• Sebastian Burchert, Mhd Salem Alkneme, Ammar Alsaod, Pim Cuijpers, Eva Heim, Jonas Hessling, Nadine Hosny, Marit Sijbrandij, Edith Van't Hof, Pieter Ventevogel, Christine Knaevelsrud, and STRENGTHS Consortium.
• Department of Education and Psychology, Division of Clinical Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
• PLoS Med. 2024 Sep 1; 21 (9): e1004460e1004460.

BackgroundDigital mental health interventions for smartphones, such as the World Health Organization (WHO) Step-by-Step (SbS) program, are potentially scalable solutions to improve access to mental health and psychosocial support in refugee populations. Our study objective was to evaluate the effectiveness of SbS as self-guided intervention with optional message-based contact-on-demand (COD) support on reducing psychological distress, functional impairment, symptoms of posttraumatic stress disorder (PTSD), and self-identified problems in a sample of Syrian refugees residing in Egypt.Methods And FindingsWe conducted a 2-arm pragmatic randomized controlled trial. A total of 538 Syrians residing in Egypt with elevated levels of psychological distress (Kessler Psychological Distress Scale; K10 > 15) and reduced psychosocial functioning (WHODAS 2.0 > 16) were randomized into SbS + CAU (N = 266) or CAU only (N = 272). Primary outcomes were psychological distress (Hopkins Symptom Checklist 25) and impaired functioning (WHO Disability Assessment Schedule 2.0) at 3-month follow-up. Secondary outcomes were symptoms of PTSD (PTSD Checklist for DSM-5 short form, PCL-5 short) and self-identified problems (Psychological Outcomes Profiles Scale, PSYCHLOPS). Intention-to-treat (ITT) analyses showed significant but small effects of condition on psychological distress (mean difference: -0.15; 95% CI: -0.28, -0.02; p = .02) and functioning (mean difference: -2.04; 95% CI: -3.87, -0.22; p = .02) at 3-month follow-up. There were no significant differences between groups on symptoms of PTSD and self-identified problems. Remission rates did not differ between conditions on any of the outcomes. COD was used by 9.4% of participants for a median of 1 contact per person. The main limitations are high intervention dropout and low utilization of COD support.ConclusionsThe trial provides a real-world implementation case, showing small positive effects of a digital, potentially scalable and self-guided mental health intervention for Syrian refugees in Egypt in reducing psychological distress and improving overall functioning. Further user-centered adaptations are required to improve adherence and effectiveness while maintaining scalability.Trial RegistrationGerman Register for Clinical Studies DRKS00023505.Copyright: © 2024 Burchert et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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