The Short-term Effects of PRISMA on Mental Health

NCT06197711 | Recruiting

• 1 other identifier: BASEC-Nr. 2023-01378
• Study Type: interventional
• Target: 1,480
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Anxiety; Depression; Suicidal Ideation

Keywords

PRISMA; psychological intervention; psychological distress; inmates; pretrial detention

Outcome Measures

Primary Outcomes (1)

• Change in psychological distress

  The primary outcome is mental health at three weeks as measured by the combined two scales. Subscales can be calculated for depression measured by Patient Health Questionnaire - 9 (PHQ9) and anxiety, measured by Generalized Anxiety Disorder-7 (GAD-7). A higher score on the PHQ9 (range = 1 - 27) means a greater severity of depressive symptoms. 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 after the intervention

Secondary Outcomes (3)

• Suicidal ideation

  Screening, 3 weeks follow-up assessment, 10 weeks after the intervention

• Assessing the extent to which the strategies taught in PRISMA are used before and after the study participation with the Reducing Tension Checklist

  3 weeks follow-up assessment (after intake)

• General Health

  3 weeks after intake, 10 weeks after the intervention

Study Arms (2)

Intervention group

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, when most inmates will already have been released from jail.

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 or extended social services, but they can still access social services upon request as well as medical support through the jails' health services.

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.

Intervention group

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 Hospital Zurich

Zurich, Canton of Zurich, 8006, Switzerland

RECRUITING

Related Publications (4)

• Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.

  PMID: 26407793 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• van Spijker BA, Batterham PJ, Calear AL, Farrer L, Christensen H, Reynolds J, Kerkhof AJ. The suicidal ideation attributes scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide Life Threat Behav. 2014 Aug;44(4):408-19. doi: 10.1111/sltb.12084. Epub 2014 Feb 24.

  PMID: 24612048 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Suicidal Ideation

Interventions

mesoglycan

Condition Hierarchy (Ancestors)

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

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 RCT will inform about the effect of PRISMA. Of the projected 5'100 people entering pretrial detention during the enrollment window, it is expected that roughly 43% (or 2'194 individuals) will be eligible for PRISMA and roughly 65% (or 3'316 individuals) will be eligible for the proactive social services intervention, respectively. Thus, it is expected that 1'428 individuals to be eligible for both interventions and, hence, constitute randomization sample C. This means that 766 individuals will be eligible for PRISMA only and 1'888 individuals for proactive social services only. 1'018 individuals will not be eligible for any of the two interventions. For the analysis, observations from the REGULAR PRETRIAL and the PRISMA group from randomization samples A and C, respectively, will pooled. This leaves N = 1480 participants who will be involved in the RCT (assigned to either receiving the PRISMA intervention (N=740) or control condition (N = 740)).

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 9, 2024
• Study Start: January 22, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2031
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)