Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Feasibility and acceptability of PM+
研究概览
简要总结
The goal of this pilot randomised controlled trial is to evaluate the feasibility and acceptability of the - specifically to the prison context adapted - World Health Organization's Problem Management Plus (PM+) intervention for individuals detained in Dutch remand prisons. The main question[s] it aims to answer are:
- To what extent is the contextually adapted PM+ intervention feasible and acceptable for individuals detained in Dutch remand prisons?
- To what extent are there preliminary indications of pre to post-effects of the PM+ intervention on, for example, anxiety and depression symptoms?
Researchers will compare two groups to answer these questions. Participants will either receive the PM+ intervention and Care-as-Usual or only Care-as-Usual.
详细描述
Rationale: Each year between 20 and 30 thousand individuals are newly incarcerated in Dutch prisons. Common mental disorders, such as depression and anxiety, are overrepresented in prison populations. As such, mental health problems are an important target for intervention, since they have been found to be associated with re-offending. The prison period may provide opportunities for addressing mental health problems, but there may be important obstacles and barriers to the actual delivery of interventions, such as a lack of mental health care specialists in prisons due to staff shortages.
Within the PROSPER study, we will evaluate the feasibility and acceptability of implementing the brief, scalable Problem Management Plus (PM+) intervention in Dutch prisons. The PM+ intervention is designed to address common mental health problems, is delivered by trained non-specialists, and will be specifically adapted for the prison setting.
Objective: The primary objective of the PROSPER study is to evaluate the feasibility and acceptability of PM+ adapted for individuals imprisoned in Dutch prisons.
Study design: This study entails a single-blind pilot randomised controlled trial (RCT) (Study Phase 2) and a qualitative study to evaluate the process following the pilot RCT (Study Phase 3).
Study population: Study Phase 2 - Dutch-speaking adults (18 years or older; N=60) who at the time of inclusion are enclosed in a Dutch remand prison and have a remaining sentence length of at least 15 weeks and who report an elevated level of psychological distress (K10 >15). Study Phase 3 - Participants (N= 20) will be from different stakeholder groups: the RCT participants, PM+ helpers, PM+ supervisors/trainers, and professionals. If permitted by RCT participants, family members, and friends are also invited.
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
The participants will know to which group they are to be allocated. The PM+ supervisors, PM+ helpers, and two principal researchers will know which participants are randomised in a specific group. Involved research assistants (the outcome assessors) and the two other involved researchers will not know.
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
- •18 years old or above;
- •Imprisoned in a Dutch prison;
- •Held on remand;
- •Dutch-speaking;
- •Elevated levels of psychological distress (K10 >15);
排除标准
- •Enclosed in a penitentiary psychiatric centre;
- •Presents a potential security risk to the research team (PM+ helper and/or research team)
- •Acute medical condition;
- •Imminent suicide risk or expressed acute needs/protection risks (e.g., someone who expresses that they are at acute risk of being assaulted or killed);
- •Severe mental disorder (psychotic disorders, substance dependence) ;
- •Severe cognitive impairment (e.g., severe intellectual disability or dementia);
- •Currently enrolled in a specialised psychological treatment program (e.g., EMDR, CBT);
- •Less than two months on a stable dose of psychotropic medication (if applicable).
研究组 & 干预措施
Care-as-usual
Care-as-usual includes all social, health, and mental health services already available for individuals detained in Dutch prisons.
Problem Management Plus and care-as-usual
The five sessions of PM+ will be delivered by trained master students in clinical psychology on an individual basis. Care-as-usual will not be withheld.
干预措施: Problem Management Plus (PM+) (Behavioral)
结局指标
主要结局
Feasibility and acceptability of PM+
时间窗: Outcomes are gathered throughout the study: during (factor 1) and after the trial finished (factors 2, 3, 4 and 5). We estimate inclusion will take about 9 months. Thus these factors will likely be gathered over a time frame of about one year.
Factors relevant to the study of this outcome are: 1. PM+ fidelity; 2. The perceptions about PM+ from RCT participants, helpers, supervisors, trainers, professionals, and family members \& friends of RCT participants; 3. Indicators of intervention delivery, such as implementation process, adaptation, and dose. 4. Retention rate PM+ sessions; and 5. Recruitment and the consent rates.
次要结局
- Preliminary indications of pre to post-effects on symptoms of depression and anxiety(Measured at baseline (week 0), week 8 and 13 weeks after baseline.)
- Preliminary indications of pre to post-effects on self-identified problems(Measured at baseline (week 0), week 8 and 13 weeks after baseline.)
- Preliminary indications of pre to post-effects on quality of life(Measured at baseline (week 0), week 8 and 13 weeks after baseline.)
- Preliminary indications of pre to post-effects on trauma(Measured at baseline (week 0), week 8 and 13 weeks after baseline.)
- Preliminary indications of pre to post-effects on suicidal vulnerability(Measured at baseline (week 0), week 8 and 13 weeks after baseline.)
研究者
Mathilde van Oudenaren
PhD-student
VU University of Amsterdam