![]() ![]() They found a decrease in users’ mean ISI scores and a corresponding increase in effect size at the beginning of each subsequent Core, compared with Core 1.īy Core 6, moderate to large increases in effect size were seen for diary-derived sleep onset latency and wake after sleep onset. Using data from this program, the study authors aimed to evaluate insomnia severity, sleep diary-derived outcomes, treatment response and remission rates, program engagement, and sleep aid use. Participants completed the Insomnia Severity Index (ISI) at the beginning of each Core, and entered sleep diary entries between Cores to track changes and receive tailored recommendations. When using SHUTi, the participants completed 6 sequential modules (Cores) less than an hour long that focused on insomnia, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. The program is delivered through a browser on either a mobile phone or desktop computer, and is also a precursor program to the first FDA-authorized prescription digital therapeutic Somryst. The study included 7216 adults with insomnia who purchased SHUTi between December 2015 and February 2019. “While RCTs are critical and necessary for understanding the efficacy of treatments, real-world data provide an important complement to RCTs by evaluating the generalizability of interventions and outcomes in the context of real-world implementation,” the authors said. ![]() While data from randomized controlled trials (RCTs) are available for many digital therapeutics, this study aimed to collect real-world data on the Sleep Health Using the Internet (SHUTi) digital therapeutic, which delivers CBT-I. Real-world data showed that cognitive behavioral therapy for insomnia (CBT-I) delivered via a digital therapeutic was effective, according to a study published in Behaviour Research and Therapy. ![]()
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