Authors' objectives: Insomnia is a prevalent and distressing sleep disorder. Multicomponent cognitive–behavioural therapy is the recommended first-line treatment, but access remains extremely limited, particularly in primary care where insomnia is managed. One principal component of cognitive–behavioural therapy is a behavioural treatment called sleep restriction therapy, which could potentially be delivered as a brief single-component intervention by generalists in primary care. The primary objective of the Health-professional Administered Brief Insomnia Therapy trial was to establish whether nurse-delivered sleep restriction therapy in primary care improves insomnia relative to sleep hygiene. Secondary objectives were to establish whether nurse-delivered sleep restriction therapy was cost-effective, and to undertake a process evaluation to understand intervention delivery, fidelity and acceptability. Insomnia disorder affects approximately 10% of the adult population. It reduces quality of life, increases risk of poor physical and mental health, and is associated with substantial direct and indirect costs. The first-line treatment is multicomponent cognitive–behavioural therapy (CBT) delivered by a trained clinician, but access remains extremely limited, particularly in primary care where insomnia is typically managed. Instead, patients are provided with self-help sleep hygiene (SH) advice, or prescribed hypnotic or sedative antidepressant medication. Sleep restriction therapy (SRT) is one of the principal active components of CBT. It involves implementation of a prescribed and restricted sleep schedule, which is reviewed and adjusted each week by a therapist in order to optimise sleep efficiency (the proportion of time spent in bed asleep). Time in bed is initially restricted to match reported total sleep time (with 5 hours set as the minimum sleep opportunity). The structured and prescriptive nature of SRT means it could potentially be delivered as a brief intervention by generalists in primary care. Meta-analysis of post-treatment data shows that single-component SRT is effective for insomnia, but trials to date have mainly been performed in specialist research settings, recruiting small samples of insomnia patients without comorbidity. While both SRT and CBT for insomnia have been evaluated in the primary care context, there has been no large-scale test to assess clinical and cost-effectiveness of a brief and scalable behavioural treatment for insomnia delivered within routine clinical practice. The primary objective of the Health-professional Administered Brief Insomnia Therapy trial was to establish whether nurse-delivered SRT in primary care improves insomnia relative to SH. Secondary objectives were to establish whether nurse-delivered SRT is cost-effective compared with SH, from a NHS and Personal Social Services (PSS) perspective, and from a societal perspective, and to explore both moderators and mediators of treatment effects. We also undertook a process evaluation to understand intervention delivery, fidelity and acceptability.

Authors' results and conclusions: We recruited 642 participants (n = 321 for sleep restriction therapy; n = 321 for sleep hygiene) between 29 August 2018 and 23 March 2020. Five hundred and eighty participants (90.3%) provided data at a minimum of one follow-up time point; 257 (80.1%) participants in the sleep restriction therapy arm and 291 (90.7%) participants in the sleep hygiene arm provided primary outcome data at 6 months. The estimated adjusted mean difference on the Insomnia Severity Index was −3.05 (95% confidence interval −3.83 to −2.28; p 

Authors' methods: Pragmatic, multicentre, individually randomised, parallel-group, superiority trial with embedded process evaluation. National Health Service general practice in three regions of England. Adults aged ≥ 18 years with insomnia disorder were randomised using a validated web-based randomisation programme. Participants in the intervention group were offered a brief four-session nurse-delivered behavioural treatment involving two in-person sessions and two by phone. Participants were supported to follow a prescribed sleep schedule with the aim of restricting and standardising time in bed. Participants were also provided with a sleep hygiene leaflet. The control group received the same sleep hygiene leaflet by e-mail or post. There was no restriction on usual care. Outcomes were assessed at 3, 6 and 12 months. Participants were included in the primary analysis if they contributed at least one post-randomisation outcome. The primary end point was self-reported insomnia severity with the Insomnia Severity Index at 6 months. Secondary outcomes were health-related and sleep-related quality of life, depressive symptoms, work productivity and activity impairment, self-reported and actigraphy-defined sleep, and hypnotic medication use. Cost-effectiveness was evaluated using the incremental cost per quality-adjusted life-year. For the process evaluation, semistructured interviews were carried out with participants, nurses and practice managers or general practitioners. Due to the nature of the intervention, both participants and nurses were aware of group allocation. While we recruited a clinical sample, 97% were of white ethnic background and 50% had a university degree, which may limit generalisability to the insomnia population in England. Pragmatic, multicentre, individually randomised, parallel-group, superiority trial with embedded process evaluation. Participants were randomised (1 : 1) to SRT or SH using a validated web-based randomisation programme (Sortition), with a non-deterministic minimisation algorithm to ensure site, use of prescribed sleep promoting medication (yes/no), age (18–65 vs. > 65 years), sex, baseline insomnia severity [Insomnia Severity Index (ISI) score

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/16/84/01

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/RJYT4275/

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/RJYT4275

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk