Feasibility and Acceptability of PRISMA for Prisoners in Switzerland

NCT06404502 | Recruiting

• 1 other identifier: BASEC-Nr. 2023-01378-pilot
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Anxiety; Depression; Suicidal Ideation

Outcome Measures

Primary Outcomes (2)

• Verification procedure to the measurement in psychological distress

  The primary outcome is mental health at three weeks as assessed by the scale for depression measured by Patient Health Questionnaire - 9 (PHQ9). A higher score on the PHQ9 (range = 1 - 27) means a greater severity of depressive symptoms.

  Three weeks (primary outcome) after intake; 10 weeks, and 6 months

• Verification procedure to the measurement in psychological distress

  The primary outcome is mental health at three weeks as assessed by the scale for anxiety, measured by Generalized Anxiety Disorder-7 (GAD-7). A higher score on the GAD-7 (range = 0 - 21) means a greater severity of anxiety symptoms.

  Three weeks (primary outcome) after intake; 10 weeks, and 6 months

Secondary Outcomes (2)

• Verification procedure to the measurement suicidal ideation

  Screening, 3 weeks follow-up assessment, 10 weeks, 6 months and 1 year after the intervention

• Feasibility of PRISMA by the number of dropouts

  Screening, 3 weeks follow-up assessment, 10 weeks, 6 months and 1 year after the intervention

Study Arms (2)

PRISMA

EXPERIMENTAL

The intervention, PRISMA, addresses the issue of poor mental health of inmates during pretrial detention and after release. PRISMA has been adapted for the context of the model trial from Problem Management Plus (PM+). PRISMA has a total of four sessions provided during the first two weeks after entry such that most inmates can benefit from it before their potential release. The four sessions involve stress management, problem solving, meaningful activities (behavioral activation, and strengthening social support) and relapse prevention (staying well, looking forward). Additionally, participants will receive 2 booster sessions, 4 and 9 weeks after the final session.

Behavioral: PRISMA

Control group

NO INTERVENTION

REGULAR PRETRIAL: participants in this group experience the same pretrial system, conditions, and services that they would have experienced if the RCT did not exist. They will not be offered PRISMA.

Interventions

PRISMA BEHAVIORAL

PRISMA has been developed adapting PM+, a brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The adapted manual was developed to tailor the sessions to the structure of the Swiss prison system and the needs of inmates of jails in Switzerland. PRISMA involves the following elements: stress management, problem-solving, meaningful activities and relapse prevention PRISMA has four core features: * Evidence-based problem-solving strategies * Brief and easy to learn * Delivered by lay-helpers ("trainers") * Transdiagnostic, addressing depression, anxiety, stress, and practical problems as defined by participants; PRISMA has four sessions.

PRISMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Entering pretrial detention inmate in any of the 11 pretrial detention facilities in the Cantons of Zurich and Bern
• aged ≥ 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• ETH Zurich: collaborator
• The University of New South Wales: collaborator

Study Sites (1)

University of Zurich

Zurich, Canton of Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Suicidal Ideation

Interventions

mesoglycan

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Central Study Contacts

Naser Morina, PhD

CONTACT

+41 44 255 5280; naser.morina@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All instruments and questions will be administered online.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The pilot RCT will inform us about the feasibility of PRISMA under usual practice conditions.

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 8, 2024
• Study Start: December 8, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CH (1)