Digital Cognitive–Behavioural Therapy for Insomnia (dCBT-I) Is Associated with Improved Sleep and Less Self-Report Use of Sleep Medication: A Large-Scale Randomized Controlled Trial

Abstract

Background: Although several large trials have demonstrated the efficacy of digital cognitive–behavioural therapy for insomnia (dCBT-I), there is a need to validate a far-reaching dissemination of dCBT-I on recommended key outcomes of insomnia. We aimed to investigate the effect of self-guided dCBT-I on insomnia severity, sleep-wake patterns, use of sleep medication, and daytime impairment. Methods: We did a parallel-group superiority randomised controlled trial (RCT) comparing digital CBT-I with online patient education about sleep (PE). Interventions were available from a free-to-access website with an online automated screening test. Primary outcome was ISI score at nine-week follow-up, and secondary outcomes included self-reported use of sleep medication, sleep diary measures, and measures of daytime impairment. Findings: A total of 1721 adults who scored ³12 on the Insomnia Severity Index (ISI) were randomized, 868 to dCBT-I and 853 to PE. At nine-week follow-up, 584 (67%) in the dCBT-I group and 534 (63%) in the PE group completed online self-report ratings. The dCBT-I group had a significantly greater reduction in the primary outcome of insomnia severity compared with the PE group (Cohen’s d = -1·21; 95% Confidence Interval [CI], -1·05 to -1·38; p < ·001). Compared with the PE intervention, the number needed to treat with dCBT-I was 2·7 (95% CI 2·4 to 3·2) for response and 3·2 (95% CI 2·8 to 3·8) for remission of insomnia. The dCBT-I group were significantly less likely to use sleep medication (secondary outcome) at follow-up, compared with the PE group (Odds ratio [OR] = 0·49; 95% CI, 0·23 to 0·74; p < ·001), and reported lower daytime impairment. Interpretation: A self-guided dCBT-I programme made widely accessible is effective in reducing both night-time and daytime impairments associated with the insomnia disorder, while also reducing the likelihood of using sleep medication. Trial Registration: This trial was registered with ClinicalTrials.gov, NCT02558647. Funding Statement: The Norwegian Research Council; grant number 239985 and the Liaison Committee for education, research and innovation in Central Norway; grant number 90061500. Declaration of Interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf. BS, HK, OV, ORFS, GM, SP, AGH, PG, KL, and TCS report no conflicts of interest. FPT and LMR report having a financial and/or business interest in BeHealth Solutions and Pear Therapeutics, two companies that develop and disseminate digital therapeutics, including by licensing the therapeutic developed, based in part, on early versions of the software utilized in research reported in the enclosed paper. These companies had no role in preparing this manuscript. LMR is also a consultant to Mahana Therapeutics, a separate digital therapeutic company not affiliated with this research. Some of the research in this paper was conducted while FPT was a faculty member at the University of Virginia. At that time for FPT, and ongoing for LMR, the terms of these arrangements have been reviewed and approved by the University of Virginia in accordance with its policies. Ethical Approval Statement: The trial protocol was approved by the Regional Committees for Medical and Health Research Ethics in South East Norway (2015/134).