Applying a mobile intervention for chronic insomnia in routine care: Study protocol for a multicenter randomized controlled trial.

Unlabelled: Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment for chronic insomnia. However, access to in-person CBT-I remains limited due to a shortage of trained providers and structural barriers. Digital CBT-I (dCBT-I) offers a scalable solution to bridge this treatment gap, yet real-world evidence of its effectiveness remains limited. This study aims to examine the effectiveness of a mobile dCBT-I intervention, "SleepQ," in a routine clinical setting. This study is a multicenter, two-arm, open-label, randomized controlled trial comparing a mobile dCBT-I intervention to a waitlist control group. A total of 120 adults with chronic insomnia will be recruited from six clinics in South Korea. Participants will be randomly assigned (1:1) to either the intervention group receiving 6 weeks of dCBT-I or the control group, which will gain access to the intervention after the posttreatment assessment. The primary outcome is the Insomnia Severity Index score change from baseline to 6 weeks post-randomization. Secondary outcomes include dysfunctional sleep beliefs, daytime sleepiness, depressive and anxiety symptoms, quality of life, and work productivity. Exploratory outcomes include adherence, usability, app satisfaction, and sleep parameters from the integrated sleep diary. In the intervention group, follow-up assessments will be conducted 3- and 6-months post-randomization to evaluate long-term effects. This trial will evaluate the effectiveness of mobile dCBT-I for chronic insomnia within routine clinical care. Findings will contribute to the evaluation of the clinical implementation of digital therapeutics for insomnia and inform the integration of mobile-based CBT-I into routine care.

Clinical Trial Registration: https://clinicaltrials.gov/study/NCT06695000, ClinicalTrials.gov (NCT06695000).