title: Digital Cognitive Behavioural Therapy for Insomnia versus sleep hygiene education: the impact of improved sleep on functional health, quality of life and psychological well-being. Study protocol for a randomised controlled trial.
abstract: 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. 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.
  
  
  
  We 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.
  
  
  
  This 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.
  
  
  
  ISRCTN60530898 .
authors.affiliation: Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Sir William Dunn School of Pathology, Oxford, UK. colin.espie@ndcn.ox.ac.uk.|Big Health Ltd., London, UK. colin.espie@ndcn.ox.ac.uk.
authors.forename: Colin A
authors.initials: CA
authors.lastname: Espie
authors.affiliation: Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Sir William Dunn School of Pathology, Oxford, UK.|Big Health Ltd., London, UK.
authors.forename: Annemarie I
authors.initials: AI
authors.lastname: Luik
authors.affiliation: Big Health Ltd., London, UK.|Division of Psychology and Language Sciences, Faculty of Brain Sciences, University College London, London, UK.
authors.forename: John
authors.initials: J
authors.lastname: Cape
authors.affiliation: Department of Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI, USA.
authors.forename: Christopher L
authors.initials: CL
authors.lastname: Drake
authors.affiliation: School of Health and Social Care, University of Lincoln, Lincoln, UK.
authors.forename: A Niroshan
authors.initials: AN
authors.lastname: Siriwardena
authors.affiliation: Rush University Medical Center, Chicago, IL, USA.
authors.forename: Jason C
authors.initials: JC
authors.lastname: Ong
authors.affiliation: CIRUS Centre for Integrated Research and Understanding of Sleep, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.
authors.forename: Christopher
authors.initials: C
authors.lastname: Gordon
authors.affiliation: Big Health Ltd., London, UK.
authors.forename: Sophie
authors.initials: S
authors.lastname: Bostock
authors.affiliation: Big Health Ltd., London, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Hames
authors.affiliation: Big Health Ltd., London, UK.
authors.forename: Mhairi
authors.initials: M
authors.lastname: Nisbet
authors.affiliation: Sleep and Circadian Neuroscience Institute, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.
authors.forename: Bryony
authors.initials: B
authors.lastname: Sheaves
authors.affiliation: Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Sir William Dunn School of Pathology, Oxford, UK.
authors.forename: Russell
authors.initials: R
authors.lastname: G Foster
authors.affiliation: Sleep and Circadian Neuroscience Institute, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.
authors.forename: Daniel
authors.initials: D
authors.lastname: Freeman
authors.affiliation: The London School of Economics and Political Science, London, UK.
authors.forename: Joan
authors.initials: J
authors.lastname: Costa-Font
authors.affiliation: Centre for Biostatistics, Institute of Population Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Emsley
authors.affiliation: Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Sir William Dunn School of Pathology, Oxford, UK.
authors.forename: Simon D
authors.initials: SD
authors.lastname: Kyle
mesh_terms: D006801:Humans; D015928:Cognitive Behavioral Therapy / Q000379:methods; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006304:Health Status; D057194:Intention to Treat Analysis; D020407:Internet; D010353:Patient Education as Topic / Q000379:methods; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D000070263:Sleep Hygiene; D007319:Sleep Initiation and Maintenance Disorders / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy; D013813:Therapy, Computer-Assisted; D013997:Time Factors; D016896:Treatment Outcome; D016032:Randomized Controlled Trials as Topic
keywords: CBT; Digital; Function; Health; Insomnia; Sleep; well-being