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 ◽  
...  

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.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mairead Furlong ◽  
Sinead McGilloway ◽  
Christine Mulligan ◽  
Colm McGuinness ◽  
Nuala Whelan

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.


10.2196/14309 ◽  
2020 ◽  
Vol 9 (5) ◽  
pp. e14309
Author(s):  
Mojtaba Yekrang Safakar ◽  
Marianne Hrabok ◽  
Liana Urichuk ◽  
Michal Juhas ◽  
Reham Shalaby ◽  
...  

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


2019 ◽  
Author(s):  
Mojtaba Yekrang Safakar ◽  
Marianne Hrabok ◽  
Liana Urichuk ◽  
Michal Juhas ◽  
Reham Shalaby ◽  
...  

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


2018 ◽  
Vol 28 (2) ◽  
pp. 118-129 ◽  
Author(s):  
Caecilie Böck Buhmann ◽  
Jessica Carlsson ◽  
Erik Lykke Mortensen

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.


2012 ◽  
Vol 42 (4) ◽  
pp. 385-401 ◽  
Author(s):  
Karolina Stasiak ◽  
Simon Hatcher ◽  
Christopher Frampton ◽  
Sally N. Merry

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.


2018 ◽  
Vol 49 (3) ◽  
pp. 491-500 ◽  
Author(s):  
Philip Cheng ◽  
Annemarie I. Luik ◽  
Cynthia Fellman-Couture ◽  
Edward Peterson ◽  
Christine L.M. Joseph ◽  
...  

AbstractBackgroundInsomnia and depression are highly comorbid and mutually exacerbate clinical trajectories and outcomes. Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces both insomnia and depression severity, and can be delivered digitally. This could substantially increase the accessibility to CBT-I, which could reduce the health disparities related to insomnia; however, the efficacy of digital CBT-I (dCBT-I) across a range of demographic groups has not yet been adequately examined. This randomized placebo-controlled trial examined the efficacy ofdCBT-I in reducing both insomnia and depression across a wide range of demographic groups.MethodsOf 1358 individuals with insomnia randomized, a final sample of 358 were retained in thedCBT-I condition and 300 in the online sleep education condition. Severity of insomnia and depression was examined as a dependent variable. Race, socioeconomic status (SES; household income and education), gender, and age were also tested as independent moderators of treatment effects.ResultsThedCBT-I condition yielded greater reductions in both insomnia and depression severity than sleep education, with significantly higher rates of remission following treatment. Demographic variables (i.e. income, race, sex, age, education) were not significant moderators of the treatment effects, suggesting thatdCBT-I is comparably efficacious across a wide range of demographic groups. Furthermore, while differences in attrition were found based on SES, attrition did not differ between white and black participants.ConclusionsResults provide evidence that the wide dissemination ofdCBT-I may effectively target both insomnia and comorbid depression across a wide spectrum of the population.


2008 ◽  
Vol 10 (2) ◽  
pp. 239-250 ◽  

Recent research has indicated that psychosocial interventions can have a valuable role in reducing the substantial psychosocial disability associated with bipolar disorder. Randomized controlled trials of these interventions indicate that improvements are seen in symptoms, psychosocial functioning, and treatment adherence. These interventions, systematically presented in the form of standardized treatment manuals, vary in format, duration, and theoretical basis. All are meant to augment pharmacotherapy, which represents the standard of treatment in the field. Modalities that have gathered the most empirical support include cognitive-behavioral therapy, family-focused therapy, interpersonal and social rhythms therapy, and psychoeducation. The enhancement of adherence to pharmacotherapy is a common therapeutic target, due to the association of nonadherence with higher relapse rates, hospitalization, and health care costs among people with bipolar disorder. Given the complexity of nonadherence behavior, multicomponent interventions are often required. In this review, we provide an overview of the rationale, evidence base, and major psychotherapeutic approaches in bipolar disorder, focusing on the assessment and enhancement of medication adherence.


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