0481 Effectiveness of a digital therapeutic compared to medications and cognitive behavioral therapy for treating chronic insomnia in adults

Abstract Introduction Limitations on the availability of guideline-recommended cognitive behavioral therapy for insomnia (CBT-I) constrain its use and create an unmet need for innovative ways to expand access. Digital therapeutics offer a potential solution. This study compared a digital intervention, traditional face-to-face CBT-I, and prescription medications for insomnia. Methods Of 184 articles identified in a systematic literature review, 13 studies reported ISI mean change from baseline data: 1 using the digital therapeutic (DT) SHUTi (now known as the prescription digital therapeutic Somryst), 1 on the medication eszopiclone, and 11 on traditional CBT. A Bayesian network meta-analysis (NMA) was performed on the mean change from baseline and the proportion of remitters using the insomnia severity index (ISI) endpoint with follow-up timepoints between 6-12 weeks. Mean change in ISI score from baseline was analyzed as a continuous endpoint while comparisons of the proportion of remitters was performed using odds ratios. The analysis used a random-effects model for the base case analysis. A surface under the cumulative ranking curve (SUCRA) analysis was performed to rank the treatments on each endpoint. Results Only the DT and CBT-I were significantly different than placebo. The DT had the greatest mean change from baseline in ISI from placebo (-5.77 points, 95% Credible Interval (CrI) [-8.53, -3.07]), followed by CBT-I (-4.3 points, 95% CrI [-6.32, -2.39]). In the SUCRA analysis, the DT had the highest probability (56%) of being the most effective treatment based on ISI mean change from baseline. 8 studies reported the proportion of ISI remitters. Only the DT showed a statistically significant difference in remission vs. placebo, and the DT had the highest odds ratio for remission vs. placebo (OR 12.33; 95%CrI [2.28, 155.91]). The DT had the highest probability (64%), of being the most effective treatment for inducing remission using ISI definitions. Conclusion The DT in this study was projected to be the most effective therapy on both mean change in ISI and ISI remission within 6-12 weeks of treatment start vs. either traditional CBT-I or medications. Support (If Any) This analysis was funded by Pear Therapeutics, Inc.