A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application

Colin A Espie, Simon D Kyle, Chris Williams, Jason C Ong, Neil J Douglas, Peter Hames, June S L Brown, Colin A Espie, Simon D Kyle, Chris Williams, Jason C Ong, Neil J Douglas, Peter Hames, June S L Brown

Abstract

Study objectives: The internet provides a pervasive milieu for healthcare delivery. The purpose of this study was to determine the effectiveness of a novel web-based cognitive behavioral therapy (CBT) course delivered by an automated virtual therapist, when compared with a credible placebo; an approach required because web products may be intrinsically engaging, and vulnerable to placebo response.

Design: Randomized, placebo-controlled trial comprising 3 arms: CBT, imagery relief therapy (IRT: placebo), treatment as usual (TAU).

Setting: Online community of participants in the UK.

Participants: One hundred sixty-four adults (120 F: [mean age 49y (18-78y)] meeting proposed DSM-5 criteria for Insomnia Disorder, randomly assigned to CBT (n = 55; 40 F), IRT placebo (n = 55; 42 F) or TAU (n = 54; 38 F).

Interventions: CBT and IRT each comprised 6 online sessions delivered by an animated personal therapist, with automated web and email support. Participants also had access to a video library/back catalogue of session content and Wikipedia style articles. Online CBT users had access to a moderated social network/community of users. TAU comprised no restrictions on usual care and access to an online sleep diary.

Measurements and results: Major assessments at baseline, post-treatment, and at follow-up 8-weeks post-treatment; outcomes appraised by online sleep diaries and clinical status. On the primary endpoint of sleep efficiency (SE; total time asleep expressed as a percentage of the total time spent in bed), online CBT was associated with sustained improvement at post-treatment (+20%) relative to both TAU (+6%; d = 0.95) and IRT (+6%: d = 1.06), and at 8 weeks (+20%) relative to IRT (+7%: d = 1.00) and TAU (+9%: d = 0.69) These findings were mirrored across a range of sleep diary measures. Clinical benefits of CBT were evidenced by modest superiority over placebo on daytime outcomes (d = 0.23-0.37) and by substantial improved sleep-wake functioning on the Sleep Condition Indicator (range of d = 0.77-1.20). Three-quarters of CBT participants (76% [CBT] vs. 29% [IRT] and 18% [TAU]) completed treatment with SE > 80%, more than half (55% [CBT] vs. 17% [IRT] and 8% [TAU]) with SE > 85%, and over one-third (38% [CBT] vs. 6% [IRT] and 0% [TAU]) with SE > 90%; these improvements were largely maintained during follow-up.

Conclusion: CBT delivered using a media-rich web application with automated support and a community forum is effective in improving the sleep and associated daytime functioning of adults with insomnia disorder.

Clinical trial registration: ISRCTN - 44615689.

Keywords: Insomnia; Sleep; animated; app; application; automated; internet; online; psychological intervention; psychological treatment; rich media; sleep; treatment; virtual; web.

Figures

Figure 1
Figure 1
Flow of Participants in the Trial.
Figure 2
Figure 2
Percentage of patients within each treatment arm achieving sleep efficiency (SE) clinical end-points.

References

    1. Singleton N, Bumpstead R, O'Brien M, et al. Psychiatric morbidity among adults living in private households, 2000. London: The Office for National Statistics, HMSO; 2001.
    1. Ohayon MM. Epidemiology of Insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6:97–111.
    1. Lichstein KL, Durrence HH, Reidel BW, et al. The epidemiology of sleep: age, gender and ethnicity. Mahwah, NJ: Lawrence Erlbaum Associates; 2004.
    1. Morin CM, Belanger L, LeBlanc M, et al. The natural history of insomnia: A population-based 3-year longitudinal study. Arch Intern Med. 2009;169:447–53.
    1. American Academy of Sleep Medicine. Westchester, IL: American Academy of Sleep Medicine; 2005. International classification of sleep disorders: diagnostic and coding manual: 2nd ed.
    1. Washington: American Psychiatric Association; 1994. Diagnostic and Statistical Manual of Mental Disorders, 4th ed (DSM-IV)
    1. Morgan K. Factors influencing persistent subjective insomnia in old age: a follow study of good and poor sleepers age 65-74. Age Ageing. 1989;18:17–125.
    1. Roth T, Ancoli-Israel S. Daytime consequences of insomnia in the United States: Results of the 1991 National Sleep Foundation Survey II. Sleep. 1999;22(Suppl 2):S354–63.
    1. Kyle SD, Morgan K, Espie C. Insomnia and health-related quality of life. Sleep Med Rev. 2010;14:69–82.
    1. Cole MG, Dendukuri N. Risk factors for depression among elderly community subjects: a systematic review and meta-analysis. Am J Psychiatry. 2003;160:1147–56.
    1. Baglioni C, Battagliese G, Feige B, et al. Insomnia as a predictor of depression: A meta-analytic evaluation of longitudinal epidemiological studies. J Affect Disord. 2011;135:10–19.
    1. Vgontzas AN, Liao D, Bixler EO, Chrousos GP, Vela-Bueno A. Insomnia with objective short sleep duration is associated with a high risk for hypertension. Sleep. 2009;32:491–7.
    1. 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;32:1980–5.
    1. Dew MA, Hoch CC, Buysse DJ, et al. Healthy older adults' sleep predicts all cause mortality at 4 to 19 years of follow-up. Psychosom Med. 2003;65:63–73.
    1. Vgontzas AN, Liao D, Pejovic S, et al. Insomnia with short sleep duration and mortality: the Penn State Cohort. Sleep. 2010;33:1159–64.
    1. Cappuccio FP, D'Elia L, Strazzullo P, Miller MA. Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep. 2010;33:585–92.
    1. Rosekind MR, Gregory KB. Insomnia risks and costs: health, safety, and quality of life. Am J Manag Care. 2010;16:617–26.
    1. Daley M, Morin CM, LeBlanc M, Grégoire JP, Savard J. The economic burden of insomnia: direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms, and good sleepers. Sleep. 2009;32:55–64.
    1. NIH. State-of-the-Science Conference Statement on Manifestations and Management of Chronic Insomnia in Adults. NIH Consens Sci Statements. 2005;22:1–30.
    1. Sateia MJ, Nowell PD. Insomnia. Lancet. 2004;364:1959–73.
    1. Kripke D. Hypnotic drugs: deadly risks, doubtful benefits. Sleep Med Rev. 2000;4:5–20.
    1. Mendelson WB. A review of the evidence for the efficacy and safety of Trazodone. J Clin Psychiatry. 2005;66:469–76.
    1. London: National Institute for Clinical Excellence; 2004. Guidance on the use of zaleplon, zolpidem and zopiclone for the short-term management of insomnia. Technology Appraisal Guidance No.77.
    1. 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;24:1577–600.
    1. Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+years of age. Health Psychol. 2006;25:3–14.
    1. Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psychological and behavioral treatment of insomnia: Update of the recent evidence (1998-2004) Sleep. 2006;29:1398–414.
    1. Riemann D, Perlis ML. The treatments of chronic insomnia: A review of benzodiazepine receptor agonists and psychological and behavioral therapies. Sleep Med Rev. 2009;13:205–214.
    1. Espie CA. Insomnia: conceptual issues in the development, persistence, and treatment of sleep disorder in adults. Annu Rev Psychol. 2002;53:215–43.
    1. Morin CM, Gaulier B, Barry T, Kowatch RA. Patients' acceptance of psychological and pharmacological therapies in insomnia. Sleep. 1992;15:302–5.
    1. Espie CA, Barrie LM, Forgan GS. Comparative investigation of the psychophysiological and idiopathic insomnia disorder phenotypes: psychological characteristics patients' perspectives and implications for clinical management. Sleep. 2012;35:385–393.
    1. Dyas JV, Apekey TA, Tilling M, Orner R, Middleton H, Siriwardena AN. Patients' and clinicians' experiences of consultation in primary care for sleep problems and insomnia: a focus group. Br J Gen Pract. 2010;60:329–33.
    1. Falloon K, Arroll B, Elley CR, Fernando A. The assessment and management of insomnia in primary care. BMJ. 2011;342:d2899.
    1. Espie, C A. ‘Stepped care’: a health technology solution for delivering Cognitive Behavioral Therapy as a first line insomnia treatment. Sleep. 2009;32:1549–58.
    1. Bennett-Levy J, Richards D, Farrand P, et al. Oxford, UK: Oxford University Press; 2010. Oxford guide to low intensity CBT Interventions (Oxford Guides in Cognitive Behavioural Therapy)
    1. Perlis ML, Smith MT. How can we make CBT-I and other BSM services widely available? J Clin Sleep Med. 2008;15:11–3.
    1. National Institute of Clinical Excellence. NICE implementation uptake report: insomnia - newer hypnotic drugs. 2006. .
    1. NHS Scotland, Information Services Division. Prescribing & Medicines: Medicines used in Mental Health 2011. .
    1. Bower P, Gilbody S. Stepped care in psychological therapies: access, effectiveness and efficiency. Br J Psychiatry. 2005;186:11–17.
    1. Espie CA, MacMahon KM, Kelly H, et al. Randomized clinical effectiveness trial of nurse-administered small group cognitive behaviour therapy for persistent insomnia in general practice. Sleep. 2007;30:574–84.
    1. Espie CA, Inglis SJ, Harvey L. Predicting clinically significant response to cognitive behavior therapy for chronic insomnia in general medical practice: Analysis of outcome data at 12 months post treatment. J Consult Clin Psychol. 2001;69:58–66.
    1. Espie CA, Fleming L, Cassidy J, et al. Randomized controlled clinical effectiveness trial of cognitive behaviour therapy compared with treatment as usual for persistent insomnia in patients with cancer. J Clin Oncol. 2008;26:4651–8.
    1. Swift N, Stewart R, Andiappan M, Smith A, Espie CA, Brown JSL. The effectiveness of community day-long CBT-I workshops for participants with insomnia symptoms: a randomised controlled trial. J Sleep Res. 2011 .
    1. van Straten A, Cuijpers P. Self-therapy for insomnia: a meta-analysis. Sleep Med Rev. 2009;13:61–71.
    1. Strom L, Pettersson R, Andersson G. Internet-based treatment for insomnia: a controlled evaluation. J Consult Clin Psychol. 2004;72:113–20.
    1. Suzuki E, Tsuchiya M, Hirokawa K, Taniguchi T, Mitsuahashi T, Kawakami N. Evaluation of an Internet-based self-help program for better quality of sleep among Japanese workers: a randomized controlled trial. J Occup Health. 2008;50:387–99.
    1. Ritterband LM, Thorndike FP, Gonder-Frederick GA, et al. Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry. 2009;66:692–8.
    1. Vincent N, Lewycky S. Logging on for better sleep: RCT of the effectiveness of online treatment for insomnia. Sleep. 2009;32:807–15.
    1. Ritterband LM, Bailey ET, Thorndike FP, Lord HR, Farrell-Carnahan L, Baum LD. Initial evaluation of an internet intervention to improve the sleep of cancer survivors with insomnia. Psychooncology. 2011 . [Epub ahead of print]
    1. Lancee J, van den Bout J, van Straten A, Spoormaker VI. Internet-delivered or mailed self-help treatment for insomnia? A randomized waiting-list controlled trial. Behav Res Ther. 2011;50:22–9.
    1. Steinmark SW, Borkovec TD. Active and placebo treatment effects on moderate insomnia under counterdemand and positive demand instructions. J Abnorm Psychol. 1974;83:157–63.
    1. TIME Specials (2011) The 50 Best Websites of 2011. .
    1. Gellatly J, Bower P, Hennessy S, Richards D, Gilbody S, Lovell K. What makes self-help interventions effective in the management of depressive symptoms? Meta-analysis and meta-regression. Psychol Med. 2007;37:1217–28.
    1. Reynolds CF, Redline S. The DSM-V sleep-wake disorders nosology: an update and an invitation to the sleep community. J Clin Sleep Med. 2010;15:9–10.
    1. American Psychiatric Association. DSM-5 development. 2010. Available from: .
    1. Espie CA, Kyle SD, Hames P. The daytime impact of DSM-V insomnia disorder: comparative analysis of insomnia subtype from the Great British Sleep Survey (n = 11,129) Sleep Biol Rhythms. 2011;9:S241.
    1. Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption. II. Addiction. 1993;88:791–804.
    1. Mayfield D, Mcleod G, Hall P. The CAGE questionnaire: validation of a new alcoholism screening instrument. Am J Psychiatry. 1974;131:1121–3.
    1. Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): Construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005;44:227–39.
    1. Schulz KF, Altman DG, Moher D for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Ann Int Med. 2010:152.
    1. Morin CM, Espie CA. Insomnia: a clinical guide to assessment and treatment. New York: Kluwer Academic/Plenum Publishers; 2003.
    1. Edinger JD, Fins AI, Sullivan RJ, et al. Sleep in the laboratory and sleep at home: comparisons of older insomniacs and normal sleepers. Sleep. 1997;20:1119–26.
    1. Coates TJ, Killen KD, George J, Marchini E, Silverman S, Thoresen C. Estimating sleep parameters: a multi-trait multi-method analysis. J Consult Clin Psychol. 1982;50:345–52.
    1. Morin CM. Measuring outcomes in randomized clinical trials of insomnia treatments. Sleep Med Rev. 2003;7:263–79.
    1. Buysse DJ, Reynolds CF, III, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28:193–213.
    1. Morin CM. Insomnia: Psychological assessment and management. New York: Guilford; 1993.
    1. Gardani M, Miller CB, Biello S, Ellis J, Von Schantz M, Archer S. The association of sleepiness and diurnal preference with salivary amylase activity. Abstracts of 4th International Congress of WASM & 5th Conference of CSS / Sleep Med; 2011. pp. S1–130.
    1. Espie CA, Brooks DN, Lindsay WR. An evaluation of tailored psychological treatment for insomnia in terms of statistical and clinical measures of outcome. J Behav Ther Exp Psych. 1989;20:143–53.
    1. Espie CA, Inglis SJ, Harvey L, Tessier S. Insomniacs' attributions: psychometric properties of the dysfunctional beliefs and attitudes about sleep scale and the sleep disturbance questionnaire. J Psychsom Res. 2000;48:141–8.
    1. Harvey KJ, Espie CA. Development and preliminary validation of the Glasgow Content of Thoughts Inventory (GCTI): a new measure for the assessment of pre-sleep cognitive activity. Br J Clin Psychol. 2004;43:409–20.
    1. Espie CA, Lindsay WR, Brooks N, Hood EM, Turvey T. A controlled comparative investigation of psychological treatments for chronic sleep-onset insomnia. Behav Res Ther. 1989;27:79–88.
    1. Edinger JD, Wohlgemuth WK, Radtke RA, Marsh GR, Quillian RE. Cognitive behavioural therapy for treatment of chronic primary insomnia: a randomized controlled trial. JAMA. 2001;285:1856–64.
    1. 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 comborbid major depressive disorder and insomnia. Sleep. 2008;31:489–95.
    1. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: Erlbaum; 1988.
    1. Norusis MJ Inc. SPSS. PASW Statistics 18 Advanced Statistical Procedures Companion. Chicago: SPSS Inc.; 2011.
    1. Department for Communities and Local Government. Office for National Statistics; The English Indices of Deprivation 2007. .
    1. Lichstein KL, Durrence HH, Taylor DJ, Bush AJ, Riedel BW. Quantitative criteria for insomnia. Behav Res Ther. 2003;41:427–45.
    1. Carney CE, Buysse DJ, Ancoli-Israel S, et al. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012;35:287–302.
    1. Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard research assessment of insomnia. Sleep. 2006;29:1155–73.
    1. Buysse DJ, Germain A, Moul DE, et al. Efficacy of brief behavioural treatment for chronic insomnia in older adults. Arch Intern Med. 2011;171:887–95.

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