Impact of Adherence to Digital Cognitive Behavioral Therapy for Insomnia Effectiveness

• Published in: Yonsei medical journal Vol. 66; no. 10; pp. 657 - 665
• Main Authors: Lee, Suonaa, Park, Kyung Mee, Lee, Do Hyun, Choi, Eun Chae, Lee, Yujin, Lee, Eun
• Format: Journal Article
• Language: English
• Published: Korea (South) 연세대학교의과대학 01.10.2025
• Subjects: Adult; Aged; Cognitive Behavioral Therapy - methods; Double-Blind Method; Female; Humans; Male; Middle Aged; Patient Compliance; Sleep - physiology; Sleep Initiation and Maintenance Disorders - therapy; Treatment Outcome; 의학일반; Adherence; cognitive behavioral therapy; digital therapeutics; insomnia
• ISSN: 0513-5796; 1976-2437; 1976-2437
• DOI: 10.3349/ymj.2024.0398

Although digital cognitive behavioral therapy for insomnia (dCBT-I) offers a promising solution to the accessibility limitations of traditional face-to-face CBT-I, few studies have examined dCBT-I against a sham app and adherence issues remain. This study assessed the efficacy of dCBT-I compared with a sham app and investigated whether adherence predicts sleep outcomes. In this combined analysis of two multicenter, double-blind, sham-controlled randomized controlled trials, 120 patients with insomnia were randomized to use the dCBT-I app (n=60) or a sham app (n=60). The primary outcome was the change in sleep efficiency (SE) from baseline after the 6-week intervention. The relationship between adherence to sleep restriction therapy (SRT) and sleep outcomes post-intervention was assessed. After adjusting for age, sex, sleep medication use, and baseline levels of each outcome variable, the dCBT-I group demonstrated better treatment outcomes than the sham app group, with significant improvements of 7.69% in SE [95% confidence interval (CI), 3.09% to 12.30%; =0.001], -16.77 minutes in sleep onset latency (95% CI, -31.48 to -2.06 minutes; =0.026), and -0.97 in dysfunctional beliefs about sleep (95% CI, -1.46 to -0.48; <0.001) from baseline. Poorer adherence to SRT was associated with reduced SE ( =0.006) and increased nighttime wakefulness ( =0.002) after controlling for age, sex, years of education, and the baseline value of each outcome variable. This combined analysis demonstrates the efficacy of dCBT-I in improving sleep outcomes compared with a sham app and highlights the role of adherence to SRT in enhancing treatment efficacy. The two studies were registered with ClinicalTrials.gov (NCT05822999, NCT05809544).