NCT05541055

Digital CBT-I for Insomnia Disorder

Clinical Effectiveness of Digital CBT-I for the Treatment of Insomnia Disorder: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Big Health Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the effectiveness of digital CBT-I versus sleep hygiene education in reducing insomnia severity, sleep onset latency, and wake after sleep onset in those with insomnia disorder.

Detailed description

This study aims to examine the effectiveness of a fully-automated web and app-based digital CBT-I for insomnia compared to sleep hygiene education (SHE) in individuals with a diagnosis of insomnia disorder. Primary outcomes of interest include changes in insomnia severity, sleep onset latency, and wake after sleep onset throughout the course of the study.

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
DEVICE	digital CBT-I	A fully-automated and personalized digital intervention based on principles from cognitive behavioral therapy for insomnia.
OTHER	Sleep hygiene education	Participants will be provided with sleep hygiene advice which will be delivered digitally all at once upon allocation to the SHE arm. Participants will be able to revisit content during the trial as they wish.

Timeline

• Start date: 2022-11-08
• Primary completion: 2023-05-15
• Completion: 2023-08-24
• First posted: 2022-09-15
• Last updated: 2024-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study