Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial
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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.
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A large-scale (n=1,711) randomized trial of Sleepio conducted in 2015 confirmed that it improved both daytime and nighttime aspects of insomnia.
“Its large-scale (n=1,711) randomized trial conducted in 2015 confirmed that it improved both daytime and nighttime aspects of insomnia.”
From A Review of Current Digital Mental Health Care Applications for Anxiety Symptoms and Future Prospects (2024) · cites this paper as [9]
The Intervention and Participants sections identify Sleepio and a final sample of 1,711. The Mediation Analysis reports improved insomnia scores, and Treatment Effects on Secondary Outcomes reports improvements in several daytime measures. However, the Research Design section says recruitment ran from December 2015 through December 2016, so describing the trial as conducted in 2015 is inaccurate. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSleepio has been well verified for its effectiveness in relieving insomnia and improving quality of life and depression related to insomnia based on numerous clinical studies.
“For example, ‘Sleepio,’ which is a cognitive-behavioral therapy (CBT)-based therapy for insomnia by Big Health, has been well verified for its effectiveness in relieving insomnia and improving quality of life and depression related to insomnia based on numerous clinical studies over the past few years [8,9].”
From A Review of Current Digital Mental Health Care Applications for Anxiety Symptoms and Future Prospects (2024) · cites this paper as [9]
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“In a feasibility RCT with a total of eleven acute psychiatric inpatients, MindShift CBT did not show significant differences from baseline on clinical measures (generalized anxiety disorder [GAD]-7, Patient Health Questionnaire-9, etc.), but a semi-structured exit interview revealed that participants were generally sa…”
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Shorter sleep: a new potential target to address cardiovascular and metabolic risk?
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Specificity in the pursuit of euthymia
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Pre-Sleep Anxiety: Mechanisms and Therapeutic Approaches in Clinical Practice.
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- Authors
- Espie, C. A., Emsley, R., Kyle, S. D., Gordon, C., Drake, C. L., Siriwardena, A. N., Cape, J., Ong, J. C., Sheaves, B., Foster, R., Freeman, D., Costa-Font, J., Marsden, A., & Luik, A. I.
- Affiliations
- University of Oxford (GB)
- King's College London (GB)
- The University of Sydney (AU)
- Henry Ford Health (US)
- University of Lincoln (GB)
- University College London (GB)
- Northwestern University (US)
- Sleep & Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom
- Department of Health Policy, The London School of Economics and Political Science, London, United Kingdom
- University of Manchester (GB)
- Corresponding author
- Espie, Colin A.
- ORCID
- Venue
- JAMA Psychiatry
- Publisher
- American Medical Association (AMA)
- Published
- 2019-01-01
- Volume
- 76
- Issue
- 1
- Pages
- 21
- ISSN
- 2168-622X (ISSN-L)
- PMC
- PMC6583463
- OpenAlex
- W2893462149
- Semantic Scholar
- bac1b87cbc39d7d93f79c5ca990bb544e20ff83f
- Cited by
- 466
- References
- 65
- Citations by year
- 2026: 53 · 2025: 72 · 2024: 66 · 2023: 62 · 2022: 67 · 2021: 72 · 2020: 47 · 2019: 25 · 2018: 1
- FWCI
- 47.48
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Psychiatry (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion, other-oa)
- Lincoln Repository (University of Lincoln) (acceptedVersion)
- London School of Economics and Political Science Research Online (London School of Economics and Political Science) (acceptedVersion, other-oa)
- London School of Economics and Political Science Theses Online (London School of Economics and Political Science) (submittedVersion, other-oa)
- Figshare (submittedVersion, cc-by-nc-nd)
- Research Portal (King's College London) (submittedVersion)
- Funders
- Northwestern University
- Henry Ford Health System
- London School of Economics and Political Science
- National Institute for Health and Care Research (RP-2014-05-003)
- King's College London
- University College London
- University of Oxford
- University of Manchester
- University of Sydney
- Feinberg School of Medicine
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- digital cognitive behavioral therapy, insomnia, sleep hygiene education, sleep-related quality of life, psychological well-being, functional health, mood, fatigue, labor productivity, relationship satisfaction, cognitive failure, sleepiness, online intervention, mobile-based interventions, Sleep Condition Indicator, Warwick-Edinburgh Mental Well-being Scale, PROMIS
- MeSH terms
- Female, Humans, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, Quality of Life, Therapy, Computer-Assisted, Cognitive Behavioral Therapy, Treatment Outcome, Self Report
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