Trials / Not Yet Recruiting
Not Yet RecruitingNCT06467071
Self Help Plus and Post-Migration Living Difficulties Support Intervention
Self Help Plus and Post-Migration Living Difficulties Support Intervention: A Randomized Controlled Trial With Syrian Women Under Temporary Protection in Turkey
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- Sponsor
- Medipol University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | SH+ combined with a session for PMLD | The intervention integrates WHO's Self Help Plus (SH+) and a session for Post-Migration Living Difficulties (PMLD) for Syrian women. SH+ is a guided self-help program with five weekly sessions led by facilitators, aimed at managing stress and psychological distress without requiring a diagnosis. This scalable intervention is based on solid research, proven effective in reducing stress and preventing mental health disorders (Tol et al., 2020; Turrini et al., 2019). The PMLD session, based on WHO's Problem Management Plus (PM+), involves focus groups to identify post-migration challenges. Participants share experiences, learn coping strategies, discover local resources, and strengthen social support networks. This integrated approach aims to enhance mental health, address post-migration difficulties, and improve stress reduction skills, supporting adaptation to a new country. |
Timeline
- Start date
- 2024-06-20
- Primary completion
- 2024-09-30
- Completion
- 2025-03-30
- First posted
- 2024-06-20
- Last updated
- 2024-06-20
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06467071. Inclusion in this directory is not an endorsement.