Abstract

Introduction
Sleep problems are common leading to physical and psychosocial morbidity and impaired quality of life. Sufferers often seek help from primary care and receive advice or hypnotic drugs which are ineffective long term. Cognitive behavioural therapy for insomnia (CBTi) is effective but is not widely used in general practice. We conducted a pilot study to test procedures and collect information in preparation for a larger definitive trial to measure effectiveness and cost-effectiveness of an educational intervention for general practitioners and primary care nurses a to deliver problem focused therapy to adults
Methods
This was a pilot cluster randomised controlled trial. General practices were randomised to an educational intervention (2x2 hours) for problem focused therapy which comprised assessment (of secondary causes, severity and using sleep diaries) and modified CBTi compared with usual care (sleep hygiene advice and hypnotic drugs). We recruited patients with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety and Pittsburgh Sleep Quality Index (PSQI≥4). The primary outcome was PSQI and secondary outcomes including Insomnia Severity Index (ISI), Epworth Sleepiness Scale, Beck Depression Inventory and PSYCHLOPS were measured at 0, 4, 8 and 13 weeks. Intervention fidelity was evaluated using telephone interviews of participating practitioners and patients.
Results
Out of 64 participants recruited, 37 completed the trial. Analysis was conducted masked to treatment allocation. We used a mixed effects model to test for overall change and whether the intervention affected the rate of change over time. There was significant dropout during the pilot study, mainly due to delays in recruitment. We detected neither an overall change over time (PSQI score increase per week 0.06 (95%CI -0.03 to 0.16) nor differential change between intervention and control groups 0.10 (-0.03 to 0.23) although the study was not powered to detect such a change.
Conclusion
This pilot study confirmed that it was feasible to undertake a trial of education for primary care clinicians to deliver problem focused therapy for insomnia in general practice but also exposed problems with study recruitment, dropout, and intervention fidelity which should be addressed in the design of a full trial.