Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT06404502
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of PRISMA for Prisoners in Switzerland
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Feasibility and Acceptability of PRISMA for Prisoners in Switzerland - a Pilot Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
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 (in German named "Modellversuch Untersuchungshaft", MV). The MV will be carried out in 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.
The present pilot RCT aims to investigate the feasibility and acceptability of an PRISMA for inmates to inform a full-scale, definitive randomized controlled trial. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, protocol adherence, study visit attendance and the time burden of parent questionnaires. These data will inform the design of a full scale randomized controlled trial to evaluate the efficacy of PRISMA in inmates.
For this purpose only 20 people in each arm will be included.
The present pilot RCT aims to investigate the feasibility and acceptability of an PRISMA for inmates to inform a full-scale, definitive randomized controlled trial. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, protocol adherence, study visit attendance and the time burden of parent questionnaires. These data will inform the design of a full scale randomized controlled trial to evaluate the efficacy of PRISMA in inmates.
For this purpose only 20 people in each arm will be included.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: