The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis

doi:10.1016/S2215-0366(17)30328-0

Randomized Controlled Trial

. 2017 Oct;4(10):749-758.

doi: 10.1016/S2215-0366(17)30328-0. Epub 2017 Sep 6.

The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis

Daniel Freeman¹, Bryony Sheaves², Guy M Goodwin², Ly-Mee Yu³, Alecia Nickless³, Paul J Harrison², Richard Emsley⁴, Annemarie I Luik⁵, Russell G Foster⁶, Vanashree Wadekar⁷, Christopher Hinds⁷, Andrew Gumley⁸, Ray Jones⁹, Stafford Lightman¹⁰, Steve Jones¹¹, Richard Bentall¹², Peter Kinderman¹³, Georgina Rowse¹², Traolach Brugha¹⁴, Mark Blagrove¹⁵, Alice M Gregory¹⁶, Leanne Fleming¹⁷, Elaine Walklet¹⁸, Cris Glazebrook¹⁹, E Bethan Davies²⁰, Chris Hollis¹⁹, Gillian Haddock²¹, Bev John²², Mark Coulson²³, David Fowler²⁴, Katherine Pugh²⁵, John Cape²⁶, Peter Moseley²⁷, Gary Brown²⁸, Claire Hughes²⁹, Marc Obonsawin³⁰, Sian Coker³¹, Edward Watkins³², Matthias Schwannauer³³, Kenneth MacMahon³³, A Niroshan Siriwardena³⁴, Colin A Espie⁵

Affiliations

¹ Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health National Health Service (NHS) Foundation Trust, Oxford, UK. Electronic address: daniel.freeman@psych.ox.ac.uk.
² Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health National Health Service (NHS) Foundation Trust, Oxford, UK.
³ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
⁴ Centre for Biostatistics, Institute of Population Health, Manchester University, Manchester Academic Health Centre, Manchester, UK.
⁵ 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.
⁶ Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Sir William Dunn School of Pathology, Oxford, UK.
⁷ Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.
⁸ Institute of Health and Wellbeing, University of Glasgow, Gartnavel Royal Hospital, Glasgow, UK.
⁹ School of Nursing and Midwifery, Faculty of Health and Human Sciences, Plymouth University, Plymouth, UK.
¹⁰ Henry Wellcome Laboratories for Integrative Neuroscience and Endocrinology, University of Bristol, Bristol, UK.
¹¹ Spectrum Centre for Mental Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.
¹² Clinical Psychology Unit, Department of Psychology, University of Sheffield, Sheffield, UK.
¹³ Psychological Sciences, Institute of Psychology Health and Society, University of Liverpool, Liverpool, UK.
¹⁴ Department of Health Sciences, College of Medicine, Biological Sciences and Psychology, Centre for Medicine, University of Leicester, Leicester, UK.
¹⁵ Department of Psychology, University of Swansea, Swansea, UK.
¹⁶ Department of Psychology, Goldsmiths, University of London, London, UK.
¹⁷ Department of Psychology, University of Strathclyde, Glasgow, UK.
¹⁸ Department of Psychology, Institute of Health and Society, University of Worcester, Worcester, UK.
¹⁹ Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Nottingham, UK; National Institute for Healthcare Research MindTech Healthcare Technology Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, UK.
²⁰ National Institute for Healthcare Research MindTech Healthcare Technology Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, UK.
²¹ Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, UK.
²² School of Psychology and Therapeutic Studies, University of South Wales, Treforest, UK.
²³ Department of Psychology, School of Science and Technology, University of Middlesex, London, UK.
²⁴ Department of Psychology, University of Sussex, Brighton, UK; Sussex Partnership NHS Foundation Trust, Worthing, UK.
²⁵ Sussex Partnership NHS Foundation Trust, Worthing, UK.
²⁶ Department of Clinical, Educational and Health Psychology, University College London, London, UK.
²⁷ School of Psychology, University of Central Lancashire, Preston, UK.
²⁸ Psychology Department, Royal Holloway, Egham, UK.
²⁹ University of Cambridge Centre for Family Research, Cambridge, UK.
³⁰ School of Psychological Sciences and Health, University of Strathclyde, Glasgow UK.
³¹ Department of Clinical Psychology, Norwich Medical School, University of East Anglia, Norwich, UK.
³² SMART Lab, College of Life and Environmental Sciences, Sir Henry Wellcome Building for Mood Disorders Research, University of Exeter, Exeter, UK.
³³ School of Health in Social Sciences, University of Edinburgh, Medical School, Edinburgh, UK.
³⁴ Community and Health Research Unit, University of Lincoln, Lincoln, UK.

PMID: 28888927
PMCID: PMC5614772
DOI: 10.1016/S2215-0366(17)30328-0

Randomized Controlled Trial

The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis

Daniel Freeman et al. Lancet Psychiatry. 2017 Oct.

. 2017 Oct;4(10):749-758.

doi: 10.1016/S2215-0366(17)30328-0. Epub 2017 Sep 6.

Authors

Affiliations

¹ Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health National Health Service (NHS) Foundation Trust, Oxford, UK. Electronic address: daniel.freeman@psych.ox.ac.uk.
² Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health National Health Service (NHS) Foundation Trust, Oxford, UK.
³ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
⁴ Centre for Biostatistics, Institute of Population Health, Manchester University, Manchester Academic Health Centre, Manchester, UK.
⁵ 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.
⁶ Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Sir William Dunn School of Pathology, Oxford, UK.
⁷ Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.
⁸ Institute of Health and Wellbeing, University of Glasgow, Gartnavel Royal Hospital, Glasgow, UK.
⁹ School of Nursing and Midwifery, Faculty of Health and Human Sciences, Plymouth University, Plymouth, UK.
¹⁰ Henry Wellcome Laboratories for Integrative Neuroscience and Endocrinology, University of Bristol, Bristol, UK.
¹¹ Spectrum Centre for Mental Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.
¹² Clinical Psychology Unit, Department of Psychology, University of Sheffield, Sheffield, UK.
¹³ Psychological Sciences, Institute of Psychology Health and Society, University of Liverpool, Liverpool, UK.
¹⁴ Department of Health Sciences, College of Medicine, Biological Sciences and Psychology, Centre for Medicine, University of Leicester, Leicester, UK.
¹⁵ Department of Psychology, University of Swansea, Swansea, UK.
¹⁶ Department of Psychology, Goldsmiths, University of London, London, UK.
¹⁷ Department of Psychology, University of Strathclyde, Glasgow, UK.
¹⁸ Department of Psychology, Institute of Health and Society, University of Worcester, Worcester, UK.
¹⁹ Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Nottingham, UK; National Institute for Healthcare Research MindTech Healthcare Technology Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, UK.
²⁰ National Institute for Healthcare Research MindTech Healthcare Technology Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, UK.
²¹ Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, UK.
²² School of Psychology and Therapeutic Studies, University of South Wales, Treforest, UK.
²³ Department of Psychology, School of Science and Technology, University of Middlesex, London, UK.
²⁴ Department of Psychology, University of Sussex, Brighton, UK; Sussex Partnership NHS Foundation Trust, Worthing, UK.
²⁵ Sussex Partnership NHS Foundation Trust, Worthing, UK.
²⁶ Department of Clinical, Educational and Health Psychology, University College London, London, UK.
²⁷ School of Psychology, University of Central Lancashire, Preston, UK.
²⁸ Psychology Department, Royal Holloway, Egham, UK.
²⁹ University of Cambridge Centre for Family Research, Cambridge, UK.
³⁰ School of Psychological Sciences and Health, University of Strathclyde, Glasgow UK.
³¹ Department of Clinical Psychology, Norwich Medical School, University of East Anglia, Norwich, UK.
³² SMART Lab, College of Life and Environmental Sciences, Sir Henry Wellcome Building for Mood Disorders Research, University of Exeter, Exeter, UK.
³³ School of Health in Social Sciences, University of Edinburgh, Medical School, Edinburgh, UK.
³⁴ Community and Health Research Unit, University of Lincoln, Lincoln, UK.

PMID: 28888927
PMCID: PMC5614772
DOI: 10.1016/S2215-0366(17)30328-0

Abstract

Background: Sleep difficulties might be a contributory causal factor in the occurrence of mental health problems. If this is true, improving sleep should benefit psychological health. We aimed to determine whether treating insomnia leads to a reduction in paranoia and hallucinations.

Methods: We did this single-blind, randomised controlled trial (OASIS) at 26 UK universities. University students with insomnia were randomly assigned (1:1) with simple randomisation to receive digital cognitive behavioural therapy (CBT) for insomnia or usual care, and the research team were masked to the treatment. Online assessments took place at weeks 0, 3, 10 (end of therapy), and 22. The primary outcome measures were for insomnia, paranoia, and hallucinatory experiences. We did intention-to-treat analyses. The trial is registered with the ISRCTN registry, number ISRCTN61272251.

Findings: Between March 5, 2015, and Feb 17, 2016, we randomly assigned 3755 participants to receive digital CBT for insomnia (n=1891) or usual practice (n=1864). Compared with usual practice, the sleep intervention at 10 weeks reduced insomnia (adjusted difference 4·78, 95% CI 4·29 to 5·26, Cohen's d=1·11; p<0·0001), paranoia (-2·22, -2·98 to -1·45, Cohen's d=0·19; p<0·0001), and hallucinations (-1·58, -1·98 to -1·18, Cohen's d=0·24; p<0·0001). Insomnia was a mediator of change in paranoia and hallucinations. No adverse events were reported.

Interpretation: To our knowledge, this is the largest randomised controlled trial of a psychological intervention for a mental health problem. It provides strong evidence that insomnia is a causal factor in the occurrence of psychotic experiences and other mental health problems. Whether the results generalise beyond a student population requires testing. The treatment of disrupted sleep might require a higher priority in mental health provision.

Funding: Wellcome Trust.

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Figures

**Figure**
Trial profile SCI=Sleep Condition Indicator. *Some participants excluded for two or more reasons. †Not all participants accessed all treatment sessions. ‡Had at least one measurement at week 3, 10, or 22.

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References

1. Harvey AG, Murray G, Chandler R, Soehner A. Sleep disturbance as transdiagnostic: consideration of neurobiological mechanisms. Clin Psychol Rev. 2011;31:225–235. - PMC - PubMed
1. Freeman D, Pugh K, Vorontsova N, Southgate L. Insomnia and paranoia. Schizophr Res. 2009;108:280–284. - PMC - PubMed
1. Reeve S, Sheaves B, Freeman D. The role of sleep dysfunction in the occurrence of delusions and hallucinations. Clin Psychol Rev. 2015;42:96–115. - PMC - PubMed
1. Kendler KS, Campbell J. Interventionist causal models in psychiatry: repositioning the mind-body problem. Psychol Med. 2009;39:881–887. - PubMed
1. Dunn G, Emsley R, Liu H. 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;19:1–115. - PMC - PubMed

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[1] Harvey AG, Murray G, Chandler R, Soehner A. Sleep disturbance as transdiagnostic: consideration of neurobiological mechanisms. Clin Psychol Rev. 2011;31:225–235. - PMC - PubMed

[2] Harvey AG, Murray G, Chandler R, Soehner A. Sleep disturbance as transdiagnostic: consideration of neurobiological mechanisms. Clin Psychol Rev. 2011;31:225–235. - PMC - PubMed

[3] Freeman D, Pugh K, Vorontsova N, Southgate L. Insomnia and paranoia. Schizophr Res. 2009;108:280–284. - PMC - PubMed

[4] Freeman D, Pugh K, Vorontsova N, Southgate L. Insomnia and paranoia. Schizophr Res. 2009;108:280–284. - PMC - PubMed

[5] Reeve S, Sheaves B, Freeman D. The role of sleep dysfunction in the occurrence of delusions and hallucinations. Clin Psychol Rev. 2015;42:96–115. - PMC - PubMed

[6] Reeve S, Sheaves B, Freeman D. The role of sleep dysfunction in the occurrence of delusions and hallucinations. Clin Psychol Rev. 2015;42:96–115. - PMC - PubMed

[7] Kendler KS, Campbell J. Interventionist causal models in psychiatry: repositioning the mind-body problem. Psychol Med. 2009;39:881–887. - PubMed

[8] Kendler KS, Campbell J. Interventionist causal models in psychiatry: repositioning the mind-body problem. Psychol Med. 2009;39:881–887. - PubMed

[9] Dunn G, Emsley R, Liu H. 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;19:1–115. - PMC - PubMed

[10] Dunn G, Emsley R, Liu H. 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;19:1–115. - PMC - PubMed

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The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis

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The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis

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