference seems to have disappeared over time.

  8. A systematic review and meta-analysis on controlled treatment trials of metacognitive therapy for anxiety disorders

    Directory of Open Access Journals (Sweden)

    Ramin Sadeghi

    2015-01-01

    Full Text Available Background: To conduct a systematic review and meta-analysis on controlled treatment trials of meta-cognitive therapy for anxiety disorders. Materials and Methods: Studies were included if they employed controlled methodology and treated people above 18 years with anxiety disorders. Case studies (with less than 4 cases and single case designed studies were excluded. A comprehensive literature search identified 15 trials for systematic review. Results: All included studies showed better treatment results in the MCT arms compared to the control groups. We also statistically pooled the results across studies (when possible. The meta-analyses also showed that MCT had statistically significant better results compared to the control groups in GAD (both immediately post-treatment and 12 months post-therapy results, OCD, and PTSD (p-values ranged <0.0001-0.025. Conclusion: Based on the results of our systematic review, MCT seems to be an effective treatment for anxiety disorders and can effectively control their psychological problems.

  9. The meaningful assessment of therapy outcomes: Incorporating a qualitative study into a randomized controlled trial evaluating the treatment of adolescent depression.

    Science.gov (United States)

    Midgley, Nick; Ansaldo, Flavia; Target, Mary

    2014-03-01

    For many years, there have been heated debates about the best way to evaluate the efficacy and effectiveness of psychological therapies. On the one hand, there are those who argue that the randomized controlled trial (RCT) is the only reliable and scientifically credible way to assess psychological interventions. On the other hand, there are those who have argued that psychological therapies cannot be meaningfully assessed using a methodology developed to evaluate the impact of drug treatments, and that the findings of RCTs lack "external validity" and are difficult to translate into routine clinical practice. In this article, we advocate the use of mixed-method research designs for RCTs, combining the rigor of quantitative data about patterns of change with the phenomenological contextualized insights that can be derived from qualitative data. We argue that such an approach is especially important if we wish to understand more fully the impact of therapeutic interventions within complex clinical settings. To illustrate the value of a mixed-method approach, we describe a study currently underway in the United Kingdom, in which a qualitative study (IMPACT-My Experience [IMPACT-ME]) has been "nested" within an RCT (the Improving Mood With Psychoanalytic and Cognitive Behavioral Therapy [IMPACT] study) designed to evaluate the effectiveness of psychological therapies in the treatment of adolescent depression. We argue that such a mixed-methods approach can help us to evaluate the effectiveness of psychological therapies and support the real-world implementation of our findings within increasingly complex and multidisciplinary clinical contexts.

  10. [Review of controled clinical trials of behavioral treatment for obesity].

    Science.gov (United States)

    Márquez-Ibáñez, B; Armendáriz-Anguiano, A L; Bacardí-Gascón, M; Jiménez-Cruz, A

    2008-01-01

    The increased prevalence of obesity has been associated to an increment in chronic-degenerative diseases. The behavioral conduct therapies (BCT) have been used to help subjects develop a series of skills to reach a healthy weight. We conducted a review of the literature of BCT from controlled clinical trials registered at PubMed from January 2000 to november 2006. We found five long-term (> or = 12 months) studies and analyzed each study. The percent of weight loss at the end of follow up ranged from 3% to 9% of the initial weight; the percent of retention fluctuated from 92% at three months to 55% at 24 months. There were no similar reported studies conducted in Latino or Hispanic population. These results suggest that the change in loss of weight with BCT are modest at the end of the follow up period and that most of the studies report low adherence to treatment. It is recommended that public and private funds are needed to implement effective and safe multicentric long term randomized studies on different cultural populations, including most Latin-American countries.

  11. Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial.

    Science.gov (United States)

    Hillier, Sharon L; Nyirjesy, Paul; Waldbaum, Arthur S; Schwebke, Jane R; Morgan, Franklin G; Adetoro, Nikki A; Braun, Carol J

    2017-08-01

    To evaluate secnidazole as a single oral dose treatment for bacterial vaginosis in a phase 2 randomized, double-blind, placebo-controlled study. In a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study, women with bacterial vaginosis who met all Amsel criteria (discharge; pH 4.7 or greater; 20% or greater clue cells; positive whiff test) were randomized one to one to one at 24 U.S. centers to 1 or 2 g secnidazole compared with placebo. The primary endpoint was clinical cure (normalization of discharge, amine odor, and clue cells) 21-30 days after treatment. Secondary endpoints included microbiologic cure, defined as a Nugent score of 0-3, and therapeutic cure, defined as meeting criteria for both clinical and microbiologic cure. The modified intent to treat was used for efficacy analyses and included all randomized patients who met the enrollment criteria. Assuming a clinical cure rate of 40% in the active groups and 15% in the placebo group, a sample size of 52 patients per group provided approximately 80% power to detect a significant difference between groups (.05 level [two-sided]) using a Cochran-Mantel-Haenszel test. Between May and September 2014, 215 patients were enrolled. In the intent-to-treat population, the clinical cure rate was 65.3% for the 2-g group, 49.3% for the 1-g group, and 19.4% for the placebo group. The modified intent-to-treat population included 188 women (median age 33 years; 32% with four or more bacterial vaginosis episodes in the previous year; 54% black) with baseline Nugent scores 4 or greater. Clinical, microbiologic, and therapeutic cure rates were 67.7%, 40.3%, and 40.3% for 2 g secnidazole and 51.6%, 23.4%, and 21.9% for 1 g secnidazole compared with 17.7%, 6.5%, and 6.5% for placebo, respectively (Pbacterial vaginosis treatment (Pbacterial vaginosis treatment. ClinicalTrials.gov, NCT02147899.

  12. Exposure to virtual social interactions in the treatment of social anxiety disorder: A randomized controlled trial.

    Science.gov (United States)

    Kampmann, Isabel L; Emmelkamp, Paul M G; Hartanto, Dwi; Brinkman, Willem-Paul; Zijlstra, Bonne J H; Morina, Nexhmedin

    2016-02-01

    This randomized controlled trial investigated the efficacy of a stand-alone virtual reality exposure intervention comprising verbal interaction with virtual humans to target heterogeneous social fears in participants with social anxiety disorder. Sixty participants (Mage = 36.9 years; 63.3% women) diagnosed with social anxiety disorder were randomly assigned to individual virtual reality exposure therapy (VRET), individual in vivo exposure therapy (iVET), or waiting-list. Multilevel regression analyses revealed that both treatment groups improved from pre-to postassessment on social anxiety symptoms, speech duration, perceived stress, and avoidant personality disorder related beliefs when compared to the waiting-list. Participants receiving iVET, but not VRET, improved on fear of negative evaluation, speech performance, general anxiety, depression, and quality of life relative to those on waiting-list. The iVET condition was further superior to the VRET condition regarding decreases in social anxiety symptoms at post- and follow-up assessments, and avoidant personality disorder related beliefs at follow-up. At follow-up, all improvements were significant for iVET. For VRET, only the effect for perceived stress was significant. VRET containing extensive verbal interaction without any cognitive components can effectively reduce complaints of generalized social anxiety disorder. Future technological and psychological improvements of virtual social interactions might further enhance the efficacy of VRET for social anxiety disorder.

  13. Psychological and psychophysiological factors in prevention and treatment of cold injuries.

    Science.gov (United States)

    Kappes, B; Mills, W; O'Malley, J

    1993-01-01

    Cold injured patients in Alaska come from many sources. Although sport and work continues to provide large numbers of cold injured, most severe repeat injuries tend to reflect other biopsychosocial consequences. Certain behaviors can increase the probability of injury, however all persons living in cold climates are potential candidates. One can decrease risk by education, knowledge and intelligent behavior. Proper respect for adequate protection and hydration seem to be critical factors. Understanding the psychological, physiological and psychophysiological aspects of the cold environment performer helps refine the prevention and treatment strategies for cold injury. Skill training with bio-behavioral methods, such as thermal biofeedback, and the value of medical psychotherapy appear to offer continued promise by facilitating physiologic recovery from injury, as well as assisting in long term rehabilitation. Both approaches increase the likelihood of a favorable healing response by soliciting active patient participation. Medical Psychotherapy for traumatic injuries can also help identify and manage cognitive emotional issues for families and patients faced with the permanent consequences of severe thermal injuries. Thermal biofeedback therapy has the potential benefit of encouraging greater self-reliance and responsibility for self-regulating overall health by integrating self-management skills regarding physiology, diet and lifestyle. Inpatient and outpatient biofeedback training offers specific influence over vascular responses for healing, as well as providing an effective tool for pain management. Interest in cold region habitation has continued to expand our study of human tolerance to harsh, extreme environments. Biological, psychological, sociological, and anthropological views on adaptation, habituation, acclimatization, and injury in cold environments acknowledges the role of development, learning and educated responses to cold environments. The study of

  14. Doing cognitive distortions: a discursive psychology analysis of sex offender treatment talk.

    Science.gov (United States)

    Auburn, Timothy; Lea, Susan

    2003-06-01

    Theories of sex offending have for several years relied upon the notion of cognitive distortions as an important cause of sexual offending. In this study we critique this notion and suggest that the sort of phenomenon addressed by cognitive distortions is better understood by adopting a discursive psychology approach. In this approach, talk is regarded as occasioned and action oriented. Thus 'cognitive distortions' are conceptualized as something people do rather than something that people have. Sessions from a prison-based sex offender treatment programme were taped and transcribed. A discursive psychology analysis was conducted on those sessions relating to offenders' first accounts of their offences. Our analysis suggests that offenders utilize a particular narrative organization to manage their blame and responsibility for the offence. This organization is based on a first part which is oriented to quotidian precursors to the offence and an immediately following second which is oriented to a sudden shift in the definition of the situation. The implications of this analysis are discussed, in relation to the status of cognitive distortions and treatment.

  15. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)

    Science.gov (United States)

    Eshuis, Emma J; Bemelman, Willem A; van Bodegraven, Ad A; Sprangers, Mirjam AG; Bossuyt, Patrick MM; de Wit, AW Marc van Milligen; Crolla, Rogier MPH; Cahen, Djuna L; Oostenbrug, Liekele E; Sosef, Meindert N; Voorburg, Annet MCJ; Davids, Paul HP; van der Woude, C Janneke; Lange, Johan; Mallant, Rosalie C; Boom, Maarten J; Lieverse, Rob J; van der Zaag, Edwin S; Houben, Martin HMG; Vecht, Juda; Pierik, Robert EGJM; van Ditzhuijsen, Theo JM; Prins, Hubert A; Marsman, Willem A; Stockmann, Henricus B; Brink, Menno A; Consten, Esther CJ; van der Werf, Sjoerd DJ; Marinelli, Andreas WKS; Jansen, Jeroen M; Gerhards, Michael F; Bolwerk, Clemens JM; Stassen, Laurents PS; Spanier, BW Marcel; Bilgen, Ernst Jan Spillenaar; van Berkel, Anne-Marie; Cense, Huib A; van Heukelem, Henk A; van de Laar, Arnold; Slot, Warner Bruins; Eijsbouts, Quirijn A; van Ooteghem, Nancy AM; van Wagensveld, Bart; van den Brande, Jan MH; van Geloven, Anna AW; Bruin, Karien F; Maring, John K; Oldenburg, Bas; van Hillegersberg, Richard; de Jong, Dirk J; Bleichrodt, Robert; van der Peet, Donald L; Dekkers, Pascal EP; Goei, T Hauwy; Stokkers, Pieter CF

    2008-01-01

    Background With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction. The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. Methods/design The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. Discussion The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the

  16. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial

    Directory of Open Access Journals (Sweden)

    van Heukelem Henk A

    2008-08-01

    Full Text Available Abstract Background With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction. The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. Methods/design The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. Discussion The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab

  17. Comparison of psychological placebo and waiting list control conditions in the assessment of cognitive behavioral therapy for the treatment of generalized anxiety disorder: a meta-analysis.

    Science.gov (United States)

    Zhu, Zhipei; Zhang, Li; Jiang, Jiangling; Li, Wei; Cao, Xinyi; Zhou, Zhirui; Zhang, Tiansong; Li, Chunbo

    2014-12-01

    There is ongoing debate about the efficacy of placebos in the treatment of mental disorders. In randomized control trials (RCTs) about the treatment of generalized anxiety disorder, the administration of a psychological placebo or placement on a waiting list are the two most common control conditions. But there has never been a systematic comparison of the clinical effect of these different strategies. Compare the change in symptom severity among individuals treated with cognitive behavioral therapy, provided a psychological placebo, or placed on a waiting list using data from RCTs on generalized anxiety disorder. The following databases were searched for RCTs on generalized anxiety disorder: PubMed, PsycInfo, EMBASE, The Cochrane Library, CNKI, Chongqing VIP, Wanfang, Chinese Biological Medical Literature Database, and Taiwan Electronic Periodical Services. Studies were selected based on pre-defined inclusion and exclusion criteria and the quality of each included study - based on the risk of bias and the level of evidence - was formally assessed. Meta-analysis was conducted using RevMan5.3 and network meta-analyses comparing the three groups were conducted using R. Twelve studies with a combined sample size of 531 were included in the analysis. Compared to either control method (placebo or waiting list), cognitive behavioral therapy was more effective for generalized anxiety disorder. Provision of a psychological placebo was associated with a significantly greater reduction of symptoms than placement on a waiting list. Eight of the studies were classified as 'high risk of bias', and the overall level of evidence was classified as 'moderate', indicating that further research could change the overall results of the meta-analysis. RCTs about the treatment of generalized anxiety disorders are generally of moderate quality; they indicate the superiority of CBT but the results cannot, as yet, be considered robust. There is evidence of a non-negligible treatment effect

  18. A randomised trial of nutrient supplements to minimise psychological stress after a natural disaster.

    Science.gov (United States)

    Kaplan, Bonnie J; Rucklidge, Julia J; Romijn, Amy R; Dolph, Michael

    2015-08-30

    After devastating flooding in southern Alberta in June 2013, we attempted to replicate a New Zealand randomised trial that showed that micronutrient (minerals, vitamins) consumption after the earthquakes of 2010-11 resulted in improved mental health. Residents of southern Alberta were invited to participate in a study on the potential benefit of nutrient supplements following a natural disaster. Fifty-six adults aged 23-66 were randomised to receive a single nutrient (vitamin D, n=17), a few-nutrients formula (B-Complex, n=21), or a broad-spectrum mineral/vitamin formula (BSMV, n=18). Self-reported changes in depression, anxiety and stress were monitored for six weeks. Although all groups showed substantial decreases on all measures, those consuming the B-Complex and the BSMV formulas showed significantly greater improvement in stress and anxiety compared with those consuming the single nutrient, with large effect sizes (Cohen's d range 0.76-1.08). There were no group differences between those consuming the B-Complex and BSMV. The use of nutrient formulas with multiple minerals and/or vitamins to minimise stress associated with natural disasters is now supported by three studies. Further research should be carried out to evaluate the potential population benefit that might accrue if such formulas were distributed as a post-disaster public health measure. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  19. The Impact of CBT and ACT Models Using Psychology Trainee Therapists: A Preliminary Controlled Effectiveness Trial

    Science.gov (United States)

    Lappalainen, Raimo; Lehtonen, Tuula; Skarp, Eerika; Taubert, Eija; Ojanen, Markku; Hayes, Steven C.

    2007-01-01

    The present study compares the impact of individualized treatment provided by trainee therapists based on a traditional cognitive behavior therapy (CBT) and acceptance and commitment therapy (ACT) model. Fourteen therapists were given initial training in CBT and ACT. Outpatients (N = 28) were randomized to either approach, with each therapist…

  20. Predictors of remission in depression to individual and combined treatments (PReDICT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dunlop Boadie W

    2012-07-01

    -week course of treatment, during which they receive a combination of CBT and antidepressant medication. Predictors of the primary outcome, remission, will be identified for overall and treatment-specific effects, and a statistical model incorporating multiple predictors will be developed to predict outcomes. Discussion The PReDICT study’s evaluation of biological, psychological, and clinical factors that may differentially impact treatment outcomes represents a sizeable step toward developing personalized treatments for MDD. Identified predictors should help guide the selection of initial treatments, and identify those patients most vulnerable to recurrence, who thus warrant maintenance or combination treatments to achieve and maintain wellness. Trial registration Clinicaltrials.gov Identifier: NCT00360399. Registered 02 AUG 2006. First patient randomized 09 FEB 2007.

  1. [Interdisciplinary treatment of chronic low back pain: psychological aspects and personality traits].

    Science.gov (United States)

    Weber, K; Sartori, M; Cedraschi, C; Genevay, S; Canuto, A; Rentsch, D

    2012-02-15

    Evidence on chronic low back pain treatments stresses the need for a multidimensional approach that aims a biopsychosocial rehabilitation. The caregiver team of the rheumatology division of the University Hospitals of Geneva has successfully applied this approach over the last years and this article emphasizes the value of a close collaboration with the division of liaison psychiatry. The use of cognitive-behavioral and psycho-educational techniques guaranties the definition of patient-centred and measurable treatment objectives. The inclusion of a psychotherapy group promotes free expression and sharing of psychological distress. Assessment of personality traits allows for considering the global nature of the patients rather than merely aiming the normalization of their deviant aspects.

  2. The challenger app for social anxiety disorder: New advances in mobile psychological treatment

    Directory of Open Access Journals (Sweden)

    Alexander Miloff

    2015-11-01

    Full Text Available Social anxiety disorder (SAD is a common debilitating mental illness with large negative effects on quality of life and economic productivity. Modern psychotherapy treatments utilizing cognitive–behavioral theory are increasingly delivered over the Internet and more recently using smartphone applications. The Challenger App written natively for the Apple iPhone was developed at the Stockholm University Department of Psychology for the treatment of SAD and uses a number of advanced features not previously seen in past mental health applications; these include real-time location awareness, notifications, anonymous social interaction between users, a high-degree of personalization and use of gamification techniques. This paper explores design considerations for the various components of the app, their theoretical and evidence base, and research opportunities that exist for apps making use of these novel features.

  3. An overview of the adaptive designs accelerating promising trials into treatments (ADAPT-IT) project.

    Science.gov (United States)

    Meurer, William J; Lewis, Roger J; Tagle, Danilo; Fetters, Michael D; Legocki, Laurie; Berry, Scott; Connor, Jason; Durkalski, Valerie; Elm, Jordan; Zhao, Wenle; Frederiksen, Shirley; Silbergleit, Robert; Palesch, Yuko; Berry, Donald A; Barsan, William G

    2012-10-01

    Randomized clinical trials, which aim to determine the efficacy and safety of drugs and medical devices, are a complex enterprise with myriad challenges, stakeholders, and traditions. Although the primary goal is scientific discovery, clinical trials must also fulfill regulatory, clinical, and ethical requirements. Innovations in clinical trials methodology have the potential to improve the quality of knowledge gained from trials, the protection of human subjects, and the efficiency of clinical research. Adaptive clinical trial methods represent a broad category of innovations intended to address a variety of long-standing challenges faced by investigators, such as sensitivity to previous assumptions and delayed identification of ineffective treatments. The implementation of adaptive clinical trial methods, however, requires greater planning and simulation compared with a more traditional design, along with more advanced administrative infrastructure for trial execution. The value of adaptive clinical trial methods in exploratory phase (phase 2) clinical research is generally well accepted, but the potential value and challenges of applying adaptive clinical trial methods in large confirmatory phase clinical trials are relatively unexplored, particularly in the academic setting. In the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) project, a multidisciplinary team is studying how adaptive clinical trial methods could be implemented in planning actual confirmatory phase trials in an established, National Institutes of Health-funded clinical trials network. The overarching objectives of ADAPT-IT are to identify and quantitatively characterize the adaptive clinical trial methods of greatest potential value in confirmatory phase clinical trials and to elicit and understand the enthusiasms and concerns of key stakeholders that influence their willingness to try these innovative strategies.

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

    Science.gov (United States)

    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.

  5. Requirements Elicitation in a Telemedicine Pain-treatment Trial

    NARCIS (Netherlands)

    Widya, I.A.; Bults, Richard G.A.; van Beijnum, Bernhard J.F.; Sandsjö, L.; Schaake, L.; Huis in 't Veld, M.H.A.; Jones, Valerie M.; Hermens, Hermanus J.; Ryan, K.; Robinson, W.

    2009-01-01

    This paper presents the early phase requirements elicitation for a work-related neck-shoulder pain teletreatment trial and the assessment of those requirements in respect of their importance to the trial and the feasibility of the needed software adaptations of the telemedicine system within the

  6. Fulfilling the psychological and information need of the family members of critically ill patients using interactive mobile technology: A randomised controlled trial.

    Science.gov (United States)

    Chiang, Vico Chung Lim; Lee, Rainbow Lai Ping; Ho, Fung Mei; Leung, Chi Kwong; Tang, Yi Pui; Wong, Wing Sze; Ho, Yee Sin; Tung, Yan Wai; Lai, Hang Louie

    2017-08-01

    Intensive care nurses may have an important role in empowering families by providing psychological support and fulfilling the family's pivotal need for information. To determine whether 'education of families by tab' about the patient's condition was more associated with improved anxiety, stress, and depression levels than the 'education of families by routine'. A randomized control trial of 74 main family caregivers (intervention: 39; control: 35). An adult intensive care unit. Depression Anxiety Stress Scale, and Communication and Physical Comfort Scale. Although information need satisfaction was not significantly different between intervention and control groups, the former reported significantly better depression score on Depression Anxiety Stress Scale comparing to the control group (pnurses to provide psychological support for family members. More studies are needed to investigate this aspect of family care for better psychological support and information need satisfaction that contributes to the evidence-based practice of intensive care nursing. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Designing a trial to evaluate potential treatments for apathy in dementia: the apathy in dementia methylphenidate trial (ADMET).

    Science.gov (United States)

    Drye, Lea T; Scherer, Roberta W; Lanctôt, Krista L; Rosenberg, Paul B; Herrmann, Nathan; Bachman, David; Mintzer, Jacobo E

    2013-06-01

    Research on efficacious treatments for apathy in Alzheimer disease has been hindered by a lack of consensus diagnosis, difficulties in measurement, and studies with small sample sizes. In designing the Apathy in Dementia Methylphenidate Trial (ADMET), a trial to evaluate the efficacy and safety of methylphenidate for the treatment of apathy in Alzheimer disease, we encountered the following issues: defining and measuring apathy, distinguishing apathy and depression, determining an appropriate test treatment, selecting relevant secondary outcomes, recruiting participants, and deciding on a suitable method for treatment unmasking. ADMET is a 6-week randomized, double-masked, placebo-controlled multicenter clinical trial with two parallel treatment groups assigned in a 1:1 ratio with randomization stratified by clinical center. The recruitment goal is 60 randomized participants over 2 years. The primary outcomes are change in apathy severity as measured by the Apathy Evaluation Scale and the Alzheimer Disease Cooperative Study-Clinical Global Impression of Change. The design decisions made for ADMET are important elements to be considered in trials assessing the safety and efficacy of medications for clinically significant apathy in Alzheimer disease. Copyright © 2013 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  8. The effectiveness of Tai Chi on the physical and psychological well-being of college students: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Zheng, Guohua; Lan, Xiulu; Li, Moyi; Ling, Kun; Lin, Hui; Chen, Lidian; Tao, Jing; Li, Junzhe; Zheng, Xin; Chen, Bai; Fang, Qianying

    2014-04-17

    The physical and mental health of college-age youths tends to continuously decline around the world. It is therefore important to promote health during this period. As a traditional Chinese mind-body exercise, Tai Chi Chuan (TCC) may be an available selection. However for the college student population, the evidence is unclear as to whether TCC can be recommended as an effective exercise for promoting their physical and psychological wellbeing. Therefore high quality, rigorous, prospective, and well-controlled randomized trials are needed to further understand TCC serving as a psychological and physical intervention in college age populations. We designed a randomized, single-blind, parallel-controlled trial with a sample size of 206 participants. All the participants who meet the inclusion criteria come from Fujian University of Traditional Chinese Medicine (FJTCM). Participants of the TCC training group will receive TCC training at a frequency of five days per week for one hour per day for 12 weeks. No specific exercise will be administered on the participants in the control group. Both physical and mental health outcomes, including balance ability, lower limb proprioception, flexibility, physical fitness, self-efficacy, psychological symptoms, attention span, stress, self-esteem, mood and mindfulness, quality of life, and quality of sleep. Safety outcomes will be evaluated by blinded operators at baseline, 12 and 24-weeks post-intervention. This protocol presents an objective design of a randomized, single-blind trial that will test the effectiveness and safety of TCC on the physical and psychological wellbeing of college students. If the outcome is positive, the results will provide higher quality evidence of TCC on the physical and mental health of college age populations. Chinese Clinical Trial Registry: ChiCTR-TRC-13003328.

  9. An Extended 4-Phases-Testmodel for Clinical Trials and its Application on Clinical Psychology Publications in the German-Speaking Countries.

    OpenAIRE

    Schui, Gabriel; Krampen, Günter

    2008-01-01

    With reference to the concept of evidence-based psychotherapy, methodology of clinical psychology research focuses on the 4-phases-testmodel for clinical trials adapted from pharmacological research and evidence-based medicine. Questions: Can the literature on clinical interventions from the German-speaking countries be classified according to an extended 4-phases-testmodel? On which phases does research focus and how do foci shift in a time span of 30+ years (1977 to 2007). Method: All clini...

  10. Association between socioeconomic and psychological experiences of parents with children on Leukemia treatment in Kenyatta National Hospital, Kenya

    Directory of Open Access Journals (Sweden)

    Roselyne Anyango Okumu

    2017-01-01

    Full Text Available Objective: The survival rate for children with leukemia has increased dramatically since the late 1990s; treatment effects of the disease can be extremely stressful for families. Research on psychological and socioeconomic effects of leukemia treatment had been conducted in Western countries, but little is known within Africa including Kenya. Methods: This was a cross-sectional study with a sample of 62 out of 72 parents of children undergoing leukemia treatment at Kenyatta National Hospital. Data were collected between May and August 2015 using structured questionnaires while qualitative data were collected using focus group discussions. This manuscript is based on quantitative data which were entered into EpiData version 3.1 and analyzed using SPSS version 20. Psychological distress index was created by counting the number of psychological experiences reported by respondents. Kendall's tau-b was used to test the association between the psychological distress index and socioeconomic characteristics; P ≤ 0.05 was considered statistically significant. Results: The respondents experienced anxiety, shock, and fatigue. Spending a higher proportion of family's income was associated with higher psychological distress index (P = 0.009. The economic challenge led to significantly heightened tension in the family (P = 0.021. Conclusions: Financial challenge is a major cause of psychological distress thus needs for financial support through collaboration with government institutions, for example, NHIF, development agencies, and nongovernment organization who can contribute toward the treatment cost. Need to decentralize effective leukemia treatment centers. Psychological support and counseling should be done to alleviate tension. The nurse needs to be empathetic when caring for the child and family as well as to apply the ethical principles of justice and beneficence so that the child gets the best care despite the financial challenge.

  11. Association between Socioeconomic and Psychological Experiences of Parents with Children on Leukemia Treatment in Kenyatta National Hospital, Kenya

    Science.gov (United States)

    Okumu, Roselyne Anyango; Muiva, Margret; Wagoro, Miriam; Abdallah, Fatmah; Oweya, Erick

    2017-01-01

    Objective: The survival rate for children with leukemia has increased dramatically since the late 1990s; treatment effects of the disease can be extremely stressful for families. Research on psychological and socioeconomic effects of leukemia treatment had been conducted in Western countries, but little is known within Africa including Kenya. Methods: This was a cross-sectional study with a sample of 62 out of 72 parents of children undergoing leukemia treatment at Kenyatta National Hospital. Data were collected between May and August 2015 using structured questionnaires while qualitative data were collected using focus group discussions. This manuscript is based on quantitative data which were entered into EpiData version 3.1 and analyzed using SPSS version 20. Psychological distress index was created by counting the number of psychological experiences reported by respondents. Kendall's tau-b was used to test the association between the psychological distress index and socioeconomic characteristics; P ≤ 0.05 was considered statistically significant. Results: The respondents experienced anxiety, shock, and fatigue. Spending a higher proportion of family's income was associated with higher psychological distress index (P = 0.009). The economic challenge led to significantly heightened tension in the family (P = 0.021). Conclusions: Financial challenge is a major cause of psychological distress thus needs for financial support through collaboration with government institutions, for example, NHIF, development agencies, and nongovernment organization who can contribute toward the treatment cost. Need to decentralize effective leukemia treatment centers. Psychological support and counseling should be done to alleviate tension. The nurse needs to be empathetic when caring for the child and family as well as to apply the ethical principles of justice and beneficence so that the child gets the best care despite the financial challenge. PMID:28217728

  12. Social, Economic, and Psychological Impacts of MDR-TB Treatment in Tijuana, Mexico: A Patient's Perspective

    Science.gov (United States)

    Morris, Meghan D.; Quezada, Liliana; Bhat, Priya; Moser, Kathleen; Smith, Jennifer; Perez, Hector; Laniado-Laborin, Rafael; Estrada-Guzman, Julia; Rodwell, Timothy C.

    2013-01-01

    Setting The state of Baja California, Mexico had the highest prevalence of multidrug-resistant tuberculosis (MDR-TB) in Mexico in 2009. Objective To understand the socioeconomic burdens of MDR-TB disease and its treatment on patients in Tijuana and Mexicali, Mexico. Design From July to November 2009, qualitative interviews were conducted with 12 patients who were enrolled in a US-Mexico binational MDR-TB treatment program called “Puentes de Esperanza” (Bridges of Hope), which was designed to support MDR-TB patients. In-depth interviews were coded to identify major themes in patient experiences of MDR-TB diagnosis and care. Results While some patients were able to maintain their pre-MDR-TB lives to a limited extent, most patients reported losing their sense of identity due to their inability to work, social isolation, and stigmatization from family and friends. The majority of participants expressed appreciation for Puentes’ role in “saving their life.” Conclusion Being diagnosed with MDR-TB and undergoing treatment imposes significant psychological, social, and economic stress on patients. Strong social support elements within Puentes helped ameliorate these burdens. Improvements to the program might include peer-support groups for patients undergoing treatment and transitioning back into the community after treatment. PMID:23743315

  13. A critical review of psychological treatments of posttraumatic stress disorder in refugees.

    Science.gov (United States)

    Nickerson, Angela; Bryant, Richard A; Silove, Derrick; Steel, Zachary

    2011-04-01

    Despite much research evidence that refugees suffer from elevated rates of posttraumatic stress disorder (PTSD), relatively few studies have examined the effectiveness of psychological treatments for PTSD in refugees. The field of refugee mental health intervention is dominated by two contrasting approaches, namely trauma-focused therapy and multimodal interventions. This article firstly defines these two approaches, then provides a critical review of 19 research studies that have been undertaken to investigate the efficacy of these treatments. Preliminary research evidence suggests that trauma-focused approaches may have some efficacy in treating PTSD in refugees, but limitations in the methodologies of studies caution against drawing definitive inferences. It is clear that research assessing the treatment of PTSD in refugees is lagging behind that available for other traumatized populations. The review examines important considerations in the treatment of refugees. A theoretical framework is offered that outlines contextual issues, maintaining factors, change mechanisms and the distinctive challenges to traditional trauma-focused treatments posed by the needs of refugees with PTSD.

  14. Effectiveness of cognitive-behavioral treatment for major depressive disorder in a university psychology clinic.

    Science.gov (United States)

    Estupiñá Puig, Francisco José; Labrador Encinas, Francisco Javier

    2012-11-01

    Major Depressive Disorder (MDD) is the most prevalent mental disorder in our environment, and one of the main causes of disability. While several empirically supported treatments (ESTs) for MDD exist, some doubts have been cast on the applicability--in time, components, and effectiveness--of these ESTs in routine clinical practice. A few attempts have been made to contrast the effectiveness of ESTs, but usually the precise components of the treatment developed are not considered in detail. The purpose of this study is to analyze the components of an EST-based treatment on a sample of 69 MDD cases from a University Psychology Clinic, and to benchmark them against the results of published efficacy studies on ESTs (behavioral activation, cognitive therapy, interpersonal therapy). Results show that treatments delivered at this clinical facility are similar in components, length, and effectiveness (in effect size, completers and improved ratio) to the benchmarked studies. Cognitive restructuring is the most frequent component of the delivered treatments. Therapy results show a 3.12 effect size, and a 55.1% improved ratio over initial sample, an 80% of completers. Results and limitations of the current study, especially those related to sample and center characteristics, are discussed.

  15. Quality of life, sense of coherence and experiences with three different treatments in patients with psychological distress in primary care: a mixed-methods study.

    Science.gov (United States)

    Arvidsdotter, Tina; Marklund, Bertil; Taft, Charles; Kylén, Sven

    2015-04-26

    Psychological distress is associated with impaired health-related quality of life (HRQL) and poor sense of coherence (SOC). In a previous study, we found that therapeutic acupuncture (TA) and an integrative treatment that combined TA with person-centred approach in a salutogenic dialogue (IT) alleviated anxiety and depression significantly more than conventional treatment (CT) in primary care patients. Here, we report on secondary analyses regarding the HRQL and SOC from that previous pragmatic randomised controlled trial (RCT). Quantitative and qualitative design. One hundred twenty patients were referred for psychological distress. Quantitative analyses were performed at baseline and after 8 weeks of treatment using the SF-36 mental component summary (MCS), physical component summary (PCS) and the Sense of Coherence-13 (SOC) questionnaires. Qualitative manifest content analyses were based on open-ended questions-"Have you experienced any changes since the start of the treatment? Will you describe these changes?" No baseline differences were found. At 8 weeks, both the IT and TA groups had statistically better scores and greater improvement from baseline on the MCS and SOC than the CT group. The effect sizes were large. No significant differences were found between the IT and TA groups or in relation to the PCS. SOC was highly correlated with the MCS but not with the PCS. Dropout rates were low. The experiences of the intervention resulted in four categories: Being heading back; Status quo; Feeling confirmed; and Feeling abandoned, with 13 related subcategories. IT and TA seem to improve sense of coherence and mental health status in primary care patients with psychological distress, whereas CT appears to be less beneficial. IT and TA appear to be well-accepted and may serve as useful adjunct treatment modalities to standard primary care. Our results are consistent with much of the previous research in highlighting a strong relationship between SOC and mental

  16. Transdermal Estradiol Treatment for Postpartum Depression: A Pilot Randomized Trial

    Science.gov (United States)

    Wisner, Katherine L.; Sit, Dorothy K.Y.; Moses-Kolko, Eydie L.; Driscoll, Kara E.; Prairie, Beth; Stika, Catherine S.; Eng, Heather F.; Dills, John L; Luther, James F.; Wisniewski, Stephen R.

    2015-01-01

    Postpartum depression occurs in 14.5% of women in the first three months after birth. This study was an 8 week acute phase randomized trial with three cells (transdermal estradiol (E2), sertraline, and placebo) for the treatment of postpartum major depressive disorder. However, the study was stopped after batch analysis revealed that the E2 serum concentrations were lower than pre-study projections. This paper explores our experiences that will inform future investigations of therapeutic E2 use. Explanations for the low E2 concentrations were: 1) Study patch non-adhesion, which did not explain the low concentrations across the entire sample. 2) Ineffective transdermal patch preparations, although two different patch preparations were used and no significant main effect of patch type on E2 concentrations was found. 3) Obesity, at study entry, E2-treated women had mean ± SD BMI=32.9 ±7.4. No pharmacokinetic data comparing E2 concentrations from transdermal patches in obese women vs. normal weight controls are available. 4) Induction of Cytochrome P450 (CYP450) 3A4 and other E2 elimination pathways in pregnancy. CYP4503A4 is induced in pregnancy and is a pathway for the metabolism of E2. Conversion to estrone and Phase II metabolism via glucuronidation and sulfation, which also increase in pregnancy, are routes of E2 elimination. The time required for these pathways to normalize after delivery has not been elucidated. The observation that transdermal E2 doses greater than 100 mcg/day did not increase serum concentrations was unexpected. Another hypothesis consistent with this observation is suppression of endogenous E2 secretion with increasing exogenous E2 dosing. PMID:26061609

  17. Extended treatment for cigarette smoking cessation: a randomized control trial.

    Science.gov (United States)

    Laude, Jennifer R; Bailey, Steffani R; Crew, Erin; Varady, Ann; Lembke, Anna; McFall, Danielle; Jeon, Anna; Killen, Diana; Killen, Joel D; David, Sean P

    2017-08-01

    To test the potential benefit of extending cognitive-behavioral therapy (CBT) relative to not extending CBT on long-term abstinence from smoking. Two-group parallel randomized controlled trial. Patients were randomized to receive non-extended CBT (n = 111) or extended CBT (n = 112) following a 26-week open-label treatment. Community clinic in the United States. A total of 219 smokers (mean age: 43 years; mean cigarettes/day: 18). All participants received 10 weeks of combined CBT + bupropion sustained release (bupropion SR) + nicotine patch and were continued on CBT and either no medications if abstinent, continued bupropion + nicotine replacement therapy (NRT) if increased craving or depression scores, or varenicline if still smoking at 10 weeks. Half the participants were randomized at 26 weeks to extended CBT (E-CBT) to week 48 and half to non-extended CBT (no additional CBT sessions). The primary outcome was expired CO-confirmed, 7-day point-prevalence (PP) at 52- and 104-week follow-up. Analyses were based on intention-to-treat. PP abstinence rates at the 52-week follow-up were comparable across non-extended CBT (40%) and E-CBT (39%) groups [odds ratio (OR) = 0.99; 95% confidence interval (CI) = 0.55, 1.78]. A similar pattern was observed across non-extended CBT (39%) and E-CBT (33%) groups at the 104-week follow-up (OR = 0.79; 95% CI= 0.44, 1.40). Prolonging cognitive-behavioral therapy from 26 to 48 weeks does not appear to improve long-term abstinence from smoking. © 2017 Society for the Study of Addiction.

  18. Characterization of IGF-II isoforms in binge eating disorder and its group psychological treatment.

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    Giorgio Tasca

    Full Text Available Binge eating disorder (BED affects 3.5% of the population and is characterized by binge eating for at least 2 days a week for 6 months. Treatment options include cognitive behavioral therapy, interpersonal psychotherapy, and pharmacotherapy which are associated with varied success. Little is known about the biology of BED. Since there is evidence that the insulin like growth factor system is implicated in regulation of body weight, insulin sensitivity and feeding behavior, we speculated it may be involved in BED.A cross-sectional comparison was made between three groups of women: overweight with BED, overweight without BED and normal weight without BED. Women were assigned to Group Psychodynamic Interpersonal Psychotherapy. Blood was collected before therapy, at completion and at 6 months follow up for evaluation of IGF-II using Western blot.97 overweight women with BED contributed to the cross-sectional comparison. The two control groups comprised 53 overweight women without BED, and 50 age matched normal weight women without BED. Obese women had significantly lower Big IGF-II than normal weight women, p = .028; Overweight women with BED had higher Mature IGF-II than normal weight women, p<.05. Big IGF-II showed a significant decreasing slope from pre- to post- to six months post-group psychological treatment, unrelated to changes in BMI (p = .008.Levels of IGF-II isoforms differed significantly between overweight and normal weight women. Overweight women with BED display abnormal levels of circulating IGF-II isoforms. BED is characterized by elevated mature IGF-II, an isoform shown to carry significant bioactivity. This finding is not related to BMI or to changes in body weight. The results also provide preliminary evidence that BIG IGF-II is sensitive to change due to group psychological treatment. We suggest that abnormalities in IGF-II processing may be involved in the neurobiology of BED.

  19. Alcohol consumption, illicit substances, and intimate partner violence in a sample of batterers in psychological treatment.

    Science.gov (United States)

    Redondo Rodríguez, Natalia; Graña Gómez, José Luis

    2015-03-01

    The purpose of this study is to analyze the alcohol and illicit substance consumption characteristics in a sample of 572 batterers in treatment by court order. The results indicate that the prevalence of alcohol consumption in the past year was 89.3%, whereas within illicit substances, the prevalences were higher for cannabis (27.8%), followed by cocaine 20.3%). In order to analyze the possible effect of consumption on levels of perpetration and victimization of partner-aggression, the sample was divided into 4 groups: nonconsumers (16.3%), alcohol consumers (58.6%), illicit drug consumers (3.5%), and consumers of alcohol and illicit drugs (21.7%), finding that the groups of nonconsumers and alcohol consumers presented the lowest level of perpetration of psychological, physical, and sexual aggression and of victimization of psychological and physical aggression, whereas the group of consumers of alcohol and illicit drugs presented the highest levels. The results reveal the need to assess substance consumption when designing intervention protocols with batterers.

  20. Misuse of Psychologically Active Substances of Convicts being in Prisons and their Treatment

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    Safuadan Plojovic

    2015-12-01

    Full Text Available Due to the data of the Ministry of Justice of the Republic of Serbia, over 70% of persons being in prisons and serving their sentences are drug addicts, and 50% of them are drug users. In the European prisons, the percentage of persons using drugs in the entire prison population is 20-70%, and in the USA 70-80%, in the Australian prisons between 50 and 80% of the convicts in prisons are addicts of psychologically active substances. The results of our survey are pursuant to official statistics data for Serbia, the European countries, USA and Australia, since 80% of our convicts in prisons have misused psychologically active substances during the period of 30 days, the previous period before coming to these institutions. More than a half of our examinees (60%, misuses narcotics and alcohol occasionally or permanently, the alcohol users only 12.7%, and only narcotics 7.3% of the ones, meaning that a treatment of addiction disease should have a significant role in prevention of recidivism.

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

    Science.gov (United States)

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

    2015-01-01

    Objective 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). Method 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. Results 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. Discussion 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. © 2015 The Authors. International Journal of Eating Disorders Published by Wiley Periodicals, Inc. (Int J Eat Disord 2015; 48:1170–1175) PMID:26769445

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

    Science.gov (United States)

    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

  3. The Effectiveness of Mindfulness-based Cognitive Therapy on Psychological Symptoms and Quality of Life in Systemic Lupus Erythematosus Patients: A Randomized Controlled Trial

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    Kamal Solati

    2017-09-01

    Full Text Available Objectives: This study was conducted to determine the efficacy of mindfulness-based cognitive therapy (MBCT on psychological symptoms and quality of life (QoL in patients with systemic lupus erythematosus (SLE. Methods: We conducted a randomized single-blind clinical trial in patients with SLE referred from the Imam Ali Clinic in Shahrekord, southwest Iran. The patients (46 in total in two groups of 23 each were randomly assigned into the experimental and control groups. Both groups underwent routine medical care, and the experimental group underwent eight group sessions of MBCT in addition to routine care. The patient,s QoL was assessed using the General Health Questionnaire-28 and 36-Item Short Form Health Survey before, after, and six months after intervention (follow-up. Results: A significant difference was seen in psychological symptoms and QoL between MBCT and control groups immediately after the intervention and at follow-up (p ≤ 0.050. However, the difference was not significant for the physical components of QoL (p ≥ 0.050. Conclusions: MBCT contributed to decreased psychological symptoms and improved QoL in patients with SLE with a stable effect on psychological symptoms and psychological components of QoL, but an unstable effect on physical components.

  4. 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

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

    Science.gov (United States)

    Echouffo-Tcheugui, Justin B; Simmons, Rebecca K; Williams, Kate M; Barling, Roslyn S; Prevost, A Toby; Kinmonth, Ann Louise; Wareham, Nicholas J; Griffin, Simon J

    2009-01-01

    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 PMID:19435491

  6. Jung's views on causes and treatments of schizophrenia in light of current trends in cognitive neuroscience and psychotherapy research II: psychological research and treatment.

    Science.gov (United States)

    Silverstein, Steven M

    2014-04-01

    Jung was the first to emphasize the importance of psychological factors in the aetiology and treatment of schizophrenia. Despite this, and other seminal contributions, his work on schizophrenia is almost completely ignored or forgotten today. This paper, a follow-up to one on Jung's theories of aetiology and symptom formation in schizophrenia (Journal of Analytical Psychology, 59, 1) reviews Jung's views on psychological approaches to research on, and treatment of, the disorder. Five themes are covered: 1) experimental psychopathology; 2) attentional disturbance; 3) psychological treatment; 4) the relationship between the environment (including the psychiatric hospital) and symptom expression; and 5) heterogeneity and the schizophrenia spectrum. Review of these areas reveal that Jung's ideas about the kind of research that can elucidate psychological mechanisms in schizophrenia, and the importance of psychotherapy for people with this condition, are very much in line with contemporary paradigms. Moreover, further exploration of several points of convergence could lead to advances in both of these fields, as well as within analytical psychology.

  7. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder.

    Science.gov (United States)

    Bateman, Anthony; Fonagy, Peter

    2009-12-01

    This randomized controlled trial tested the effectiveness of an 18-month mentalization-based treatment (MBT) approach in an outpatient context against a structured clinical management (SCM) outpatient approach for treatment of borderline personality disorder. Patients (N=134) consecutively referred to a specialist personality disorder treatment center and meeting selection criteria were randomly allocated to MBT or SCM. Eleven mental health professionals equal in years of experience and training served as therapists. Independent evaluators blind to treatment allocation conducted assessments every 6 months. The primary outcome was the occurrence of crisis events, a composite of suicidal and severe self-injurious behaviors and hospitalization. Secondary outcomes included social and interpersonal functioning and self-reported symptoms. Outcome measures, assessed at 6-month intervals, were analyzed using mixed effects logistic regressions for binary data, Poisson regression models for count data, and mixed effects linear growth curve models for self-report variables. Substantial improvements were observed in both conditions across all outcome variables. Patients randomly assigned to MBT showed a steeper decline of both self-reported and clinically significant problems, including suicide attempts and hospitalization. Structured treatments improve outcomes for individuals with borderline personality disorder. A focus on specific psychological processes brings additional benefits to structured clinical support. Mentalization-based treatment is relatively undemanding in terms of training so it may be useful for implementation into general mental health services. Further evaluations by independent research groups are now required.

  8. Hubble trial: time to stick to basics for treatment of haemorrhoids?

    Science.gov (United States)

    Brown, S R

    2017-01-01

    The results of the Hubble trial, a randomised controlled trial comparing haemorrhoidal artery ligation with rubber band ligation for early-grade prolapsing haemorrhoids, are discussed. The difficulties in defining treatment success are debated along with the trial design highlighting the pitfalls of previous research. A finding that haemorrhoidal artery ligation is not necessarily superior to cheap alternatives has implications for current practice and future commissioning of surgeons.

  9. Nonadherence to treatment protocol in published randomised controlled trials: a review

    Directory of Open Access Journals (Sweden)

    Dodd Susanna

    2012-06-01

    Full Text Available Abstract This review aimed to ascertain the extent to which nonadherence to treatment protocol is reported and addressed in a cohort of published analyses of randomised controlled trials (RCTs. One hundred publications of RCTs, randomly selected from those published in BMJ, New England Journal of Medicine, the Journal of the American Medical Association and The Lancet during 2008, were reviewed to determine the extent and nature of reported nonadherence to treatment protocol, and whether statistical methods were used to examine the effect of such nonadherence on both benefit and harms analyses. We also assessed the quality of trial reporting of treatment protocol nonadherence and the quality of reporting of the statistical analysis methods used to investigate such nonadherence. Nonadherence to treatment protocol was reported in 98 of the 100 trials, but reporting on such nonadherence was often vague or incomplete. Forty-two publications did not state how many participants started their randomised treatment. Reporting of treatment initiation and completeness was judged to be inadequate in 64% of trials with short-term interventions and 89% of trials with long-term interventions. More than half (51 of the 98 trials with treatment protocol nonadherence implemented some statistical method to address this issue, most commonly based on per protocol analysis (46 but often labelled as intention to treat (ITT or modified ITT (23 analyses in 22 trials. The composition of analysis sets for their benefit outcomes were not explained in 57% of trials, and 62% of trials that presented harms analyses did not define harms analysis populations. The majority of defined harms analysis populations (18 out of 26 trials, 69% were based on actual treatment received, while the majority of trials with undefined harms analysis populations (31 out of 43 trials, 72% appeared to analyse harms using the ITT approach. Adherence to randomised intervention is poorly considered

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

    Science.gov (United States)

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

    2016-09-24

    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.

  11. The Inference-Based Approach (IBA) to the Treatment of Obsessive-Compulsive Disorder: An Open Trial Across Symptom Subtypes and Treatment-Resistant Cases.

    Science.gov (United States)

    Aardema, Frederick; O Connor, Kieron P; Delorme, Marie-Eve; Audet, Jean-Sebastien

    2017-03-01

    The current open trial evaluated an inference-based approach (IBA) to the treatment of obsessive-compulsive disorder (OCD) across symptom subtypes and treatment-resistant cases. Following formal diagnosis through semi-structured interview by an independent evaluator, a total of 125 OCD participants across five major symptom subtypes entered a program of 24 sessions of treatment based on the IBA. An additional group of 22 participants acted as a natural wait-list control group. Participants were administered the Yale-Brown Obsessive-Compulsive Scale before and after treatment as the principal outcome measure, as well as measures of negative mood states, inferential confusion and obsessive beliefs. Level of overvalued ideation was assessed clinically at pre-treatment using the Overvalued Ideation Scale. After 24 weeks of treatment, 102 treatment completers across all major subtypes of OCD showed significant reductions on the Yale-Brown Obsessive-Compulsive Scale with effect sizes ranging from 1.49 to 2.53 with a clinically significant improvement in 59.8% of participants. No improvement was observed in a natural wait-list comparison group. In addition, IBA was effective for those with high levels of overvalued ideation. Change in inferential confusion and beliefs about threat and responsibility were uniquely associated with treatment outcome. The study is the first large-scale open trial showing IBA to be effective across symptom subtypes and treatment-resistant cases. The treatment may be particularly valuable for those who have previously shown an attenuated response to other treatments. Copyright © 2016 John Wiley & Sons, Ltd. Psychological treatment based on the inference-based approach is an effective treatment for all major subtypes of obsessive-compulsive disorder. The treatment is equally effective for those with high and low levels of overvalued ideation. Treatment based on the inference-based approach may be particularly valuable for those who have shown

  12. 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...

  13. Psychological treatment of essential hypertension: a controlled comparison of meditation and meditation plus biofeedback.

    Science.gov (United States)

    Hafner, R J

    1982-09-01

    Twenty-one patients with essential hypertension were randomly allocated to eight 1-hour sessions of meditation training, meditation plus biofeedback-aided relaxation, or a no-treatment control group. Statistically significant falls in systolic and diastolic blood pressure occurred after both training programs, although overall reductions in blood pressure were not significantly greater in either program than in the control group. Meditation plus biofeedback-aided relaxation produced falls in diastolic blood pressure earlier in the training program than did meditation alone. All patients practiced mediation regularly between training sessions: The amount of practice did not correlate with the amount of blood pressure reduction after training. On questionnaire measures of psychological symptoms and personality, sex differences emerged, with females showing significant abnormalities in hostility scores and males showing significantly raised levels of somatopsychic symptoms. In females, outward-directed hostility fell significantly and assertiveness increased after training, but in males, somatopsychic symptoms were unchanged.

  14. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial.

    Science.gov (United States)

    Rahman, Atif; Hamdani, Syed Usman; Awan, Naila Riaz; Bryant, Richard A; Dawson, Katie S; Khan, Muhammad Firaz; Azeemi, Mian Mukhtar-Ul-Haq; Akhtar, Parveen; Nazir, Huma; Chiumento, Anna; Sijbrandij, Marit; Wang, Duolao; Farooq, Saeed; van Ommeren, Mark

    2016-12-27

    The mental health consequences of conflict and violence are wide-ranging and pervasive. Scalable interventions to address a range of mental health problems are needed. To test the effectiveness of a multicomponent behavioral intervention delivered by lay health workers to adults with psychological distress in primary care settings. A randomized clinical trial was conducted from November 1, 2014, through January 28, 2016, in 3 primary care centers in Peshawar, Pakistan, that included 346 adult primary care attendees with high levels of both psychological distress and functional impairment according to the 12-item General Health Questionnaire and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Lay health workers administered 5 weekly 90-minute individual sessions that included empirically supported strategies of problem solving, behavioral activation, strengthening social support, and stress management. The control was enhanced usual care. Primary outcomes, anxiety and depression symptoms, were independently measured at 3 months with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes were posttraumatic stress symptoms (Posttraumatic Stress Disorder Checklist for DSM-5), functional impairment (WHODAS 2.0), progress on problems for which the person sought help (Psychological Outcome Profiles), and symptoms of depressive disorder (9-item Patient Health Questionnaire). Among 346 patients (mean [SD] age, 33.0 [11.8] years; 78.9% women), 172 were randomly assigned to the intervention and 174 to enhanced usual care; among them, 146 and 160 completed the study, respectively. At baseline, the intervention and control groups had similar mean (SD) HADS scores on symptoms of anxiety (14.16 [3.17] vs 13.64 [3.20]; adjusted mean difference [AMD], 0.52; 95% CI, -0.22 to 1.27) and depression (12.67 [3.27] vs 12.49 [3.34]; AMD, 0.17, 95% CI, -0.54 to 0.89). After 3 months of treatment, the intervention group had significantly lower

  15. Scores on the eysenck personality questionnaire for a sample of children and adolescents receiving psychological treatment in Puerto Rico.

    Science.gov (United States)

    Porrata, Jose Luis; Rosa, Abraham; Mendez, Viviana

    2003-08-01

    Personality questionnaire scores obtained by children and adolescents (n = 28) receiving psychological treatment at a health facility in Humacao, Puerto Rico were examined. The scores were compared with those of regular school children of the same age, of Gurabo, Puerto Rico, who were not in treatment (n = 30). The children in treatment obtained higher scores on Psychoticism, lower scores on Extraversion, and similar scores on Neuroticism and Dissimulation by comparison with regular students.

  16. THE IMPORTANCE OF PSYCHOLOGICAL CHARACTERISTICS OF THE PATIENT FOR THE EFFECTIVE TREATMENT OF METABOLIC SYNDROME

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    L. A. Zavrazhnyh

    2011-01-01

    Full Text Available The aim – the identification of hormonal and psychological characteristics of patients with metabolic syndrome (MS, determining the effectivenessof drug-free weight loss.Materials and methods. The study included 180 patients with MS (according to the criteria of ATP III, received dietary treatment and thermal bath at the spa. Anthropometric measures, the data of the daily blood pressure monitoring, blood levels of hormones (insulin, leptin, were assessed , following surveys were conducted – the definition of eating disorders (PP tests SANT (estimate well-being, activity, mood,anxiety and LOBI (diagnosis related to types of illness. According to the results of the course non-drug treatment, all patients were divided into 2 groups: group 1 – with a positive effect of therapy (n = 87 and 2nd – no effect (n = 93. The criterion for the division served as the simultaneous presence of four factors: decrease in body weight by 2 kg or more, reduction in waist circumference by 2 cm or more, decreasedlevels of triglycerides and blood glucose.Results. The group of patients therapy who proved to be ineffective, characterized by significantly higher levels of insulin and leptin, a predominance of emotiogenic PP, high self-esteem of his being. In relation to the state of neglect of the disease, its denial, indifference to the fate were prevailing. A correlation of levels of insulin and leptin levels with parameters of arterial pressure, PP, test results SANT.Conclusion. In patients with MS psychological and behavioral pattern that has adverse effects on weight loss and associated with the levels of leptin and insulin are diagnosed. Taking into account of these characteristics will increase the effectiveness of therapy.

  17. THE IMPORTANCE OF PSYCHOLOGICAL CHARACTERISTICS OF THE PATIENT FOR THE EFFECTIVE TREATMENT OF METABOLIC SYNDROME

    Directory of Open Access Journals (Sweden)

    L. A. Zavrazhnyh

    2014-07-01

    Full Text Available The aim – the identification of hormonal and psychological characteristics of patients with metabolic syndrome (MS, determining the effectivenessof drug-free weight loss.Materials and methods. The study included 180 patients with MS (according to the criteria of ATP III, received dietary treatment and thermal bath at the spa. Anthropometric measures, the data of the daily blood pressure monitoring, blood levels of hormones (insulin, leptin, were assessed , following surveys were conducted – the definition of eating disorders (PP tests SANT (estimate well-being, activity, mood,anxiety and LOBI (diagnosis related to types of illness. According to the results of the course non-drug treatment, all patients were divided into 2 groups: group 1 – with a positive effect of therapy (n = 87 and 2nd – no effect (n = 93. The criterion for the division served as the simultaneous presence of four factors: decrease in body weight by 2 kg or more, reduction in waist circumference by 2 cm or more, decreasedlevels of triglycerides and blood glucose.Results. The group of patients therapy who proved to be ineffective, characterized by significantly higher levels of insulin and leptin, a predominance of emotiogenic PP, high self-esteem of his being. In relation to the state of neglect of the disease, its denial, indifference to the fate were prevailing. A correlation of levels of insulin and leptin levels with parameters of arterial pressure, PP, test results SANT.Conclusion. In patients with MS psychological and behavioral pattern that has adverse effects on weight loss and associated with the levels of leptin and insulin are diagnosed. Taking into account of these characteristics will increase the effectiveness of therapy.

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

    Directory of Open Access Journals (Sweden)

    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.

  19. The role of psychological flexibility in a self-help acceptance and commitment therapy intervention for psychological distress in a randomized controlled trial.

    NARCIS (Netherlands)

    Fledderus, M.; Bohlmeijer, E.T.; Fox, Jean-Paul; Schreurs, K.M.G.; Spinhoven, Philip

    2013-01-01

    This study examined the role of psychological flexibility, as a risk factor and as a process of change, in a self-help Acceptance and Commitment Therapy (ACT) intervention for adults with mild to moderate depression and anxiety. Participants were randomized to the self-help programme with e-mail sup

  20. The morbidity of treatment for patients with stage I endometrial cancer : Results from a randomized trial

    NARCIS (Netherlands)

    Creutzberg, CL; van Putten, WLJ; Koper, PC; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van der Steen-Banasik, E; Beerman, H; van Lent, M

    2001-01-01

    Purpose: To compare the treatment complications for patients with Stage I endometrial cancer treated with surgery and pelvic radiotherapy (RT) or surgery alone in a multicenter randomized trial. Methods and Materials: The Postoperative Radiation Therapy in Endometrial Carcinoma (PORTEC) trial includ

  1. Using a personalized decision support algorithm for dosing in warfarin treatment: A randomised controlled trial

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    Peter Brønnum Nielsen

    2017-01-01

    Conclusions: We found no difference between the two trial-arms in a high-quality warfarin treatment setup. However in general, the model performed similarly as to routine patient self-management care. (ClinicalTrials.gov number: NCT02705976

  2. Resource utilization implications of treatment were able to be assessed from appropriately reported clinical trial data

    NARCIS (Netherlands)

    Poole-Wilson, Philip A.; Kirwan, Bridget-Anne; Voko, Zoltan; de Brouwer, Sophie; Dunselman, Peter H. J. M.; van Dalen, Frederik J.; Lubsen, Jacobus

    2007-01-01

    Background and Objective: Published clinical trial data rarely allow assessment of the health care resource utilization implications of treatment. We give an example of how these can be assessed given appropriate tabulation of data. Methods: Data from a trial comparing long-acting nifedipine gastroi

  3. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... treatment, screening, diagnostic, prevention, and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, ...

  4. Treatment of music performance anxiety via psychological approaches: a review of selected CBT and psychodynamic literature.

    Science.gov (United States)

    Nagel, Julie J

    2010-12-01

    Performance anxiety, or stage fright, is anxiety aroused about potential mishaps in performance that expose feared inadequacies before an audience and which evoke feelings of embarrassment and humilation. For affected musicians, performance anxiety can be emotionally devastating, as their career choice in music may be terminated or severely compromised. This paper focuses on the cognitive and psychodynamic literature about music performance anxiety, with the emphasis that for treatment "one size does not fit all." It reviews the factors underlying performance anxiety and those factors which can exacerbate the condition in musicians. The two major clinical treatment modalities within contemporary psychology, cognitive behavior therapy (CBT) and psychodynamic treatments, are reviewed. While there are more empirical studies of CBT in various populations in the literature, until recently there was an indifference to empirical research by psychodynamic investigators. However, meta-analyses show strong efficacy for psychodynamic psychotherapy (in various disorders, not specifically music performance anxiety), but also that the benefits of psychodynamic psychotherapy may endure longer and increase with time.

  5. Antenatal exposure to betamethasone: psychological functioning and health related quality of life 31 years after inclusion in randomised controlled trial

    OpenAIRE

    Dalziel, Stuart R; Lim, Vanessa K; Lambert, Anthony; McCarthy, Dianne; Parag, Varsha; Rodgers, Anthony; Harding, Jane E.

    2005-01-01

    Objectives To determine if antenatal exposure to betamethasone for the prevention of neonatal respiratory distress syndrome alters psychological functioning and health related quality of life in adulthood.

  6. Primary outcomes in two randomized controlled trials of treatments for cannabis use disorders.

    Science.gov (United States)

    Peters, Erica N; Nich, Charla; Carroll, Kathleen M

    2011-11-01

    While several randomized controlled trials evaluating a range of treatments for cannabis use disorders have appeared in recent years, these have been marked by inconsistency in selection of primary outcomes, making it difficult to compare outcomes across studies. With the aim of identifying meaningful and reliable outcome domains in treatment studies of cannabis use disorders, we evaluated multiple indicators of marijuana use, marijuana problems, and psychosocial functioning from two independent randomized controlled trials of behavioral treatments for cannabis use disorders (Ns=450 and 136). Confirmatory factor analysis indicated that the best-fitting model of outcomes in both trials encompassed three distinct factors: frequency of marijuana use, severity of marijuana use, and psychosocial functioning. In both trials, frequency of marijuana use and longest period of abstinence during treatment were most strongly associated with outcome during follow-up. Using two categorical definitions of "clinically significant improvement," individuals who demonstrated improvement differed on most end-of-treatment and long-term outcomes from those who did not improve. Results may guide future randomized controlled trials of treatments for cannabis use disorders in the collection of relevant end-of-treatment outcomes and encourage consistency in the reporting of outcomes across trials. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  7. TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Koeneman, M M; Kruse, A J; Kooreman, L F S; Zur Hausen, A; Hopman, A H N; Sep, S J S; Van Gorp, T; Slangen, B F M; van Beekhuizen, H J; van de Sande, M; Gerestein, C G; Nijman, H W; Kruitwagen, R F P M

    2016-02-20

    Cervical intraepithelial neoplasia (CIN) is the premalignant condition of cervical cancer. Whereas not all high grade CIN lesions progress to cervical cancer, the natural history and risk of progression of individual lesions remain unpredictable. Therefore, high-grade CIN is currently treated by surgical excision: large loop excision of the transformation zone (LLETZ). This procedure has potential complications, such as acute haemorrhage, prolonged bleeding, infection and preterm birth in subsequent pregnancies. These complications could be prevented by development of a non-invasive treatment modality, such as topical imiquimod treatment. The primary study objective is to investigate the efficacy of topical imiquimod 5% cream for the treatment of high-grade CIN and to develop a biomarker profile to predict clinical response to imiquimod treatment. Secondary study objectives are to assess treatment side-effects, disease recurrence and quality of life during and after different treatment modalities. The study design is a randomized controlled trial. One hundred forty women with a histological diagnosis of high-grade CIN (CIN 2-3) will be randomized into two arms: imiquimod treatment during 16 weeks (experimental arm) or immediate LLETZ (standard care arm). Treatment efficacy will be evaluated by colposcopy with diagnostic biopsies at 20 weeks for the experimental arm. Successful imiquimod treatment is defined as regression to CIN 1 or less, successful LLETZ treatment is defined as PAP 1 after 6 months. Disease recurrence will be evaluated by cytology at 6, 12 and 24 months after treatment. Side-effects will be evaluated using a standardized report form. Quality of life will be evaluated using validated questionnaires at baseline, 20 weeks and 1 year after treatment. Biomarkers, reflecting both host and viral factors in the pathophysiology of CIN, will be tested at baseline with the aim of developing a predictive biomarker profile for the clinical response to

  8. Representation of people with intellectual disabilities in randomised controlled trials on antipsychotic treatment for behavioural problems

    NARCIS (Netherlands)

    Scheifes, A.; Stolker, J.J.; Nijman, H.L.I.; Egberts, A.C.G.; Heerdink, E.R.

    2011-01-01

    Background Behavioural problems are common in people with intellectual disability (ID) and are often treated with antipsychotics. Aim To establish the frequency and characteristics of people with ID included in randomised controlled trials (RCTs) on antipsychotic treatment for behavioural problems

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

    Science.gov (United States)

    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.

  10. The efficacy of a new translational treatment for persecutory delusions: study protocol for a randomised controlled trial (The Feeling Safe Study).

    Science.gov (United States)

    Freeman, Daniel; Waite, Felicity; Emsley, Richard; Kingdon, David; Davies, Linda; Fitzpatrick, Ray; Dunn, Graham

    2016-03-11

    Persecutory delusions (strong unfounded fears that others intend harm to the person) occur in more than 70 % of the patients diagnosed with schizophrenia. This major psychotic experience is a key clinical target, for which substantial improvement in treatment is needed. Our aim is to use advances in theoretical understanding to develop a much more efficacious treatment that leads to recovery in at least 50 % of people with persistent persecutory delusions. Our cognitive conceptualisation is that persecutory delusions are threat beliefs, developed in the context of genetic and environmental risk, maintained by a number of psychological processes including excessive worry, low self-confidence, intolerance of anxious affect and other internal anomalous experiences, reasoning biases, and safety-seeking strategies. The clinical implication is that safety has to be relearned, by entering the feared situations after reduction of the influence of the maintenance factors. We have been individually evaluating modules targeting causal factors. These will now be tested together as a full treatment, called The Feeling Safe Programme. The treatment is modular, personalised, and includes patient preference. We will test whether the new treatment leads to greater recovery in persistent persecutory delusions, psychological well-being, and activity levels compared to befriending (that is, controlling for therapist attention). The Feeling Safe Study is a parallel group randomised controlled trial for 150 patients who have persecutory delusions despite previous treatment in mental health services. Patients will be randomised (1:1 ratio) to The Feeling Safe Programme or befriending (both provided in 20 sessions over 6 months). Standard care will continue as usual. Online randomisation will use a permuted blocks algorithm, with randomly varying block size, stratified by therapist. Assessments, by a rater blind to allocation, will be conducted at 0, 6 (post treatment), and 12 months. The

  11. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  12. Comparison of Topical Nifedipine With Oral Nifedipine for Treatment of Anal Fissure: A Randomized Controlled Trial

    OpenAIRE

    Golfam, Farzaneh; Golfam, Parisa; Golfam, Babak; Pahlevani, Puyan

    2014-01-01

    Background: Medical sphincterotomy has gained popularity as a treatment for anal fissure. Calcium channel blockers in topical forms could also be appropriate with low adverse effects. Objectives: This was a prospective randomized controlled trial to compare topical and oral nifedipine in the treatment of chronic anal fissure. Patients and Methods: A prospective randomized controlled trial was conducted at two centers of Shahed University. One hundred and thirty patients with chronic anal fiss...

  13. Comparison of treatment effects between animal experiments and clinical trials: systematic review

    OpenAIRE

    2006-01-01

    Objective To examine concordance between treatment effects in animal experiments and clinical trials.Study design Systematic review.Data sources Medline, Embase, SIGLE, NTIS, Science Citation Index, CAB, BIOSIS.Study selection Animal studies for interventions with unambiguous evidence of a treatment effect (benefit or harm) in clinical trials: head injury, antifibrinolytics in haemorrhage, thrombolysis in acute ischaemic stroke, tirilazad in acute ischaemic stroke, antenatal corticosteroids t...

  14. Pragmatic consideration of recent randomized, placebo-controlled clinical trials for treatment of fibromyalgia.

    Science.gov (United States)

    Holman, Andrew J

    2008-12-01

    A flurry of recent randomized, placebo-controlled trials assessing dissimilar pharmacotherapeutic treatment options for fibromyalgia (FM) have been presented in the past few years. This review evaluates these trials in light of recent pathophysiological concepts germane to FM, including mood disorders, autonomic dysregulation, altered sleep stage architecture, and the diagnostic tender point controversy. Studies with gabapentin, pregabalin, duloxetine, milnacipran, sodium oxybate, and pramipexole for treatment of FM are discussed.

  15. Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes.

    Science.gov (United States)

    Latner, Janet D; Ciao, Anna C; Wendicke, Annemarie U; Murakami, Jessica M; Durso, Laura E

    2013-08-01

    Obesity is a significant public health problem, and sustainable long-term treatments are needed. This study examined a community-based model of weight-loss treatment. Ninety participants were recruited from eight community organizations (mean age: 49.65 years, mean body mass index: 35.80 kg/m(2); 64% female). Treatment groups were randomly assigned to two maintenance conditions: 1) self-help continuing care, or 2) assessment-only. Both received the same initial 20-session group behavioral treatment. Those randomized to continuing care were additionally instructed to meet as self-sustaining groups for 18 months post-treatment. Weight, physiological, behavioral, and psychological outcomes were assessed at baseline, post-treatment, and at six-month and 18-month follow-up. Eighty-seven percent of participants completed treatment. Participant treatment satisfaction and therapist adherence to treatment protocol were high. No group differences or time by group interaction effects emerged. Participants achieved significant weight losses at post-treatment, with no significant weight regain at six-month or 18-month follow-up. Treatment produced sustained changes in waist circumference, cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, insulin, eating patterns, physical activity, quality of life, and body image. A community-based treatment program may be an effective form of behavioral-weight-loss treatment for overweight/obese adults. Weight losses, along with physiological and psychological benefits, were sustained over time. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. Effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult Portuguese men with haemophilia (PSY-HaEMOPEQ): study protocol for a single-centre prospective randomised controlled trial

    Science.gov (United States)

    Pinto, Patrícia Ribeiro; Paredes, Ana Cristina; Costa, Patrício; Carvalho, Manuela; Lopes, Manuela; Fernandes, Susana; Almeida, Armando

    2017-01-01

    Introduction Haemophilia is a bleeding disorder associated with significant pain, emotional distress, quality of life (QoL) impairment and considerable healthcare costs. Psychosocial health and effective pain management are considered essential end points for optimal haemophilia care, but there is a significant gap in evidence-based treatments targeting these outcomes in people with haemophilia (PWH). Psychological interventions are cost-effective in promoting emotional well-being, QoL and pain control, although these have been scarcely used in haemophilia field. This investigation aims to evaluate the effectiveness of two psychological interventions for pain management, emotional regulation and promotion of QoL in PWH. Methods and analysis This is a single-centre parallel randomised controlled trial conducted at a European Haemophilia Comprehensive Care Centre in Portugal, with five assessment points: baseline (T0), postintervention (T1), 3 (T2), 6 (T3) and 12 (T4) months follow-up. Eligible adult males, with moderate or severe haemophilia A or B will be randomised to experimental (EG) or control (CG) group. Intervention is either cognitive-behavioural therapy (EG1) or hypnosis (EG2), both consisting of four weekly sessions following standardised scripts delivered by trained psychologists. Randomisation will be computer generated, allocation concealment will be guaranteed and outcome assessors will be blind to EG/CG allocation. Main outcomes are pain and haemophilia-related QoL and secondary outcomes include clinical (clotting factor replacement consumption, joint bleeding episodes, analgesic intake) and psychological (pain coping strategies, anxiety, depression, illness perceptions) variables, functional assessment of the joints, inflammatory biomarkers (cytokines, high-sensitivity C reactive protein) and white blood cell count. Ethics and dissemination This study was approved by the competent authorities and all procedures will comply with international ethical

  17. 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...

  18. 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 k...

  19. Ivermectin--clinical trials and treatment schedules in onchocerciasis.

    Science.gov (United States)

    Brown, K R; Neu, D C

    1990-01-01

    Initial clinical trials with ivermectin were performed in patients with both roundworm infestation and onchocerciasis. Obvious clinical safety allowed for rapid progression through 5-30-50-100-150-200 mcg/kg in infected patients. Initial studies showed some effect at 50 mcg/kg; subsequent double-blind controlled studies, either with placebo or diethylcarbamazine (DEC), confirmed the efficacy of ivermectin as well as further defining its safety profile. Absence of adverse eye findings or serious systemic reactions justified the further open trials. Studies of patients treated at 6, 12, or 18 month intervals showed a long lasting effect of ivermectin in reducing skin microfilaria counts. Phase III studies confirmed safety and efficacy and further refined the dose to 150 mcg/kg every 12 months. Large trials in Liberia and other countries in West Africa, and subsequently under Onchocerciasis Control Program (OCP), included approximately 120,000 persons carefully followed during which few patients with serious adverse experiences were reported. These extensive field trials confirmed the relative safety allowing for broad distribution of ivermectin in programs not able to provide physician monitoring.

  20. [Headache in children and adolescents. Epidemiology, biopsychosocial correlates, and psychological treatment approaches].

    Science.gov (United States)

    Kröner-Herwig, B

    2014-08-01

    An abundance of studies have consistently shown that headache is the most prevalent pain in children and adolescents. Weekly headache is experienced by more than 10 % and is distinctly more frequent in girls. The number of headache-affected youths with high disability is lower than expected (~ 4 %). Headache is associated with pain in other body sites, thus multiple pain is experienced more often than isolated headache. Various somatic symptoms and even chronic diseases are also correlated with headache. Headache in parents carries a high risk of also occurring in their children. Various other psychosocial factors such as dysfunctional psychological traits are closely linked with headache, the most prominent being internalizing symptoms. However, externalizing symptoms also correlate with headache. Pain catastrophizing, as well as somatosensory amplification and anxiety sensitivity, have been shown to characterize individuals with headache. Features of the social environment, such as life events, school, as well as family stressors and socioeconomic parameters, are among the risk factors. Psychological interventions such as biofeedback, relaxation, and cognitive-behavioral training have proved their efficacy in headache treatment according to several meta-analyses. The latter has also been conducted in group settings and more recently in self-management focused trainings using electronic media. They mainly aim at the prevention of further headache episodes. The goal of this training is the strengthening of self-efficacy beliefs and active coping strategies. It is proposed that these competencies could contribute to the successful long-term prevention of an adverse course of headache into adulthood.

  1. Estimation of treatment efficacy with complier average causal effects (CACE) in a randomized stepped wedge trial.

    Science.gov (United States)

    Gruber, Joshua S; Arnold, Benjamin F; Reygadas, Fermin; Hubbard, Alan E; Colford, John M

    2014-05-01

    Complier average causal effects (CACE) estimate the impact of an intervention among treatment compliers in randomized trials. Methods used to estimate CACE have been outlined for parallel-arm trials (e.g., using an instrumental variables (IV) estimator) but not for other randomized study designs. Here, we propose a method for estimating CACE in randomized stepped wedge trials, where experimental units cross over from control conditions to intervention conditions in a randomized sequence. We illustrate the approach with a cluster-randomized drinking water trial conducted in rural Mexico from 2009 to 2011. Additionally, we evaluated the plausibility of assumptions required to estimate CACE using the IV approach, which are testable in stepped wedge trials but not in parallel-arm trials. We observed small increases in the magnitude of CACE risk differences compared with intention-to-treat estimates for drinking water contamination (risk difference (RD) = -22% (95% confidence interval (CI): -33, -11) vs. RD = -19% (95% CI: -26, -12)) and diarrhea (RD = -0.8% (95% CI: -2.1, 0.4) vs. RD = -0.1% (95% CI: -1.1, 0.9)). Assumptions required for IV analysis were probably violated. Stepped wedge trials allow investigators to estimate CACE with an approach that avoids the stronger assumptions required for CACE estimation in parallel-arm trials. Inclusion of CACE estimates in stepped wedge trials with imperfect compliance could enhance reporting and interpretation of the results of such trials.

  2. Comparison of Initial Psychological Treatment Selections by US and Japanese Early-Career Psychiatrists for Patients with Major Depression: A Case Vignette Study.

    Science.gov (United States)

    Williams, Aya; Nakagawa, Atsuo; Sado, Mitsuhiro; Fujisawa, Daisuke; Mischoulon, David; Smith, Felicia; Mimura, Masaru; Sato, Yuji

    2016-04-01

    The authors compared early-career psychiatrists' selection of psychological treatments for patients with mild to moderate major depressive disorder (MDD) in the US and Japan. A total of 120 early-career psychiatrists from two residency programs in the US and Japan participated in web-based surveys. The psychiatrists selected first- and second-line psychological treatments in response to two case vignettes of patients with mild and moderate MDD. Eighty-one psychiatrists (68%) returned the surveys, of whom 39 (48%) were American and 42 (52%) Japanese. In response to the mild MDD case, more US psychiatrists selected high-intensity psychological treatments (P US psychiatrists selected high-intensity psychological treatments (P cultural beliefs may shape differences in treatment selections, which in turn may impact the dissemination and implementation of psychological treatment in clinical practice across cultures.

  3. Psychological predictors of substantial pain reduction after minimally invasive radiofrequency and injection treatments for chronic low back pain

    NARCIS (Netherlands)

    van Wijk, Roelof M. A. W.; Geurts, Jos W. M.; Lousberg, Richel; Wynne, Herman J.; Hammink, Edwin; Knape, Johannes T. A.; Groen, Gerbrand J.

    2008-01-01

    Objective. In this post hoc observational study, we investigated psychological predictors of outcome after radiofrequency and injection treatments, commonly performed in the management of chronic low back pain (CLBP). Design & Setting. Data, comprising 161 patients (29 eventually lost to follow-up),

  4. A randomized controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus treatment-as-usual (TAU) for chronic, treatment-resistant depression: study protocol

    NARCIS (Netherlands)

    Cladder-Micus, M.B.; Vrijsen, J.N.; Becker, E.S.; Donders, A.R.T.; Spijker, J.; Speckens, A.E.M.

    2015-01-01

    Background: Major depression is a common psychiatric disorder, frequently taking a chronic course. Despite provision of evidence-based treatments, including antidepressant medication and psychological treatments like cognitive behavioral therapy or interpersonal therapy, a substantial amount of pati

  5. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An american academy of sleep medicine report.

    Science.gov (United States)

    Morgenthaler, Timothy; Kramer, Milton; Alessi, Cathy; Friedman, Leah; Boehlecke, Brian; Brown, Terry; Coleman, Jack; Kapur, Vishesh; Lee-Chiong, Teofilo; Owens, Judith; Pancer, Jeffrey; Swick, Todd

    2006-11-01

    Insomnia is highly prevalent, has associated daytime consequences which impair job performance and quality of life, and is associated with increased risk of comorbidities including depression. These practice parameters provide recommendations regarding behavioral and psychological treatment approaches, which are often effective in primary and secondary insomnia. These recommendations replace or modify those published in the 1999 practice parameter paper produced by the American Sleep Disorders Association. A Task Force of content experts was appointed by the American Academy of Sleep Medicine to perform a comprehensive review of the scientific literature since 1999 and to grade the evidence regarding non-pharmacological treatments of insomnia. Recommendations were developed based on this review using evidence-based methods. These recommendations were developed by the Standards of Practice Committee and reviewed and approved by the Board of Directors of the American Academy of Sleep Medicine. Psychological and behavioral interventions are effective in the treatment of both chronic primary insomnia (Standard) and secondary insomnia (Guideline). Stimulus control therapy, relaxation training, and cognitive behavior therapy are individually effective therapies in the treatment of chronic insomnia (Standard) and sleep restriction therapy, multicomponent therapy (without cognitive therapy), biofeedback and paradoxical intention are individually effective therapies in the treatment of chronic insomnia (Guideline). There was insufficient evidence to recommend sleep hygiene education, imagery training and cognitive therapy as single therapies or when added to other specific approaches. Psychological and behavioral interventions are effective in the treatment of insomnia in older adults and in the treatment of insomnia among chronic hypnotic users (Standard).

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

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    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

  8. Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yan Jie

    2009-08-01

    Full Text Available Abstract Background Acupuncture is widely used in China to treat functional dyspepsia (FD. However, its effectiveness in the treatment of FD, and whether FD-specific acupoints exist, are controversial. So this study aims to determine if acupuncture is an effective treatment for FD and if acupoint specificity exists according to traditional acupuncture meridians and acupoint theories. Design This multicenter randomized controlled trial will include four acupoint treatment groups, one non-acupoint control group and one drug (positive control group. The four acupoint treatment groups will focus on: (1 specific acupoints of the stomach meridian; (2 non-specific acupoints of the stomach meridian; (3 specific acupoints of alarm and transport points; and (4 acupoints of the gallbladder meridian. These four groups of acupoints are thought to differ in terms of clinical efficacy, according to traditional acupuncture meridians and acupoint theories. A total of 120 FD patients will be included in each group. Each patient will receive 20 sessions of acupuncture treatment over 4 weeks. The trial will be conducted in eight hospitals located in three centers of China. The primary outcomes in this trial will include differences in Nepean Dyspepsia Index scores and differences in the Symptom Index of Dyspepsia before randomization, 2 weeks and 4 weeks after randomization, and 1 month and 3 months after completing treatment. Discussion The important features of this trial include the randomization procedures (controlled by a central randomization system, a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy. Trial registration number Clinical Trials

  9. Review of randomized controlled trials on psychological interventions in child sexual abuse: Current status and emerging needs in the Indian context

    Directory of Open Access Journals (Sweden)

    Vandana Choudhary

    2016-01-01

    Full Text Available 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.

  10. Economic evaluation of a minimal psychological intervention in chronically ill elderly patients with minor or mild to moderate depression: A randomized trial (the DELTA-study)

    NARCIS (Netherlands)

    Jonkers, C.C.M.; Lamers, F.; Evers, S.M.; Bosma, H.; Metsemakers, J.F.M.; Eijk, van J.T.M.

    2009-01-01

    Objectives: Depression is associated with high healthcare utilization and related costs. Effective treatments might reduce the economic burden. The objective of this study was to establish the cost-utility of a minimal psychological intervention (MPI) aimed at reducing depression and improving

  11. Controlled trial of D-penicillamine with low dosis in the treatment of chronic liver diseases.

    Science.gov (United States)

    Nakano, H; Ohnishi, S; Sugiyama, T; Miyamura, M; Imura, H; Yamamoto, Y; Ito, K

    1980-01-01

    Controlled trial of D-penicillamine was carried out with low dosis in 10 patients with chronic persistent hepatitis, 11 patients with chronic aggressive hepatitis and 7 patients with liver cirrhosis. After 6 weeks and 6 months treatment mean values of transaminases improved in patients with chronic persistent hepatitis. The mean serum transaminases levels of the patients with chronic aggressive hepatitis were statistically decreased after 6 weeks treatment but not significantly lower after 6 months treatment than on entry. D-penicillamine is not effective for the treatment of patients with liver cirrhosis. Eight of 36 patients treated were withdrawn from the trial because of adverse drug toxicity side effects.

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

    Directory of Open Access Journals (Sweden)

    Peter A Coventry

    Full Text Available BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSION: 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

  13. Time Course of Leptin in Patients with Anorexia Nervosa during Inpatient Treatment: Longitudinal Relationships to BMI and Psychological Factors

    Science.gov (United States)

    Friederich, Hans-Christoph; Wesche, Daniela; Kopf, Stefan; Herzog, Wolfgang; Wild, Beate

    2016-01-01

    Background 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. Objective The present study addresses whether leptin changes during inpatient treatment play a role for treatment outcome and psychological factors in underweight AN patients. Methods 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. Results 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. Conclusions Our results suggest that leptin changes are differently associated with weight gain and psychological symptoms depending on the severity of starvation. PMID:28030575

  14. Internet-delivered cognitive-behavioral treatment for adolescents with chronic pain and their parents: a randomized controlled multicenter trial.

    Science.gov (United States)

    Palermo, Tonya M; Law, Emily F; Fales, Jessica; Bromberg, Maggie H; Jessen-Fiddick, Tricia; Tai, Gabrielle

    2016-01-01

    Internet-delivered interventions are emerging as a strategy to address barriers to care for individuals with chronic pain. This is the first large multicenter randomized controlled trial of Internet-delivered cognitive-behavioral therapy (CBT) for pediatric chronic pain. Participants included were 273 adolescents (205 females and 68 males), aged 11 to 17 years with mixed chronic pain conditions and their parents, who were randomly assigned in a parallel-group design to Internet-delivered CBT (n = 138) or Internet-delivered Education (n = 135). Assessments were completed before treatment, immediately after treatment, and at 6-month follow-up. All data collection and procedures took place online. The primary analysis used linear growth models. Results demonstrated significantly greater reduction on the primary outcome of activity limitations from baseline to 6-month follow-up for Internet CBT compared with Internet education (b = -1.13, P = 0.03). On secondary outcomes, significant beneficial effects of Internet CBT were found on sleep quality (b = 0.14, P = 0.04), on reducing parent miscarried helping (b = -2.66, P = 0.007) and protective behaviors (b = -0.19, P = 0.001), and on treatment satisfaction (P values pain, and improvement in parent behavioral responses to pain). In conclusion, our Internet-delivered CBT intervention produced a number of beneficial effects on adolescent and parent outcomes, and could ultimately lead to wide dissemination of evidence-based psychological pain treatment for youth and their families.

  15. Developing Treatment, Treatment Validation & Treatment Scope in the Setting of an Autism Clinical Trial

    Science.gov (United States)

    2011-10-01

    autism. We will also measure changes in excretion of the polyunsaturated fatty acid ( PUFA ) derived biomarkers of oxidative stress (isoprostanes and...Alternative Treatments in Autism” at the conference. In her talk she will be speaking of the use of Omega -3 fatty acids in autism. We will...T.P. Stein PhD, X. Ming MD, PhD, M.D. Schluter BS, A. Rodriguez PhD, B.W. Spur PhD and G. Lambert MD. POLYUNSATURATED FATTY ACIDS METABOLISM

  16. Biofeedback-Based Behavioral Treatment for Chronic Tinnitus: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Weise, Cornelia; Heinecke, Kristin; Rief, Winfried

    2008-01-01

    Many tinnitus sufferers believe that their tinnitus has an organic basis and thus seek medical rather than psychological treatments. Tinnitus has been found to be associated with negative appraisal, dysfunctional attention shift, and heightened psychophysiological arousal, so cognitive-behavioral interventions and biofeedback are commonly…

  17. Biofeedback-Based Behavioral Treatment for Chronic Tinnitus: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Weise, Cornelia; Heinecke, Kristin; Rief, Winfried

    2008-01-01

    Many tinnitus sufferers believe that their tinnitus has an organic basis and thus seek medical rather than psychological treatments. Tinnitus has been found to be associated with negative appraisal, dysfunctional attention shift, and heightened psychophysiological arousal, so cognitive-behavioral interventions and biofeedback are commonly…

  18. Choosing relevant endpoints for older breast cancer patients in clinical trials: an overview of all current clinical trials on breast cancer treatment.

    Science.gov (United States)

    de Glas, N A; Hamaker, M E; Kiderlen, M; de Craen, A J M; Mooijaart, S P; van de Velde, C J H; van Munster, B C; Portielje, J E A; Liefers, G J; Bastiaannet, E

    2014-08-01

    With the ongoing ageing of western societies, the proportion of older breast cancer patients will increase. For several years, clinicians and researchers in geriatric oncology have urged for new clinical trials that address patient-related endpoints such as functional decline after treatment of older patients. The aim of this study was to present an overview of trial characteristics and endpoints of all currently running clinical trials in breast cancer, particularly in older patients. The clinical trial register of the United States National Institutes of Health Differences was searched for all current clinical trials on breast cancer treatment. Trial characteristics and endpoints were retrieved from the register and differences in characteristics between studies in older patients specifically (defined as a lower age-limit of 60 years or older) and trials in all patients were assessed using χ(2) tests. We included 463 clinical trials. Nine trials (2 %) specifically investigated breast cancer treatment in older patients. Ninety-one breast cancer trials included any patient-related endpoint (20 %), while five trials specifically addressing older patients included any patient-related endpoint (56 %, P = 0.02). Five of the trials in older patients incorporated a geriatric assessment (56 %). Clinical trials still rarely incorporate patient-related endpoints, even in trials that specifically address older patients. Trials that are specifically designed for older patients do not often incorporate a geriatric assessment in their design. This implicates that current clinical studies are not expected to fill the gap in knowledge concerning treatment of older breast cancer patients in the next decade.

  19. 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

    DEFF Research Database (Denmark)

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

    2008-01-01

    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...... 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....

  20. [Clinical trials and licensing of monoclonal antibodies and biological medicines for cancer treatment in Brazil].

    Science.gov (United States)

    Silva, Cecilia Ferreira da; Silva, Miriam Ventura da; Osorio-de-Castro, Claudia Garcia Serpa

    2016-03-01

    Objective To analyze the pathway of clinical trials of monoclonal antibodies and biological medicines for cancer treatment involving Brazilian institutions from 2003 to 2012. Method This retrospective, descriptive study was based on review of two clinical trial registries, ClinicalTrials.gov and the Brazilian registry ReBEC. Phase II or III studies with participation from Brazilian institutions listed in at least one of the registries were included. Following selection of the trials, the pathway of monoclonal antibodies and biological medicines was investigated from the research stage until licensing by the Brazilian Agency for Sanitary Surveillance (Anvisa), Food and Drug Administration (FDA), and European Medicines Agency (EMA). Results Nine trials (eight phase III and one phase II) were selected. All had a randomized, controlled design. Two trials were double-blind and seven were open-label, and all recruited adults (≥ 18 years of age) of both sexes. The mean number of patients recruited per trial was 985.2. Seven trials had been completed and two had been terminated early. All trials were sponsored by non-Brazilian pharmaceutical companies and focused on renal, colorectal, gastric, and lung (non-small cell) cancer, non-Hodgkin lymphoma, and melanoma, and involved the use of cetuximab, figitumumab, ipilimumab, rituximab, bevacizumab and interferon alfa-2a. The FDA was the first agency to license the drugs, followed by EMA, except in the case of interferon alfa-2a, which was not approved by EMA. We were unable to determine the year of drug licensing by Anvisa in Brazil. Conclusions The participation of Brazil in clinical trials of monoclonal antibodies and biological medications for cancer treatment is insufficient. The quality of the available information on trials, history of licensing, and other relevant elements is a major weakness of the sources reviewed.

  1. Physiological Markers of Arousal Change with Psychological Treatment for Insomnia: A Preliminary Investigation.

    Directory of Open Access Journals (Sweden)

    Christopher B Miller

    Full Text Available The aim of this preliminary study was to evaluate if Sleep Restriction Therapy for insomnia is associated with modifications to physiological arousal, indexed through overnight measures of plasma cortisol concentrations and core body temperature.In a pre-to-post open label study design, eleven patients with chronic and severe Psychophysiological Insomnia underwent 5 weeks of Sleep Restriction Therapy.Eight (73% patients out of 11 consented completed therapy and showed a decrease in insomnia severity pre-to-post treatment (mean (SD: 18.1 (2.8 versus 8.4 (4.8; p = .001. Six patients were analyzed with pre-to-post overnight measures of temperature and cortisol. Contrary to our hypothesis, significantly higher levels of plasma cortisol concentrations were found during the early morning at post-treatment compared to baseline (p < .01, while no change was observed in the pre-sleep phase or early part of the night. Core body temperature during sleep was however reduced significantly (overall mean [95% CI]: 36.54 (°C [36.3, 36.8] versus 36.45 [36.2, 36.7]; p < .05.Sleep Restriction Therapy therefore was associated with increased early morning cortisol concentrations and decreased core body temperature, supporting the premise of physiological changes in functioning after effective therapy. Future work should evaluate change in physiological variables associated with clinical treatment response.Australian New Zealand Clinical Trials Registry ANZCTR 12612000049875.

  2. Enrollment and Racial Disparities in National Cancer Institute Cancer Treatment Clinical Trials in North Carolina

    Science.gov (United States)

    Zullig, Leah L.; Fortune-Britt, Alice G.; Rao, Shangbang; Tyree, Seth D.; Godley, Paul A.; Carpenter, William R.

    2015-01-01

    Background Clinical trials provide access to innovative, quality cancer treatment. Simultaneously, broad access helps ensure trial inclusion of heterogeneous patient populations, which improves generalizability of findings and development of interventions that are effective for diverse populations. We provide updated data describing enrollment into cancer treatment trials in North Carolina. Methods For 1996 to 2009, person-level data regarding cancer clinical trial enrollment and cancer incidence were obtained from the North Carolina Central Cancer Registry and the National Cancer Institute (NCI). Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for race, gender, and year for each county, Area Health Education Center (AHEC) region, and the state overall. Enrollment rates for common cancers are presented. Results From 1996 to 2009, North Carolina NCI treatment trial enrollment rate was 2.4% and 2.2% for whites and minorities, respectively. From 2007 to 2009, rates were 3.8% for white females, 3.5% for minority females, 1.3% for white men, and 1.0% for minority men, with greater enrollment among more urban populations (2.4%) than the most rural populations (1.5%). Limitations This study is limited to NCI-sponsored treatment trials in North Carolina. Policies governing collection of original data necessitate a delay in data availability. Conclusions Effort is needed to ensure trial access and enrollment among all North Carolina populations. Specifically, we identified racial and gender disparities, particularly for certain cancers (e.g., breast). Programs in North Carolina and across the nation can use the methods we employ to assess their success in broadening clinical trials enrollment for diverse populations. PMID:26763244

  3. Mapping randomized controlled trials of treatments for eczema - The GREAT database (The Global Resource of Eczema Trials: a collection of key data on randomized controlled trials of treatments for eczema from 2000 to 2010

    Directory of Open Access Journals (Sweden)

    Williams Hywel C

    2011-05-01

    Full Text Available Abstract Background Massive duplication of effort occurs when researchers all over the world undertake extensive searches for randomized controlled trials when preparing systematic reviews, when developing evidence-based guidelines and when applying for research funding for eczema treatments. Such duplication wastes valuable resources. Searching for randomized controlled trials of eczema is a laborious task involving scrutiny of thousands of individual references from diverse electronic databases in order to obtain a few papers of interest. Clinicians and patients who wish to find out more about a particular treatment are at risk of missing the relevant evidence if they are not trained in electronic bibliographic searching. Systematic reviews cannot be relied upon to comprehensively inform current optimal eczema treatments due to incomplete coverage and because many may be out of date. An international, publically available and comprehensive resource which brings together all randomized controlled trials on eczema treatment using a highly sensitive search has the potential to release more filtered knowledge about patient care to those who need it most and to significantly shorten the duration and costs of many clinical eczema research and guideline projects. Description The Global Resource of EczemA Trials brings together information on all randomized controlled trials of eczema treatments published from the beginning of 2000 up to the end of 2010 and will be updated every month. We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library and the Cochrane Skin Group Specialised Register, MEDLINE, EMBASE, LILACS, AMED and CINHAL databases. We included 268 RCTs (24th March 2011 covering over 70 different treatment interventions. The structure of the Global Resource of Eczema Trials allows the user as much, or as little, specificity when retrieving information on trials as they wish, in an easy to use format. For each

  4. 自伤行为的心理治疗分析%Analysis of Psychological Treatment of Self Injurious Behavior

    Institute of Scientific and Technical Information of China (English)

    郭秀华

    2015-01-01

    Objective To analyze the psychological characteristics of self injuriousbehavior, to explore the effective treatment Methods .Methods Analysis of the psychological characteristics of patients with suicidal behavior,suicidal behavior assessment approach,to explore the psychological treatment.Results Self injurious behavior belongs to the adverse response of human psychological process,the main reason of this problem is emotional management disorder,cognitive behavioraltherapy is the treatment method,but the effect is not obvious.Conclusion In evaluating injury patients,to focus on patients' motivation, psychological barriers,self mutilation,self injury history,the core goal of treatment is to help patients to improve the ability of emotional management.%目的 分析自伤行为者的心理特征,探讨有效的治疗方法.方法 分析自伤行为患者的心理特征,结合自伤行为的评估办法,探讨心理治疗办法.结果 自伤行为属于人类心理应对过程中出现的不良应对措施,出现该问题的主要原因就是情绪管理障碍,治疗方法是行为认知法,但是治疗效果并不明显.结论 在评估自伤患者时,需要重点观察患者的行为动机、心理障碍、自伤功能、自伤史等问题,核心治疗目标则是帮助病患提高情绪管理的能力.

  5. A Consensus-Based Interpretation of the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure Trial.

    Science.gov (United States)

    Chesnut, Randall M; Bleck, Thomas P; Citerio, Giuseppe; Classen, Jan; Cooper, D James; Coplin, William M; Diringer, Michael N; Grände, Per-Olof; Hemphill, J Claude; Hutchinson, Peter J; Le Roux, Peter; Mayer, Stephan A; Menon, David K; Myburgh, John A; Okonkwo, David O; Robertson, Claudia S; Sahuquillo, Juan; Stocchetti, Nino; Sung, Gene; Temkin, Nancy; Vespa, Paul M; Videtta, Walter; Yonas, Howard

    2015-11-15

    Widely-varying published and presented analyses of the Benchmark Evidence From South American Trials: Treatment of Intracranial Pressure (BEST TRIP) randomized controlled trial of intracranial pressure (ICP) monitoring have suggested denying trial generalizability, questioning the need for ICP monitoring in severe traumatic brain injury (sTBI), re-assessing current clinical approaches to monitored ICP, and initiating a general ICP-monitoring moratorium. In response to this dissonance, 23 clinically-active, international opinion leaders in acute-care sTBI management met to draft a consensus statement to interpret this study. A Delphi method-based approach employed iterative pre-meeting polling to codify the group's general opinions, followed by an in-person meeting wherein individual statements were refined. Statements required an agreement threshold of more than 70% by blinded voting for approval. Seven precisely-worded statements resulted, with agreement levels of 83% to 100%. These statements, which should be read in toto to properly reflect the group's consensus positions, conclude that the BEST TRIP trial: 1) studied protocols, not ICP-monitoring per se; 2) applies only to those protocols and specific study groups and should not be generalized to other treatment approaches or patient groups; 3) strongly calls for further research on ICP interpretation and use; 4) should be applied cautiously to regions with much different treatment milieu; 5) did not investigate the utility of treating monitored ICP in the specific patient group with established intracranial hypertension; 6) should not change the practice of those currently monitoring ICP; and 7) provided a protocol, used in non-monitored study patients, that should be considered when treating without ICP monitoring. Consideration of these statements can clarify study interpretation.

  6. Better Access to Psychological Treatments through Medicare: Rejoinder to Carey, Rickwood and Baker

    Science.gov (United States)

    O'Kearney, Richard; Wilmoth, Deborah

    2009-01-01

    The inclusion of evidence-based psychological interventions within Medicare through Better Access addresses an inequity within the Australian health system against people with mental disorders. The question of "Who is qualified to provide these services" is the overriding focus of many commentaries on Better Access within psychology.…

  7. Better Access to Psychological Treatments through Medicare: Rejoinder to Carey, Rickwood and Baker

    Science.gov (United States)

    O'Kearney, Richard; Wilmoth, Deborah

    2009-01-01

    The inclusion of evidence-based psychological interventions within Medicare through Better Access addresses an inequity within the Australian health system against people with mental disorders. The question of "Who is qualified to provide these services" is the overriding focus of many commentaries on Better Access within psychology.…

  8. 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

  9. Psychological, physical, and sexual abuse in addicted patients who undergo treatment.

    Science.gov (United States)

    Fernández-Montalvo, Javier; López-Goñi, José J; Arteaga, Alfonso

    2015-05-01

    This study explored the prevalence of a history as victims of abuse among patients who sought outpatient treatment for drug addiction. A sample of 252 addicted patients was assessed. Information was collected on the patients' lifetime history of abuse (psychological, physical, and/or sexual abuse), sociodemographic factors, consumption factors, psychopathological factors, and personality variables. Drug-addicted patients who present a lifelong history of abuse were compared with patients who were not abused. Of the total sample, 46% of the patients (n = 115) who were addicted to drugs had been victims of abuse. There was a statistically significant difference between the victimization rates of men (37.8%) and women (79.6%). Moreover, for some variables, significant differences were observed between patients who had been abused and those who had not. Compared with patients who had not been abused, the addicted patients with a history of victimization scored significantly higher on several European Addiction Severity Index, Millon Clinical Multiaxial Inventory-II, and maladjustment variables but not on the Symptom Checklist-90-Revised. The current results indicate that patients who present a lifelong history of abuse exhibit both a more severe addiction than patients who were not abused and several comorbidities. The implications of these results for further research and clinical practice are discussed.

  10. 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

    Directory of Open Access Journals (Sweden)

    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

  11. Treatment of food anaphylaxis with traditional Chinese herbal remedies: from mouse model to human clinical trials.

    Science.gov (United States)

    Wang, Julie

    2013-08-01

    To describe the development of a novel treatment for food allergy, named the food allergy herbal formula-2 (FAHF-2), that is based on traditional Chinese medicine. FAHF-2 has proven to be well tolerated and effective for the treatment of food allergies in murine models of peanut and multiple food allergies. These results are accompanied by evidence of favorable immune modulation, and the effects are persistent after the discontinuation of treatment. Early clinical trials demonstrate the safety and tolerability of this formula in individuals with food allergies. An ongoing Phase II clinical trial will evaluate the efficacy of FAHF-2 in protecting individuals from allergen-induced allergic reactions during oral food challenges. FAHF-2 is an herbal formula that has a high safety profile and has shown to prevent anaphylaxis in murine models of food allergy. Similar findings in clinical trials could bring a novel treatment for food allergies.

  12. Randomized Controlled Trial of Video Self-Modeling Following Speech Restructuring Treatment for Stuttering

    Science.gov (United States)

    Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

    2010-01-01

    Purpose: In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. Method: The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech…

  13. Randomized Controlled Non-Inferiority Trial of a Telehealth Treatment for Chronic Stuttering: The Camperdown Program

    Science.gov (United States)

    Carey, Brenda; O'Brian, Sue; Onslow, Mark; Block, Susan; Jones, Mark; Packman, Ann

    2010-01-01

    Background: Although there are treatments that can alleviate stuttering in adults for clinically significant periods, in Australia there are barriers to the accessibility and availability of best-practice treatment. Aims: This parallel group, non-inferiority randomized controlled trial with multiple blinded outcome assessments investigated whether…

  14. Syllable-Timed Speech Treatment for School-Age Children Who Stutter: A Phase I Trial

    Science.gov (United States)

    Andrews, Cheryl; O'Brian, Sue; Harrison, Elisabeth; Onslow, Mark; Packman, Ann; Menzies, Ross

    2012-01-01

    Purpose: This clinical trial determined the outcomes of a simple syllable-timed speech (STS) treatment for school-age children who stutter. Method: Participants were 10 children, ages 6-11 years, who stutter. Treatment involved training the children and their parents to use STS at near normal speech rates. The technique was practiced in the clinic…

  15. Dresden PTSD treatment study: randomized controlled trial of motor vehicle accident survivors

    Directory of Open Access Journals (Sweden)

    Menning Hans

    2006-07-01

    Full Text Available Abstract Background We translated, modified, and extended a cognitive behavioral treatment (CBT protocol by Blanchard and Hickling (2003 for the purpose of treating survivors of MVA with full or subsyndromal posttraumatic stress disorder (PTSD whose native language is German. The treatment manual included some additional elements, e. g. cognitive procedures, imaginal reliving, and facilitating of posttraumatic growth. The current study was conducted in order to test the efficacy of the modified manual by administering randomized controlled trial in which a CBT was compared to a wait-list control condition. Methods Forty-two motor vehicle accident survivors with chronic or severe subsyndromal posttraumatic stress disorder (PTSD completed the treatment trial with two or three detailed assessments (pre, post, and 3-month follow-up. Results CAPS-scores showed significantly greater improvement in the CBT condition as compared to the wait list condition (group × time interaction effect size d = 1.61. Intent-to-treat analysis supported the outcome (d = 1.34. Categorical diagnostic data indicated clinical recovery of 67% (post-treatment and 76% (3 months FU in the treatment group. Additionally, patients of the CBT condition showed significantly greater reductions in co-morbid major depression than the control condition. At follow-up the improvements were stable in the active treatment condition. Conclusion The degree of improvement in our treatment group was comparable to that in previously reported treatment trials of PTSD with cognitive behavioral therapy. Trial registration ISRCTN66456536

  16. Prophylactic treatment of migraine in children. Part 1. A systematic review of non-pharmacological trials

    NARCIS (Netherlands)

    Damen, L; Bruijn, J; Koes, BW; Berger, MY; Passchier, J; Verhagen, AP

    2006-01-01

    The aim of this study was to assess the efficacy of non-pharmacological prophylactic treatments of migraine in children. Databases were searched from inception to June 2004 and references were checked. We selected controlled trials reporting the effects of non-pharmacological prophylactic treatments

  17. Prophylactic treatment of migraine in children. Part 2. A systematic review of pharmacological trials

    NARCIS (Netherlands)

    Damen, L; Bruijn, J; Verhagen, AP; Berger, MY; Passchier, J; Koes, BW

    2006-01-01

    The aim of this study was to assess the efficacy of pharmacological prophylactic treatments of migraine in children. Databases were searched from inception to June 2004 and references were checked. We selected controlled trials on the effects of pharmacological prophylactic treatments in children wi

  18. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears : a randomized controlled trial

    NARCIS (Netherlands)

    Lambers Heerspink, Okke; van Raay, Jos J. A. M.; Koorevaar, Rinco C. T.; van Eerden, Pepijn J. M.; Westerbeek, Robin E.; van 't Riet, Esther; van den Akker-Scheek, Inge; Diercks, Ronald L.

    2015-01-01

    Background: Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears. The primary aim of this randomized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff tea

  19. Estimating the Causal Effect of Randomization versus Treatment Preference in a Doubly Randomized Preference Trial

    Science.gov (United States)

    Marcus, Sue M.; Stuart, Elizabeth A.; Wang, Pei; Shadish, William R.; Steiner, Peter M.

    2012-01-01

    Although randomized studies have high internal validity, generalizability of the estimated causal effect from randomized clinical trials to real-world clinical or educational practice may be limited. We consider the implication of randomized assignment to treatment, as compared with choice of preferred treatment as it occurs in real-world…

  20. Low-profile stent system for treatment of atherosclerotic renal artery stenosis: The GREAT trial

    NARCIS (Netherlands)

    Sapoval, M.; Zahringer, M.; Pattynama, P.; Rabbia, C.; Vignali, C.; Maleux, G.; Boyer, L.; Szczerbo-Trojanowska, M.; Jaschke, W.; Hafsahl, G.; Downes, M.; Beregi, J.P.; Veeger, N.; Talen, A.

    2005-01-01

    PURPOSE: The Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent in Renal Artery Treatment (GREAT) Trial was designed to assess the safety and performance of a low-profile stent for the treatment of obstructive renal artery disease by looking at 6-month renal artery patency uniformly

  1. Low-profile stent system for treatment of atherosclerotic renal artery stenosis : The GREAT trial

    NARCIS (Netherlands)

    Sapoval, M; Zahringer, M; Pattynama, P; Rabbia, C; Vignali, C; Maleux, G; Boyer, L; Szczerbo-Trojanowska, M; Jaschke, W; Hafsahl, G; Downes, M; Beregi, JP; Veeger, N; Talen, A

    2005-01-01

    PURPOSE: The Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent in Renal Artery Treatment (GREAT) Trial was designed to assess the safety and performance of a low-profile stent for the treatment of obstructive renal artery disease by looking at 6-month renal artery patency uniformly

  2. HIV Rapid Testing in Substance Abuse Treatment: Implementation Following a Clinical Trial

    Science.gov (United States)

    Haynes, L. F.; Korte, J. E.; Holmes, B. E.; Gooden, L.; Matheson, T.; Feaster, D. J.; Leff, J. A.; Wilson, L.; Metsch, L. R.; Schackman, B. R.

    2011-01-01

    The Substance Abuse Mental Health Services Administration has promoted HIV testing and counseling as an evidence-based practice. Nevertheless, adoption of HIV testing in substance abuse treatment programs has been slow. This article describes the experience of a substance abuse treatment agency where, following participation in a clinical trial,…

  3. Stuttering Treatment Research 1970-2005: II. Systematic Review Incorporating Trial Quality Assessment of Pharmacological Approaches

    Science.gov (United States)

    Bothe, Anne K.; Davidow, Jason H.; Bramlett, Robin E.; Franic, Duska M.; Ingham, Roger J.

    2006-01-01

    Purpose: To complete a systematic review, incorporating trial quality assessment, of published research about pharmacological treatments for stuttering. Goals included the identification of treatment recommendations and research needs based on the available high-quality evidence. Method: Multiple readers reviewed 31 articles published between 1970…

  4. Auricular Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial

    Science.gov (United States)

    2014-10-01

    TITLE: Auricular Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A...Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial fdfdf 5b. GRANT NUMBER W81XWH-10-2-0163 5c. PROGRAM...approval and initiated enrollment. 15. SUBJET TERMS Auricular Therapy; Musculoskeletal Pain 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF

  5. Prophylactic treatment of migraine in children. Part 1. A systematic review of non-pharmacological trials

    NARCIS (Netherlands)

    Damen, L; Bruijn, J; Koes, BW; Berger, MY; Passchier, J; Verhagen, AP

    The aim of this study was to assess the efficacy of non-pharmacological prophylactic treatments of migraine in children. Databases were searched from inception to June 2004 and references were checked. We selected controlled trials reporting the effects of non-pharmacological prophylactic treatments

  6. Prophylactic treatment of migraine in children. Part 2. A systematic review of pharmacological trials

    NARCIS (Netherlands)

    Damen, L; Bruijn, J; Verhagen, AP; Berger, MY; Passchier, J; Koes, BW

    The aim of this study was to assess the efficacy of pharmacological prophylactic treatments of migraine in children. Databases were searched from inception to June 2004 and references were checked. We selected controlled trials on the effects of pharmacological prophylactic treatments in children

  7. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears : a randomized controlled trial

    NARCIS (Netherlands)

    Lambers Heerspink, Okke; van Raay, Jos J. A. M.; Koorevaar, Rinco C. T.; van Eerden, Pepijn J. M.; Westerbeek, Robin E.; van 't Riet, Esther; van den Akker-Scheek, Inge; Diercks, Ronald L.

    Background: Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears. The primary aim of this randomized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff

  8. A randomized controlled trial of Minnesota day clinic treatment of alcoholics

    DEFF Research Database (Denmark)

    Grønbaek, Morten; Nielsen, Bent

    2007-01-01

    AIM: To compare the Minnesota day clinic treatment with the traditional public psychosocial treatment. DESIGN: Randomized controlled trial. SETTING: Public out-patient alcohol clinic and privately funded Minnesota day clinic in Denmark. PARTICIPANTS: A total of 148 individuals with alcohol...

  9. Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial

    NARCIS (Netherlands)

    Koeneman, M. M.; Kruse, A. J.; Kooreman, L. F S; zur Hausen, A.; Hopman, A. H N; Sep, S. J S; Van Gorp, T.; Slangen, B. F M; van Beekhuizen, H. J.; van de Sande, A. J M; Gerestein, C. G.; Nijman, H. W.; Kruitwagen, R. F P M

    2017-01-01

    The "TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia" (TOPIC) trial was stopped preliminary, due to lagging inclusions. This study aimed to evaluate the treatment efficacy and clinical applicability of imiquimod 5% cream in high-grade cervical intraepithelial neoplasia (

  10. The Association Between Medical Treatment of Physical Diseases and Psychological Distress After the Great East Japan Earthquake: The Shichigahama Health Promotion Project.

    Science.gov (United States)

    Nakaya, Naoki; Nakamura, Tomohiro; Tsuchiya, Naho; Tsuji, Ichiro; Hozawa, Atsushi; Tomita, Hiroaki

    2015-08-01

    Physical disease patients are known to experience high levels of psychological distress. This study examined the association between the medical treatment of physical diseases and psychological distress in the coastal area affected by the Great East Japan Earthquake. Using cross-sectional data, we studied 3032 individuals aged ≥40 years who lived in Shichigahama, Miyagi, Japan. We examined the associations between 8 medical treatments for physical diseases and psychological distress, defined as Kessler Psychological Distress scale score ≥13 of 24 points. To investigate the associations, we performed multiple logistic regression analyses. There were statistically significant associations between psychological distress and medical treatments for myocardial infarction/angina pectoris (odds ratio [OR]=1.8, 95% confidence interval [CI]=1.0-3.0) and liver disease (OR=3.1, 95% CI=1.0-7.7). The other 4 medical treatments for physical diseases had ORs of 1.3 or higher and were positively associated with psychological distress: cancer, hyperlipidemia, kidney disease, and diabetes mellitus. The degree of damage to homes did not affect the association between most of the medical treatments for physical diseases and psychological distress. In the disaster area, most of the medical treatments for physical diseases had positive associations with psychological distress, irrespective of the degree of damage to homes.

  11. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  12. Family Treatment of Childhood Anxiety: A Controlled Trial.

    Science.gov (United States)

    Barrett, Paula M.; And Others

    1996-01-01

    Evaluates a family-based treatment for childhood anxiety. Children (N=79) with separation anxiety, overanxious disorder or social phobia were randomly allocated to three treatment conditions: cognitive-behavioral therapy (CBT), CBT and family management, or a waiting list. Indicated 69.8% of the children no longer fulfilled diagnostic criteria for…

  13. Raloxifene trial in postmenopausal woman with treatment-resistant schizophrenia.

    Science.gov (United States)

    Tharoor, Hema; Goyal, Aparna

    2015-10-01

    Raloxifene augmentation in postmenopausal women with schizophrenia has shown promising results. Younger patients diagnosed as treatment-resistant schizophrenia and treated with raloxifene (120 mg/day) have reported significant improvement in symptoms. This case highlights how raloxifene, a selective estrogen receptor modulator (SERM), can play a major role in alleviating positive and negative symptoms in postmenopausal women with treatment-resistant schizophrenia.

  14. Sexual assault and posttraumatic stress disorder: a review of the biological, psychological and sociological factors and treatments.

    Science.gov (United States)

    Chivers-Wilson, Kaitlin A

    2006-07-01

    Sexual assault occurs with alarming frequency in Canada. The prevalence of Posttraumatic Stress Disorder (PTSD) in assault survivors is drastically higher than the national prevalence of the disorder, which is a strong indication that the current therapies for sexual-assault-related PTSD are in need of improvement. Increasing knowledge and understanding of the pathologies associated with rape trauma in biological, psychological and sociological domains will help to develop more effective treatments for survivors. A dysregulation of the Hypothalamic-Pituitary-Adrenal (HPA) axis is observed in survivors of sexual assault and this may be a fundamental cause of the structural and functional abnormalities contributing to PTSD symptoms. Pharmacotherapies are available to treat PTSD; however, they are often inadequate or unwanted by the survivor. Psychological health is compromised following interpersonal trauma and many psychological therapies are available, but with varying efficacy. A person's cognitions have a dramatic effect on the onset, severity, and progress of PTSD following sexual assault. Sociological impacts of assault influence the development of PTSD through victim-blaming attitudes and the perpetuation of rape myths. Perceived positive regard and early social support is shown to be important to successful recovery. Education is vital in rape prevention and to foster a supportive environment for survivors. The biological, psychological and sociological impacts and treatments should not remain mutually exclusive. A better appreciation of the biopsychosocial repercussions of sexual assault will aid in developing a more holistic and individualized therapy to help alleviate the physical and emotional pain following the trauma of rape.

  15. Surgery versus prolonged conservative treatment for sciatica: 5-year results of a randomised controlled trial

    OpenAIRE

    Lequin, Michiel B.; Verbaan, Dagmar; Jacobs, Wilco C. H.; Brand, Ronald; Gerrit J. Bouma; Vandertop, William P.; Peul, Wilco C; ,

    2013-01-01

    Objective This study describes the 5 years’ results of the Sciatica trial focused on pain, disability, (un)satisfactory recovery and predictors for unsatisfactory recovery. Design A randomised controlled trial. Setting Nine Dutch hospitals. Participants Five years’ follow-up data from 231 of 283 patients (82%) were collected. Intervention Early surgery or an intended 6 months of conservative treatment. Main outcome measures Scores from Roland disability questionnaire, visual analogue scale (V...

  16. The FIB-PPH trial: fibrinogen concentrate as initial treatment for postpartum haemorrhage: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Wikkelsoe Anne

    2012-07-01

    Full Text Available Abstract Background Postpartum haemorrhage (PPH remains a leading cause of maternal mortality worldwide. In Denmark 2% of parturients receive blood transfusion. During the course of bleeding fibrinogen (coagulation factor I may be depleted and fall to critically low levels, impairing haemostasis and thus worsening the ongoing bleeding. A plasma level of fibrinogen below 2 g/L in the early phase of postpartum haemorrhage is associated with subsequent development of severe haemorrhage. Use of fibrinogen concentrate allows high-dose substitution without the need for blood type crossmatch. So far no publications of randomised controlled trials involving acutely bleeding patients in the obstetrical setting have been published. This trial aims to investigate if early treatment with fibrinogen concentrate reduces the need for blood transfusion in women suffering severe PPH. Methods/Design In this randomised placebo-controlled double-blind multicentre trial, parturients with primary PPH are eligible following vaginal delivery in case of: manual removal of placenta (blood loss ≥ 500 ml or manual exploration of the uterus after the birth of placenta (blood loss ≥ 1000 ml. Caesarean sections are also eligible in case of perioperative blood loss ≥ 1000 ml. The exclusion criteria are known inherited haemostatic deficiencies, prepartum treatment with antithrombotics, pre-pregnancy weight Primary outcome is the need for blood transfusion. To investigate a 33% reduction in the need for blood transfusion, a total of 245 patients will be included. Four university-affiliated public tertiary care hospitals will include patients during a two-year period. Adverse events including thrombosis are assessed in accordance with International Conference on Harmonisation (ICH good clinical practice (GCP. Discussion A widespread belief in the benefits of early fibrinogen substitution in cases of PPH has led to increased off-label use. The FIB

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

    Science.gov (United States)

    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.

  18. Design and analysis of non-pharmacological treatment trials with multiple therapists per patient.

    Science.gov (United States)

    Roberts, Chris; Walwyn, Rebecca

    2013-01-15

    In trials of physical and talking therapies, nesting of patients within therapists has statistical implications analogous to those of cluster randomised trials. Nevertheless, the clustering effect may be more complex, as it interacts with treatment. For some therapies, individual patients may receive care from multiple therapists of the same type, so that patients are no longer strictly nested within therapists, creating a 'multiple-membership' relationship between patients and therapists. This paper considers methods of analysis and sample size estimation for trials with multiple-membership clustering effects. It is motivated by a trial of a psychotherapy for the treatment of adolescent depression with cognitive behavioural therapy. We tested methods and issues in a Monte Carlo simulation study, simulating trials with multiple membership. Results demonstrate satisfactory performance in terms of convergence and give estimates of the intra-cluster correlation coefficient and empirical test size similar to a simple hierarchical design. We derive formulae for sample size and power for multiple-membership trial designs. We then compare estimates of power from this formula with empirical power derived from the simulation study. Finally, we show that we can easily extend formulae for sample size and power to allow consideration of power and sample size for certain types of more complex interventions. These include situations where therapists of different types deliver separate components of the intervention, creating a cross-classified relationship, or where several therapists deliver a group-administered treatment, creating further levels. Copyright © 2012 John Wiley & Sons, Ltd.

  19. Parent and medical professional willingness to enroll children in a hypothetical pediatric optic neuritis treatment trial

    Directory of Open Access Journals (Sweden)

    Amy eWaldman

    2011-11-01

    Full Text Available The Optic Neuritis Treatment Trial and subsequent studies have had a tremendous impact on the treatment and prognosis of optic neuritis and multiple sclerosis in adults. The results of these studies have been extrapolated to children; however, pediatric data are sparse. Using the method of prospective preference assessment, the willingness of parents and medical professionals to enroll children in a hypothetical Pediatric Optic Neuritis Treatment Trial was assessed using a mock consent form and questionnaire. A 3-arm trial was proposed: 1 intravenous corticosteroids, 2 high-dose oral corticosteroids, and 3 an oral placebo. The forms were completed by 198 parents and 49 physicians. After reviewing the hypothetical scenario, trial design, risks and benefits, and alternatives to the study, 21% of parents would enroll their children in the trial whereas 98% of medical professionals would enroll their patients. With medical professional recommendation, 43% of parents would enroll their children. The manner in which this hypothetical trial was presented to parents, specifically with respect to the recommendation of their child’s health care team, influenced a parent’s willingness to participate.

  20. 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

  1. The Effects of Mind Subtraction Meditation on Breast Cancer Survivors' Psychological and Spiritual Well-being and Sleep Quality: A Randomized Controlled Trial in South Korea.

    Science.gov (United States)

    Yun, Mi Ra; Song, Misoon; Jung, Kyung-Hae; Yu, Boas J; Lee, Kyung Jae

    Most breast cancer survivors experience psychological and spiritual distress, including depression, anxiety, perceived stress, and loss of meaningfulness in life. This distress can negatively impact physical health, quality of life, and quality of sleep. The aim of this study was to compare and examine the effectiveness of mind subtraction meditation (MSM) and a self-management education (SME) group on breast cancer survivors. A randomized controlled trial was conducted with South Korean female breast cancer survivors (stages I-III). Self-reported questionnaires were administered to both MSM group (n = 22) and SME group (n = 24) to measure psychological and spiritual well-being, as well as quality of sleep. Compared with the SME group, the MSM group reported a significant decrease in depression (P = .034), anxiety (P = .036), and perceived stress (P = .009) and an increase in quality of life (P meditation may have positive therapeutic effects among breast cancer survivors. This meditation program may be useful to manage psychological and spiritual distress, as well as improve quality of life and sleep, in clinical settings among breast cancer survivors. This study demonstrated the clinical effectiveness and the feasibility of applying the MSM method to breast cancer survivors. The participants had a high attendance rate in the program, which speaks to the likelihood of the applicability of the meditation program on an outpatient basis.

  2. Brief Intervention in Type 1 diabetes – Education for Self-efficacy (BITES: Protocol for a randomised control trial to assess biophysical and psychological effectiveness

    Directory of Open Access Journals (Sweden)

    Dromgoole Paul

    2007-09-01

    Full Text Available Abstract Background Self management is the cornerstone of effective preventive care in diabetes. Educational interventions that provide self-management skills for people with diabetes have been shown to reduce blood glucose concentrations. This in turn has the potential to reduce rates of complications. However, evidence to support type, quantity, setting and mode of delivery of self-management education is sparse. Objectives: To study the biophysical and psychological effectiveness of a brief psycho-educational intervention for type 1 diabetes in adults. Methods/Design Design: Randomised controlled clinical trial. Setting: Multidisciplinary specialist diabetes centre. Hypothesis: Our hypothesis was that the brief (2.5-day intervention would be biophysically and psychologically effective for people with type 1 diabetes. Intervention: A brief psycho-educational intervention for type 1 diabetes developed by a multi-professional team comprising of a consultant diabetologist, a diabetes specialist nurse, a specialist diabetes dietician and a clinical health psychologist and delivered in 20 hours over 2.5 days. Primary outcomes: HbA1c and severe hypoglycaemia. Secondary outcomes: Blood pressure, weight, height, lipid profile and composite psychometric scales. Participants: We shall consent and recruit 120 subjects with postal invitations sent to eligible participants. Volunteers are to be seen at randomisation clinics where independent researcher verify eligibility and obtain consent. We shall randomise 60 to BITES and 60 to standard care. Eligibility Criteria: Type 1 diabetes for longer than 12 months, multiple injection therapy for at least two months, minimum age of 18 and ability to read and write. Randomisation: An independent evaluator to block randomise (block-size = 6, to intervention or control groups using sealed envelopes in strict ascendant order. Control group will receive standard care. Assessment: Participants in both groups would

  3. Innovations in the Treatment of Bulimia: Transpersonal Psychology, Relaxation, Imagination, Hypnosis, Myth, and Ritual.

    Science.gov (United States)

    Brown, Michael H.

    1991-01-01

    Written for counselors who must help clients deal with bulimia, this article reviews bulimia's most obvious physical signs and symptoms, etiology, and behavioral characteristics. Considers innovative counseling approaches including Transpersonal Psychology, relaxation training, imagination, fantasy, hypnosis, myths, and rituals. (Author)

  4. Innovations in the Treatment of Bulimia: Transpersonal Psychology, Relaxation, Imagination, Hypnosis, Myth, and Ritual.

    Science.gov (United States)

    Brown, Michael H.

    1991-01-01

    Written for counselors who must help clients deal with bulimia, this article reviews bulimia's most obvious physical signs and symptoms, etiology, and behavioral characteristics. Considers innovative counseling approaches including Transpersonal Psychology, relaxation training, imagination, fantasy, hypnosis, myths, and rituals. (Author)

  5. Role of technology in supporting quality control and treatment fidelity in a family caregiver clinical trial.

    Science.gov (United States)

    Farran, Carol J; Etkin, Caryn D; McCann, Judith J; Paun, Olimpia; Eisenstein, Amy R; Wilbur, Joellen

    2011-11-01

    This article describes how a family caregiver lifestyle physical activity clinical trial uses research technology to enhance quality control and treatment fidelity. This trial uses a range of Internet, Blaise(®) Windows-based software and Echo Server technologies to support quality control issues, such as data collection, data entry, and study management advocated by the clinical trials literature, and to ensure treatment fidelity concerning intervention implementation (i.e., design, training, delivery, receipt, and enactment) as proposed by the National Institutes of Health Behavior Change Consortium. All research staff are trained to use these technologies. Strengths of this technological approach to support quality control and treatment fidelity include the comprehensive plan, involvement of all staff, and ability to maintain accurate and timely data. Limitations include the upfront time and costs for developing and testing these technological methods, and having support staff readily available to address technological issues if they occur.

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

    Directory of Open Access Journals (Sweden)

    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.

  7. Niemann-Pick disease treatment: a systematic review of clinical trials

    Science.gov (United States)

    Villamandos García, Diana; Sanchis-Gomar, Fabian; Fiuza-Luces, Carmen; Pareja-Galeano, Helios; Garatachea, Nuria; Nogales Gadea, Gisela; Lucia, Alejandro

    2015-01-01

    The aim of this systematic review was to analyse all the published clinical trials assessing treatments for Niemann-Pick (NP) disease. At present there are only trials investigating the treatment of NP disease type C. Furthermore, there is no uniformity among studies in treatment outcomes or in data analysis and presentation of results. Miglustat is able to delay neurodegeneration, with greater benefits in patients with a late onset of the disease and β-cyclodextrin-hydroxypropyl (HBP-CD) can attenuate clinical symptoms. As for cholesterol-lowering drugs, the combination of lovastatin, cholestyramine and nicotinic acid is the most effective one for lowering cholesterolemia. Further research is much needed, and ongoing trials using enzyme replacement therapy might hopefully show promising results in the foreseeable future. PMID:26807415

  8. Managing Injuries of the Neck Trial (MINT: design of a randomised controlled trial of treatments for whiplash associated disorders

    Directory of Open Access Journals (Sweden)

    Williamson Esther M

    2007-01-01

    Full Text Available Abstract Background A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED, followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. Methods Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI, and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. Conclusion This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised.

  9. The Treatment of Adolescent Suicide Attempters Study (TASA): Predictors of Suicidal Events in an Open Treatment Trial

    Science.gov (United States)

    Brent, David A.; Greenhill, Laurence L.; Compton, Scott; Emslie, Graham; Wells, Karen; Walkup, John T.; Vitiello, Benedetto; Bukstein, Oscar; Stanley, Barbara; Posner, Kelly; Kennard, Betsy D.; Cwik, Mary F.; Wagner, Ann; Coffey, Barbara; March, John S.; Riddle, Mark; Goldstein, Tina; Curry, John; Barnett, Shannon; Capasso, Lisa; Zelazny, Jamie; Hughes, Jennifer; Shen, Sa; Gugga, S. Sonia; Turner, J. Blake

    2009-01-01

    Objective: To identify the predictors of suicidal events and attempts in adolescent suicide attempters with depression treated in an open treatment trial. Method: Adolescents who had made a recent suicide attempt and had unipolar depression (n =124) were either randomized (n = 22) or given a choice (n = 102) among three conditions. Two…

  10. Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial

    OpenAIRE

    Mann, Eleanor; Smith, Melanie J; Hellier, Jennifer; Balabanovic, Janet A; Hamed, Hisham; Grunfeld, Elizabeth A; Hunter, Myra S.

    2012-01-01

    Summary Background Hot flushes and night sweats (HFNS) affect 65–85% of women after breast cancer treatment; they are distressing, causing sleep problems and decreased quality of life. Hormone replacement therapy is often either undesirable or contraindicated. Safe, effective non-hormonal treatments are needed. We investigated whether cognitive behavioural therapy (CBT) can help breast cancer survivors to effectively manage HFNS. Methods In this randomised controlled trial, we recruited women...

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

    Directory of Open Access Journals (Sweden)

    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.

  12. 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.

  13. The use of functional neuroimaging to evaluate psychological and other non-pharmacological treatments for clinical pain

    OpenAIRE

    Jensen, Karin B.; Berna, Chantal; Loggia, Marco L.; Wasan, Ajay; Edwards, Robert R; Randy L Gollub

    2012-01-01

    A large number of studies have provided evidence for the efficacy of psychological and other non-pharmacological interventions in the treatment of chronic pain. While these methods are increasingly used to treat pain, remarkably few studies focused on the exploration of their neural correlates. The aim of this article was to review the findings from neuroimaging studies that evaluated the neural response to distraction-based techniques, cognitive behavioral therapy (CBT), clinical hypnosis, m...

  14. Feasibility randomised controlled trial of a self-help acceptance and commitment therapy intervention for grief and psychological distress in carers of palliative care patients.

    Science.gov (United States)

    Davis, Esther L; Deane, Frank P; Lyons, Geoffrey Cb; Barclay, Gregory D; Bourne, Joan; Connolly, Vivienne

    2017-06-01

    We tested the feasibility and preliminary effectiveness of an acceptance and commitment therapy self-help intervention for grief and psychological distress in carers of patients in palliative care. Carers were randomised to the control group, which received treatment as usual, or the intervention group, which received treatment as usual plus an acceptance and commitment therapy-based self-help booklet and telephone support call. Questionnaires were completed at baseline, 1-month post-allocation and 6 months post-loss. Results indicated that the intervention was generally feasible and viewed as acceptable to carers. Preliminary effectiveness analyses showed at least a small effect in acceptance, valued-living, grief and psychological distress.

  15. Eye Movement Desensitization and Reprocessing (EMDR Versus Treatment as Usual for Non-Specific Chronic Back Pain Patients with Psychological Trauma: A Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Andreas Gerhardt

    2016-12-01

    Full Text Available Objective: Eye-Movement-Desensitization and Reprocessing (EMDR – an evidence-based approach to eliminate emotional distress from traumatic experiences – was recently suggested for the treatment of chronic pain. Aim of this study was to estimate preliminary efficacy of a pain-focused EMDR intervention for the treatment of non-specific chronic back pain.Design: Randomized controlled pilot study.Methods: Forty non-specific chronic back pain patients reporting previous experiences of psychological trauma were consecutively recruited from outpatient tertiary-care pain centers. After baseline assessment, patients were randomized to intervention or control group (1:1. The intervention group received ten sessions standardized pain-focused EMDR in addition to treatment-as-usual. The control group received treatment-as-usual alone.The primary outcome was preliminary efficacy, measured by pain intensity, disability, and treatment satisfaction from the patients' perspective. Clinical relevance of changes was determined according to established recommendations. Assessments were conducted at the baseline, post-treatment, and at a 6-month follow-up. Intention-to-treat-analysis with last-observation-carried-forward method was used. Registered with ClinicalTrials.gov (NCT01850875.Results: Estimated effect sizes (between-group, pooled standard deviation for pain intensity and disability were d=0.79 (CI95%: 0.13, 1.42 and d=0.39 (CI95%: -0.24, 1.01 post-treatment, and d=0.50 (CI95%: 0.14, 1.12 and d=0.14 (CI95%: -0.48, 0.76 at 6-month follow-up. Evaluation on individual patient basis showed that about 50% of the patients in the intervention group improved clinically relevant and also rated their situation as clinically satisfactory improved, compared to zero patients in the control group.Conclusions: There is preliminary evidence that pain-focused EMDR might be useful for non-specific chronic back pain patients with previous experiences of psychological trauma

  16. 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

    gap leaves important questions unanswered. For example, when a first antipsychotic failed, is switching to another drug effective? And when should we use clozapine? The aim of this article is to review the efficacy of switching antipsychotics in case of nonresponse. We also present the European...... 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...

  17. Treatment of superficial thrombophlebitis. A comparative trial between placebo, Hirudoid cream and piroxicam gel.

    Science.gov (United States)

    Bergqvist, D; Brunkwall, J; Jensen, N; Persson, N H

    1990-01-01

    A prospective randomized trial on the treatment of superficial thrombophlebitis has been performed in 68 patients randomized to either Hirudoid cream, piroxicam gel or placebo. Both spontaneous and infusion thrombophlebitis were included. Treatment effect was evaluated using the status of thrombophlebitis, the thrombophlebitic area, pain intensity with a visual analogue scale, and side effects were registered. Both in the treatment groups and the placebo group there was a significant decrease of signs and symptoms during the treatment period. There was no statistical difference between the treatment groups and no difference between spontaneous and infusion thrombophlebitis.

  18. Improving treatment of depression in the elderly: two innovations in statistical design of clinical trials.

    Science.gov (United States)

    Lavori, Philip W

    2005-08-01

    Depression in the elderly patient may present special challenges for the design of clinical treatment trials due to a complex antidepressant treatment history, individual contraindications to certain medications, medical comorbidity, as well as concurrent medications for other medical conditions. The chronic, relapsing, and remitting nature of depression calls for a dynamic, adaptive treatment strategy, matching treatment changes to patient responses. To market a drug successfully in a cost-conscious environment, it also may be necessary to define the unique contribution that a new drug makes to the treatment of patients, in addition to proving that it is efficacious (by comparison to placebo). These issues, although not unique to the elderly, take on greater importance and weight as patient populations age. This article describes 2 innovations in clinical trials design that may help deal with these issues.

  19. A compound herbal preparation (CHP) in the treatment of children with ADHD: a randomized controlled trial.

    Science.gov (United States)

    Katz, M; Levine, A Adar; Kol-Degani, H; Kav-Venaki, L

    2010-11-01

    Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. A randomized, double-blind, placebo-controlled trial. University-affiliated tertiary medical center. 120 children newly diagnosed with ADHD, meeting DSM-IV criteria. Random assignment to the herbal treatment group (n = 80) or control group (placebo; n = 40); 73 patients in the treatment group (91%) and 19 in the control group (48%) completed the 4-month trial. Test of Variables of Attention (TOVA) administered before and after the treatment period; overall score and 4 subscales. The treatment group showed substantial, statistically significant improvement in the 4 subscales and overall TOVA scores, compared with no improvement in the control group, which persisted in an intention-to-treat analysis. The well-tolerated CHP demonstrated improved attention, cognition, and impulse control in the intervention group, indicating promise for ADHD treatment in children.

  20. Design and analysis of clinical trials in the presence of delayed treatment effect.

    Science.gov (United States)

    Sit, Tony; Liu, Mengling; Shnaidman, Michael; Ying, Zhiliang

    2016-05-20

    In clinical trials with survival endpoint, it is common to observe an overlap between two Kaplan-Meier curves of treatment and control groups during the early stage of the trials, indicating a potential delayed treatment effect. Formulas have been derived for the asymptotic power of the log-rank test in the presence of delayed treatment effect and its accompanying sample size calculation. In this paper, we first reformulate the alternative hypothesis with the delayed treatment effect in a rescaled time domain, which can yield a simplified sample size formula for the log-rank test in this context. We further propose an intersection-union test to examine the efficacy of treatment with delayed effect and show it to be more powerful than the log-rank test. Simulation studies are conducted to demonstrate the proposed methods. Copyright © 2016 John Wiley & Sons, Ltd.

  1. 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

    of pump users (95% confidence interval -0.53 to 0.05, P=0.10). Most psychosocial measures showed no difference, but pump users showed greater improvement in treatment satisfaction and some quality of life domains (dietary freedom and daily hassle) at 12 and 24 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.

  2. Cognitive Defusion for Psychological Distress, Dysphoria, and Low Self-Esteem: A Randomized Technique Evaluation Trial of Vocalizing Strategies

    Science.gov (United States)

    Hinton, Marchion J.; Gaynor, Scott T.

    2010-01-01

    Cognitive defusion procedures, as used in acceptance and commitment therapy (ACT), attempt to alter how an individual relates to negative thoughts (without challenging, disputing, or trying to change their content) so as to promote psychological flexibility, the key feature of the ACT model of adaptive functioning. The current study examined the…

  3. Mindfulness Training Improves Problem-Focused Coping in Psychology and Medical Students: Results from a Randomized Controlled Trial

    Science.gov (United States)

    Halland, E.; De Vibe, M.; Solhaug, I.; Friborg, O.; Rosenvinge, J. H.; Tyssen, R.; Sørlie, T.; Bjørndal, A.

    2015-01-01

    Background: Students of clinical psychology and medicine experience high levels of mental distress and low levels of life satisfaction. Using adaptive coping strategies can modify the negative effect of stressors on health. Mindfulness, it has been claimed, more adaptive coping with stress, yet few studies have investigated whether mindfulness…

  4. Mindfulness Training Improves Problem-Focused Coping in Psychology and Medical Students: Results from a Randomized Controlled Trial

    Science.gov (United States)

    Halland, E.; De Vibe, M.; Solhaug, I.; Friborg, O.; Rosenvinge, J. H.; Tyssen, R.; Sørlie, T.; Bjørndal, A.

    2015-01-01

    Background: Students of clinical psychology and medicine experience high levels of mental distress and low levels of life satisfaction. Using adaptive coping strategies can modify the negative effect of stressors on health. Mindfulness, it has been claimed, more adaptive coping with stress, yet few studies have investigated whether mindfulness…

  5. The use of functional neuroimaging to evaluate psychological and other non-pharmacological treatments for clinical pain.

    Science.gov (United States)

    Jensen, Karin B; Berna, Chantal; Loggia, Marco L; Wasan, Ajay D; Edwards, Robert R; Gollub, Randy L

    2012-06-29

    A large number of studies have provided evidence for the efficacy of psychological and other non-pharmacological interventions in the treatment of chronic pain. While these methods are increasingly used to treat pain, remarkably few studies focused on the exploration of their neural correlates. The aim of this article was to review the findings from neuroimaging studies that evaluated the neural response to distraction-based techniques, cognitive behavioral therapy (CBT), clinical hypnosis, mental imagery, physical therapy/exercise, biofeedback, and mirror therapy. To date, the results from studies that used neuroimaging to evaluate these methods have not been conclusive and the experimental methods have been suboptimal for assessing clinical pain. Still, several different psychological and non-pharmacological treatment modalities were associated with increased pain-related activations of executive cognitive brain regions, such as the ventral- and dorsolateral prefrontal cortex. There was also evidence for decreased pain-related activations in afferent pain regions and limbic structures. If future studies will address the technical and methodological challenges of today's experiments, neuroimaging might have the potential of segregating the neural mechanisms of different treatment interventions and elucidate predictive and mediating factors for successful treatment outcomes. Evaluations of treatment-related brain changes (functional and structural) might also allow for sub-grouping of patients and help to develop individualized treatments.

  6. The use of functional neuroimaging to evaluate psychological and other non-pharmacological treatments for clinical pain

    Science.gov (United States)

    Jensen, Karin B.; Berna, Chantal; Loggia, Marco L.; Wasan, Ajay; Edwards, Robert R.; Gollub, Randy L.

    2013-01-01

    A large number of studies have provided evidence for the efficacy of psychological and other non-pharmacological interventions in the treatment of chronic pain. While these methods are increasingly used to treat pain, remarkably few studies focused on the exploration of their neural correlates. The aim of this article was to review the findings from neuroimaging studies that evaluated the neural response to distraction-based techniques, cognitive behavioral therapy (CBT), clinical hypnosis, mental imagery, physical therapy/exercise, biofeedback, and mirror therapy. To date, the results from studies that used neuroimaging to evaluate these methods have not been conclusive and the experimental methods have been suboptimal for assessing clinical pain. Still, several different psychological and non-pharmacological treatment modalities were associated with increased painrelated activations of executive cognitive brain regions, such as the ventral- and dorsolateral prefrontal cortex. There was also evidence for decreased pain-related activations in afferent pain regions and limbic structures. If future studies will address the technical and methodological challenges of today’s experiments, neuroimaging might have the potential of segregating the neural mechanisms of different treatment interventions and elucidate predictive and mediating factors for successful treatment outcomes. Evaluations of treatment-related brain changes (functional and structural) might also allow for sub-grouping of patients and help to develop individualized treatments. PMID:22445888

  7. Systematic review and meta-analysis of transdiagnostic psychological treatments for anxiety and depressive disorders in adulthood.

    Science.gov (United States)

    Newby, Jill M; McKinnon, Anna; Kuyken, Willem; Gilbody, Simon; Dalgleish, Tim

    2015-08-01

    A broad array of transdiagnostic psychological treatments for depressive and anxiety disorders have been evaluated, but existing reviews of this literature are restricted to face-to-face cognitive behavioural therapy (CBT) protocols. The current meta-analysis focused on studies evaluating clinician-guided internet/computerised or face-to-face manualised transdiagnostic treatments, to examine their effects on anxiety, depression and quality of life (QOL). Results from 50 studies showed that transdiagnostic treatments are efficacious, with large overall mean uncontrolled effects (pre- to post-treatment) for anxiety and depression (gs=.85 and .91 respectively), and medium for QOL (g=.69). Uncontrolled effect sizes were stable at follow-up. Results from 24 RCTs that met inclusion criteria showed that transdiagnostic treatments outperformed control conditions on all outcome measures (controlled ESs: gs=.65, .80, and .46 for anxiety, depression and QOL respectively), with the smallest differences found compared to treatment-as-usual (TAU) control conditions. RCT quality was generally poor, and heterogeneity was high. Examination of the high heterogeneity revealed that CBT protocols were more effective than mindfulness/acceptance protocols for anxiety (uncontrolled ESs: gs=.88 and .61 respectively), but not depression. Treatment delivery format influenced outcomes for anxiety (uncontrolled ESs: group: g=.70, individual: g=.97, computer/internet: g=.96) and depression (uncontrolled ESs: group: g=.89, individual: g=.86, computer/internet: g=.96). Preliminary evidence from 4 comparisons with disorder-specific treatments suggests that transdiagnostic treatments are as effective for reducing anxiety, and may be superior for reducing depression. These findings show that transdiagnostic psychological treatments are efficacious, but higher quality research studies are needed to explore the sources of heterogeneity amongst treatment effects.

  8. [Treatment with montelukast in children with asthma. Test trial].

    Science.gov (United States)

    Pérez, O

    2000-01-01

    To study of antileukotrienes with participation in the genesis of the asthma appeared in the last years. 17 children with a mean age of 10.29 years, male seven and ten girls. They were tried with montelukast 5 mg/day the 12-year-old smellers and with 10 mg/day the such age greats, during a period middle to 5.7 months. Ten of they had a concomitant treatment fluticasona, budesonide, salmeterol or formoterol. Was valued the clinic improvement, the saving in medication and the sound effects. a) Clinic improvement in 82.3%; b) elimination of medication associated in 90% and c) sound effects: in a case drowsiness and in other abdominal pain. Montelukast seems be a very useful product in the treatment of the bronchial asthma in children since generates a saving of corticoids and longtime beta 2 in the mild or moderate asthma, associate or not with the inmunoterapia.

  9. [Clinical trials of solcoseryl in the treatment of parodontium diseases].

    Science.gov (United States)

    Jedrzejewska, T; Bałczewska, E; Peterson, R; Urbaniak, B; Ostrowska, B

    1990-06-01

    The effect of Solcoseryl on the clinical state of the parodontium was assessed in 26 patients aged from 18 to 57 years with the diagnosis of deep parodontopathies. Each patient received 30 ampoules of 2 ml of Solcoseryl for one course of the treatment. Submucous injections of the drug near the teeth 13, 23, 33 and 43 were done as follows: during the first 10 days one ampoule daily, then 10 injections every other day, and 10 injections at three-day intervals. The condition of the parodontium was assessed before and after the treatment by means of the PI, GI, GBI and teeth mobility indices, and measurements of the depth of gingival pouches--K, and volume of fluid in pouches SFFR according to Brill. The therapeutic method applied in these cases had a good effect on reduction of gingivitis, bleeding and volume of secreted pouch fluid but had only a small effect on teeth mobility and depth of gingival pouches.

  10. Treatment of occult bacteremia: a prospective randomized clinical trial.

    Science.gov (United States)

    Carroll, W L; Farrell, M K; Singer, J I; Jackson, M A; Lobel, J S; Lewis, E D

    1983-11-01

    Antibiotic therapy for children without foci of infection and at risk for bacteremia is controversial. A prospective randomized clinical trial was conducted using expectant antibiotic therapy in children at risk for bacteremia. A total of 96 children (aged 6 to 24 months) with temperature of more than 40 degrees C, no identifiable source of infection, and a leukocyte count greater than or equal to 15,000/microL and/or sedimentation rate greater than or equal to 30 were enrolled. The following tests were performed on all children: blood culture, chest roentgenogram, urinalysis, and urine culture. A lumbar puncture was performed if a child was 12 months or less. Patients were randomized to receive either no antibiotic therapy or Bicillin C-R, 50,000 U/kg intramuscularly, followed by penicillin V, 100 mg/kg/d, orally four times a day for three days. Patients were examined at 24 and 72 hours. Fifty patients were treated expectantly and 46 received no antimicrobial therapy. Ten of the 96 patients were bacteremic (nine had Streptococcus pneumoniae, one had Haemophilus influenzae). Four of the five children treated for bacteremia showed improvement at the first follow-up visit (afebrile and no obvious focus of infection). The five untreated patients showed no improvement; four patients developed focal infections (two had meningitis, two had otitis media) (P less than or equal to .05, Fisher exact test). No complications of expectant therapy were detected. Thus, expectant antibiotic therapy for children who have no obvious source of infection and who meet these criteria associated with occult bacteremia is warranted.

  11. International dosimetry: an evaluation of treatment planning in clinical trials.