Abstract

Background: Innovative solutions are required to provide mental health support at scale in low-resource humanitarian contexts. We aimed to assess the effectiveness of a guided self-help intervention (Self-Help Plus; SH+) to reduce psychological distress in female refugees. Methods: We conducted a cluster randomized trial in rural refugee settlements in northern Uganda. Participants were female South Sudanese refugees with at least moderate levels of psychological distress (cut-off ≥5 on the Kessler 6). Intervention comprised access to usual care and five 2-hour audio-recorded stress management workshops (20-30 refugees) led by briefly trained lay facilitators, accompanied by an illustrated self-help book. Villages were randomized on a 1:1 basis. Within 14 villages, randomly selected households were approached. Screening of women in households continued until 20-30 eligible participants were identified. The primary outcome was individual psychological distress, assessed using the Kessler 6 one-week before, one-week after, and three-months after intervention. Secondary outcomes included: personally-identified problems; posttraumatic stress; depression symptoms; feelings of anger; social interactions with other ethnic groups; functional impairment; and subjective well-being. Assessors were masked to allocation. Findings: Of 694 eligible participants (331 SH+, 363 EUC), 613 (88.3%) completed all assessments. We found stronger improvements for SH+ on psychological distress three months post-intervention (β = -1.20; p =0.04; 95% CI= -2.33, -.08, d= -0.26). We also found larger improvements for SH+ three months post-intervention for five of eight secondary outcomes (effect size range d=-0.30 to d=-0.36). Refugees with different trauma exposure, length of time in settlements, and initial psychological distress benefited similarly. Interpretation: An innovative guided self-help intervention that can be rapidly deployed to large numbers of participants resulted in meaningful reductions in psychological distress at three months among South Sudanese female refugees. Trial Registration: Prospectively registered at ISRCTN50148022 Funding Statement: This study was funded by the Research for Health in Humanitarian Crises (R2HC) Program, managed by Elhra (grant#12934). Declaration of Interests: None of the authors have conflicts of interests to disclose. Ethics Approval Statement: The project was approved by the MildMay Uganda Research Ethics Committee, the Uganda National Council for Science and Technology, and the WHO Ethical Review Committee and all participants provided informed consent.

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