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.
Age 18 to 65 years, inclusive.
Meet DSM-5 diagnostic criteria for chronic insomnia disorder, confirmed by a trained study physician.
ISI ≥12 at screening and at the end of the 7-day run-in period, with an absolute difference <4 points.
Complete at least 5 valid sleep diary days during the run-in period.
Another untreated or inadequately controlled sleep disorder likely to affect outcomes or safety.
Regular night-shift/rotating shift work or another substantially disruptive sleep-wake schedule.
Severe or unstable medical disease, clinically significant chronic pain interfering with sleep, or physical/motor impairment preventing safe participation.
Clinically significant cognitive impairment preventing independent informed consent or reliable participation.
Parallel
Online Tai Chi
BehavioralParticipants 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
BehavioralParticipants 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.
Change in Insomnia Severity Index Score From Baseline to Week 6
The Insomnia Severity Index (ISI) is a 7-item self-report measure with a total score ranging from 0 to 28; higher scores indicate greater insomnia severity. The primary outcome is Week 6 ISI minus baseline ISI. A negative value indicates improvement.
Change in ISI Score From Baseline to Week 30
Change in ISI total score from baseline to Week 30
Change in ISI Score From Baseline to Week 3
Change in ISI total score from baseline to Week 3.
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