Feasibility and Acceptability of PRISMA for Prisoners in Switzerland

Depression Clinical Trial

Official title:

Feasibility and Acceptability of PRISMA for Prisoners in Switzerland - a Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06404502
• Other study ID #: BASEC-Nr. 2023-01378-pilot
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: Naser Morina, PhD
• Phone: +41 44 255 5280
• Email: naser.morina[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Distress
• Suicidal Ideation

Intervention

Behavioral:
• PRISMA
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.

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zürich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	ETH Zurich, The University of New South Wales

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Verification procedure to the measurement suicidal ideation	Suicidal Ideation is measured using an adapted version of the Suicidal Ideation Attribution Scale (SIDAS), a brief measure of severity of suicidal ideation assessing frequency, controllability, closeness to attempt, level of distress associated with the thoughts and impact on daily functioning. It consists of 3 items rated on an 11-point scale (0 = "Never" to 10 = "Always").	Screening, 3 weeks follow-up assessment, 10 weeks, 6 months and 1 year after the intervention
Secondary	Feasibility of PRISMA by the number of dropouts	Monitoring of the dropouts by number of participants	Screening, 3 weeks follow-up assessment, 10 weeks, 6 months and 1 year after the intervention