A Randomized Controlled Trial With an Internal Pilot of a Co-Designed App Targeting Upstream Suicide-Related Risk and Protective Factors Among International Students.

چکیده اصلی

BACKGROUND: International students frequently report suicidal thoughts, yet often do not access support. Bud is a co-designed, self-guided mobile app developed as an upstream suicide-prevention intervention targeting transdiagnostic mechanisms related to suicide risk. AIM: To evaluate the effectiveness, acceptability, engagement, and safety of Bud compared with an active and structured psychoeducational comparator. MATERIALS AND METHODS: A two-arm, parallel-group randomized controlled trial was conducted with international students in Australia. Participants were randomized 1:1 to Bud (n = 156) or psychoeducational fact sheets (n = 156), completing assessments at baseline, 2 weeks and 4 weeks. The primary outcome was psychological distress (K10). Secondary outcomes included help-seeking intentions, interpersonal risk processes, emotion regulation, suicidal ideation, and mental health literacy. Analyses used intention-to-treat mixed-effects models. RESULTS: Contrary to the hypotheses, psychological distress decreased from baseline to 4 weeks (Bud: -2.23; Comparator: -2.15), with no group × time interaction (F(2,342.45) = 0.43, p = 0.652); emotion regulation and suicidal ideation showed similar patterns across groups, and other secondary outcomes remained stable across groups. As expected, Bud was rated as enjoyable, worthwhile, and usable. Engagement was moderate (median 10 activities), and no iatrogenic effects occurred. CONCLUSION: Bud was feasible, acceptable, and safe but did not outperform an active psychoeducational comparator over 4 weeks. TRIAL REGISTRATION: ClinicalTrials.gov identifier: ACTRN12625000584437.

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