Self Help Plus and Post-Migration Living Difficulties Support Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMedipol University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
Have an acute medical condition,
At risk of suicide,
Have a severe mental disorder,
Have severe cognitive impairment
Trial design
Design model
Parallel
Treatments tested in this trial
SH+ combined with a session for PMLD
BehavioralThe 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 groups
210 Participants
are divided into 2 treatment groupsGroup A: Self Help Plus (SH+) combined with a session for Post Migration Living Difficulties (PMLD)Experimental treatment 1 intervention
Group B: Treatment-As-Usual (TAU)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the interventionSecondary outcomes
1
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.
Time frame
Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention2
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).
Time frame
Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention3
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.
Time frame
Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention4
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).
Time frame
Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: