A pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy for insomnia disorder to sleep hygiene in primary care
A nurse-delivered sleep restriction therapy will be tested against standard sleep hygiene advice in a trial of 628 adults with chronic insomnia across UK GP practices. Insomnia affects roughly one in ten adults, yet access to effective non-drug treatments remains limited in primary care. Sleep restriction therapy—a core component of cognitive behavioural therapy—works by limiting time in bed to rebuild sleep pressure and strengthen the body’s internal clock. But it is rarely offered because specialist therapists are scarce. This trial asks whether practice nurses, who already see patients for long-term conditions, can deliver a brief, manualised version of the therapy effectively and at lower cost. If the approach works, it could give GPs a practical, scalable alternative to prescribing sleeping pills. The trial measures not just insomnia severity at six months, but also quality of life, depression, work productivity, and hypnotic medication use. An economic evaluation will tell the NHS whether the therapy saves money over the long term. A process evaluation will reveal what helps or hinders delivery in real-world clinics. The results could reshape how the health service manages one of its most common and costly complaints.
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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 aim to recruit a minimum sample size of 628 (314 in each arm). This sample size has 90% power to detect a minimum effect size difference of 0.3, accounting for 25% 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.
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