Mobile App–Based Interventions for Clinical Insomnia: A Systematic Review and Meta-analysis (Preprint)

BACKGROUND Insomnia is a prevalent and disabling condition with considerable public health implications. While cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, access is limited. Mobile app–based interventions offer a potentially scalable alternative, yet their effectiveness in individuals with clinically significant insomnia remains under-examined. OBJECTIVE This review aimed to evaluate the efficacy of mobile app–based interventions in reducing insomnia severity among adults with clinical insomnia. Secondary objectives included exploring changes in sleep parameters, treatment adherence, adverse events, and potential moderators of treatment outcomes. METHODS A systematic search of seven electronic databases and grey literature sources was conducted through March 2025. Eligible studies were randomized controlled trials (RCTs) involving adults (≥18 years) with clinical insomnia who received app-based interventions. The primary outcome was post-treatment insomnia severity measured by validated scales. A random-effects meta-analysis was performed. Sensitivity analyses, subgroup analyses, and meta-regression were conducted to examine heterogeneity and potential moderators. RESULTS Thirteen RCTs (N=2,573) met inclusion criteria. The pooled standardized mean difference (SMD) for insomnia severity was –0.81 (95% CI: –0.99 to –0.63), indicating a large treatment effect favoring mobile interventions. Sensitivity analyses confirmed the robustness of findings. Meta-regression did not identify significant moderators. Secondary outcomes showed modest improvements in sleep onset latency (SMD = –0.37), wake after sleep onset (SMD = –0.41), and sleep efficiency (SMD = +0.42), with no significant change in total sleep time. Adverse events were infrequent and typically unrelated to the intervention. Attrition ranged from 0% to 39%. CONCLUSIONS Mobile app–based interventions are effective for reducing insomnia severity in adults with clinical insomnia. These findings support their integration into stepped-care approaches, particularly where access to therapist-guided CBT-I is limited. Further research is needed to optimize app features, assess long-term outcomes, and evaluate effectiveness in psychiatric populations. CLINICALTRIAL PROSPERO CRD42023494699