Self Help Plus and Post-Migration Living Difficulties Support Intervention

NCT06467071 | Not Yet Recruiting DMC

• 2 other identifiers: SH+ZKX20725E271X2
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Psychological Trauma; Mental Health; Refugee Health

Keywords

Syrian Women Refugees; Self Help Plus; Post Migration Living Difficulties

Outcome Measures

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).

  Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention

Secondary Outcomes (7)

• Disability Assessment

  Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention

• Psychological Flexibility

  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

  Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention

• Psychological Outcome Profiles

  Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention

• Well-being

  Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: SH+ combined with a session for PMLD

Treatment-As-Usual (TAU)

NO INTERVENTION

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.

Interventions

SH+ combined with a session for PMLD 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.

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is exclusively for women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Refugees and Asylum Seekers Assistance and Solidarity Association (RASAS)

Istanbul, Sultanbeyli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Trauma; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Zeynep Keklik

  Medipol University

  STUDY DIRECTOR

Central Study Contacts

Zeynep Keklik

CONTACT

444 85 44; zeynep.keklik@std.medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist, MSc Student

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 20, 2024
• Study Start: June 20, 2024
• Primary Completion: September 30, 2024
• Study Completion: March 30, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: IPD will be made available to other researchers starting from May 2025, following the completion of the study.
• Access Criteria: Researchers requesting access to the IPD must submit a formal request detailing the purpose of their research and how they intend to use the data. Requests will be reviewed by the study's ethical committee to ensure compliance with privacy and ethical guidelines. Approved researchers will be required to sign a data use agreement, committing to use the data solely for scientific purposes, maintaining participant confidentiality, and adhering to all stipulated conditions.

Locations

TU (1)