NCT04996433Recruiting
A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) vs. Behavioral Activation (BA) in Persistently Depressed Treatment-resistant Inpatients: Efficacy, Moderators, and Mediators of Change
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
The purpose of this study is to compare the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) conducted over 16 weeks (acute and continuation treatment) with Behavioral Activation (BA; same dose and duration) in persistently depressed treatment-resistant inpatients regarding efficacy, moderators and mediators of change.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 396 (estimated)
- First submitted
- 27 Jun 2021
- Start date
- 1 Dec 2021
- Primary completion date
- Aug 2026
- Lead sponsor
- University of Greifswald
- Diseases
- Depression
- NCT number
- NCT04996433
What you commit to
- Study type: Interventional
- Planned participants: 396
- From 1 Dec 2021 to the primary completion date, Aug 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous CBASP or BA treatment within the last year
Other illness
- Bipolar I or II disorder
- Active substance use disorders (abstinence shorter than 6 months)
- Schizophrenia spectrum and other psychotic disorders
- Antisocial personality disorder
- Inability to tolerate CBASP or BA (e.g., organic brain disorders, severe cognitive deficits)
Other
- Acute suicidality (HRSD item 3 \> 2 or agreement with C-SSRS item 4 and/or item 5)
- Inability to participate in dayclinic or outpatient continuation treatment
- Participation in another (psycho)therapeutic study of an interventional nature
Who the study is looking for
- 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 by the 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité - University Medicine Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitätsklinikum Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Terminated |
| Universitätsklinikum Jena Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Universität zu Lübeck Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
| Universitätsklinikum Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
| Klinikum der Universität München Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Universitätsklinikum Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.