Mode of Delivery of Cognitive Behaviour Therapy for Insomnia: A Randomized Controlled Non-Inferiority Trial of Digital or Face-to-Face Therapy

Abstract

Background: Digital CBT-I (dCBT-I) has demonstrated significant efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary care services. Methods: Parallel-group non-inferiority randomized controlled trial of fully automated dCBT-I versus FtF CBT-I. Eligible participants were adults with insomnia referred to a sleep clinic via public mental health services in Norway. The primary outcome measure was the Insomnia Severity Index (ISI). The non-inferiority margin was defined a priori as 2-points on the ISI at week 33 post-randomization i.e. dCBT-I is non-inferior if the 95% Confidence Interval (CI) for the mean difference is between -2 and ∞, whilst individual FtF CBT-I is superior if the 95% CI is between -∞ and 0. Secondary outcomes were tested using superiority analyses. These were sleep-wake variables, psychological distress and fatigue. Findings: Between October 2014 and January 2016, 101 patients from 288 potential participants were recruited. Individuals were randomized to FtF CBT-I (n=52) or dCBT-I (n=49); mean baseline ISI scores were 18·4 (SD 3·7) and 19·4 (SD 4·1) respectively. At week 33, 48 (92%) in the FtF CBT-I group and 41 (85%) in the dCBT-I group completed the ISI; the mean scores were 8·9 (SD 6·0) and 12·3 (SD 6·9) respectively. There was a significant time effect for both interventions (p<0·001); and the mean difference in ISI at week 33 was -2·8 (95% CI: -4·8 to -0·8; p=0·007). No significant differences were found on secondary outcomes. Interpretation: In a clinical sample, individual FtF CBT-I was superior to dCBT-I in reducing insomnia severity; however, both were associated with significant reductions in insomnia. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I. Trial Registration: ClinicalTrials.gov NCT02044263. Funding Statement: St. Olavs Hospital and SOVno. Declaration of Interests: Havard Kallestad, Jan Scott, Oystein Vedaa, Daniel Vethe, Gunnar Morken, Stian Lydersen, Tore C. Stiles, Borge Sivertsen, and Knut Langsrud: Declare no known conflicts of interest in relation to this research project and the submitted manuscript. Ethics Approval Statement: The protocol was approved by the Regional Ethical Committee of South-East Norway (Reference: 2013/1836).