NCT04996433 A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
| NCT ID | NCT04996433 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Greifswald |
| Condition | Persistent Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 396 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 396 participants in total. It began in 2021-12-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Eva-Lotta Brakemeier, Prof. Dr.
PRINCIPAL INVESTIGATOR
University Greifswald
Frequently Asked Questions
Who can join the NCT04996433 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Persistent Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04996433 currently recruiting?
Yes, NCT04996433 is actively recruiting participants. Contact the research team at eva-lotta.brakemeier@uni-greifswald.de for enrollment information.
Where is the NCT04996433 trial being conducted?
This trial is being conducted at Berlin, Germany, Bonn, Germany, Hanover, Germany, Jena, Germany and 4 additional locations.
Who is sponsoring the NCT04996433 clinical trial?
NCT04996433 is sponsored by University of Greifswald. The principal investigator is Eva-Lotta Brakemeier, Prof. Dr. at University Greifswald. The trial plans to enroll 396 participants.