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Abstract Background Lebanon is a low-to-middle-income country, hosting more than 1.1 million Syrian refugees, with 90% mental health treatment gap. The National Mental Health Programme (NMHP) in Lebanon along with the World Health Organization (WHO) launched the Step-by-Step (SbS) e-mental health intervention for adults with depression. Step-by-Step is a 5-sessions, self-help, minimally guided digital program for adults with depression. Two Randomized Controlled Trials (RCTs) assessed its effectiveness and cost-effectiveness in the local setting. Methods Participants (n = 569 Syr, n = 680 Leb) were recruited online and randomly allocated to Step-by-Step (n = 283 Syr, n = 331), or Enhanced Care as Usual (n = 286 Syr, n = 349). The ECAU group received one-page psychoeducation and a referral list to services. Online assessments were administered at baseline, post-assessments at eight weeks after enrolment, and follow-up assessments at 20 weeks after enrolment. Primary outcomes were the Patient Health Questionnaire-9 and World Health Organization Disability Assessment Scale 2.0 scores at all post-assessments. Results Intention-to-treat analyses showed significant effects on depression scores (standardized mean differences, SMD: 0.71; 95% CI: 0.45 to 0.97 for Lebanese, and SMD: 0.48; 95% CI: 0.26; 0.70 for Syrians). Significant results were maintained on all secondary outcomes and at follow-up assessments. Conclusions SbS proved effective for depressive and functionality symptoms. Subsequently, it was adopted by MoPH as an official, free-of-charge, and first-line service for depression. A global version of SbS is currently being developed by WHO to be replicated and used in several settings worldwide. Key messages • This landmark study provided unique evidence on the effectiveness of guided-e-mental health interventions for the Lebanese and Syrian refugees affected by adversity in Lebanon. • This study guided the scaled-up of SbS into a widely accessible service among the general population.
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