Childhood Maltreatment in Women with Borderline Personality Disorder, Chronic Depression, and Episodic Depression, and in Healthy Controls.
Eva-Lotta Brakemeier, Jana Dobias, Julia Hertel...
https://pubmed.ncbi.nlm.nih.gov/29306947Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID04996433
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) vs. Behavioral Activation (BA) in Persistently Depressed Treatment-resistant Inpatients: Efficacy, Moderators, and Mediators of Change
Led by University of Greifswald · Updated on 2026-05-26
396
Participants Needed
8
Research Sites
87 weeks
Total Duration
On this page
Sponsors
U
University of Greifswald
Lead Sponsor
G
German Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two psychotherapy programs, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and Behavioral Activation (BA), in adults with persistent depressive disorder (PDD) who have not responded well to previous treatments. This study focuses on hospitalized patients with treatment-resistant depression and aims to evaluate which therapy is more effective in reducing depressive symptoms over 16 weeks. The study also explores factors that affect treatment response and the long-term effects of these therapies. Participants will receive either CBASP or BA treatment during a 10-week acute phase consisting of inpatient or dayclinic therapy followed by a 6-week outpatient continuation phase with group therapy. Both therapies include individual and group sessions, nurse contacts, and exercise therapy during inpatient treatment. All patients will also receive optimized antidepressant medication according to standard guidelines, with adjustments if needed based on response. During the study, participants will undergo regular assessments using various depression rating scales, symptom inventories, and quality of life questionnaires from baseline through 64 weeks after treatment start. Researchers will monitor responses, remission, relapse rates, and cost-effectiveness of the treatments. The total study duration includes acute treatment, continuation therapy, and long-term follow-up to evaluate sustained outcomes and health economic impacts.
CONDITIONS
Brief Title
A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Primary DSM-5 diagnosis of persistent depressive disorder
- Hamilton Depression Rating Scale (HDRS-24) score of 20 or higher
- Treatment-resistant depression defined by specific medication or psychotherapy history
- Sufficient knowledge of the German language
- Written informed consent provided
You will not qualify if you...
- Diagnosis of bipolar I or II disorder
- Active substance use disorder with less than 6 months abstinence
- Schizophrenia spectrum or other psychotic disorders
- Antisocial personality disorder
- Acute suicidality as defined by specific rating scales
- Previous CBASP or Behavioral Activation treatment within the last year
- Inability to tolerate CBASP or Behavioral Activation due to brain disorders or cognitive deficits
- Inability to participate in dayclinic or outpatient continuation treatments
- Participation in another interventional psychotherapeutic study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Inpatient Treatment
Duration - 10 weeks
Participants receive 10 weeks of inpatient or dayclinic treatment involving individual and group psychotherapy sessions, nurse contacts, exercise therapy, and standardized antidepressant medication.
Weekly therapy sessions and nurse contacts during inpatient/dayclinic stay
Outpatient Treatment
Duration - 6 weeks
Participants continue treatment with weekly outpatient group therapy sessions for 6 weeks following inpatient care.
Weekly outpatient group therapy visits
Follow-up
Duration - Up to 48 weeks after treatment ends
Participants are monitored to assess long-term treatment outcomes including symptom remission and relapse rates.
Periodic follow-up visits for assessments
Trial Site Locations
Total: 8 locations
1
Charité, University Medicine Berlin
Berlin, State of Berlin, Germany, 10117
Actively Recruiting
2
Universitätsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
3
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Terminated
4
Universitätsklinikum Jena
Jena, Germany, 07743
Actively Recruiting
5
Universität zu Lübeck
Lübeck, Germany, 23562
Actively Recruiting
6
Universitätsklinikum Marburg
Marburg, Germany, 35039
Actively Recruiting
7
Klinikum der Universität München
München, Germany, 80336
Actively Recruiting
8
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
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Research Team
E
Eva-Lotta Brakemeier, Prof. Dr.
J
Johannes Zimmermann, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Feasibility and outcome of cognitive behavioral analysis system of psychotherapy (CBASP) for chronically depressed inpatients: a pilot study.
Eva-Lotta Brakemeier, Vera Engel, Elisabeth Schramm...
https://pubmed.ncbi.nlm.nih.gov/21389759Overcoming treatment resistance in chronic depression: a pilot study on outcome and feasibility of the cognitive behavioral analysis system of psychotherapy as an inpatient treatment program.
Eva-Lotta Brakemeier, Martina Radtke, Vera Engel...
https://pubmed.ncbi.nlm.nih.gov/25547778Chronic and treatment resistant depression: diagnosis and stepwise therapy.
Tom Bschor, Michael Bauer, Mazda Adli
https://pubmed.ncbi.nlm.nih.gov/25467053Behavioral activation treatments of depression: a meta-analysis.
Pim Cuijpers, Annemieke van Straten, Lisanne Warmerdam
https://pubmed.ncbi.nlm.nih.gov/17184887Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression.
Sona Dimidjian, Steven D Hollon, Keith S Dobson...
https://pubmed.ncbi.nlm.nih.gov/16881773Value of genetic and epigenetic testing as biomarkers of response to antidepressant treatment.
Helge Frieling, André Tadić
https://pubmed.ncbi.nlm.nih.gov/24151802Cognitive Behavioral Analysis System of Psychotherapy for inpatients with persistent depressive disorder: a naturalistic trial on a general acute psychiatric unit.
Anne Guhn, Stephan Köhler, Eva-Lotta Brakemeier...
https://pubmed.ncbi.nlm.nih.gov/31300878[Psychiatric-psychotherapeutic inpatient treatment for depression. Process and outcome quality based on a model project in Baden-Wurttemberg].
M Härter, P Sitta, F Keller...
https://pubmed.ncbi.nlm.nih.gov/15197451[Risk factors for non-response in inpatient depression treatment].
Lars Hölzel, Alessa von Wolff, Levente Kriston...
https://pubmed.ncbi.nlm.nih.gov/19823968