A pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy for insomnia disorder to sleep hygiene in primary care (HABIT trial)

PROJECT TITLE A PRAGMATIC, MULTICENTRE, RANDOMISED CONTROLLED TRIAL COMPARING NURSE-DELIVERED SLEEP RESTRICTION THERAPY FOR INSOMNIA DISORDER TO SLEEP HYGIENE IN PRIMARY CARE (HABIT TRIAL)
Funding body NIHR Health Technology Assessment Programme
Total funding  £1823976
Team
  • Dr Simon D. Kyle Sleep & Circadian Neuroscience Institute, University of Oxford (chief investigator)
  • Prof Colin A. Espie Sleep & Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford
  • Professor Paul Aveyard, University of Oxford
  • Professor Ly-Mee Yu, University of Oxford
  • Dr Emma Ogburn, University of Oxford
  • Ms Lucy Abel, University of Oxford
  • Professor A. Niroshan Siriwardena, Julie Pattinson, Stephanie Armstrong, University of Lincoln
  • Professor Peter Bower, University of Manchester
Team/consortium
  • University of Oxford
  • University of Lincoln
  • University of Manchester
Overarching aim This study aims to investigate the effectiveness and cost-effectiveness of nurse-delivered sleep restriction therapy (+sleep hygiene) for insomnia disorder in primary care compared with sleep hygiene.
Objectives
  1. To establish whether nurse-delivered sleep restriction therapy (+sleep hygiene) for insomnia disorder in primary care is clinically effective relative to sleep hygiene. Both groups will continue to receive treatment as usual without restriction.
  2. To establish whether nurse-delivered sleep restriction therapy (+sleep hygiene) for insomnia disorder in primary care is cost-effective relative to sleep hygiene, from NHS and societal perspectives.
  3. To undertake a process evaluation to explain trial results and understand intervention delivery, fidelity and acceptability.
Methods Randomised controlled trial
Outcomes

Primary outcome is self-rated insomnia severity using the insomnia severity index (ISI) questionnaire at 6 (3, 12) months.

Secondary outcomes include:

  • Self-rated HRQoL using the SF-36 questionnaire (Mental component summary [MSC] score and Physical component summary [PCS] score)
  • Subjective sleep recorded over 7 nights using the consensus sleep diary (CSD) (sleep-onset latency [SOL]; wake-time after sleep onset [WASO]; sleep efficiency [SE]; total sleep time [TST]; sleep quality [SQ]).
Outputs Peer reviewed publications, conference presentations and guidelines for primary care of insomnia.
Impact This is the first large-scale, specifically designed investigation of the effect of sleep restriction therapy delivery by primary care practitioners.

 

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