Journal Article

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

Maurer, Leonie F, Kyle, Simon D, Lee, Victoria, Bower, Peter, Siriwardena, A Niroshan, Yu, Ly-Mee, Petrou, Stavros, Robinson, Barbara, Mort, Sam, Armstrong, Stephanie, Espie, Colin A, Harris, Victoria, Ogburn, Emma, Begum, Nargis, Yang, Yaling, Gardner, Caroline, Pattinson, Julie, Temple, Eleanor, Aveyard, Paul

2023

Overview

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

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Adult / Aged / Aged, 80 and over / Behavior modification / Clinical medicine / Cognitive ability / Cognitive behavioral therapy / Cost analysis / Cost-Benefit Analysis / Effectiveness / Female / Habits / Health services / Humans / Hygiene / Insomnia / Intervention / Labels / Male / Mental disorders / Middle Aged / Nurses / Primary care / Primary Health Care / Quality of Life / Questionnaires / Randomization / Restless legs syndrome / Sleep / Sleep deprivation / Sleep disorders / Sleep Initiation and Maintenance Disorders - therapy / Social services / State Medicine / Suicides & suicide attempts / Technology assessment / Therapy / Treatment Outcome / Young Adult