Efficacy and acceptability of digital safety planning therapy for self‐injurious thoughts and behaviors in adolescents with depressive episodes: a randomized controlled trial

BACKGROUND: Self-injurious thoughts and behaviors (SITB) represent a significant mental health issue among Chinese adolescents. Research on smartphone-based safety planning as digital therapeutics for SITB in China remains limited. This randomized controlled trial evaluated the efficacy and acceptability of a safety planning mobile application (LIFES) for reducing SITB in adolescents with depressive episodes. METHODS: Among 189 adolescents with depressive episodes screened, 122 were randomized to either the intervention group (LIFES app plus treatment as usual [TAU], n = 61) or the control group (TAU only, n = 61). Follow-up assessments at 1, 3, and 6 months measured SITB, depression, anxiety, and sleep quality. This trial is registered with the Chinese Clinical Trial Registry (ChiCTR2300075663; https://www.chictr.org.cn/). RESULTS: Generalized linear mixed models showed significant time-by-group interaction effects for non-suicidal self-injury frequency (F = 3.39, p = .018), suicide planning seriousness (F = 2.93, p = .034), confidence in suicide completion during preparation (F = 3.10, p = .027), suicide threat/gesture frequency (F = 3.64, p = .013), and total suicidal behavior frequency (F = 3.31, p = .020) after adjusting for depression and anxiety symptom severity, sleep quality, and years of education. The intervention group showed significantly greater reductions in SITB characteristics compared to the control group. User experience surveys indicated good satisfaction with the application. CONCLUSIONS: This study demonstrates that safety planning-based digital therapeutics are an effective adjunctive intervention for SITB in adolescents with depressive episodes. Future research should examine the applicability of this intervention to broader populations.