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Primary care treatment of insomnia: study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial)
  1. Simon D Kyle1,
  2. Claire Madigan2,
  3. Nargis Begum2,
  4. Lucy Abel2,
  5. Stephanie Armstrong3,
  6. Paul Aveyard2,
  7. Peter Bower4,
  8. Emma Ogburn2,
  9. Aloysius Siriwardena3,
  10. Ly-Mee Yu2,
  11. Colin A Espie1
  1. 1Sleep and Circadian Neuroscience Institute, University of Oxford, Oxford, UK
  2. 2Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  3. 3School of Health and Social Care, Community and Health Research Unit, College of Social Science, University of Lincoln, Lincoln, UK
  4. 4Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK
  1. Correspondence to Dr Simon D Kyle; simon.kyle{at}ndcn.ox.ac.uk

Abstract

Introduction Insomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice.

Methods and analysis In the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4 weekly sessions; total therapy time is approximately 1 hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6 months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed.

Ethics and dissemination Ethical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder.

Trial registration number ISRCTN42499563

  • insomnia disorder
  • sleep restriction therapy
  • primary care
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Twitter @DrSDArmstrong, @Bowercpcman, @nsiriwardena

  • Contributors SDK is the Chief Investigator, conceived the project, had overall responsibility for the trial design and treatment design and drafted the trial protocol. CM contributed to the trial protocol and drafted the manuscript. PA, CAE, PB, AS, LMY, LA, EO, SA contributed to trial design. SDK, CAE and AS contributed to treatment design. LMY is responsible for statistical analysis. LA is responsible for economic analysis. AS/SA are responsible for the process evaluation analysis. NB is the Trial Manager and helped draft the manuscript. Centre leads are SDK/PA (Oxford), PB (Greater Manchester) and AS (Lincoln). All authors inputted to the trial protocol and commented on the manuscript.

  • Funding The trial is funded by the National Institute for Health Research Health Technology Assessment Programme. HTA Project: 16/84/01. SDK and CE are supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) based at Oxford University Hospitals NHS Trust and the University of Oxford. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests Colin Espie is co-founder of and shareholder in Big Health Ltd, a company which specialises in the digital delivery of cognitive behavioural therapy for sleep improvement (the Sleepio programme). This study is in no way connected to Big Health Ltd or Sleepio. SDK declares non-financial support from Big Health Ltd in relation to no-cost access to Sleepio for use in clinical trial research. All other authors declare no competing interests.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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