Clinical trial NCT06404502: Feasibility and Acceptability of PRISMA for Prisoners in Switzerland
Official title: Feasibility and Acceptability of PRISMA for Prisoners in Switzerland - a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
Anxiety
Depression
Suicidal Ideation
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich
name: The University of New South Wales
First posted: 2024-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The pilot RCT will inform us about the feasibility of PRISMA under usual practice conditions.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Verification procedure to the measurement in psychological distress
timeFrame: Three weeks (primary outcome) after intake; 10 weeks, and 6 months
measure: Verification procedure to the measurement in psychological distress
timeFrame: Three weeks (primary outcome) after intake; 10 weeks, and 6 months
Secondary outcomes:
measure: Verification procedure to the measurement suicidal ideation
timeFrame: Screening, 3 weeks follow-up assessment, 10 weeks, 6 months and 1 year after the intervention
measure: Feasibility of PRISMA by the number of dropouts
timeFrame: Screening, 3 weeks follow-up assessment, 10 weeks, 6 months and 1 year after the intervention
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University of Zurich
state: Zurich
Study officials:
References: