HABIT
Research type
Research Study
Full title
A pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy (SRT) for insomnia disorder to sleep hygiene (SH) in primary care
IRAS ID
238138
Contact name
Simon D. Kyle
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN42499563
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
Research Summary
Insomnia is a condition where people have persistent problems with falling asleep or staying asleep. Insomnia can have a significant effect on 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. The best treatment for insomnia is a psychological therapy called cognitive-behavioural therapy (CBT), which involves supporting people with insomnia to improve their sleep behaviours and sleep-related thoughts. However, access to CBT in the UK is limited and there are not enough trained therapists to help the number of poor sleepers. The aim of this study is to test if a brief version of CBT that we have developed called sleep restriction therapy (SRT), delivered by nurses working in GP practices, can help people with insomnia regain normal sleep pattern. SRT involves introducing a new sleep-wake pattern and supporting patients to try it each night. Nurses will be trained in SRT, which can be delivered to patients in just two brief sessions and followed up with two phone calls over four weeks. Patients with insomnia will be invited by their GP to take part in the study. Patients will be randomised into one of two groups to receive: SRT+SH (or) SH only. Both groups will receive sleep hygiene advice and this will involve receiving a leaflet of “sleep do’s and don’ts”. Patients will be asked to complete a number of questionnaires to measure their sleep, quality of life and daytime functioning before treatment, and also at 3, 6 and 12 months after treatment begins. The study will look at 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.
Summary of Results
WHAT WAS THE QUESTION?
Insomnia refers to problems with falling asleep or staying asleep, which affects 10% of the adult population. The recommended treatment for insomnia is a psychological treatment called cognitive-behavioural therapy. 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.We have developed a brief version of cognitive behavioural therapy, called sleep restriction therapy, which involves supporting the patient to follow a new sleep-wake pattern. We carried out this study to see if sleep restriction therapy, given by nurses working in general practice, can improve insomnia and quality of life.
WHAT DID WE DO?
We searched general practice records and invited people with insomnia to take part. 642 participants were assigned, by chance, to either sleep restriction therapy or a comparison treatment, called sleep hygiene. Sleep restriction therapy involved meeting with a nurse on four occasions and following a prescribed sleep schedule. Sleep hygiene involved receiving a leaflet of sleep "do’s and dont’s". Those receiving sleep restriction therapy were also provided with the same sleep hygiene leaflet so that the difference between the two groups was whether or not they received nurse treatment. We measured sleep, quality of life, daytime functioning and use of sleep medication through questionnaires, before and after treatment. We calculated the cost to deliver the treatment, as well as the cost of other NHS treatments that participants accessed during the study. We also interviewed participants and nurses to understand their views of the treatment.WHAT DID WE FIND?
We found that participants in the sleep restriction therapy group experienced greater reduction in their insomnia symptoms compared to sleep hygiene. They also experienced improved sleep, mental health, quality of life, and work productivity. The two groups did not differ in their use of prescribed sleep medication. Our results suggest that the treatment is likely to represent good value for money for the NHS. Both nurses and participants considered the treatment to be acceptable and beneficial, and they suggested some potential refinements.WHAT DOES THIS MEAN?
Our study shows that nurse-delivered sleep restriction therapy is likely to be a clinically-effective approach to the treatment of insomnia, and good value for money for the NHS.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0153
Date of REC Opinion
15 May 2018
REC opinion
Further Information Favourable Opinion