Comparing two psychotherapy programs for persistently depressed inpatients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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

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 (HRSD item 3 \> 2 or agreement with C-SSRS item 4 and/or item 5)
* 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
* Participation in another (psycho)therapeutic study of an interventional nature

Where it's running

• Charité, University Medicine Berlin
  Berlin, State of Berlin, Germany Recruiting
• Universitätsklinikum Bonn
  Bonn, Germany Recruiting
• Universitätsklinikum Jena
  Jena, Germany Recruiting
• Universität zu Lübeck
  Lübeck, Germany Recruiting
• Universitätsklinikum Marburg
  Marburg, Germany Recruiting
• Klinikum der Universität München
  München, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.