Feasibility and Acceptability of PRISMA for Prisoners in Switzerland (NCT06404502) | Clinical Trial Compass
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Feasibility and Acceptability of PRISMA for Prisoners in Switzerland
Switzerland40 participantsStarted 2023-12-08
Plain-language summary
In response to the significant mental health challenges faced by pretrial detainees, the Swiss Federal Justice Department has initiated a model trial in pretrial detention centres in Zurich and Bern. This model trial, named in German as a "Modellversuch," is designed to enhance detainees' wellbeing and evaluates various interventions through a randomized controlled trial. The "Prison Stress Management" (PRISMA) programme, a key intervention derived from the WHO's cognitive-behavioral therapy strategies, seeks to address the lack of mental health support within jails.
The goal of this pilot RCT is to evaluate the feasibility and acceptability of PRISMA for inmates inform a full-scale, definitive randomized controlled trial.
Who can participate
Age range
18 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:
* Entering pretrial detention inmate in any of the 11 pretrial detention facilities in the Cantons of Zurich and Bern
* aged ≥ 18 years
Exclusion Criteria:
* Not fluently speaking any of the nine languages in which PRISMA is offered: German, Albanian, Arabic, English, French, Italian, Romanian, Serbian/ Croatian, Spanish
* Acute suicidality
* Not interested in PRISMA and its randomized evaluation
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
Verification procedure to the measurement in psychological distress
Timeframe: Three weeks (primary outcome) after intake; 10 weeks, and 6 months
2
Verification procedure to the measurement in psychological distress
Timeframe: Three weeks (primary outcome) after intake; 10 weeks, and 6 months