biostudies-literatureUnknown13Staiano W<h4>Background</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>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 mindfulnJMIR mHealth and uHealthe68665https://www.ebi.ac.uk/biostudies/studies/S-EPMC12059489biostudies-literatureAssessment of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population: Randomized Controlled Trial.PMC12059489Kirk UCallahan CTanner LCoe CStaiano WDavis MKunkle SfalseAssessment of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population: Randomized Controlled Trial.<h4>Background</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>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 mindfuln2025-01-01T00:00:00Z2025 Apr2026-06-02T17:57:30.777Z2026-04-18T03:12:04.711ZS-EPMC120594894026747210.2196/68665