HABIT
Trial question
What is the effect of nurse-delivered sleep restriction therapy in primary care patients with insomnia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
76.0% female
24.0% male
N = 642
642 patients (489 female, 153 male)
Inclusion criteria: adult patients with insomnia disorder
Key exclusion criteria: pregnancy; additional sleep disorder diagnosis; dementia or MCI; epilepsy, schizophrenia, or bipolar disorder; current suicidal ideation with intent or attempted suicide within past 2 months
Interventions
N=321 sleep restriction therapy (nurse-delivered manualized behavioral intervention over 4 consecutive weeks plus a sleep hygiene)
N=321 sleep hygiene booklet (booklet comprising standard behavioral guidance in relation to lifestyle and environmental factors associated with sleep and sleeplessness)
Primary outcome
Mean Insomnia Severity Index at 6 months
10.9
13.9
13.9 points
10.4 points
7.0 points
3.5 points
0.0 points
Sleep restriction
therapy
Sleep hygiene
booklet
Significant
decrease ▼
Significant decrease in mean Insomnia Severity Index at 6 months (10.9 points vs. 13.9 points; MD -3.05, 95% CI -3.83 to -2.28)
Secondary outcomes
No significant difference in 36-Item Short-Form Health Survey physical health-related QoL score at 6 months (48.1 points vs. 47.2 points; AD 0.77 points, 95% CI -0.35 to 1.89)
Significant increase in 36-Item Short-Form Health Survey mental health-related QoL score at 6 months (44.7 points vs. 42.2 points; AD 1.97 points, 95% CI 0.52 to 3.43)
Significant increase in Glasgow Sleep Impact Index score at 6 months (50.6 points vs. 37.7 points; AD 12.8 points, 95% CI 8.63 to 16.96)
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In adult patients with insomnia disorder, sleep restriction therapy was superior to sleep hygiene booklet with respect to mean Insomnia Severity Index at 6 months.
Reference
Simon D Kyle, A Niroshan Siriwardena, Colin A Espie 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 Sep 16;402(10406):975-987.
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