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Sleep restriction therapy -- systematically restricting and regularizing time in bed to stabilize sleep -- conducted by a nurse in a primary care setting reduced insomnia symptoms compared with sleep hygiene alone, according to the randomized HABIT trial.
At 6 months, the mean score on the Insomnia Severity Index (ISI) was 10.9 among participants who received nurse-delivered sleep restriction therapy versus 13.9 for those who received a sleep hygiene booklet only (P<0.0001), reported Simon Kyle, PhD, of the Sleep and Circadian Neuroscience Institute at the University of Oxford in England, and co-authors in .
Mean adjusted differences in ISI -- which ranges from 0 to 28, with higher scores indicating more severe symptoms -- also significantly favored the intervention at both 3 and 12 months as well:
- 3 months: -3.88 (95% CI -4.66 to -3.10, P<0.0001)
- 12 months: -2.96 (95% CI -3.75 to -2.16, P<0.0001)
In addition, the incremental cost per quality-adjusted life-year (QALY) gained was £2,076 ($2638) with sleep restriction therapy, suggesting that the treatment had a 95.3% probability of being cost-effective based on a £20,000 ($25,412) cost-effectiveness threshold, Kyle and team said.
"Insomnia is a serious condition because it's highly prevalent, has a major effect on quality of life, and increases risk for developing other physical and mental health problems," Kyle said . "The key issue is that people with chronic insomnia rarely receive evidence-based treatment."
Guidelines suggest that first-line treatment for insomnia should be multi-component cognitive behavioral therapy, "but access is extremely limited worldwide because of inadequate resources and expertise," the authors noted, with patients instead often prescribed hypnotic medication or off-label sedative antidepressants.
Sleep restriction therapy is a principal component of cognitive behavioral therapy, which "counters behaviors that perpetuate insomnia, specifically time-in-bed extension, variability in sleep-wake timing, and daytime napping," Kyle and team explained.
This brief nurse-delivered therapy can be both effective in treating insomnia disorder and improving certain aspects of mental health and functioning for these patients, they pointed out, adding that their study results could have implications for clinical practice in primary care settings because it is cost-effective without major increases in demands on nursing time.
"Future research is needed to understand how the nurse-delivered program could be implemented in the NHS, for example as part of a stepped care approach to insomnia management, and whether this may lead to reduction in prescriptions for sleep medication," Kyle said.
In , Annemieke van Straten, PhD, of Vrije Universiteit Amsterdam in the Netherlands, and co-authors, agreed that this approach could become an important therapy option for patients with insomnia.
"The study by Kyle and colleagues shows that sleep restriction therapy is a simple and effective treatment for at least part of the population of people with chronic insomnia and can be carried out by nurses in primary care," they wrote.
Just 1% of these patients typically receive the preferred treatment of cognitive behavioral therapy for insomnia, despite research that has suggested that the disorder may be prevalent in up to 50% of patients who visit their primary care physicians, they noted.
"This is an important contribution in tackling the public health burden of insomnia," they concluded. "Urgent efforts are needed to adapt treatments for underserved populations and to educate primary care staff in recognizing insomnia."
This enrolled 642 patients from 35 general practices across England from August 2018 to March 2020 and randomly assigned them 1:1 using a web-based randomization program to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only.
Mean participant age was 55.4 years (range 19-88 years), 76.2% were women, and 97.2% were white.
Overall, 25.4% were currently taking prescribed sleep medications, and 49.2% had a Patient Health Questionnaire-9 score ≥10, indicating depressive symptoms.
The primary outcome was a self-reported insomnia severity score at 6 months, using the seven-item ISI for assessing night- and daytime symptoms of insomnia.
In total, 64.5% of participants in the sleep restriction therapy group attended all four sessions, with a mean total therapy duration of 85.5 minutes.
Of the included patients, 90.3% provided data on a minimum of one outcome measurement.
Eight patients in each group experienced serious adverse events, but none of these events were deemed to be related to the intervention.
Disclosures
This study was funded by the National Institute for Health and Care Research Health Technology Assessment Program.
Kyle reported non-financial support from Big Health in the form of no-cost access to the digital sleep improvement program, Sleepio, for use in clinical research, outside the submitted work. Co-authors reported consultancy fees from Mementor DE and being cofounder of and shareholder in Big Health.
van Straten and a co-author developed the online insomnia intervention i-Sleep, which contains cognitive behavioral therapy for insomnia. van Straten also holds IP in the i-Sleep intervention, which is commercially available to healthcare professionals. The authors did not receive any income from this collaboration.
Primary Source
The Lancet
Kyle SD, et al "Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial" Lancet 2023; DOI: 10.1016/ S0140-6736(23)00683-9.
Secondary Source
The Lancet
van Straten A, et al "How to boost implementation for insomnia treatment in primary care?" Lancet 2023; DOI: 10.1016/ S0140-6736(23)01040-1.