Ignite Creation Date:
2024-07-17 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467071
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-09
Brief Title:
Self Help Plus and Post-Migration Living Difficulties Support Intervention
Sponsor:
Medipol University
Organization:
Medipol University
Study Overview
Official Title:
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Organizations 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0725E271X2 | OTHER | None | None |