RecruitingNot ApplicableNCT04996433

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

Sponsor

University of Greifswald

Enrollment

396 participants

Start Date

Dec 1, 2021

Study Type

INTERVENTIONAL

Conditions

Persistent Depressive Disorder

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.

Eligibility

Min Age: 20 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of psychotherapy — Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and Behavioral Activation (BA) — for patients admitted to an inpatient or day-clinic setting with chronic, treatment-resistant depression that has not responded to medication. **You may be eligible if...** - You have a primary diagnosis of persistent depressive disorder (PDD) or chronic/recurrent major depression - Your depression score (HDRS-24) is 20 or higher - Your depression is treatment-resistant (failed at least 3 medication trials, had medication intolerance, or tried psychotherapy for 25+ sessions without success) - You have sufficient German language skills - You have given written informed consent **You may NOT be eligible if...** - You have bipolar I or II disorder - You have an active substance use disorder (less than 6 months of sobriety) - You have schizophrenia or another psychotic disorder - You have antisocial personality disorder - You are acutely suicidal - You received CBASP or BA therapy within the past year - You have severe cognitive deficits or organic brain disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALinpatient 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).

BEHAVIORALinpatient 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).

BEHAVIORALinpatient 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).

BEHAVIORALinpatient 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).

BEHAVIORALoutpatient 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).

BEHAVIORALinpatient 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).

BEHAVIORALinpatient 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).

BEHAVIORALinpatient 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)

BEHAVIORALinpatient 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).

BEHAVIORALoutpatient 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).

DRUGalgorithm-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

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NCT04996433

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