Title: A pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy for insomnia disorder to sleep hygiene in primary care
Funder: Department of Health and Social Care

Abstract: BACKGROUND: Systematic review evidence shows that a single component of Cognitive Behavioural Therapy for insomnia, called Sleep Restriction Therapy (SRT), is clinically efficacious [1]. AIM: To test whether nurse-delivered sleep restriction therapy (SRT) for insomnia disorder in UK primary care is both clinically- and cost-effective. DESIGN: Multicentre pragmatic individual randomised parallel group clinical trial of SRT+sleep hygiene (SH) versus SH in primary care, with a 6-month internal pilot phase. Stop/Go criteria will be based on feasibility of recruitment, treatment fidelity and contamination. Participants will be randomised (1:1) to SRT(+SH) or SH using a web-based randomisation programme, carried out by Oxford Primary Care Clinical Trials Unit (PC-CTU), with minimisation algorithm to ensure use of hypnotic medication at baseline, age, sex, site, and baseline insomnia severity are balanced across the two trial arms. SETTING: Participants will be recruited through general practices in Thames Valley, Lincolnshire, and Greater Manchester. TARGET POPULATION: Adults 18+yrs who meet clinical criteria (DSM-5) for persistent insomnia disorder. HEALTH TECHNOLOGY ASSESSED: SRT is an evidence-based behavioural insomnia therapy. It involves restricting and standardising time in bed to improve sleep consolidation and sleep quality. Likely mechanisms include potentiation of sleep pressure, attenuation of cognitive and physiological arousal, and strengthening of the circadian control of sleep. We have manualised a brief version of SRT and developed training materials for practice nurses. SRT combined with SH advice will be compared with SH advice. There will be no restriction on usual care for both arms. OUTCOMES: The primary outcome will be self-reported insomnia severity (ISI) at 6 months. Secondary outcomes include sleep parameters (collected via one week of sleep diary and actigraphy), health-related quality of life (SF-36), patient-generated quality of life (GSII), health status (EQ-5D), depression (PHQ-9), work productivity (WPAI) and hypnotic use. Primary and secondary outcomes will be collected at baseline, 3, 6, and 12 months. A within-trial economic evaluation alongside the RCT will estimate the incremental cost-effectiveness of SRT+SH over SH, from both NHS and societal perspectives. A process evaluation will be undertaken to explain trial results and understand intervention delivery, fidelity and acceptability. SAMPLE SIZE AND ANALYSIS: We will recruit 294 participants in each group (588 in total). This sample size has 90% power to detect a minimum effect size difference of 0.3, accounting for 20% attrition. Analysis will be intention-to-treat and follow the CONSORT statement. We will use a mixed-effect model for the analysis of the primary outcome. A full detailed analysis plan will be prepared prior to recruitment. TIMETABLE: Total duration=42 Months. M1-M6=trial set-up; M7-M12= internal pilot phase [recruitment of ~33 participants per month across three centres and appraisal of progress against pre-specified stop-go criteria by trial steering committee]; M13-M24= recruitment of ~33 participants per month; M25-M36=Follow-up; M37-M42=analysis, write-up, trial close-out. TEAM: We have assembled a multidisciplinary team, comprising world-leading expertise in sleep medicine, CBT/SRT, primary care, clinical trials methodology, statistics, qualitative scholarship, health economics and PPI.

Lay abstract: BACKGROUND Insomnia refers to problems with falling asleep or staying asleep and affects 10% of the adult population. Insomnia can affect our health and daily life. For example, it reduces our ability to concentrate, lowers our mood and puts us at risk of developing mental and physical illness. Good treatments exist, including psychological therapies and sleeping pills. However, sleeping pills do not lead to long-term improvements in sleep and have been linked to significant side-effects, such as addiction and next-day sleepiness. This may lead to long-term health consequences, as well as accidents and falls. The best treatment for insomnia is a psychological therapy called cognitive-behavioural therapy, which involves supporting the person with insomnia to improve their sleep behaviours and sleep-related thoughts. Research shows this to be a very effective and long-lasting treatment but there are not enough trained therapists to support the large number of poor sleepers in the UK. Therefore, most people who seek treatment for insomnia from their General Practitioner (GP) continue to experience poor sleep and are left frustrated. GPs are similarly frustrated by the limited treatments they have available to help their patients with long-term insomnia. WHY DO WE WANT TO DO THIS STUDY? We want to help people with insomnia regain a normal sleep pattern and as a consequence improve their health and quality of life. We have developed a brief version of cognitive behavioural therapy, called sleep restriction therapy (SRT), which involves introducing a new sleep-wake pattern and supporting the patient to try it each night. SRT can be given in just two brief sessions by a nurse, and supported by two follow-up phone calls. We want to carry out this study to see if SRT, given by nurses working in GP practices, can improve insomnia and quality of life. HOW WILL WE DO THIS? We will search GP records and invite people with persistent insomnia to take part. Participants will be assigned, by chance, to either SRT, or a control treatment, called sleep hygiene. Sleep hygiene will involve receiving a leaflet of “sleep do’s and dont’s” (for example, avoiding caffeine in the evening, keeping a regular sleep schedule, or ensuring one’s bedroom is not too hot or too cold). Although this seems like common sense, there is no evidence that sleep hygiene improves sleep in those with insomnia, yet this is what people are currently offered by their GP. We will measure sleep, quality of life and daytime functioning through a number of questionnaires, before treatment, and also 3, 6 and 12 months after treatment begins. We will also collect information on what treatments (e.g. sleep medication) people have received during the study and how many times they have visited their doctor. We will use this information to work out if SRT represents good value for money for the NHS. At each stage of the project, we will involve members of the public to help inform how we carry out our research, for example through reviewing study materials and supporting us in making our results available to the general public. We hope to understand whether SRT can be delivered in primary care to treat insomnia, improve quality of life, and reduce the cost of poor sleep to the NHS and wider society. If shown to be successful, primary care nurses across the UK could be trained to deliver SRT within the NHS, helping to improve sleep for millions of people with insomnia.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH