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NOT YET RECRUITING
NCT06695000
NA

Digital CBT-I for Chronic Insomnia

Sponsor: WELT corp

View on ClinicalTrials.gov

Summary

This study evaluates the effectiveness and safety of a digital Cognitive Behavioral Therapy program for Insomnia (CBT-I) in individuals with chronic insomnia. Participants will be randomly assigned to either begin digital CBT-I immediately or join a wait-list.

Official title: A Multi-Site, Randomized, Wait-List Controlled Trial to Assess the Effectiveness and Safety of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) in Patients with Chronic Insomnia

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-01

Completion Date

2026-03

Last Updated

2024-11-19

Healthy Volunteers

No

Interventions

DEVICE

digital CBT-I

The intervention is a digital Cognitive Behavioral Therapy for Insomnia (CBT-I) program, delivered via a mobile application. The program includes structured, self-guided modules focusing on sleep hygiene education, cognitive restructuring, stimulus control, bed time restriction, and relaxation techniques. Each module offers interactive exercises and weekly assignments designed to support behavior change and improve sleep. Participants will receive app-based reminders to encourage regular engagement, with features for tracking progress and adherence throughout the 6 week program.

Locations (5)

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul, South Korea

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, Seoul, South Korea

Ewha Womans University Medical Center

Seoul, Seoul, South Korea