Boosting Refugee Integration Through Psychological Intervention (BRIGHT) - a Pilot Randomised Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- Problem Management Plus
- 疾病 / 适应症
- Psychological Distress
- 发起方
- University of Zurich
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in psychological distress
- 状态
- 已完成
- 最后更新
- 12天前
概览
简要总结
Refugees and asylum seekers (RAS) face numerous stressors and adversities which put them at risk for developing mental health problems. However, access to adequate mental health care in host countries is limited. To address this problem, the World Health Organization (WHO) introduced Problem Management Plus (PM+), a short, low-intensity psychological intervention administered by non-professionals, aiming to alleviate common mental disorders among crisis-affected communities.
The objective of this pilot RCT is to assess the feasibility and acceptability of an adapted version of PM+ for refugees and asylum-seekers. This will inform the design of a definitive RCT and implementation study.
详细描述
Refugees and asylum seekers (RAS) are often exposed not only to potentially traumatic events before and during migration but also to significant post-migration stressors. Due to this combined burden, RAS are at increased risk for developing mental health problems. In accessing mental health care in the host countries, however, they face several barriers including waitlists, stigma and communication difficulties. Consequently, RAS are frequently underdiagnosed and often do not receive adequate medical treatment despite an urgent need. To improve the access to evidence-based psychological interventions, the WHO developed a series of scalable interventions. One of these is Problem Management Plus (PM+), a brief, low-intensity psychological intervention, delivered by paraprofessionals, that addresses common mental disorders in people affected by adversity. PM+ consists of 5 sessions that comprise evidence-based techniques of (a) problem solving, (b) stress management, (c) behavioral activation, and (d) accessing social support. The present study aims at expanding the existing PM+ intervention by providing additional booster sessions and access to a digital support program. PM+ has been proven to be an effective method for reducing mental health problems and improving the psychosocial functioning of people in crisis in various countries and contexts, including Switzerland. Despite its effectiveness, far too little attention has been paid to the successful implementation of such low-intensity psychological interventions into real-world health care systems. The present pilot RCT aims to investigate the feasibility and acceptability of an augmented version of PM+ for refugees and asylum-seekers to inform a full-scale, definitive randomized controlled trial and implementation study. 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 augmented PM+ in refugees and asylum-seekers.
研究者
入排标准
入选标准
- •refugees and asylum seekers (RAS) aged 16 or older;
- •residing in one of the participating local sites (Swiss municipalities, namely, Gemeinden, and transitional asylum centers, namely, Durchgangszentren) where PM+ is offered and which gave their consent for participation in the RCT;
- •speaking at least one of the following 12 languages: German, English, French, Arabic, Farsi, Kurdish, Tigrinya, Turkish, Ukrainian, Russian, Tamil, and Pashto;
- •obtaining a score of 20 or higher on the Kessler Psychological Distress Scale (K10; Kessler et al., 2002), a brief clinically validated screening questionnaire that assesses general psychological distress in the past 30 days. A score equal to or higher than 20 is used as an indication of moderate to high levels of psychological distress.
排除标准
- •significant cognitive or neurological impairment measured through specific tools developed by the WHO and integrated into the PM+ manual (impairment questionnaire);
- •acute medical conditions or severe mental disorders (e.g., psychotic or substance-abuse disorders) measured through specific tools developed by the WHO and integrated into the PM+ manual (impairment questionnaire);
- •acute risk of suicide as measured by the Suicidal Ideation Attribution Scale (SIDAS; van Spijker et al., 2014) and the Thoughts of Suicide Questionnaire (World Health Organization WHO, 2016).
研究组 & 干预措施
Problem Management Plus
The participants who are assigned to the intervention group will receive five sessions of PM+, a psychological intervention which has been developed by the WHO. PM+ is a short, transdiagnostic (i.e., not specifically aimed at treating a certain mental disorder) program aiming to reduce common mental health symptoms and improve psychosocial functioning. In addition, participants will receive three telephone booster sessions.
干预措施: Problem Management Plus
waitlist control group
The control group will receive the augmented PM+ intervention 12 months after the baseline assessment.
干预措施: Problem Management Plus
observational control group
Participants who scored below 20 on the K10 will will only be part of the baseline assessments and receive no intervention.
结局指标
主要结局
Change in psychological distress
时间窗: Baseline assessment, 3 month FU assessment (3 months after baseline)
Change in psychological distress will be measured with the Hopkins Symptom Checklist (HSCL-25). Items are rated on a scale from 1 to 4. Higher scores indicate more pronounced symptom severity.
次要结局
- Change in posttraumatic stress disorder symptoms(Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment)
- General psychological distress(Screening, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment)
- Somatic symptoms(Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment)
- Reduction of post-migration stressors(Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment)
- Exposure to potentially traumatic events(Baseline assessment)
- Level of integration(Baseline assessment, 6 month FU assessment (6 months after baseline), 12 months FU assessment)
- Suicidal Ideation(Baseline assessment, 6 month FU assessment (6 months after baseline), 12 months FU assessment)
- Change in psychological distress(6 month FU assessment (6 months after baseline), 12 months FU assessment)
- Feasibility of PM+ by the number of dropouts(Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment)