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Recruiting NCT06197711

NCT06197711 The Short-term Effects of PRISMA on Mental Health

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Clinical Trial Summary
NCT ID NCT06197711
Status Recruiting
Phase
Sponsor University of Zurich
Condition Psychological Distress
Study Type INTERVENTIONAL
Enrollment 1,480 participants
Start Date 2024-01-22
Primary Completion 2026-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
PRISMA

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 1,480 participants in total. It began in 2024-01-22 with a primary completion date of 2026-12-31.

⚠ 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

Given the high prevalence of mental health issues, such as anxiety and depression, in pretrial detainees, the Swiss Federal Justice Department (SFJD) approved a model trial ("Modellversuch Untersuchungshaft", MV). The MV will be carried out in 11 pretrial detention facilities in the cantons of Zurich and Bern and aims to improve the wellbeing and social integration of individuals in pretrial detention. As part of the MV the investigators are evaluating the impact of two interventions using a randomized controlled trial (RCT). The first intervention, "Prison Stress Management" (PRISMA), addresses the issue of poor mental health of inmates during pretrial detention and after release. PRISMA is a scalable World Health Organization (WHO)-developed psychological intervention based on cognitive-behavioral therapy (CBT) program and goes beyond the status-quo mental health support offered in jails. Currently, only inmates with severe mental health problems are referred to the psychiatric ward of the health services provided in jails and no continuation of support is offered after the transition to the outside world. The second intervention (SOCIAL) uses extended social services to address potential disruptions incarceration might cause in detainees' social and economic lives. The isolation from the outside world implies that detainees might lose their jobs and housing, their relationships with their family and friends are strained, all factor hindering re-integration into society and taxing their mental wellbeing. This project will provide much needed insights to criminal justice authorities to design detention facilities and the detention experience in ways that empower incarcerated individuals to cope with the disruptions and psychological stress that come along with their detention.

Eligibility Criteria

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

Frequently Asked Questions

Who can join the NCT06197711 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Psychological Distress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06197711 currently recruiting?

Yes, NCT06197711 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Zurich to inquire about joining.

Where is the NCT06197711 trial being conducted?

This trial is being conducted at Zurich, Switzerland.

Who is sponsoring the NCT06197711 clinical trial?

NCT06197711 is sponsored by University of Zurich. The trial plans to enroll 1,480 participants.

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