Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial

Abstract

Importance: Digital cognitive behavioral therapy (dCBT) is a scalable and effective intervention for treating insomnia. Most people with insomnia, however, seek help because of the daytime consequences of poor sleep, which adversely affects quality of life.

Objectives: To investigate the effect of dCBT for insomnia on functional health, psychological well-being, and sleep-related quality of life and to determine whether a reduction in insomnia symptoms was a mediating factor.

Design, setting, and participants: This online, 2-arm, parallel-group randomized trial comparing dCBT for insomnia with sleep hygiene education (SHE) evaluated 1711 participants with self-reported symptoms of insomnia. Participants were recruited between December 1, 2015, and December 1, 2016, and dCBT was delivered using web and/or mobile channels plus treatment as usual; SHE comprised a website and a downloadable booklet plus treatment as usual. Online assessments took place at 0 (baseline), 4 (midtreatment), 8 (posttreatment), and 24 (follow-up) weeks. Programs were completed within 12 weeks after inclusion.

Main outcomes and measures: Primary outcomes were scores on self-reported measures of functional health (Patient-Reported Outcomes Measurement Information System: Global Health Scale; range, 10-50; higher scores indicate better health); psychological well-being (Warwick-Edinburgh Mental Well-being Scale; range, 14-70; higher scores indicate greater well-being); and sleep-related quality of life (Glasgow Sleep Impact Index; range, 1-100; higher scores indicate greater impairment). Secondary outcomes comprised mood, fatigue, sleepiness, cognitive failures, work productivity, and relationship satisfaction. Insomnia was assessed with the Sleep Condition Indicator (range: 0-32; higher scores indicate better sleep).

Results: Of the 1711 participants included in the intention-to-treat analysis, 1329 (77.7%) were female, mean (SD) age was 48.0 (13.8) years, and 1558 (91.1%) were white. Use of dCBT was associated with a small improvement in functional health compared with SHE (adjusted difference [95% CI] at week 4, 0.90 [0.40-1.40]; week 8, 1.76 [1.24-2.28]; week 24, 1.76 [1.22-2.30]) and psychological well-being (adjusted difference [95% CI] at week 4, 1.04 [0.28-1.80]; week 8, 2.68 [1.89-3.47]; week 24, 2.95 [2.13-3.76]), and with a large improvement in sleep-related quality of life (at week 4, -8.76 [-11.83 to -5.69]; week 8, -17.60 [-20.81 to -14.39]; week 24, -18.72 [-22.04 to -15.41]) (all P < .01). A large improvement in insomnia mediated these outcomes (range mediated, 45.5%-84.0%).

Conclusions and relevance: Use of dCBT is effective in improving functional health, psychological well-being, and sleep-related quality of life in people reporting insomnia symptoms. A reduction in insomnia symptoms mediates these improvements. These results confirm that dCBT improves both daytime and nighttime aspects of insomnia, strengthening existing recommendations of CBT as the treatment of choice for insomnia.

Trial registration: isrctn.org identifier: ISRCTN60530898.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Espie reports being a cofounder, chief medical officer, and shareholder of and receiving salary from Big Health Ltd and being a developer of Sleepio. Drs Kyle and Drake report receiving nonfinancial support from Big Health Ltd (provision of Sleepio for use in clinical trials). Dr Cape reports providing clinical advice and support to Sleepio and receiving payment from Big Health Ltd. Dr Ong reports receiving nonfinancial support from Big Health Ltd (provision of Sleepio for use in clinical trials), providing consultancy support for Sleepio, and receiving payment from Big Health Ltd. Dr Sheaves reports providing monthly support for an online discussion forum run by Sleepio and receiving payment from Big Health Ltd. Dr Freeman reports being a cofounder of the University of Oxford spinout company, Oxford VR; receiving nonfinancial support from Big Health Ltd (provision of Sleepio for use in clinical trials); and being supported by an NIHR Research Professorship. Dr Luik held a research position at the University of Oxford during the conduct of the study that was funded by Big Health Ltd. No other conflicts were reported.

Figures

Figure.. Trial Design for the Digital Insomnia Therapy to Assist Your Life as Well as Your Sleep (DIALS) Study

dCBT indicates digital cognitive behavioral therapy; SHE, sleep hygiene education.