STRENGTHS: Fostering Responsive Mental Health Systems in the Syrian Refugee Crisis - The Turkey Site
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Hopkins Symptom Checklist-25 (HSCL-25)
研究概览
简要总结
To implement Problem Management Plus (PM+) in Syrian refugees with this pilot study in Turkey with the aim of informing the definitive RCT about drop-out rates and estimated effect sizes.
详细描述
The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study is a 5-year study that started in January 2017 with funding from the European Commission Horizon 2020 scheme and Turkey is one of the sites that this study will be conducted. The main aim of STRENGTHS in Turkey is to evaluate the feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted psychological intervention Problem Management Plus (PM+) intervention for adult Syrian refugees in Turkey.
The current trial registration is for the pilot trial to investigate the feasibility and acceptability (e.g., obtain estimates of drop-out rates), to inform a full-scale, definitive randomized controlled trial. Study participants (n=60) will consist of adult Syrian refugees (18 years and older) in Turkey with self-reported functional impairment (WHODAS 2.0 >16) and elevated psychological distress (K10 >15.9). Participants will be randomly allocated either to the treatment group who will receive five sessions of PM+ or to the enhanced care-as-usual (E-CAU) group. Participants in the comparison group will receive E-CAU only. The primary outcome will be the decrease in psychological distress from baseline to three-month post-intervention assessment, measured through the Hopkins Symptoms Checklist (HSCL-25).
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)
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
- •Adults of 18 years or above
- •Syrian under temporary protection status
- •Arabic-speaking
- •Elevated levels of psychological distress (K10 >15.9) and reduced psychosocial functioning (WHODAS 2.0 >16)
排除标准
- •Acute medical conditions
- •Imminent suicide risk or expressed acute needs/protection risks (e.g., a young woman who expresses that she is 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)
研究组 & 干预措施
E-CAU with Problem Management Plus (PM+)
30 participants will be randomly assigned to E-CAU with PM+ group. The PM+ is developed by the World Health Organization (WHO) especially for the communities who are exposed to adversity. PM+ (Dawson et al., 2015) belongs to a set of programs which are low-intensity, shorter, less expensive and trans-diagnostic (i.e., not condition-specific, but targeted at a broader set of symptoms of common mental disorders) programs to reduce common mental health symptoms (including depression, anxiety and stress symptoms) and improve psychosocial functioning.
干预措施: Problem Management Plus (PM+) (Behavioral)
Enhanced care as usual (E-CAU) only
30 participants will be randomly assigned to E-CAU group. CAU ranges from the free health services government provides to Refugee and Asylum Seekers Assistance and Solidarity Association's (RASASA) mental health services which are provided by the Psychological Support Unit (MHPSS Support Unit) which includes counselling as well. The enhanced care arm (CAU, with the addition of a referral document), is to be used as a benchmark for measuring the effectiveness of STRENGTHS's intervention, which is Problem Management Plus (PM+).
结局指标
主要结局
Hopkins Symptom Checklist-25 (HSCL-25)
时间窗: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline)
The aim is to measure the change in psychological distress. Sub-scales can be calculated for depression (13 items) and anxiety symptoms (10 items). There are two items related to somatic symptoms. The items are rated on a 1-4 point Likert scale, with a well-validated cut-off score of 1.75. The current study will primarily look at the total score in which the lower values represent a better outcome. Furthermore, aim is to examine changes in caseness in depression, a cut-off score for the depression sub-scale of 2.1 will be used.
次要结局
- PTSD Checklist for DSM-5 (PCL-5)(Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from post intervention assessment at 3 month post-intervention assessment (4-4.5 months after baseline))
- Psychological Outcome Measures (PSYCHLOPS)(Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from post intervention assessment at 3 month post-intervention assessment (4-4.5 months after baseline))
- Access to health care: own questionnaire(Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from the post-intervention assessment at 3 month post-intervention assessment (4-4.5 months after baseline))
- Client Service Receipt Inventory (CSRI)(Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline))