Comparing two psychotherapy programs for persistently depressed inpatients
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) vs. Behavioral Activation (BA) in Persistently Depressed Treatment-resistant Inpatients: Efficacy, Moderators, and Mediators of Change
NA · University of Greifswald · NCT04996433
This study is testing which of two therapy programs, one designed for long-term depression and the other a simpler approach, works better for people who are hospitalized and struggling with severe depression.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 396 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | University of Greifswald (other) |
| Locations | 6 sites (Berlin and 5 other locations) |
| Trial ID | NCT04996433 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two psychotherapy programs, Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and Behavioral Activation (BA), in treating persistently depressed treatment-resistant inpatients over a 16-week period. The study will involve a randomized controlled trial with 396 participants, assessing the efficacy of CBASP, which is specifically designed for persistent depressive disorder (PDD), against BA, a simpler variant of cognitive behavioral therapy. Both therapies will be delivered in an inpatient setting followed by outpatient continuation treatment, alongside standardized pharmacotherapy. The study seeks to identify moderators and mediators of change in treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with persistent depressive disorder who have a history of treatment resistance.
Not a fit: Patients with bipolar disorder, active substance use disorders, or those who have previously undergone CBASP or BA treatment within the last year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from persistent depressive disorder who have not responded to previous therapies.
How similar studies have performed: Previous pilot studies have shown promising outcomes for the CBASP approach, indicating potential success for this comparative study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary DSM-5 diagnosis of PDD (300.4, 296.2x, 296.3x) * Total Hamilton Depression Rating Scale (HDRS-24) Score ≥ 20 * Treatment-resistance (TR) (defined as a level of 3 or higher on the Antidepressant Treatment History Form: Short Form (ATHF-SF) or medication intolerance or one psychotherapy at least 25 sessions by a certified therapist in the current episode) * Sufficient knowledge of the German language * Written informed consent Exclusion Criteria: * Bipolar I or II disorder * Active substance use disorders (abstinence shorter than 6 months) * Schizophrenia spectrum and other psychotic disorders * Antisocial personality disorder * Acute suicidality * Previous CBASP or BA treatment within the last year * Inability to tolerate CBASP or BA (e.g., organic brain disorders, severe cognitive deficits) * Inability to participate in dayclinic or outpatient continuation treatment
Where this trial is running
Berlin and 5 other locations
- Charité, University Medicine Berlin — Berlin, Germany (RECRUITING)
- Medizinische Hochschule Hannover — Hanover, Germany (NOT_YET_RECRUITING)
- Universität zu Lübeck — Lübeck, Germany (RECRUITING)
- Universitätsklinikum Marburg — Marburg, Germany (RECRUITING)
- Klinikum der Universität München — München, Germany (RECRUITING)
- Universitätsklinikum Tübingen — Tübingen, Germany (RECRUITING)
Study contacts
- Principal investigator: Eva-Lotta Brakemeier, Prof. Dr. — University Greifswald
- Study coordinator: Eva-Lotta Brakemeier, Prof. Dr.
- Email: eva-lotta.brakemeier@uni-greifswald.de
- Phone: +49 3834 420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Persistent Depressive Disorder, Treatment-resistant Depression, Psychotherapy, Depression, Inpatient Treatment, Childhood Maltreatment, Epigenetic, Moderator