Self Help Plus and Post-Migration Living Difficulties Support Intervention

NCT ID: NCT06467071

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2025-03-30

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 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

Psychological Distress; Psychological Trauma; Mental Health; Refugee Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self Help Plus (SH+) combined with a session for Post Migration Living Difficulties (PMLD)

The intervention integrates Self Help Plus (SH+) and a session for Post-Migration Living Difficulties (PMLD) for Syrian women. Participants will be randomly assigned to the SH+ combined with the PMLD session (n = 105). The participants in the experimental arm will receive SH+ combined with the PMLD session, by non-specialist facilitators.

Group Type: EXPERIMENTAL

SH+ combined with a session for PMLD

Intervention Type: BEHAVIORAL

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.

Treatment-As-Usual (TAU)

105 participants will be randomly allocated to the Treatment as Usual (TAU) group. Mental health services for asylum seekers in Turkey are provided by the Ministry of Health and different non-governmental organizations. These services include psychosocial support, counseling, mental health screenings, and psychotherapy (AIDA, 2020). As usual, treatment includes usual mental health support and assessment following the standard procedures of the Refugees Association Mental Health Unit.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Keklik

Psychologist, MSc Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep Keklik

Role: STUDY_DIRECTOR

Medipol University

Locations

Refugees and Asylum Seekers Assistance and Solidarity Association (RASAS)

Istanbul, Sultanbeyli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Zeynep Keklik

Role: CONTACT

zeynep.keklik@std.medipol.edu.tr

444 85 44

Facility Contacts

Zeynep Keklik, Psychologist

Role: primary

Other Identifiers

0725E271X2

Identifier Type: OTHER

Identifier Source: secondary_id

SH+ZKX2

Identifier Type: -

Identifier Source: org_study_id