@Article{info:doi/10.2196/68665,
author="Staiano, Walter
and Callahan, Christine
and Davis, Michelle
and Tanner, Leah
and Coe, Chelsea
and Kunkle, Sarah
and Kirk, Ulrich",
title="Assessment of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population: Randomized Controlled Trial",
journal="JMIR Mhealth Uhealth",
year="2025",
month="Apr",
day="23",
volume="13",
pages="e68665",
keywords="cognitive behavioral therapy for insomnia; mindfulness; randomized controlled trial; RCT; therapy; insomnia; behavioral; app based; app",
abstract="Background: Insomnia is the most commonly reported sleep disturbance and significantly impacts mental health and quality of life. Traditional treatments for insomnia include pharmacological interventions or cognitive behavioral therapy for insomnia (CBT-I), but these options may not be accessible to everyone who needs treatment. Objective: This study aims to assess the effectiveness of the app-based Headspace Sleep Program in adults with clinical insomnia on sleep disturbance and mental health outcomes, compared with a waitlist control group. Methods: This randomized controlled trial included 132 adults with clinical insomnia who were assigned to either the Headspace Sleep Program (an 18-session self-guided, in-app program utilizing CBT-I techniques augmented by mindfulness) or a waitlist control group. Sleep disturbance outcomes were assessed by changes in insomnia symptoms (measured using the Insomnia Severity Index) and sleep efficiency (measured via sleep diary and actigraphy). Mental health outcomes included perceived stress (measured by the 10-item Perceived Stress Scale), depressive symptoms (measured by the 8-item Patient Health Questionnaire), sleep quality (measured by the Pittsburgh Sleep Quality Index), anxiety symptoms (measured by the 7-item Generalized Anxiety Disorder Scale), and mindfulness (measured by the Mindful Attention Awareness Scale). Changes from baseline to postintervention and follow-up were assessed for each outcome. Results: Participants had a mean (SD) age of 37.2 (10.6) years, with 69 out of 132 (52.3{\%}) identifying as female. Those randomized to the Headspace Sleep Program group experienced significantly greater improvements in insomnia symptoms from baseline to postintervention and follow-up compared with participants in the waitlist control group (P<.001, $\eta${\texttwosuperior}p=0.107). Improvements from baseline to postintervention and follow-up were also observed in the Headspace Sleep Program group for sleep efficiency, as measured by both sleep diary (P=.01, $\eta${\texttwosuperior}p=.03) and actigraphy outcomes (P=.01, $\eta${\texttwosuperior}p=.03). Participants in the Headspace Sleep Program group showed greater improvements in insomnia remission rates (8/66, 12{\%}, at postintervention and 9/66, 14{\%}, at follow-up) and treatment response (11/66, 17{\%}, at postintervention and 15/66, 23{\%}, at follow-up) compared with the control group (remission rate 2/66, 3{\%}, at postintervention and 0/66, 0{\%}, at follow-up; treatment response 3/66, 5{\%}, at postintervention and 1/66, 2{\%}, at follow-up). The results suggest significant improvements in depressive symptoms (P=.01, $\eta${\texttwosuperior}p=.04), anxiety symptoms (P=.02, $\eta${\texttwosuperior}p=.02), and mindfulness (P=.01, $\eta${\texttwosuperior}p=.03) in the Headspace Sleep Program group. Conclusions: The Headspace Sleep Program is an effective intervention for improving sleep disturbances in adults with clinical insomnia. Trial Registration: ClinicalTrials.gov NCT05872672; https://clinicaltrials.gov/ct2/show/NCT05872672 ",
issn="2291-5222",
doi="10.2196/68665",
url="https://mhealth.jmir.org/2025/1/e68665",
url="https://doi.org/10.2196/68665"
}