Clinical trial NCT06197711: The Short-term Effects of PRISMA on Mental Health
Official title: The Short-term Effects of PRISMA on Mental Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
Anxiety
Depression
Suicidal Ideation
Keywords: PRISMA
psychological intervention
psychological distress
inmates
pretrial detention
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich
name: The University of New South Wales
First posted: 2024-01-09
Enrollment: 1480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)).
Primary purpose: TREATMENT

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.

Detailed description: The RCT will inform about the effect of PRISMA.

The sample size is determined by the enrollment window (from November 27, 2023 to September 30, 2026). Based on historical data, the investigators expect roughly 5,100 subjects to enter pretrial detention in the cantons of Zurich and Bern during this period.

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 (or 28% = 43% of 65%) to be eligible for both interventions and, hence, constitute randomization sample C. This means that 766 individuals (= 2'194 - 1'428) will be eligible for PRISMA only (randomization sample A) and 1'888 individuals (= 3'316 - 1'428) for proactive social services only (randomization sample B). 1'018 (= 5'100 - 1'428 - 766 - 1'888) individuals will not be eligible for any of the two interventions. If samples are split with equal probability into experimental groups, the investigators expect the following group sizes:

Randomization sample A:

REGULAR PRETRIAL: 383 PRISMA: 383

Randomization sample B:

REGULAR PRETRIAL: 944 SOCIAL: 944

Randomization sample C:

REGULAR PRETRIAL: 357 PRISMA: 357 SOCIAL: 357 PRISMA \& SOCIAL: 357 For the analysis, observations from the REGULAR PRETRIAL and the PRISMA group from randomization samples A and C, respectively, will be 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 (REGULAR PRETRIAL) (N = 740)).

This preregistration focuses on the short-term effects of PRISMA on mental wellbeing and therefore only considers the REGULAR PRETRIAL and PRISMA treatment arms. See "Mental Health Intervention and Social Service in Pretrial Detention" on www.socialscienceregistry.org for preregistration of the other treatment arms.

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: Change in psychological distress
timeFrame: Three weeks (primary outcome) after intake; 10 weeks after the intervention
Secondary outcomes:
measure: Suicidal ideation
timeFrame: Screening, 3 weeks follow-up assessment, 10 weeks after the intervention
measure: Assessing the extent to which the strategies taught in PRISMA are used before and after the study participation with the Reducing Tension Checklist
timeFrame: 3 weeks follow-up assessment (after intake)
measure: General Health
timeFrame: 3 weeks after intake, 10 weeks after the intervention
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: ZH
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.