JMIR Publications

ABSTRACT

Background:

Insomnia is the most commonly reported sleep disturbance and greatly impacts one's mental health and quality of life. Traditional insomnia treatments include pharmacological and/or cognitive behavioral therapy for insomnia (CBT-I), options that may not be accessible for all who need treatment.

Objective:

Assess the effectiveness of the app-based 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 using CBT-I techniques augmented by mindfulness) 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), sleep quality (measured by the Pittsburgh Sleep Quality Index), 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:

Participants had a mean (SD) age of 37.2 (10.6) years and 52.3% 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 (P < .001). 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) (all P’s < .01). Participants in the Headspace Sleep Program group saw greater improvements in insomnia remission rates (12.1% at post-intervention and 13.6% at follow-up) and treatment response (16.6% at post-intervention and 22.7% at follow-up) versus the control group (remission rate: 3.0% post-intervention and 0% follow-up, treatment response: 4.5% post-intervention and 1.5% follow-up). Results suggest significant improvements in depressive symptoms, anxiety symptoms, and mindfulness in the Headspace Sleep Program group (all P’s < .02).

Conclusions:

The Headspace Sleep Program is an effective intervention for improving sleep disturbance in adults with clinical insomnia. Clinical Trial: ClinicalTrials.gov: NCT05872672