A randomized controlled comparative trial of digital cognitive behavioral therapy for insomnia with or without virtual coaching

Abstract

The present study aims to contribute to the evidence-base for developing and selecting entry level CBT-I interventions. A fully automated mobile-app-based CBT-I intervention (dCBT-I) was developed with an additional rule-based text-messaging chatbot that mimics therapist coaching. A randomised controlled comparative study that used a three-arm parallel group design with repeated measures at three time points was conducted in a community adult population. Linear mixed modelling was used to examine the treatment effectiveness of (1) dCBT-I compared with an active control and (2) dCBT-I with and without a virtual coaching function, and independent t-tests were used to examine the differences in treatment adherence between the two formats of dCBT-I. The primary outcome measure was insomnia severity measured by ISI, and the secondary outcome measures included sleep variables, insomnia symptom severity, daytime sleepiness, fatigue, dysfunctional sleep-related cognitions, maladaptive sleep-related behaviours, depressive and anxiety symptoms and life satisfaction. Results revealed a significant interaction of time and condition from baseline to posttreatment when comparing dCBT-I with control for insomnia symptom severity, sleep onset latency, wake at sleep onset, sleep efficiency, dysfunctional sleep-related cognitions, maladaptive sleep-related behaviours, as well as depressive and anxiety symptoms. There was also a significant time and condition interaction for maladaptive sleep-related behaviours, fatigue and depressive symptoms from baseline to 1-month follow-up. Although there was a significant time and condition interaction when comparing dCBT-I with and without virtual coaching in sleep onset latency, dCBT-I with virtual coaching was not found to be more effective. Besides, there were no significant differences in treatment adherence. Limitations of the present study and recommendations for further research were discussed.