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A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
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.
ClinicalTrials.gov IDNCT04996433
PhaseNA
Enrollment396
SponsorUniversity of Greifswald
Age18 Years
SexALL
Conditions studied
Persistent Depressive Disorder, Treatment-resistant Depression
About this study
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.
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: 25 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: 25 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.
Primary outcomes
- Hamilton Depression Rating Scale (HDRS-24), 24-item version (16 weeks)
Eligibility information
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 by the 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 (HRSD item 3 \> 2 or agreement with C-SSRS item 4 and/or item 5)
* 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
* Participation in another (psycho)therapeutic study of an interventional nature
Study locations
- Charité, University Medicine Berlin, Berlin, State of Berlin 10117 Germany
- Universitätsklinikum Bonn, Bonn, 53127 Germany
- Medizinische Hochschule Hannover, Hanover, 30625 Germany
- Universitätsklinikum Jena, Jena, 07743 Germany
- Universität zu Lübeck, Lübeck, 23562 Germany
- Universitätsklinikum Marburg, Marburg, 35039 Germany
- Klinikum der Universität München, München, 80336 Germany
- Universitätsklinikum Tübingen, Tübingen, 72076 Germany
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.