Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07853651 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Online Tai Chi Versus Digital CBT-I for Chronic Insomnia: A Multicenter Randomized Noninferiority Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This multicenter randomized controlled trial will compare online Tai Chi (OTC) with digital cognitive behavioral therapy for insomnia (dCBT-I) in adults with chronic insomnia disorder. A total of 172 participants aged 18 to 65 years will be randomly assigned in a 1:1 ratio to receive either a 6-week standardized online Tai Chi intervention or a 6-week structured dCBT-I intervention. Both groups will receive the same standardized sleep hygiene education. The primary objective is to determine whether online Tai Chi is noninferior to dCBT-I in improving insomnia severity at Week 6, as measured by change in the Insomnia Severity Index (ISI) from baseline. Participants will be followed through Week 30. Approximately 120 participants will additionally participate in an actigraphy substudy with 7-day assessments at baseline, Week 6, and Week 30.
Trial Details
NCT Number NCT07853651
Lead Sponsor The Third Xiangya Hospital of Central South University
Conditions
(from sponsor)		 Chronic Insomnia Disorder
Enrollment 172 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov