Participants receiving the tailored digital program showed a 42% remission rate in insomnia symptoms compared to 0% in the control group at 8 weeks.
The tailored digital CBTi program was linked to significant reductions in insomnia, depression, anxiety, sleepiness, and maladaptive beliefs about sleep.
At 8 weeks, the CBTi group experienced an average insomnia score decrease of 8.3 points compared to the control group.
Improvements in insomnia symptoms were maintained through 24 weeks of follow-up.
The CBTi group had a 75% rate of clinically meaningful insomnia symptom improvement, while only 14% of the control group achieved similar results.
Fatigue levels did not show significant differences between the CBTi and control groups.
Simplified
(COMISA) is a prevalent and debilitating condition. Cognitive behavioural therapy for insomnia () is an effective but largely inaccessible treatment in patients with COMISA. We aimed to test a self-guided interactive digital CBTi program tailored for COMISA and insomnia alone. A pilot randomised controlled trial was conducted to investigate the effect of an interactive tailored digital CBTi program, versus digital sleep education (control) on symptoms of insomnia, depression, anxiety, sleepiness, fatigue, and maladaptive beliefs about sleep in people with COMISA. Online questionnaires were administered at baseline, 8 weeks, 16 weeks, and 24 weeks. Intent-to-treat mixed models and complete-case Fisher's exact analyses were used. Participants were 30 adults with COMISA (Age M[sd] = 61.0[10.3], 60% female, BMI = 33.5[6.5]). Compared to control, CBTi was associated with lower insomnia (M[95% CI] difference = 8.3[5.0-11.6], p < 0.001, d = 2.88), depression (3.7[1.0-6.5], p = 0.008, d = 1.66), anxiety (2.9[0.9-4.9], p = 0.005, d = 0.62), sleepiness (2.7[0.8-4.5], p = 0.007, d = 0.71), and maladaptive beliefs about sleep (13.9[5.7-22.2], p = 0.001, d = 1.16), but not fatigue (1.9[-1.2-4.9], p = 0.229, d = 0.68) at 8-week follow-up, controlling for baseline scores. The CBTi group experienced greater rates of insomnia remission (ISI < 8; 42%, vs. 0%, p = 0.012), and improvement (ISI reduction ≥ 6; 75% vs. 14%; p = 0.004) by 8-weeks. Improvements in the CBTi group were sustained by 24-weeks. This tailored digital CBTi program led to large and sustained improvements in insomnia, depression, anxiety, sleepiness, and maladaptive beliefs about sleep in people with COMISA. Trial Registration: This trial was prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR, ACTRN12622001218785). https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384648&isReview=true.
Key numbers
8.3
Insomnia Severity Reduction
Mean difference on the Insomnia Severity Index at 8 weeks.
42%
Insomnia Remission Rate
Proportion of participants in the group with ISI < 8 at 8 weeks.
75%
Improvement Rate
Proportion of participants with ISI reduction ≥ 6 at 8 weeks.
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ASw, CRe and CRi developed the intervention used in this study. No funding was received for the coordination of this study or development of the intervention. ASw reports unrelated research equipment and/or funding support from the Australian Department of Health and Aged Care, National Health and Medical Research Council, Medical Research Future Fund, Flinders University, the Flinders Foundation, the Hospital Research Foundation, Big Health, Philips Respironics, Compumedics, and commissioned/consultancy work for Australian Doctor, Sleep Review Mag, Re‐Time Australia, Air Liquide and ResMed, and Honorarium from the American Academy of Dental Sleep Medicine, Taiwan Society of Sleep Medicine, TMJ Therapy Centres, Cerebra, and the Australian and New Zealand Academy of Orofacial Pain.
