Project Details
Projekt
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) vs. Behavioral Activation (BA) in persistently depressed treatment-resistant inpatients: Efficacy, moderators, and mediators of change
Applicant
Professorin Dr. Eva-Lotta Brakemeier
Subject Area
Personality Psychology, Clinical and Medical Psychology, Methodology
Clinical Psychiatry, Psychotherapy, Child and Adolescent Psychiatry
Clinical Psychiatry, Psychotherapy, Child and Adolescent Psychiatry
Term
since 2020
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 405994555
Up to 30% of individuals with depression develop persistent depressive disorder (PDD), an often disabling and difficult to treat condition. The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is the only psychotherapy developed specifically for treating individuals with PDD. While several randomized controlled trials (RCTs) have demonstrated its efficacy in outpatient settings, evidence for its use in inpatient settings remains limited. Pilot studies of CBASP inpatient programs in Germany have shown promising feasibility and effectiveness; however, no RCTs to date have systematically evaluated their outcomes. This study represents the first RCT to compare the short- and long-term efficacy and safety of CBASP with Behavioral Activation (BA), a first-line psychotherapy for depression, within an intensive multimodal inpatient setting. In this prospective, multi-center, rater-blinded RCT with an active control group, we aim to recruit 396 adults (aged 18–75 years) with treatment-resistant PDD at eight German university hospitals. Participants will be randomly assigned to receive either (1) CBASP or (2) BA within an intensive treatment program consisting of 10 weeks acute treatment in an inpatient and/or day clinic setting, followed by 6 weeks of outpatient continuation treatment. Primary and secondary outcome assessments will be conducted at multiple time points: baseline (T0), treatment onset (T1), after 5 and 10 weeks of acute treatment (T2, T3), at the end of continuation treatment (T4, week 16), and every two months up to week 64 (T5, naturalistic follow-up). The primary outcome measure will be the change in depression severity, as assessed by the Hamilton Depression Rating Scale (24-item version), after 16 weeks of treatment (from T0 to T4). Secondary outcomes will include response, remission, deterioration, and relapse rates, self-reported depression and anxiety symptoms, and additional psychological variables. A cost-benefit analysis will evaluate the health-economic benefits of both interventions. Additionally, this RCT will explore personalized treatment selection and mechanisms of change, including potential moderators and mediators of treatment effects. The findings from this trial are expected to provide clinicians with evidence-based guidance on choosing CBASP vs. BA for inpatients with treatment-resistant PDD.
DFG Programme
Clinical Trials
