Effects of a Digital CBT-I Therapeutic in Improving Sleep and Reducing Anxiety and Depression Symptoms in Adults With Chronic Insomnia: Interim Analysis of DREAM Study

Abstract: Introduction: Chronic insomnia (CI) often co-occurs with depression and anxiety. This ongoing study collected real-world data on changes in insomnia, depression, and anxiety symptoms among adults with CI treated with a prescription digital therapeutic (PDT; Somryst®, previously SHUTi) delivering cognitive-behavioral therapy for insomnia (CBT-I). Methods: This prospective, single-arm, pragmatic clinical study enrolled U.S. adults (22-75 years) with CI and mobile device access. The PDT includes 6 Core modules, completed over 6-9 weeks. Participants completed the Insomnia Severity Index (ISI), 8-item Patient Health Questionnaire (PHQ-8), and Generalized Anxiety Disorder-7 scale (GAD-7) and other self-reported outcomes—at screening (baseline/prior to Core 1), end of treatment (Day 63), and 6-month follow-up (Day 243). Results: Mean ISI decreased (p