||A PRAGMATIC, MULTICENTRE, RANDOMISED CONTROLLED TRIAL COMPARING NURSE-DELIVERED SLEEP RESTRICTION THERAPY FOR INSOMNIA DISORDER TO SLEEP HYGIENE IN PRIMARY CARE (HABIT TRIAL)
||NIHR Health Technology Assessment Programme
- 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, CaHRU, University of Lincoln
- Professor Peter Bower, University of Manchester
- SCNI, University of Oxford
- CaHRU, University of Lincoln
- University of Manchester
||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.
- 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.
- 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.
- To undertake a process evaluation to explain trial results and understand intervention delivery, fidelity and acceptability.
||Randomised controlled trial
||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]).
||Peer reviewed publications, conference presentations and recommendations for services.
Peer reviewed publications:
Kyle SD, Madigan CD, Begum N, Abel L, Armstrong S, Aveyard P, Bower P, Ogburn E, Siriwardena AN, Yu LM, Espie C (2020). 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. BMJ Open 10:e036248.
||This is the first large-scale, specifically designed investigation of the effect of sleep restriction therapy delivery by primary care practitioners.