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

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.

Conditions

• Persistent Depressive Disorder
• Treatment-resistant Depression

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.

Sponsors & Collaborators

• German Research Foundation

  collaborator OTHER

• University of Kassel

  collaborator OTHER

• University Medicine Greifswald

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• Hannover Medical School

  collaborator OTHER

• University Hospital Lübeck

  collaborator OTHER

• Philipps University Marburg

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• University of Greifswald

  lead OTHER

Principal Investigators

• Eva-Lotta Brakemeier, Prof. Dr. · University Greifswald

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2024-07-31

Completion

2026-05-31

Countries

• Germany

Study Locations