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

Introduction: Chronic 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. Methods: This 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. Results: After 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