Telemedicine versus face-to-face delivery of cognitive behavioral therapy for insomnia: a randomized controlled noninferiority trial

Abstract Study Objectives In a randomized controlled noninferiority trial, we compared face-to-face and telemedicine delivery (via the AASM SleepTM platform) of cognitive-behavioral therapy (CBT) for insomnia for improving insomnia/sleep and daytime functioning at posttreatment and 3-month follow-up. A secondary objective compared the modalities on treatment credibility, satisfaction, and therapeutic alliance. Methods A total of 65 adults with chronic insomnia (46 women, 47.2 ± 16.3 years of age) were randomized to 6 sessions of CBT for insomnia delivered individually via AASM SleepTM (n = 33, CBT-TM) or face-to-face (n = 32, CBT-F2F). Participants completed sleep diaries, the Insomnia Severity Index (ISI), and daytime functioning measures at pretreatment, posttreatment, and 3-month follow-up. Treatment credibility, satisfaction, and therapeutic alliance were compared between treatment modalities. The ISI was the primary noninferiority outcome. Results Based on a noninferiority margin of four points on the ISI and, after adjusting for confounders, CBT-TM was noninferior to CBT-F2F at posttreatment (β = 0.54, SE = 1.10, 95% CI = 1.64 to 2.72) and follow-up (β = 0.34, SE = 1.10, 95% CI = 1.83 to 2.53). Daytime functioning measures, except the physical composite scale of the SF-12, were significantly improved at posttreatment and follow-up, with no difference between treatment formats. CBT-TM sessions were, on average, nearly 10 min shorter, yet participant ratings of therapeutic alliance were similar to CBT-F2F. Conclusions Telemedicine delivery of CBT for insomnia is not inferior to face-to-face for insomnia severity and yields similar improvements on other sleep and daytime functioning outcomes. Further, telemedicine allows for more efficient treatment delivery while not compromising therapeutic alliance. Clinical Trial Registration Number NCT03293745