Effect of a prescription digital therapeutic for chronic insomnia on post-treatment insomnia severity, depression, and anxiety symptoms: results from the real-world DREAM study

Abstract

IntroductionChronic insomnia is a substantial public health burden that often presents with co-occurring depression and anxiety. Randomized clinical trials and preliminary real-world evidence have shown that digitally delivered cognitive-behavioral therapy for insomnia (dCBT-I) is associated with improvements in insomnia, but real-world evidence is needed to determine the true impact of digital CBT-I. This pragmatic study aimed to evaluate the benefits of treating chronic insomnia with a tailored prescription digital therapeutic in a real-world population. MethodsThis prospective, single-arm clinical study involved adults aged 22-75 with chronic insomnia living in the US who had access to a mobile device. Participants accessed the FDA-cleared prescription digital therapeutic (PDT; Somryst®) over a 9-week intervention period. The PDT delivers cognitive-behavioral therapy for insomnia via six interactive treatment cores and daily sleep diaries used for tailoring treatment. Participants completed validated patient-reported instruments at baseline, before completing treatment cores, immediately post-intervention, and at 6-month and 1-year follow-ups. The Insomnia Severity Index [ISI], the 8-item Patient Health Questionnaire [PHQ-8], and the Generalized Anxiety Disorder-7 scale [GAD-7] were used to determine the effect of the PDT on insomnia, depression, and anxiety.ResultsAfter screening, 1565 adults accessed the PDT. 58% of those who began the program completed Core 4, established as exposure to all mechanisms of action in the digital therapeutic. For those who completed assessments for all 6 cores (48.4%), the ISI was lowered from 18.8 to a mean of 9.9 (P <.001). These scores continued to be lower than baseline at immediate post (11.0), 6-month (11.6), and 1-year follow-ups (12.2) (P <.001). The results of the PHQ-8 and GAD-7 also show significant decreases at all measured timepoints from baseline (P <.001). Of the patients that began the program, 908 (58.0%) were considered adherent and 733 (46.8%) completed all 6 cores.ConclusionData from the DREAM study contributes to the growing body of clinical evidence of how patients are utilizing a PDT in the real world, outside of controlled settings, offering insights for clinicians who use these therapeutics in practice. Clinical trial registrationClinicalTrials.gov, identifier NCT04325464.