Abstract
BACKGROUND: Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia treatment, but access is limited. Digital CBT-I (dCBT-I) may help to address this access issue. Numerous studies worldwide have demonstrated the beneficial effects of dCBT-I. However, there is a lack of studies comparing dCBT-I with a control group using the same interface. AIMS & OBJECTIVES: This study assessed the efficacy and the safety of the smartphone-based dCBT-I app compared with the sham app. METHODS: Data were pooled from 2 double-blind, sham-controlled RCT studies. A total of 120 patients with insomnia were randomized to dCBT-I app “WELT-I” (n=60) or a sham app (n=60) group. WELT-I is a multicomponent intervention such as sleep hygiene education, stimulus control, sleep restriction, cognitive restructuring, and relaxation therapy. The Sham app was designed to match WELT-I on installation, log-in, engagement, and delivery of content to ensure double-blindness, except the content had no therapeutic effect. The primary outcome was the change in sleep efficiency from baseline after 6 weeks of intervention. The first trial was a conventional trial with face-to-face onsite visits, and the second trial was a fully decentralized clinical trial (DCT) except for the informed consent, which was obtained onsite. RESULTS: The final analysis included 106 patients. Both the WELT-I and sham app groups exhibited improvements in sleep outcomes. The WELT-I group had a significantly greater improvement in sleep efficiency (SE) from baseline (63.5 %, standard deviation [SD] 14.9) to post-intervention (76.0 %, SD 14.5) than sham app group (from 59.6 % [SD 11.7] to 65.8 % [SD 14.6]; estimated mean difference 7.70 (95% confidence interval [CI] 3.1 to 12.3; partial η2 0.10; p=0.001). Sleep onset latency (SOL) was also significantly reduced in WELT-I group (from 58.64 min [SD 41.0] to 33.5 min [SD 45.3]) compared to sham app group (from 67.5 min [SD 50.7] to 54.1 min [SD 39.3]; estimated mean difference -16.7 (95% CI -31.4 to -2.0; partial η2 0.05; p=0.026). As for the safety assessment, no instances of temporarily halting the application of apps or fatalities occurred due to adverse events in WELT-I group. DISCUSSION & CONCLUSION: The results of this pooled analysis demonstrate the robust efficacy of dCBT-I app in improving insomnia symptoms. These findings support the possibility of widespread dissemination of dCBT-I. DCT can facilitate participant recruitment, reduce geographical barriers and provide a platform for evaluating the efficacy and safety of digital therapeutics. Future studies of DCT with larger sample sizes in real-world settings are needed to validate its efficacy and evaluate its generalizability REFERENCES: LEE, S., OH, J. W., PARK, K. M., LEE, S. &LEE, E. 2023. Digital cognitive behavioral therapy for insomnia on depression and anxiety: a systematic review and meta-analysis. npj Digital Medicine, 6, 52. VEDAA, Ø., KALLESTAD, H., SCOTT, J., SMITH, O. R. F., PALLESEN, S., MORKEN, G., LANGSRUD, K., GEHRMAN, P., THORNDIKE, F. P., RITTERBAND, L. M., HARVEY, A. G., STILES, T. &SIVERTSEN, B. 2020. Effects of digital cognitive behavioural therapy for insomnia on insomnia severity: a large-scale randomised controlled trial. Lancet Digit Health, 2, e397-e406.