Online Tai Chi Versus Digital CBT-I for Chronic Insomnia

Sex: All

Ages: 18 Years – 65 Years

Healthy volunteers: No

Phase: NA

Enrollment: 172

Sponsor: The Third Xiangya Hospital of Central South University

Location: The Third Xiangya Hospital, Central South University Changsha Hunan

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.

Eligibility Criteria

Inclusion Criteria: 1. Age 18 to 65 years, inclusive. 2. Meet DSM-5 diagnostic criteria for chronic insomnia disorder, confirmed by a trained study physician. 3. ISI ≥12 at screening and at the end of the 7-day run-in period, with an absolute difference \

Source: ClinicalTrials.gov (NCT07853651). StuddyBuddy aggregates publicly available trial information.