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  £1,823,976
Team
  • Dr Simon D. Kyle Sleep & Circadian Neuroscience Institute, University of Oxford (chief investigator)
  • Professor A. Niroshan Siriwardena, Julie Pattinson, Stephanie Armstrong, CaHRU, University of Lincoln
  • 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 Peter Bower, University of Manchester
Team/consortium
  • SCNI, University of Oxford
  • CaHRU, University of Lincoln
  • University of Manchester
Overarching aim This study aimed 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 was self-rated insomnia severity using the insomnia severity index (ISI) questionnaire at 6 (3, 12) months.Secondary outcomes included:

  • 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 publicationsKyle SD, Siriwardena AN, Espie C, Yang Y, Petrou S, Ogburn E, Begum N, Maurer L, Robinson B, Gardner C, Lee V, Armstrong S, Pattinson J, Mort S, Temple E, Harris V, Yu L-M, Bower P, Aveyard P (2023). Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care: a pragmatic randomised controlled trial. Lancet; 401; 975–87.

Armstrong S, Pattinson J, Siriwardena AN, Kyle SD, Bower P, Yu L-M, Yang Y, Ogburn E, Begum N, Maurer L Robinson B, Gardner C, Lee V,, Gavriloff D, Espie C, Aveyard P (2023). Nurse delivered Sleep Restriction Therapy for adults with Insomnia Disorder: process evaluation. British Journal of General Practice (in press).

Kyle SD, Bower P, Yu LM, Siriwardena AN, Yang Y, Ogburn E, Begum N, Maurer L, Robinson B, Gardner C, Armstrong S, Pattinson J, Espie CA, Aveyard P (2022). Nurse-delivered sleep restriction therapy to improve insomnia disorder in primary care: the HABIT RCT. Health Technol Assess 26 (in press).

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.

Impact This is the first large-scale, specifically designed investigation of the effect of sleep restriction therapy delivery by primary care practitioners.

Brief sleep therapy delivered by nurses in primary care reduces insomnia symptoms and demonstrated high likelihood of being cost-effective. Primary care nurses
received brief training on sleep, received insomnia, and delivery of sleep restriction therapy, which was  in 4 brief weekly sessions in less than 1.5 hours in total. Sleep restriction therapy has the potential to be widely implemented in primary care as first-line behavioural treatment for insomnia.

The study has been cited in The European Insomnia Guideline: An update on the diagnosis and treatment of insomnia 2023

Leave a Reply

Your email address will not be published. Required fields are marked *

*