Combined Mental Health and Cash Transfer Intervention With Afghan Refugees in Turkiye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Kessler-10 Psychological Distress Scale (K-10)
研究概览
简要总结
This pilot project aims to evaluate the implementation outcomes and preliminary impacts of a combined low-intensity psychological intervention paired with cash assistance for Dari-speaking adult Afghan asylum-seeking women in Türkiye. The psychological intervention utilized is Self Help Plus (SH+), developed by the World Health Organization (WHO) for individuals in low-resource settings experiencing high stress levels.
This pilot, which builds on a previous needs assessment, will deliver the SH+ intervention through five two-hour sessions, supplemented by a cash transfer of USD 300 or equal amount in Turkish Lira per participant (USD 60 or equal amount in Turkish Lira after each session) to 40 Afghan asylum-seeking women in Türkiye.
The study will test the feasibility, acceptability, and practicality of the combined SH+ and cash transfer intervention and evaluate its effectiveness in addressing the mental health needs of forcibly displaced individuals through a two-arm randomized trial. The first group will receive SH+ and cash transfer simultaneously, and the second group will receive the cash transfer at the same time as the first group then receive the SH+ intervention after a 3-month delay.
Our local partners in Türkiye are the Afghan Refugees Solidarity Association (ARSA) and Boğaziçi University. We have already obtained IRB approval from Boğaziçi University.
详细描述
Afghan women asylum seekers and refugees who are already part of our ARSA's women's group will be screened for eligibility and enrollment in the study by a counselor from ARSA. The characteristics for recruited participants in this study will include a) being an Afghan refugee or asylum seeker residing in Türkiye, b) being a woman, c) being aged 18 or older, d) having the ability to read, speak, and consent in Dari, e) having high levels of psychological distress (scoring above 15 on the Kessler-10 Psychological Distress Scale [K-10]), and f) without an imminent risk of suicide (measured by the WHO PM+ assessment tool).
At the end of the screening questionnaire, eligible participants will receive a written consent form in both English and Dari. Qualified participants will also be provided with an informational presentation about the study and given a week to review the consent form carefully. Recruitment will continue until 40 eligible participants have provided consent.
Following the screening and consent process, 40 eligible participants will be randomized to two arms according to the 1:1 principle with automatized randomization software.
Group 1 (Receiving SH+ and cash transfer simultaneously):
Participants will complete the baseline assessment 1 week before the intervention. They will then participate in 5 weekly 2-hour SH+ session in person at ARSA in a private conference room. With each session, they will receive a $60 or equal amount in Turkish Lira in cash transfer. The program will be delivered by bilingual community facilitators who have completed a 3-day training on SH+ by WHO-certified SH+ trainers. Each session will follow the SH+ manual and the SH+ illustrated guide.
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
Participants will not be blinded to their study arm due to the nature of the intervention, but outcome assessors will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The characteristics for recruited participants in this study will include
- •being an Afghan refugee or asylum seeker residing in Türkiye,
- •being a woman,
- •being aged 18 or older,
- •having the ability to read, speak, and consent in Dari,
- •having high levels of psychological distress (scoring above 15 on the Farsi version of the Kessler-10 Psychological Distress Scale (K-10), and
- •without an imminent risk of suicide (measured by WHO PM+ assessment tool).
排除标准
- •Having an imminent risk of suicide (measured by WHO PM+ assessment tool)
结局指标
主要结局
Kessler-10 Psychological Distress Scale (K-10)
时间窗: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
Kessler-10 Psychological Distress Scale is a 10-item questionnaire that aims to measure psychological distress symptoms. Each of the 10 items are scored as 1, 2, 3, 4 and 5 to the response categories (1 = "none of the time" to 5= "all of the time"), providing a 10-50 severity score. Higher scores indicate higher levels of psychological distress. The Farsi version of the K-10 will be used in this study.
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
- General Anxiety Disorder-7 (GAD-7)(Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment))
研究者
Mitra Naseh
Assistant Professor
Washington University School of Medicine