After completing 6 modules in a digital therapeutic for insomnia, most users met criteria for meaningful treatment response and 40% met criteria for remission.
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.
“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.
The study included 7216 adults with insomnia who purchased SHUTi between December 2015 and February 2019. 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.
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. 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.
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.
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.
By Core 6, moderate to large increases in effect size were seen for diary-derived sleep onset latency and wake after sleep onset. Also seen were reductions in the amount of medicated nights, with participants with severe insomnia having the greatest reduction (d = 0.3).
By the end of the last module, 61% of participants met criteria for meaningful treatment response, defined as a reduction of more than 7 points on the ISI. Additionally, 40% met criteria for remission, defined as a score of less than 8 on the ISI. Real-world engagement with the modules was comparable with SHUTi research trials.
With this real-world data, the authors concluded that CBT-I delivered digitally was effective.
“It is important to examine outcomes of empirically-supported digital interventions in the real-world in order to fully understand and appreciate the potential for effective large-scale dissemination,” they said. “Insomnia outcomes were consistent with those demonstrated in RCTs of CBT-I, supporting the utility of digitally-delivered CBT-I, which is an approach that may help overcome many current barriers to guideline-recommended care and augment the care provided by face-to-face behavioral therapists.”
Ritterband LM, Thorndike FP, Morin CM, et al. Real-world evidence from users of a behavioral digital therapeutic for chronic insomnia. Behav Res Ther. 2022;153:104084. doi:10.1016/j.brat.2022.104084