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Digital CBT-I Treatment Improves Sleep and Reduces Anxiety and Depression Symptoms in Adults With Chronic Insomnia: Interim Analysis of DREAM Study

Published online by Cambridge University Press:  14 April 2023

Charles Morin
Laval University, Quebec City, Canada
Frances P Thorndike
Pear Therapeutics (US), Inc., Boston, MA, USA
Joseph M. Ojile
Clayton Sleep Institute, USA
Robert Gerwien
Pear Therapeutics (US), Inc., Boston, MA, USA
Angela Wendorf
Pear Therapeutics (US), Inc., Boston, MA, USA
Yuri A Maricich
Pear Therapeutics (US), Inc., Boston, MA, USA
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Chronic insomnia (CI) often co-occurs with depression and anxiety, and treatment may positively impact mood. 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) delivering cognitive-behavioral therapy for insomnia (CBT-I; Somryst®, previously SHUTi).


This prospective, single-arm, pragmatic clinical study enrolled adults (≥18 years) in the US with CI and mobile device access. The PDT consists of six core modules completed over 6–9 weeks. In this interim analysis, 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).


Mean ISI scores decreased (p<0.0001) from baseline (n=991) to post-treatment (n=777;18.8 vs 11.3) and to Day 243 (n=193; 18.8 vs 12.1). Mean GAD-7 scores improved from baseline to Day 63 (n=744; p<0.0001, Cohen’s d = 0.48) and to Day 243 (n=186; p<0.0001, d = 0.45). Similarly, PHQ-8 scores improved from baseline to Day 63 (n=747; p<0.001, d = 0.76) and to Day 243 (n=186; p<0.0001, d = 0.60). These patterns persisted across baseline anxiety and depressive severity levels among people with any baseline depressive or anxiety symptoms (all p<0.05 for depression, all p<0.0001 for anxiety), with large effect sizes observed for severe anxiety (d=1.43 Day 63, d=1.55 Day 243) and for moderate to severe depression (d range = 0.96-1.51).


In this study, treatment with digital CBT-I was associated with significant reductions in ISI, anxiety, and depression at posttreatment and at 6 months. The largest observed decreases in GAD-7 and PHQ-8 scores were among people with more severe baseline mood symptoms.


Pear Therapeutics (US), Inc.

© The Author(s), 2023. Published by Cambridge University Press