A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients

• Status: Not yet recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Greifswald
• Collaborators: Charite University, Berlin, Germany; German Research Foundation; Hannover Medical School; Ludwig-Maximilians - University of Munich; Philipps University Marburg Medical Center; University Hospital Lübeck; University Hospital Tuebingen; University Medicine Greifswald; University of Kassel
• Treatments: Antidepressive Agents

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