After completing 6 modules in a digital treatment for insomnia, most users met the criteria for a significant treatment response and 40% met the criteria for remission.
According to a study published in Behavioral Research and Therapy.
Although data from randomized controlled trials (RCTs) are available for many digital therapies, this study aimed to collect real data on SHUTi (sleep and health using internet) digital therapy, which delivers CBT-I.
“While RCTs are essential and necessary to understand the effectiveness of treatments, real-world data provide an important complement to RCTs by assessing the generalizability of interventions and outcomes in the context of real-world implementation” , the authors said.
The study included 7,216 adults with insomnia who purchased SHUTi between December 2015 and February 2019. The program is delivered through a browser on a mobile phone or desktop computer, and is also a precursor program to Somryst’s first digital therapeutic prescription cleared by the FDA.
While using SHUTi, participants completed 6 sequential modules (Cores) of less than an hour that focused on insomnia, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene and relapse prevention. Participants completed the Insomnia Severity Index (ISI) at the start of each core and entered sleep diary entries between cores to track changes and receive personalized recommendations.
Using data from this program, the study authors aimed to assess insomnia severity, sleep diary-derived outcomes, treatment response and remission rates, program engagement and the use of sleeping pills.
They found a decrease in average user ISI scores and a corresponding increase in effect size at the start of each subsequent core, compared to Core 1.
At Core 6, moderate to large increases in effect size were observed for diary-derived sleep onset latency and post-sleep awakening. Reductions in the number of medication nights were also observed, with participants with severe insomnia having the greatest reduction (d = 0.3).
At the end of the last module, 61% of participants met the criteria for a significant treatment response, defined as a reduction of more than 7 points on the ISI. In addition, 40% met the criteria for remission, defined as an ISI score of less than 8. Real-world engagement with the modules was comparable to SHUTi research trials.
With this real-world data, the authors concluded that digitally delivered CBT-I was effective.
“It is important to examine the results of empirically supported digital interventions in the real world to fully understand and appreciate the potential for effective dissemination at scale,” they said. “The insomnia results were consistent with those demonstrated in RCTs of CBT-I, supporting the utility of digitally delivered CBT-I, which is an approach that can help overcome many current barriers to patient-recommended care. guidelines and to augment the care provided by face- to face behavioral therapists.
Ritterband LM, Thorndike FP, Morin CM, et al. Real-world evidence of users of a digital behavioral therapy for chronic insomnia. Behav Res Ther. 2022;153:104084. doi:10.1016/j.brat.2022.104084