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)
| Autor: | Paul Aveyard, Lucy Abel, Aloysius Niroshan Siriwardena, Colin A. Espie, Nargis Begum, Stephanie Armstrong, Emma Ogburn, Ly-Mee Yu, Peter Bower, Claire D Madigan, Simon D. Kyle |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Mediation (statistics) medicine.medical_specialty law.invention primary care Quality of life (healthcare) Randomized controlled trial law Sleep Initiation and Maintenance Disorders Pragmatic Clinical Trials as Topic medicine Insomnia Humans Multicenter Studies as Topic Sleep Hygiene Research ethics Sleep disorder Sleep hygiene Primary Health Care business.industry sleep restriction therapy General Medicine medicine.disease Mental Health Treatment Outcome Physical therapy Medicine insomnia disorder Sleep (system call) medicine.symptom business B990 Subjects Allied to Medicine not elsewhere classified |
| Zdroj: | BMJ Open BMJ Open, Vol 10, Iss 3 (2020) |
| Popis: | IntroductionInsomnia 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 analysisIn 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 disseminationEthical 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 numberISRCTN42499563 |
| Databáze: | OpenAIRE |
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