Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial

Kyle, Simon D, Siriwardena, A. Niroshan, Espie, Colin A , Yang, Yaling, Petrou, Stavros, Ogburn, Emma, Begum, Nargis, Maurer, Leonie F, Robinson, Barbara, Gardner, Caroline, Lee, Victoria, Armstrong, Stephanie, Pattinson, Julie, Mort, Sam, Temple, Eleanor, Harris, Victoria, Yu, Ly-Mee, Bower, Peter and Aveyard, Paul (2023) Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial. The Lancet, 402 (10406). ISSN 0140-6736

Full content URL: https://doi.org/10.1016/S0140-6736%2823%2900683-9

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Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial
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Abstract

Background
Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented.

Methods
We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563).

Findings
Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19–88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference –3·05, 95% CI –3·83 to –2·28; p<0·0001; Cohen's d –0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention.

Interpretation
Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder.

Funding
The National Institute for Health and Care Research Health Technology Assessment Programme.

Keywords:insomnia, cognitive-behavioural therapy (CBT), nurse-delivered, sleep restriction therapy, sleep hygiene, cost-utility analysis, depressive symptoms, mental health-related quality of life, sleep-related quality of life, work productivity
Subjects:B Subjects allied to Medicine > B714 Practice Nursing
A Medicine and Dentistry > A300 Clinical Medicine
Divisions:COLLEGE OF HEALTH AND SCIENCE > School of Health & Social Care
ID Code:55745
Deposited On:14 Aug 2023 09:59

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