Abstract
BackgroundPrevious research has demonstrated that digital CBT (dCBT), delivered via the Internet, is a scalable and effective intervention for treating insomnia in otherwise healthy adults and leads to significant improvements in primary outcomes relating to sleep. The majority of people with insomnia, however, seek help because of the functional impact and daytime consequences of poor sleep, not because of sleep discontinuity per se. Although some secondary analyses suggest that dCBT may have wider health benefits, no adequately powered study has investigated these as a primary endpoint. This study specifically aims to investigate the impact of dCBT for insomnia upon health and well-being, and will investigate sleep-related changes as mediating factors.Methods/designWe propose a pragmatic, parallel-group, randomised controlled trial of 1000 community participants meeting criteria for insomnia disorder. In the DIALS trial (Digital Insomnia therapy to Assist your Life as well as your Sleep), participants will be randomised to dCBT delivered using web and/or mobile channels (in addition to treatment as usual (TAU)) or to sleep hygiene education (SHE), comprising a website plus a downloadable booklet (in addition to TAU). Online assessments will take place at 0 (baseline), 4 (mid-treatment), 8 (post-treatment), and 24 (follow-up) weeks. At week 25 all participants allocated to SHE will be offered dCBT, at which point the controlled element of the trial will be complete. Naturalistic follow-up will be invited at weeks 36 and 48. Primary outcomes are functional health and well-being at 8 weeks. Secondary outcomes are mood, fatigue, sleepiness, cognitive function, productivity and social functioning. All main analyses will be carried out at the end of the final controlled follow-up assessments and will be based on the intention-to-treat principle. Further analyses will determine whether observed changes in functional health and well-being are mediated by changes in sleep. The trial is funded by Big Health Ltd.DiscussionThis study will be the first large-scale, specifically designed investigation of the health and well-being benefits of CBT for insomnia, and the first examination of the association between CBT-mediated sleep improvement and health status.Trial registrationISRCTN60530898.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1364-7) contains supplementary material, which is available to authorized users.
Highlights
Previous research has demonstrated that digital Cognitive behavioural therapy (CBT), delivered via the Internet, is a scalable and effective intervention for treating insomnia in otherwise healthy adults and leads to significant improvements in primary outcomes relating to sleep
The importance of insomnia Insomnia disorder comprises a complaint of poor sleep, with associated significant daytime effects, occurring at least 3 nights per week for at least 3 months [1]
Considered as ‘secondary’, subsumed as symptoms of other clinical diagnoses within mental health care, the recently revised Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5) outlines the ‘need for independent clinical attention of a sleep disorder’ (p. 1) [1]. This is supported by research demonstrating that rates of mental and physical health co-morbidity are high, but that pre-existing chronic insomnia is an independent risk factor for development of depression [6], cardiovascular disease [7] and type 2 diabetes [8, 9]
Summary
Previous research has demonstrated that digital CBT (dCBT), delivered via the Internet, is a scalable and effective intervention for treating insomnia in otherwise healthy adults and leads to significant improvements in primary outcomes relating to sleep. This study aims to investigate the impact of dCBT for insomnia upon health and well-being, and will investigate sleep-related changes as mediating factors. The importance of insomnia Insomnia disorder comprises a complaint of poor sleep, with associated significant daytime effects, occurring at least 3 nights per week for at least 3 months [1]. Epidemiologic studies report the prevalence of a chronic clinical insomnia disorder at 10 to 12 % [2,3,4]. This is supported by research demonstrating that rates of mental and physical health co-morbidity are high, but that pre-existing chronic insomnia is an independent risk factor for development of depression [6], cardiovascular disease [7] and type 2 diabetes [8, 9]. From the standpoint of public health and well-being, sleep appears to be a more important matter than has been hitherto recognised [10, 11]
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