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

NCT07853651 | Not Yet Recruiting

• 1 other identifier: OTC-dCBTI-INSOMNIA-2026-01
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Insomnia Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (end of the 7-day run-in period) to Week 6

Secondary Outcomes (2)

• Change in ISI Score From Baseline to Week 30

  Baseline to Week 30

• Change in ISI Score From Baseline to Week 3

  Baseline to Week 3

Study Arms (2)

Online Tai Chi

EXPERIMENTAL

Behavioral: Online Tai Chi

Digital Cognitive Behavioral Therapy for Insomnia

ACTIVE COMPARATOR

Behavioral: Digital Cognitive Behavioral Therapy for Insomnia

Interventions

Online Tai Chi BEHAVIORAL

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.

Online Tai Chi

Digital Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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.

Digital Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have a suitable smart device and stable internet connection and be able to complete study procedures.
• Provide written informed consent.
• Be willing to accept randomized assignment, complete the 6-week intervention, and participate through Week 30.

You may not qualify if:

• 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.
• Acute or unstable severe psychiatric illness, clinically significant suicide risk, or active substance use disorder requiring priority treatment.
• A condition making sleep restriction/compression unsuitable, including uncontrolled epilepsy, current mania/hypomania or clinically significant triggering risk, hazardous daytime sleepiness, or an inadequately mitigated safety-sensitive occupation.
• Regular participation during the previous 3 months in a highly similar mind-body training program likely to affect treatment evaluation.
• Current systematic CBT-I, or prior CBT-I with continued regular implementation of core therapeutic strategies likely to affect treatment evaluation.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital, Central South University

Changsha, Hunan, China

Location

Central Study Contacts

Jinze Wu

CONTACT

+86 13548671685; 602587@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either a 6-week standardized online Tai Chi intervention or a 6-week digital cognitive behavioral therapy for insomnia intervention. Randomization will be stratified by study center and run-in ISI score (12-14 versus ≥15).

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): October 10, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)