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Online Tai Chi Versus Digital CBT-I for Chronic Insomnia: A Multicenter Randomized Noninferiority Trial
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
- Sponsor
- The Third Xiangya Hospital of Central South University (Academic or other)
- Enrolment
- 172 planned
- Conditions
- Chronic Insomnia Disorder
- Interventions
- Online Tai Chi; Digital Cognitive Behavioral Therapy for Insomnia
- Ages
- adults, older adults
- Registry
- NCT07853651
From the registry
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.
Primary outcomes
- Change in Insomnia Severity Index Score From Baseline to Week 6