A comparative randomized controlled trial of digital cognitive behavioral therapy for insomnia with and without human therapist support

Abstract

Digital cognitive behavioral therapy for insomnia (dCBTi) is an alternative delivery approach to conventional cognitive behavioral therapy for insomnia (CBTi), a first-line treatment for insomnia disorder recommended by clinical practice guidelines. Despite its established efficacy, there is currently no research that directly examines and compares intervention efficacy and adherence of automated virtual support with or without human support. There is also no research that specifically examines and compares intervention efficacy and adherence of automated virtual support with human therapist support as an addition or with human assistant support as an addition. The current three-arm, parallel, comparative superiority study evaluated the efficacy and adherence of a dCBTi smartphone app (Sleep Sensei) with different types of coaching support using a randomized controlled trial (RCT). Sixty-three adults with insomnia were randomized to one of the three conditions – fully automated virtual coach with human therapist support as an addition (C1), fully automated virtual coach with human assistant support as an addition (C2), and fully automated virtual coach only (C3). Outcome measures were administered at three assessment time points – baseline (T1), immediate post-intervention (T2), four-week post-intervention follow-up (T3). Participants also filled out daily sleep diaries throughout the 12-week study period. Intention to treat analysis was conducted with two-way mixed-design ANOVAs. Results regarding efficacy revealed significant condition-by-time interaction in dysfunctional beliefs and attitudes related to sleep (DBAS-16), sleep efficiency (SE), and fatigue (FAS), but not in other insomnia, sleep, and mental health measures. DBAS-16 was statistically significantly reduced in C1 compared to C3 at T2 and T3. Results regarding adherence revealed significant condition-by-time interaction in the total number of intervention videos, sessions, daily sleep diaries completed. Adherence was statistically significantly higher in C1 compared to C3. Taken together, these findings suggest that dCBTi with fully automated virtual support might be sufficient in rendering intervention efficacy. In circumstances where improving DBAS-16 efficacy and intervention adherence are the foci, human therapist support on top of dCBTi with automated virtual support could be indicated.