scholarly journals Mechanisms of change and heterogeneous treatment effects in psychodynamic and cognitive behavioural therapy for patients with depressive disorder: a randomized controlled trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
J. I. Røssberg ◽  
J. Evensen ◽  
T. Dammen ◽  
T. Wilberg ◽  
O. Klungsøyr ◽  
...  
Keyword(s):  
Depressive Disorder ◽  
Psychosocial Functioning ◽  
Treatment Effects ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Evidence Base ◽  
Behavioural Therapy ◽  
Symptom Improvement ◽  
Differential Outcomes ◽  
Weekly Session

Abstract Background Major depressive disorder (MDD) is a prevalent psychiatric condition associated with significant disability, mortality and economic burden. Cognitive behavioral therapy (CBT) and psychodynamic psychotherapy (PDT) are found to be equally effective for patients with depression. However, many patients do not respond sufficiently to either treatment. To offer individualized treatment, we need to know if some patients benefit more from one of the two therapies. At present little is known about what patient characteristics (moderators) may be associated with differential outcomes of CBT and PDT, and through what therapeutic processes and mechanisms (mediators) improvements occur in each therapy mode. Presently only theoretical assumptions, sparsely supported by research findings, describe what potentially moderates and mediates the treatment effects of CBT and PDT. The overall aim of this study is to examine theoretically derived putative moderators and mediators in CBT and PDT and strengthen the evidence base about for whom and how these treatments works in a representative sample of patients with MDD. Methods One hundred patients with a diagnosis of MDD will be randomized to either CBT or PDT. Patients will be treated over 28 weeks with either CBT (one weekly session over 16 weeks and three monthly booster sessions) or PDT (one weekly session over 28 weeks). The patients will be evaluated at baseline, during the course of therapy, at the end of therapy, and at follow-up investigations 1 and 3 years post treatment. A large range of patient and observer rated questionnaires (specific preselected putative moderators and mediators) are included. Discussion The clinical outcome of this study may better guide clinicians when deciding what kind of treatment any individual patient should be offered. Moreover, the study aims to further our knowledge of what mechanisms lead to symptom improvement and increased psychosocial functioning. Trial registration ClinicalTrials.gov Identifier: NCT03022071.

scholarly journals Family Talk versus usual services in improving child and family psychosocial functioning in families with parental mental illness (PRIMERA—Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children): study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mairead Furlong ◽  
Sinead McGilloway ◽  
Christine Mulligan ◽  
Colm McGuinness ◽  
Nuala Whelan
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Randomised Controlled Trial ◽  
Psychosocial Functioning ◽  
Controlled Trial ◽  
Evidence Base ◽  
Parental Mental Illness ◽  
Research And Innovation ◽  
Mental Health Settings ◽  
Randomised Controlled

Abstract Background Parental mental illness is common and can lead to dependent children incurring a high risk of developing mental disorders, physical illness, and impaired educational and occupational outcomes. Family Talk is one of the better known interventions designed to prevent the intergenerational transmission of mental illness. However, its evidence base is small, with few robust independent randomised controlled trials, and no associated process or cost evaluations. The PRIMERA (Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children) research programme involves a mixed method evaluation of Family Talk which is being delivered in mental health settings in Ireland to improve child and family psychosocial functioning in families with parental mental illness. Methods The study comprises a multi-centre, randomised controlled trial (RCT), with nested economic and process evaluations, to assess the clinical and cost-effectiveness and implementation mechanisms of Family Talk compared to usual services. The study is being conducted in 15 adult and child mental health settings in Ireland. Families with a parent with mental illness, and children aged 5–18 years (n = 144 families) will be randomised to either the 7-session Family Talk programme (n = 96) or to standard care (n = 48) using a 2:1 allocation ratio. The primary outcomes are child psychosocial functioning and family functioning. Secondary outcomes are as follows: understanding and experience of parental mental illness, parental mental health, child and parental resilience, partner wellbeing and service utilisation. Blind assessments will take place at pre-intervention and at 6- and 12-month follow-up. Discussion Given the prevalence and burden of intergenerational mental illness, it is imperative that prevention through evidence-based interventions becomes a public health priority. The current study will provide an important contribution to the international evidence base for Family Talk whilst also helping to identify key implementation lessons in the scaling up of Family Talk, and other similar interventions, within routine mental health settings. Trial registration ISRCTN Registry, ISRCTN13365858. Registered 5th February 2019.

scholarly journals Effectiveness of Group Cognitive Behavioral Therapy and Exercise in the Management of Major Depressive Disorder: Protocol for a Pilot Randomized Controlled Trial

10.2196/14309 ◽  
2020 ◽  
Vol 9 (5) ◽  
pp. e14309
Author(s):  
Mojtaba Yekrang Safakar ◽  
Marianne Hrabok ◽  
Liana Urichuk ◽  
Michal Juhas ◽  
Reham Shalaby ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Major Depressive ◽  
Randomized Controlled ◽  
To Receive ◽  
Group Cbt

Background Despite evidence in scientific literature indicating the effectiveness of both cognitive behavioral therapy (CBT) and physical exercise in the management of major depressive disorder (MDD), few studies have directly compared them. Objective This study aims to evaluate and compare the effectiveness of group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU) in the management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or exercise arms of the study will achieve superior outcomes compared with participants wait-listed to receive TAU only. Methods This prospective rater-blinded randomized controlled trial assesses the benefits of group CBT and exercise for participants with MDD. A total of 120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada, will be randomly assigned to one of the three equal-sized arms of the study to receive either weekly sessions of group CBT plus TAU, group exercise three times a week plus TAU, or only TAU for 14 weeks. Participants will be assessed at enrollment, 3 and 6 months post enrollment, midtreatment, and upon treatment completion for primary (functional and symptom variables) and secondary outcomes (service variables and health care utilization). In addition, participants in the intervention groups would be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point. Results The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines). Written informed consent will be obtained from each subject. The study received ethical clearance from the Health Ethics Research Board of the University of Alberta on September 7, 2018 (Pro 00080975) and operational approval from the provincial health authority (Alberta Health Services 43638). As of October 13, 2019, we have enrolled 32 participants. The results will be disseminated at several levels, including patients, practitioners, academics, researchers, and health care organizations. Conclusions The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care. Trial Registration ClinicalTrials.gov NCT03731728; https://clinicaltrials.gov/ct2/show/NCT03731728 International Registered Report Identifier (IRRID) PRR1-10.2196/14309

scholarly journals Effectiveness of Group Cognitive Behavioral Therapy and Exercise in the Management of Major Depressive Disorder: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Mojtaba Yekrang Safakar ◽  
Marianne Hrabok ◽  
Liana Urichuk ◽  
Michal Juhas ◽  
Reham Shalaby ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Major Depressive ◽  
Randomized Controlled ◽  
To Receive ◽  
Group Cbt

BACKGROUND Despite evidence in scientific literature indicating the effectiveness of both cognitive behavioral therapy (CBT) and physical exercise in the management of major depressive disorder (MDD), few studies have directly compared them. OBJECTIVE This study aims to evaluate and compare the effectiveness of group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU) in the management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or exercise arms of the study will achieve superior outcomes compared with participants wait-listed to receive TAU only. METHODS This prospective rater-blinded randomized controlled trial assesses the benefits of group CBT and exercise for participants with MDD. A total of 120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada, will be randomly assigned to one of the three equal-sized arms of the study to receive either weekly sessions of group CBT plus TAU, group exercise three times a week plus TAU, or only TAU for 14 weeks. Participants will be assessed at enrollment, 3 and 6 months post enrollment, midtreatment, and upon treatment completion for primary (functional and symptom variables) and secondary outcomes (service variables and health care utilization). In addition, participants in the intervention groups would be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point. RESULTS The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines). Written informed consent will be obtained from each subject. The study received ethical clearance from the Health Ethics Research Board of the University of Alberta on September 7, 2018 (Pro 00080975) and operational approval from the provincial health authority (Alberta Health Services 43638). As of October 13, 2019, we have enrolled 32 participants. The results will be disseminated at several levels, including patients, practitioners, academics, researchers, and health care organizations. CONCLUSIONS The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care. CLINICALTRIAL ClinicalTrials.gov NCT03731728; https://clinicaltrials.gov/ct2/show/NCT03731728 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/14309

scholarly journals Satisfaction of trauma-affected refugees treated with antidepressants and Cognitive Behavioural Therapy

2018 ◽  
Vol 28 (2) ◽  
pp. 118-129 ◽  
Author(s):  
Caecilie Böck Buhmann ◽  
Jessica Carlsson ◽  
Erik Lykke Mortensen
Keyword(s):  
Patient Satisfaction ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Trauma Exposure ◽  
Behavioural Therapy ◽  
Dropping Out ◽  
Patient Satisfaction Score ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Western Psychotherapy

Purpose: This study seeks to evaluate the satisfaction of trauma-affected refugees after treatment with antidepressants, psycho-education and flexible Cognitive Behavioral Therapy (CBT) including trauma exposure. Material and methods: A treatment satisfaction questionnaire was completed by patients at the end of a randomised controlled trial (RCT) comparing treatment with CBT and antidepressants. A patient satisfaction score was developed based on the questionnaire, and predictors of satisfaction were analysed in regression models. Telephone interviews were conducted with patients dropping out of treatment before the end of the trial. Results: In total, 193 trauma-affected refugees with PTSD were included in the study. Patients were overall satisfied with flexible CBT including exposure treatment in cases where this was part of the treatment. There was no statistically significant association between treatment outcome and satisfaction and satisfaction and treatment efficacy were independent of each other. The results showed that bi-cultural patients who had lived in Denmark for more than a decade were satisfied with the treatment based on a western psychotherapy model. Discussion: Treatment with selective serotonin reuptake inhibitor and flexible CBT, including trauma exposure, is acceptable for trauma-affected refugees. More studies are needed to evaluate patient satisfaction with western psychotherapy models in refugee patients who have recently arrived and to compare satisfaction with alternative treatment models.

A Pilot Double Blind Randomized Placebo Controlled Trial of a Prototype Computer-Based Cognitive Behavioural Therapy Program for Adolescents with Symptoms of Depression

2012 ◽  
Vol 42 (4) ◽  
pp. 385-401 ◽  
Author(s):  
Karolina Stasiak ◽  
Simon Hatcher ◽  
Christopher Frampton ◽  
Sally N. Merry
Keyword(s):  
Cognitive Behavioural Therapy ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Secondary Outcome ◽  
Symptom Improvement ◽  
Double Blind ◽  
School Counsellors ◽  
Cognitive Behavioural

Background:Depressive disorder is common in adolescents and largely untreated. Computers offer a way of increasing access to care. Computerized therapy is effective for depressed adults but to date little has been done for depressed adolescents.Aims:The objective of this study was to examine the feasibility, acceptability, and effects of The Journey, a computerized cognitive behavioural therapy (cCBT) program for depressed adolescents.Method:Thirty-four adolescents (mean age 15.2 years,SD= 1.5) referred by school counsellors were randomly assigned to either cCBT or a computer-administered attention placebo program with psychoeducational content (CPE). Participants completed the intervention at school. Data were collected at baseline, post-intervention and at a 1-month follow-up. The primary outcome measure was the Child Depression Rating Scale Revised (CDRS-R); secondary outcome measures were: RADS-2; Pediatric Quality of Life Inventory; Adolescent Coping Scale (short form); response and remission rates on CDRS-R. Completion rates and self-reported satisfaction ratings were used to assess feasibility and acceptabililty of the intervention.Results:Ninety-four percent of cCBT and 82% of CPE participants completed the intervention. Eighty-nine percent liked The Journey a lot or thought it was “okay” and 89% of them would recommend it for use with others as is or after some improvement. Adolescents treated with cCBT showed greater symptom improvement on CDRS-R than those treated with CPE program (mean change on cCBT = 17.6, CI = 14.13–21.00; CPE = 6.06, CI = 2.01–10.02;p< .001).Conclusions:It is feasible, acceptable and efficacious to deliver computerized CBT to depressed adolescents in a school setting. Generalizability is limited by the size of the study.

scholarly journals Family Talk Versus Usual Services In Improving Child And Family Psychosocial Functioning In Families With Parental Mental Illness (PRIMERA - Promoting Research And Innovation In Mental Health Services For Families And Children): Study Protocol For A Randomised Controlled Trial

2021 ◽  
Author(s):  
Mairead Furlong ◽  
Sinead McGilloway ◽  
Christine Mulligan ◽  
Colm McGuinness ◽  
Nuala Whelan
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Randomised Controlled Trial ◽  
Psychosocial Functioning ◽  
Controlled Trial ◽  
Evidence Base ◽  
Service Utilisation ◽  
Parental Mental Illness ◽  
Mental Health Settings ◽  
Randomised Controlled

Abstract Background: Parental mental illness is common and can lead to dependent children incurring a high risk of developing mental disorders, physical illness, and impaired educational and occupational outcomes. Family Talk is one of the better known interventions designed to prevent the intergenerational transmission of mental illness. However, its evidence base is small, with few robust independent randomised controlled trials, and no associated process or cost evaluations. The PRIMERA (Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children) research programme involves a mixed methods evaluation of Family Talk which is being delivered in mental health settings in Ireland to improve child and family psychosocial functioning in families with parental mental illness.Methods: The study comprises a multi-centre, randomised controlled trial (RCT), with nested economic and process evaluations, to assess the clinical and cost effectiveness and implementation mechanisms of Family Talk compared to usual services. The study is being conducted in 15 adult and child mental health settings in Ireland. Families with a parent with mental illness, and children aged 5-18 years (n = 144 families) will be randomised to either the 7-session Family Talk programme (n = 96) or to standard care (n = 48) using a 2:1 allocation ratio. The primary outcomes are child psychosocial functioning and family functioning. Secondary outcomes are: understanding and experience of parental mental illness, parental mental health, child and parental resilience, partner wellbeing and service utilisation. Blind assessments will take place at pre-intervention, and at 6-, 12-month follow up.Discussion: Given the prevalence and burden of intergenerational mental illness, it is imperative that prevention through evidence-based interventions becomes a public health priority. The current study will provide an important contribution to the international evidence base for Family Talk whilst also helping to identify key implementation lessons in the scaling up of Family Talk, and other similar interventions, within routine mental health settings.Trial registration: ISRCTN Registry, ISRCTN13365858. Registered 5th February 2019. http://www.isrctn.com/ISRCTN13365858

scholarly journals New Developments in Virtual Reality-Assisted Treatment of Aggression in Forensic Settings: The Case of VRAPT

2022 ◽  
Vol 2 ◽  
Author(s):  
Fernando Renee González Moraga ◽  
Stéphanie Klein Tuente ◽  
Sean Perrin ◽  
Pia Enebrink ◽  
Kristina Sygel ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Psychological Treatment ◽  
Behavioral Therapy ◽  
Ecological Validity ◽  
Controlled Trial ◽  
Scientific Evidence ◽  
Real Life ◽  
Evidence Base ◽  
Theoretical Background ◽  
Lessons Learned

Aggression is a known problem in individuals being cared for in forensic settings, yet the evidence base for its treatment is scarce. Virtual Reality (VR) has been proposed as a promising addition to interventions in forensic settings, as it may increase the motivation among participants, bridge the gap between real life, therapeutic and laboratory experiences, and increase the ecological validity of psychological research. Recently, a new treatment for aggression using VR as the treatment environment, Virtual Reality Aggression Prevention Training (VRAPT), was developed to provide realistic and safe environments for participants to practice aggression management. In its current revised version, VRAPT is conceptualized as a form of cognitive behavioral therapy with its theoretical background in the General Aggression Model. Its purpose is to increase awareness of, and improve control over, one’s own aggression and that of others through social interactions in individually tailored virtual environments. This manuscript describes how the lessons learned from the first randomized controlled trial of VRAPT have been applied to further develop the method and discusses challenges and future directions for VR-assisted treatment of aggression in forensic settings. VRAPT is a new psychological treatment for aggression and the coming years will provide expanded scientific evidence for further developments and adaptations.

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