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Online Tai Chi Versus Digital CBT-I for Chronic Insomnia: A Multicenter Randomized Noninferiority Trial
Sponsor: The Third Xiangya Hospital of Central South University
Summary
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.
Official title: Efficacy of Online Tai Chi Versus Digital Cognitive Behavioral Therapy for Insomnia in Adults With Chronic Insomnia Disorder: A Multicenter Pragmatic Randomized Controlled Noninferiority Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
172
Start Date
2026-10-10
Completion Date
2028-12-31
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
Online Tai Chi
Participants will receive standardized sleep hygiene education followed by a standardized 6-week online Tai Chi program. Participants will practice at least three times per week, preferably three to five times per week, for approximately 30-45 minutes per session. Each session includes warm-up, core Tai Chi movements, and cool-down. All centers will use the same standardized training materials and procedures.
Digital Cognitive Behavioral Therapy for Insomnia
Participants will receive standardized sleep hygiene education followed by a structured 6-week digital CBT-I program. Week 1 covers insomnia-maintaining factors and stimulus control; Week 2 sleep-time management; Week 3 review of behavioral prescriptions; Week 4 cognitive restructuring; Week 5 relaxation and arousal management; and Week 6 integration of skills and relapse prevention. Daily sleep diaries and behavioral practice are incorporated into treatment.
Locations (1)
The Third Xiangya Hospital, Central South University
Changsha, Hunan, China