A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients (NCT04996433) | Clinical Trial Compass
RecruitingNot Applicable
A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
Germany396 participantsStarted 2021-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hamilton Depression Rating Scale (HDRS-24), 24-item version