A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
Recruiting · NCT04996433 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Greifswald
View the official record on ClinicalTrials.gov →Interventions studied
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What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
8 locations listed.
- Universitätsklinikum Bonn - Bonn, Germany
- Medizinische Hochschule Hannover - Hanover, Germany
- Universitätsklinikum Jena - Jena, Germany
- Universität zu Lübeck - Lübeck, Germany
- Universitätsklinikum Marburg - Marburg, Germany
- Klinikum der Universität München - München, Germany
- Universitätsklinikum Tübingen - Tübingen, Germany
- Charité, University Medicine Berlin - Berlin, State of Berlin, Germany