{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T14:04:53Z","timestamp":1792159493334,"version":"4.4.0"},"reference-count":32,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2024,9,10]],"date-time":"2024-09-10T00:00:00Z","timestamp":1725926400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Psychiatry"],"abstract":"\n Introduction<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n 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\n \u00ae<\/jats:sup>\n ) 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.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n 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 &lt;.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 &lt;.001). The results of the PHQ-8 and GAD-7 also show significant decreases at all measured timepoints from baseline (P &lt;.001). Of the patients that began the program, 908 (58.0%) were considered adherent and 733 (46.8%) completed all 6 cores.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Data 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.<\/jats:p>\n <\/jats:sec>\n \n Clinical trial registration<\/jats:title>\n \n ClinicalTrials.gov<\/jats:uri>\n , identifier NCT04325464.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.3389\/fpsyt.2024.1450615","type":"journal-article","created":{"date-parts":[[2024,9,10]],"date-time":"2024-09-10T00:36:11Z","timestamp":1725928571000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":10,"title":["Effect of a prescription digital therapeutic for chronic insomnia on post-treatment insomnia severity, depression, and anxiety symptoms: 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