CONSORT standards of reporting trials.

<div><p>Background</p><p>Digital 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.</p><p>Methods and findings</p><p>We 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 (<i>N</i> = 266) or CAU only (<i>N</i> = 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; <i>p</i> = .02) and functioning (mean difference: −2.04; 95% CI: −3.87, −0.22; <i>p</i> = .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.</p><p>Conclusions</p><p>The 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.</p><p>Trial registration</p><p>German Register for Clinical Studies <a href="https://clinicaltrials.gov/ct2/show/DRKS00023505" target="_blank">DRKS00023505</a>.</p></div>