Status:
RECRUITING
A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
Lead Sponsor:
University of Greifswald
Collaborating Sponsors:
German Research Foundation
University of Kassel
Conditions:
Persistent Depressive Disorder
Treatment-resistant Depression
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief 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; sam...
Detailed Description
About half of all psychiatric inpatients with depression suffer from persistent depressive disorder (PDD). Given their high degree of treatment-resistance (TR), comorbidity, suicidality, and hospitali...
Eligibility 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT04996433
Start Date
December 1 2021
End Date
May 1 2026
Last Update
October 12 2023
Active Locations (6)
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1
Charité, University Medicine Berlin
Berlin, Germany, 10117
2
Medizinische Hochschule Hannover
Hanover, Germany, 30625
3
Universität zu Lübeck
Lübeck, Germany, 23562
4
Universitätsklinikum Marburg
Marburg, Germany, 35039