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 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. CLINICALTRIAL The trial was prospectively registered (NCT05541055) on 15 September 2022.
Prather et al. (Wed,) studied this question.