A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Greifswald
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Bipolar I or II disorder
Active substance use disorders (abstinence shorter than 6 months)
Schizophrenia spectrum and other psychotic disorders
Antisocial personality disorder
Trial design
Treatments tested in this trial
- inpatient CBASP individual therapy
- inpatient CBASP group therapy
- inpatient CBASP nurse contact
- inpatient CBASP exercise therapy
- outpatient CBASP group therapy
- inpatient BA individual therapy
- inpatient BA group therapy
- inpatient BA nurse contact
- inpatient BA exercise therapy
- outpatient BA group therapy
- algorithm-based study medication
Treatment groups
396 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Greifswald
Lead sponsor
German Research Foundation
Collaborator
University of Kassel
Collaborator
University Medicine Greifswald
Collaborator
Charite University, Berlin, Germany
Collaborator
Hannover Medical School
Collaborator
University Hospital Lübeck
Collaborator
Philipps University Marburg
Collaborator
Ludwig-Maximilians - University of Munich
Collaborator
University Hospital Tuebingen
Collaborator
University Hospital, Bonn
Collaborator
Jena University Hospital
Collaborator
Source ClinicalTrials.gov