Self Help Plus and Post-Migration Living Difficulties Support Intervention
NCT Number: NCT06467071
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psychological Distress|Psychological Trauma|Mental Health|Refugee Health
Interventions: BEHAVIORAL: SH+ combined with a session for PMLD
Sponsor: Medipol University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2025-03-30
Locations: Refugees and Asylum Seekers Assistance and Solidarity Association (RASAS), Istanbul, Sultanbeyli, Turkey

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.

Primary Outcome Measures: 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 (α) 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 Outcome Measures: 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|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 (α) 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|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|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|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|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|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