The Short-term Effects of PRISMA on Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,480
- 试验地点
- 2
- 主要终点
- Change in psychological distress
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All instruments and questions will be administered online.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Entering pretrial detention inmate in any of the 11 pretrial detention facilities in the Cantons of Zurich and Bern
- •aged ≥ 18 years
排除标准
- •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
结局指标
主要结局
Change in psychological distress
时间窗: Three weeks (primary outcome) after intake; 10 weeks after the intervention
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.
次要结局
- 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)