Hostname: page-component-77c89778f8-sh8wx Total loading time: 0 Render date: 2024-07-24T10:36:37.955Z Has data issue: false hasContentIssue false

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
Affiliation:
Laval University, Quebec City, Canada
Frances P Thorndike
Affiliation:
Pear Therapeutics (US), Inc., Boston, MA, USA
Joseph M. Ojile
Affiliation:
Clayton Sleep Institute, USA
Robert Gerwien
Affiliation:
Pear Therapeutics (US), Inc., Boston, MA, USA
Angela Wendorf
Affiliation:
Pear Therapeutics (US), Inc., Boston, MA, USA
Yuri A Maricich
Affiliation:
Pear Therapeutics (US), Inc., Boston, MA, USA
Rights & Permissions [Opens in a new window]

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.
Introduction

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).

Methods

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).

Results

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).

Conclusion

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.

Funding

Pear Therapeutics (US), Inc.

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