0445 Comparing Adherence for a Prescription Digital Therapeutic for Insomnia Across Controlled and Real-world Settings

Abstract Introduction Digital Cognitive Behavioral Therapy for insomnia (dCBT-I) offers scalable first-line treatment versus face-to-face care, but a potential trade-off is lower treatment adherence. In clinical trials, adherence rates to dCBT-I have been variable, and there is no defined standard for acceptable adherence to dCBT-I. Further, the generalizability of adherence data from clinical trials to real-world settings is unknown. This study compared adherence data from two dCBT-I clinical trials to adherence within a real-world study. Methods The dCBT-I intervention was a prescription digital therapeutic (Somryst) that includes 6 treatment Cores (e.g., sleep restriction, stimulus control) delivered over 9 weeks. Participants must complete a Core and wait 7 days before starting the next Core. Clinical trial adherence data was derived from two RCTs previously submitted to FDA as part of its authorization (RCT-1 USA; N=151, age 21-65 years and RCT-2 Australia; N=574, age 18-64 years). Real-world adherence data was derived from a prospective, single-arm, pragmatic clinical study (DREAM USA; N=991, age ≥18 years). Adherence was defined as the percentage of participants with dCBT-I access who completed each treatment Core. Automated notifications prompt engagement with the therapeutic. Results Real-world adherence rates from the DREAM study were 94.1%, 71.1%, 60.7%, 55.7%, 49.1%, and 42.8% for Cores 1-6. For RCT-1, adherence rates of Cores 1-6 were 93.4%, 88.1%, 76.8%, 67.5%, 66.9%, and 60.3%, respectively, whereas adherence rates of Cores 1-6 in RCT-2 were 80.8%, 67.9%, 60.5%, 54.0%, 47.6%, and 40.8%. Conclusion Real-world adherence to dCBT-I appears comparable to RCTs, with the largest decrease occurring between Cores 1 and 2. These findings support the generalizability of adherence data from RCTs and potential opportunities to increase adherence early in treatment. Further work is needed to determine acceptable standards for adherence to dCBT-I in the real world. Support (if any) DREAM study: Pear Therapeutics, Inc. RCT-1: NIMH grant #R01 MH86758; NCT01438697. RCT-2: NHMRC project grant #1005867; ACTRN12611000121965. Additional support provided by Nox Health, Inc.