Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Nov 11, 2024
Date Accepted: Mar 18, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
App-Based Sleep Program Improves Sleep in Clinical Insomnia Population: Randomized Controlled Trial
ABSTRACT
Background:
Over 20% of Americans report a sleep disturbance with traditional treatment being pharmacological and/or cognitive behavioral therapy for insomnia (CBT-I) - treatments, which may not be accessible due to cost, provider availability, and/or stigma.
Objective:
Assess the effectiveness of the Headspace Sleep Program in adults with clinical insomnia on sleep disturbance and mental health outcomes versus waitlist control.
Methods:
This randomized controlled trial included 132 adults with clinical insomnia who completed the Headspace Sleep Program (in-app, 18-session self-guided program integrating mindfulness concepts and CBT-I techniques) or waitlist control. Sleep disturbance outcomes included the change in insomnia symptoms (measured by the Insomnia Severity Index) and sleep efficiency (measured using a sleep diary and actigraphy). Mental health outcomes were perceived stress (measured by the Perceived Stress Scale-10), depressive symptoms (measured by the Patient Health Questionnaire-8), anxiety symptoms (measured by the Generalized Anxiety Disorder Scale-7), and mindfulness (measured by the Mindful Attention Awareness Scale). The change from baseline to post-intervention and follow-up was examined for each outcome.
Results:
The 132 participants had a mean (SD) age of 37.3 (11.1) years and 55% identified as female. Participants randomized to the Headspace Sleep Program group experienced significantly greater improvements in insomnia symptoms from baseline to post-intervention and follow-up compared to participants randomized to the waitlist control group. Improvements from baseline to post-intervention and follow-up were also observed in the Headspace Sleep Program group for sleep efficiency (both sleep diary and actigraphy outcomes). Participants in the Headspace Sleep Program group saw greater improvements in insomnia remission rates (11.9% at post-intervention and 13.5% at follow-up) and treatment response (18.5% at post-intervention and 23.8% at follow-up) versus the control group (remission rate: 1.6% post-intervention and 0% follow-up, treatment response: 4.9% post-intervention and 1.5% follow-up). Results suggest significant improvements in depressive symptoms, anxiety symptoms, and mindfulness in the Headspace Sleep Program group.
Conclusions:
The Headspace Sleep Program was an effective intervention for improving sleep disturbance in adults with clinical insomnia. Clinical Trial: ClinicalTrials.gov identifier: NCT05872672
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.