NCT06593262

Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I)

Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) With Artificial Intelligence Chatbot for Youth With Insomnia: An Assessor-blind, Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

Insomnia is a common sleep problem, which affects 9.4-38.2% of youths worldwide. Youth insomnia is linked to mental health problems, leading to substantial health and economic burden. The project aims to conduct an assessor-blind, randomized controlled trial to evaluate the efficacy of an app-based CBT-I with AI chatbot in reducing insomnia symptoms among youths, compared to an app-based CBT-I without AI chatbot.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	app-based digital cognitive behavioral therapy for insomnia with AI chatbot	digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and patient-centered conversational agents
BEHAVIORAL	app-based digital cognitive behavioral therapy for insomnia without AI chatbot	digital cognitive behavioral therapy for insomnia without two-way interactive, intelligent, and patient-centered conversational agents

Timeline

• Start date: 2024-07-26
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2024-09-19
• Last updated: 2026-03-18

Locations

1 site across 1 country: Hong Kong