Self Help Plus and Post-Migration Living Difficulties Support Intervention

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467071
• Other study ID #: SH+ZKX2
• Secondary ID: 0725E271X2
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: June 2024
• Source: Medipol University
• Contact: Zeynep Keklik
• Phone: 444 85 44
• Email: zeynep.keklik[@]std.medipol.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: March 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health
• Psychological Distress
• Psychological Trauma

Intervention

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.

Locations

Country	Name	City	State
Turkey	Refugees and Asylum Seekers Assistance and Solidarity Association (RASAS)	Istanbul	Sultanbeyli

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological Distress	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 (a) value was found to be .88 (Easton et al., 2017).	Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Secondary	Disability Assessment	WHO Disability Assessment Schedule (WHODAS 2.0) The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 5-point Likert-type scale for general and clinical use, developed by Ustun et al. (2010) and validated by Akhtar et al. (2021) with a Cronbach's Alpha value of .74 for Arabic, and is designed to measure the disability of individuals.	Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Secondary	Psychological Flexibility	The Acceptance and Action Questionnaire (AAQ-II) Within the scope of the study, the Acceptance and Action Questionnaire (AAQ-II) (Hayes et al., 2004) will be used to assess psychological flexibility. The translation of the scale into Arabic and validation study was conducted by Hemaid et al. (2016). The 7-item scale evaluates each item on a 7-point Likert scale (1: Never true; 7: Always true). As a result of the reliability studies conducted for the Arabic translation of the scale, Cronbach's Alpha (a) value was found to be .78 (Hemaid et al., 2016).	Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Secondary	Symptoms of Post Traumatic Stress Disorder	PTSD Checklist for DSM-5 (PCL-5) The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) was developed by Weathers et al. (2013) as a 20-item 5-point Likert-type scale to measure PTSD symptoms and severity, and adapted into Arabic by Ibrahim et al. (2018) and gained validity and reliability with a Cronbach's Alpha value of .86.	Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Secondary	Psychological Outcome Profiles	PSYCHLOPS PSYCHLOPS is a 6-point Likert-type scale with four and six items for pre and post-assessments, respectively, created by Ashworth et al. (2006) to assess individuals' psychological health conditions and the effects of their problems on their lives. The Arabic version has been used especially in studies on Syrian refugees (Acarturk et al., 2022; Uygun et al., 2020).	Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Secondary	Well-being	The World Health Organization- Five Well-Being Index (WHO-5) The WHO-5 Well-being Index is a short self-report rating scale developed by WHO (1998) to assess subjective well-being and general mental health condition and interest in the last two weeks on a 6-point Likert scale (0: Never; 5: Always). As a result of the Arabic validity and reliability study conducted by Alshayea (2023), it was found reliable with a Cronbach's alpha value of .91.	Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Secondary	Post Migration Living Difficulties	Post Migration Living Difficulties Checklist (PMLDC) The Post Migration Living Difficulties Checklist was developed by Silove et al. (1997) to measure post-asylum difficulties and related stress levels. It is a 17-item, 5-point Likert scale, the Arabic version of which has been used effectively in studies on forcibly displaced communities (Schick et al., 2016, 2018; Spaaij et al., 2023).	Baseline, during the intervention, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Secondary	Service Uses	The study will include a service use inventory based on the Client Service Utilization Inventory (CSRI) (Beecham & Knapp, 1992) to assess the frequency and duration of use of association services by participants in both arms.	After the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention