Accepted for Publication: August 4, 2018.
Corresponding Author: Colin A. Espie, PhD, Sleep & Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Sir William Dunn School of Pathology, South Parks Road, Oxford OX1 3RE, United Kingdom (colin.espie@ndcn.ox.ac.uk).
Published Online: September 25, 2018. doi:10.1001/jamapsychiatry.2018.2745
Author Contributions: Dr Espie had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Espie, Kyle, Gordon, Drake, Siriwardena, Cape, Ong, Sheaves, Foster, Freeman, Costa-Font, Luik.
Acquisition, analysis, or interpretation of data: Emsley, Kyle, Gordon, Drake, Costa-Font, Marsden, Luik.
Drafting of the manuscript: Espie, Emsley, Kyle, Marsden, Luik.
Critical revision of the manuscript for important intellectual content: Espie, Emsley, Kyle, Gordon, Drake, Siriwardena, Cape, Ong, Sheaves, Foster, Freeman, Costa-Font, Luik.
Statistical analysis: Emsley, Marsden.
Administrative, technical, or material support: Kyle, Gordon, Siriwardena, Sheaves, Freeman, Luik.
Supervision: Espie, Gordon, Costa-Font.
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.
Funding/Support: The study was funded by Big Health Ltd. The work was supported in part by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, NIHR Oxford Health Biomedical Research Centre, NIHR Biomedical Research Centre at South London, Maudsley National Health Service (NHS) Foundation Trust, King’s College London, and the Dr Mortimer & Theresa Sackler Foundation.
Role of the Funder/Sponsor: Big Health Ltd was involved in the design and conduct of the study; collection, management, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The funder was not involved in the analysis of the data. Other funders had no role in the design and conduct of the study, collection of the data, data analysis, management, interpretation, or review or approval of the manuscript.
Disclaimer: The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Dr Freeman is supported by an NIHR Research Professorship.
Meeting Presentation: This paper was presented at the 24th Congress of the European Sleep Research Society; September 25, 2018; Basel, Switzerland.
Additional Contribution: Alasdair Henry, PhD, Big Health Ltd, helped with formatting the manuscript, which was performed as part of his regular duties; he was not additionally compensated. Sleepio was provided to participants at no cost. The study was conducted at the University of Oxford, Sleep & Circadian Neuroscience Institute. The University of Oxford has a memorandum of understanding with Big Health for the conduct of joint research.
1.American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Association; 2013.
3.Lichstein
KL. Epidemiology of Sleep: Age, Gender, and Ethnicity. Mahwah, NJ: Lawrence Erlbaum Assoc; 2004.
4.Morphy
H, Dunn
KM, Lewis
M, Boardman
HF, Croft
PR. Epidemiology of insomnia: a longitudinal study in a UK population.
Sleep. 2007;30(3):274-280.
PubMedGoogle Scholar 7.Vgontzas
AN, Liao
D, Pejovic
S, Calhoun
S, Karataraki
M, Bixler
EO. Insomnia with objective short sleep duration is associated with type 2 diabetes: a population-based study.
Diabetes Care. 2009;32(11):1980-1985. doi:
10.2337/dc09-0284PubMedGoogle ScholarCrossref 8.Cappuccio
FP, D’Elia
L, Strazzullo
P, Miller
MA. Quantity and quality of sleep and incidence of type 2 diabetes: a systematic review and meta-analysis.
Diabetes Care. 2010;33(2):414-420. doi:
10.2337/dc09-1124PubMedGoogle ScholarCrossref 10.Espie
CA, Kyle
SD, Hames
P, Cyhlarova
E, Benzeval
M. The daytime impact of
DSM-5 insomnia disorder: comparative analysis of insomnia subtypes from the Great British Sleep Survey.
J Clin Psychiatry. 2012;73(12):e1478-e1484. doi:
10.4088/JCP.12m07954PubMedGoogle ScholarCrossref 11.Roth
T, Ancoli-Israel
S. Daytime consequences and correlates of insomnia in the United States: results of the 1991 National Sleep Foundation Survey: II.
Sleep. 1999;22(suppl 2):S354-S358.
PubMedGoogle Scholar 13.Qaseem
A, Kansagara
D, Forciea
MA, Cooke
M, Denberg
TD; Clinical Guidelines Committee of the American College of Physicians. Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians.
Ann Intern Med. 2016;165(2):125-133. doi:
10.7326/M15-2175PubMedGoogle ScholarCrossref 15.Wilson
SJ, Nutt
DJ, Alford
C,
et al. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders.
J Psychopharmacol. 2010;24(11):1577-1601. doi:
10.1177/0269881110379307PubMedGoogle ScholarCrossref 16.National Institutes of Health. NIH State-of-the-Science Conference Statement on manifestations and management of chronic insomnia in adults.
NIH Consens State Sci Statements. 2005;22(2):1-30.
PubMedGoogle Scholar 23.Peoples
AR, Garland
SN, Perlis
ML,
et al. Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial.
J Cancer Surviv. 2017;11(3):401-409. doi:
10.1007/s11764-017-0597-0PubMedGoogle ScholarCrossref 25.Van Houdenhove
L, Buyse
B, Gabriëls
L, Van den Bergh
O. Treating primary insomnia: clinical effectiveness and predictors of outcomes on sleep, daytime function and health-related quality of life.
J Clin Psychol Med Settings. 2011;18(3):312-321. doi:
10.1007/s10880-011-9250-7PubMedGoogle ScholarCrossref 26.Palermo
TM, Beals-Erickson
S, Bromberg
M, Law
E, Chen
M. A single arm pilot trial of brief cognitive behavioral therapy for insomnia in adolescents with physical and psychiatric comorbidities.
J Clin Sleep Med. 2017;13(3):401-410. doi:
10.5664/jcsm.6490PubMedGoogle ScholarCrossref 29.Espie
CA, Fleming
L, Cassidy
J,
et al. Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.
J Clin Oncol. 2008;26(28):4651-4658. doi:
10.1200/JCO.2007.13.9006PubMedGoogle ScholarCrossref 30.Espie
CA, Kyle
SD, Miller
CB, Ong
J, Hames
P, Fleming
L. Attribution, cognition and psychopathology in persistent insomnia disorder: outcome and mediation analysis from a randomized placebo-controlled trial of online cognitive behavioural therapy.
Sleep Med. 2014;15(8):913-917. doi:
10.1016/j.sleep.2014.03.001PubMedGoogle ScholarCrossref 31.Pillai
V, Anderson
JR, Cheng
P,
et al. The anxiolytic effects of cognitive behavior therapy for insomnia: preliminary results from a web-delivered protocol.
J Sleep Med Disord. 2015;2(2):1017.
Google Scholar 32.Manber
R, Edinger
JD, Gress
JL, San Pedro-Salcedo
MG, Kuo
TF, Kalista
T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia.
Sleep. 2008;31(4):489-495. doi:
10.1093/sleep/31.4.489PubMedGoogle ScholarCrossref 35.Alessi
C, Martin
JL, Fiorentino
L,
et al. Cognitive behavioral therapy for insomnia in older veterans using nonclinician sleep coaches: randomized controlled trial.
J Am Geriatr Soc. 2016;64(9):1830-1838. doi:
10.1111/jgs.14304PubMedGoogle ScholarCrossref 36.Omvik
S, Sivertsen
B, Pallesen
S, Bjorvatn
B, Havik
OE, Nordhus
IH. Daytime functioning in older patients suffering from chronic insomnia: treatment outcome in a randomized controlled trial comparing CBT with zopiclone.
Behav Res Ther. 2008;46(5):623-641. doi:
10.1016/j.brat.2008.02.013PubMedGoogle ScholarCrossref 38.Espie
CA, Luik
AI, Cape
J,
et al. 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.
Trials. 2016;17(1):257. doi:
10.1186/s13063-016-1364-7PubMedGoogle ScholarCrossref 43.Espie
CA, Kyle
SD, Williams
C,
et al. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application.
Sleep. 2012;35(6):769-781. doi:
10.5665/sleep.1872PubMedGoogle ScholarCrossref 45.Espie
CA, MacMahon
KM, Kelly
HL,
et al. Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice.
Sleep. 2007;30(5):574-584. doi:
10.1093/sleep/30.5.574PubMedGoogle ScholarCrossref 46.Espie
CA. Overcoming Insomnia and Sleep Problems: A Self-help Guide Using Cognitive Behavioral Techniques. London, UK: Constable & Robinson Ltd; 2006.
50.Cheng
P, Luik
AI, Fellman-Couture
C,
et al. The efficacy of digital CBT for insomnia to reduce depression across demographic groups: a randomized controlled trial [published online May 24, 2018].
Psychol Med. doi:
10.1017/S0033291718001113PubMedGoogle Scholar 51.American Academy of Sleep Medicine. How to Sleep Better. Darien, IL: American Academy of Sleep Medicine; 2012.
52.Hays
RD, Bjorner
JB, Revicki
DA, Spritzer
KL, Cella
D. Development of physical and mental health summary scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) global items.
Qual Life Res. 2009;18(7):873-880. doi:
10.1007/s11136-009-9496-9PubMedGoogle ScholarCrossref 54.Kyle
SD, Crawford
MR, Morgan
K, Spiegelhalder
K, Clark
AA, Espie
CA. The Glasgow Sleep Impact Index (GSII): a novel patient-centred measure for assessing sleep-related quality of life impairment in insomnia disorder.
Sleep Med. 2013;14(6):493-501. doi:
10.1016/j.sleep.2012.10.023PubMedGoogle ScholarCrossref 57.Gradisar
M, Lack
L, Richards
H,
et al. The Flinders Fatigue Scale: preliminary psychometric properties and clinical sensitivity of a new scale for measuring daytime fatigue associated with insomnia.
J Clin Sleep Med. 2007;3(7):722-728.
PubMedGoogle Scholar 67.Dunn
G, Emsley
R, Liu
H,
et al. Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme.
Health Technol Assess. 2015;19(93):1-115, v-vi. doi:
10.3310/hta19930PubMedGoogle ScholarCrossref