In a recent study published in The Lancet, researchers compare the cost-effectiveness and clinical impact of nurse-delivered sleep restriction therapy with sleep hygiene for insomnia treatment.
Study: Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial. Image Credit: Ground Picture / Shutterstock.com
Background
About 10% of all adults are affected by insomnia disorders. Previous studies have reported that insomnia contributes to reduced quality of life and an increased risk of psychiatric illnesses, suicide, type 2 diabetes, and cardiovascular diseases.
Long-term insomnia management cannot rely on current treatment options, including sleep hygiene advice, as they lack evidence-based support. However, there remains limited access to CBT, the primary treatment for insomnia recommended by international guidelines. Thus, new models of care are needed to improve access to insomnia guideline interventions, particularly in general practice.
Sleep restriction therapy, which is a primary component of CBT, has shown positive results for the treatment of insomnia. However, there is ambiguity about whether sleep restriction can be delivered as a single-component intervention by generalists that can be cost-effective and eventually lead to long-term improvements in insomnia.
About the study
In the present study, researchers compare the cost- and clinical effectiveness of brief sleep restriction therapy delivered by nurses to sleep hygiene advice in insomnia management. This study includes results from the open-label, pragmatic, randomized controlled, superiority denoted as the health-professional-administered brief insomnia therapy (HABIT) trial.
A web-based randomization program was used to randomly assign adult insomnia disorder patients to a sleep hygiene booklet-only approach or four nurse-delivered sleep restriction therapy sessions that involved two telephonic and in-person sessions, together with a sleep hygiene booklet category in a 1:1 ratio.
All study participants were selected from 35 England general practices from the Greater Manchester, Thames Valley, and Lincolnshire regions. These patients met the diagnostic and statistical manual of mental disorders (DSM)-5 criteria for insomnia disorder. Notably, standard care was not restricted in either study group.
Outcome assessments were conducted at baseline, three, six, and 12 months following randomization. At six months, the insomnia severity index (ISI) was used to quantify the primary endpoint of self-reported insomnia severity. Secondary outcomes included physical health, sleep-related quality of life, depressive symptoms, work productivity, pre-sleep arousal, and sleep effort.
Eligible patients with at least one outcome measure comprised the primary analysis group. The cost-effectiveness of sleep restriction insomnia therapy was estimated from personal social services and the United Kingdom National Health Service (NHS) data and expressed as incremental cost per quality-adjusted life year (QALY) gained.
Study findings
A total of 642 individuals were included in the current study, with both sleep restriction therapy and sleep hygiene groups consisting of 321 patients each. The current study was conducted between August 29, 2018, to March 23, 2020. All study participants had similar baseline characteristics and belonged to the White ethnicity.
The mean age of the subjects was 55.4 years and ranged from 19 to 88 years, with 76.2% of subjects female and 23.8% male. Most of the patients had comorbidities and mental health problems.
At least one outcome measurement was provided by 90.3% of participants. The mean ISI score for sleep restriction and sleep hygiene therapies at six months was 10.9 and 13.9, respectively, thus demonstrating that participants in the sleep restriction therapy group documented less severe insomnia than those in the sleep hygiene group.
Although more subjects met the clinically significant treatment response criteria in the sleep restriction therapy group than the sleep hygiene group, sensitivity analysis indicated that the treatment effect remained consistent when accounting for missing data and baseline compliance predictors. The investigators also found that reduced sleep effort and pre-sleep arousal at three months mediated the treatment effect on ISI at six months.
The sleep restriction intervention did not significantly impact physical health-related quality of life or medication use. Furthermore, improvements in actigraphy-defined sleep were observed only at six months.
The occurrence of adverse events did not vary significantly between the intervention and control groups. While eight subjects in the sleep restriction and sleep hygiene groups experienced serious adverse events, none were thought to be caused by the implemented insomnia interventions.
At a £20,000 National Institute for Health and Care Excellence (NICE) cost-effectiveness threshold, the incremental cost per QALY gained was £2,076. This finding is associated with a 95.3% chance that the sleep restriction treatment for insomnia is cost-effective as compared to the sleep hygiene intervention.
Conclusions
The current study was the first large-scale pragmatic trial to investigate the impact of sleep restriction therapy, a psychological intervention, on insomnia disorder.
Brief sleep restriction therapy delivered by nurses in primary care is a cost-effective insomnia treatment that is a promising option for first-line insomnia disorder therapy. In the context of limited access to CBT, the study highlights the possible scalability of sleep restriction as a single-component intervention for insomnia.
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