Feasibility and Acceptability of PRISMA for Prisoners in Switzerland - a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Verification procedure to the measurement in psychological distress
研究概览
简要总结
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.
详细描述
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.
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
研究组 & 干预措施
PRISMA
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.
干预措施: PRISMA (Behavioral)
Control group
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.
结局指标
主要结局
Verification procedure to the measurement in psychological distress
时间窗: Three weeks (primary outcome) after intake; 10 weeks, and 6 months
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.
次要结局
- 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)