Accepted for/Published in: JMIR Mental Health
Date Submitted: Sep 17, 2025
Date Accepted: Sep 24, 2025
The effectiveness of digital CBT to treat insomnia disorder in US adults: A nationwide decentralized randomized controlled trial
ABSTRACT
Background:
Cognitive Behavioral Therapy for insomnia (CBT-I) is recommended as the first-line treatment for insomnia, however, few patients can get access to it. Digital CBT-I programs have been developed and are an effective treatment, however trials often fail to enroll diverse populations.
Objective:
To evaluate the effectiveness of digital CBT-I for the treatment of insomnia compared to online sleep hygiene education
Methods:
This is a decentralized randomized controlled trial compared SleepioRx against online sleep hygiene (SHE) in a diverse group of 336 adults recruited nationally across the US with insomnia disorder diagnosed via structured clinical interview. Participants were allocated 1:1 to either digital CBT-I (SleepioRx) or to online sleep hygiene education (SHE). Participant recruitment occurred between November 2022 and February 2023. The primary endpoints were insomnia severity assessed using the insomnia severity index (ISI) and sleep diary sleep onset latency (SOL) and wake after sleep onset (WASO) at 10-weeks, with follow-up assessments at 16- and 24-weeks post-randomization.
Results:
Compared to SHE, SleepioRx showed statistically and clinically significant improvements on the insomnia severity index (ISI) at post-treatment (10 weeks; d=0.60, p<0.001), with effects sustained at follow-up (16 weeks, d=0.65, p<0.001; and 24 weeks, d=0.77, p<0.001). SleepioRx led to significant reductions in WASO at all timepoints, however effects on SOL were not statistically significant at an adjusted alpha. Sustained statistically and clinically significant effects were observed for ISI response and remission for SleepioRx compared to SHE. SleepioRx also demonstrated improvements in mood and secondary sleep-diary outcomes.
Conclusions:
The results of this trial underscore the effectiveness of digital CBT-I across patients with insomnia and reinforce that availability of FDA-cleared digital CBT-I should be expanded to increase access to first-line treatment. Clinical Trial: The trial was prospectively registered (NCT05541055) on 15 September 2022.
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