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临床试验/NCT06467071
NCT06467071尚未招募不适用

Self Help Plus and Post-Migration Living Difficulties Support Intervention: A Randomized Controlled Trial With Syrian Women Under Temporary Protection in Turkey

Medipol University2 个研究点 分布在 2 个国家目标入组 210 人开始时间: 2024年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
210
试验地点
2
主要终点
Psychological Distress

研究概览

简要总结

This study will conduct a two-arm, single-blind, randomized controlled trial among Syrian refugee women living in Turkey who experience psychological distress. In the study, participants will be randomly assigned to either the SH+ intervention (n = 105) combined with a session on Post-Migration Living Difficulties (PMLD) or Treatment as Usual (TAU) (n = 105). SH+ is a five-session guided self-help intervention focusing on stress management based on Acceptance and Commitment Therapy (ACT). In addition, a session discussing post-migration difficulties and possible problem-management techniques will be integrated after the SH+ intervention. This study aims to fill an important gap in refugee health and well-being research by focusing on the integrated expansion and implementation of an intervention program to address the psychosocial challenges faced by refugee Syrian women. The results will assess the effectiveness of the intervention on psychological distress, focusing on its potential positive effects on psychological distress, stress management, and adaptation processes. Furthermore, the impact of the intervention on the use of association services and psychological flexibility will be examined.

详细描述

The number of displaced people worldwide has reached 110 million, underscoring the urgent need to investigate and address the psychosocial effects of conflict and displacement. Syrian refugees, the largest displaced population, face significant mental health challenges, including heightened risks of Post-Traumatic Stress Disorder (PTSD), depression, and anxiety due to both traumatic experiences and post-migration stressors. The World Health Organization's (WHO) Self-Help Plus (SH+) intervention provides a valuable psychological support tool to help manage stress and mitigate these difficulties. Additionally, post-migration living difficulties, such as social integration issues, employment barriers, and cultural adaptation, critically affect asylum seekers' adjustment to new environments and their mental health. Addressing both the psychological and psychosocial aspects is crucial for effectively mitigating the complex challenges faced by asylum seekers, emphasizing the need for comprehensive support to improve integration and well-being in post-migration contexts.

This study will conduct a two-arm, single-blind, randomized controlled trial among Syrian refugee women living in Turkey who experience psychological distress. Participants will be randomly assigned to one of two groups: the SH+ intervention combined with a session on Post-Migration Living Difficulties (PMLD) or Treatment as Usual (TAU). Each group will consist of 105 participants, totaling 210 participants in the study. The SH+ intervention is a five-session guided self-help program based on Acceptance and Commitment Therapy (ACT), focusing on stress management. This intervention is designed to be accessible and does not require a diagnosis, making it suitable for a wide audience and particularly useful in areas with limited mental health services.

In addition to the SH+ intervention, the intervention group will participate in a session specifically addressing post-migration living difficulties. This session will occur after the completion of the SH+ intervention and will focus on identifying and managing challenges such as social integration, employment barriers, and cultural adaptation. Using problem-management techniques, this session aims to empower participants by enhancing their coping skills, building solidarity through shared experiences, and providing information about local resources available for asylum seekers. The integrated intervention aims to strengthen the mental health of the participants and provide comprehensive support for adapting to their new country.

The study will measure several outcomes to assess the effectiveness of the intervention. Primary outcomes include the reduction of psychological distress, measured using standardized tools such as Kessler Psychological Distress (K10). Secondary outcomes will focus on psychosocial traits. Additionally, the study will examine the impact of the intervention on the use of association services and psychological flexibility, which is a key component of ACT.

The intervention aims to fill an important gap in refugee health and well-being research by focusing on the integrated expansion and implementation of a comprehensive intervention program to address the psychosocial challenges faced by Syrian refugee women. By combining SH+ with a PMLD session, the study seeks to provide a holistic approach to improving the mental health and well-being of participants, offering them the necessary tools and knowledge to navigate the complexities of post-migration life. The results of this study are expected to provide valuable insights into the effectiveness of integrated psychosocial interventions and inform future efforts to support displaced populations globally.

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
Female
接受健康志愿者

入选标准

  • Participants must be adults (18 years and above),
  • Selected among Syrian women residing in Turkey under temporary protection,
  • Speak Arabic,
  • Have not received any services from the Refugee Association before,
  • A score of more than 16 on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0),
  • A score of more than 15 on the Kessler-10 (K10) Psychological Distress Scale.

排除标准

  • Have an acute medical condition,
  • At risk of suicide,
  • Have a severe mental disorder,
  • Have severe cognitive impairment

结局指标

主要结局

Psychological Distress

时间窗: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention

Kessler Psychological Distress Scale (K10) The primary outcome measure of this study is the Kessler 10 (K10) scale developed by Kessler \& Mroczek (2002). This scale is designed to measure general psychological distress experienced in the past 30 days without a specific cause. The scale was translated into Arabic and validated by Easton et al. (2017). This 10-item scale assesses each item using a 5-point Likert scale (1: Never; 5: Always). As a result of the reliability studies conducted for the Arabic translation of the scale, Cronbach's alpha (α) value was found to be .88 (Easton et al., 2017).

次要结局

  • Psychological Flexibility(Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention)
  • Symptoms of Post Traumatic Stress Disorder(Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention)
  • Psychological Outcome Profiles(Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention)
  • Post Migration Living Difficulties(Baseline, during the intervention, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention)
  • Disability Assessment(Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention)
  • Well-being(Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention)
  • Service Uses(After the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeynep Keklik

Psychologist, MSc Student

Medipol University

研究点 (2)

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