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RECRUITING
NCT04996433
NA

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

Sponsor: University of Greifswald

View on ClinicalTrials.gov

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.

Official title: Cognitive Behavioral Analysis System of Psychotherapy (CBASP) vs. Behavioral Activation (BA) in Persistently Depressed Treatment-resistant Inpatients: Efficacy, Moderators, and Mediators of Change

Key Details

Gender

All

Age Range

20 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

396

Start Date

2021-12-01

Completion Date

2026-05

Last Updated

2023-10-12

Healthy Volunteers

No

Interventions

BEHAVIORAL

inpatient CBASP individual therapy

During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual CBASP therapy sessions (duration: 50 min per session).

BEHAVIORAL

inpatient CBASP group therapy

During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 CBASP group therapy sessions (duration: 100 min per session).

BEHAVIORAL

inpatient CBASP nurse contact

During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP nurse contact (duration: 30 min per session).

BEHAVIORAL

inpatient CBASP exercise therapy

During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP exercise therapy (duration: 75 min per session).

BEHAVIORAL

outpatient CBASP group therapy

During the 6-week outpatient treatment all patients in this arm will receive 1 CBASP group therapy session (duration: 100 min per session).

BEHAVIORAL

inpatient BA individual therapy

During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual BA therapy sessions (duration: 50 min per session).

BEHAVIORAL

inpatient BA group therapy

During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 BA group therapy sessions (duration: 100 min per session).

BEHAVIORAL

inpatient BA nurse contact

During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA nurse contact (duration: 30 min per session)

BEHAVIORAL

inpatient BA exercise therapy

During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA exercise therapy (duration: 75 min per session).

BEHAVIORAL

outpatient BA group therapy

During the 6-week outpatient treatment all patients in this arm will receive 1 BA group therapy session (duration: 100 min per session).

DRUG

algorithm-based study medication

All patients will receive an optimized, algorithm-based antidepressant medication following the current S3-Guidelines on Unipolar Depression. In case of nonresponse: * 1st line dose escalation (if appropriate) * 2nd line lithium augmentation * 3rd line augmentation with 2nd generation antipsychotics or evidence-based combinations of antidepressants * 4th line change of antidepressant.

Locations (6)

Charité, University Medicine Berlin

Berlin, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universität zu Lübeck

Lübeck, Germany

Universitätsklinikum Marburg

Marburg, Germany

Klinikum der Universität München

München, Germany

Universitätsklinikum Tübingen

Tübingen, Germany