Chronic Insomnia DisorderNCT07853651
Online Tai Chi Versus Digital CBT-I for Chronic Insomnia
A study testing Online Tai Chi and Digital Cognitive Behavioral Therapy for Insomnia in people with Chronic Insomnia Disorder, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Insomnia Disorder
- What is being tested?
- Online Tai Chi and Digital Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Xiangya Hospital, Central South University
Changsha, Hunan
About this study
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
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.
Read the detailed description
This is a three-center, pragmatic, open-label, parallel-group randomized controlled noninferiority trial. Eligible participants will complete a 7-day run-in period and will then be randomized 1:1 to online Tai Chi or dCBT-I, stratified by study center. Both groups will receive the same 15-20 minute standardized sleep hygiene education. The online Tai Chi group will complete a standardized 6-week program, with at least three sessions per week and three to five sessions recommended, approximately 30-45 minutes per session. The dCBT-I group will complete a structured 6-week digital program consisting of one core module per week, behavioral practice, and sleep diaries. The primary efficacy assessment will occur at Week 6. After Week 6, no protocol-mandated maintenance treatment will be provided. The final scheduled assessment will occur at Week 30. The protocol currently uses a proposed noninferiority margin of 3 ISI points for sample-size planning. The final margin will be locked before the first participant is randomized. The intention-to-treat population will be used for the primary analysis, with a per-protocol analysis as a key supportive analysis.
- Conditions
- Chronic Insomnia Disorder
- Being tested
- Online Tai Chi, Digital Cognitive Behavioral Therapy for Insomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Tai ChiBehavioural
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 InsomniaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online Tai Chi | Experimental | Not described Receives: Behavioral: Online Tai Chi |
| Digital Cognitive Behavioral Therapy for Insomnia | Active comparator | Not described Receives: Behavioral: Digital Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (end of the 7-day run-in period) to Week 6
Secondary outcomes (2)
Change in ISI Score From Baseline to Week 30
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.
Measured: Baseline to Week 30
Change in ISI Score From Baseline to Week 3
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.
Measured: Baseline to Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jinze wu, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853651
- Sponsor's protocol ID
- OTC-dCBTI-INSOMNIA-2026-01
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07853651
- Acronym / sponsor ID
- OTC-dCBTI-INSOMNIA-2026-01
- Conditions
- Chronic Insomnia Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a three-center, pragmatic, open-label, parallel-group randomized controlled noninferiority trial. Eligible participants will complete a 7-day run-in period and will then be randomized 1:1 to online Tai Chi or dCBT-I, stratified by study center. Both groups will receive the same 15-20 minute standardized sleep hygiene education. The online Tai Chi group will complete a standardized 6-week program, with at least three sessions per week and three to five sessions recommended, approximately 30-45 minutes per session. The dCBT-I group will complete a structured 6-week digital program consisting of one core module per week, behavioral practice, and sleep diaries. The primary efficacy assessment will occur at Week 6. After Week 6, no protocol-mandated maintenance treatment will be provided. The final scheduled assessment will occur at Week 30. The protocol currently uses a proposed noninferiority margin of 3 ISI points for sample-size planning. The final margin will be locked before the first participant is randomized. The intention-to-treat population will be used for the primary analysis, with a per-protocol analysis as a key supportive analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Online Tai Chi | Experimental | Behavioral: Online Tai Chi |
| Digital Cognitive Behavioral Therapy for Insomnia | Active comparator | Behavioral: Digital Cognitive Behavioral Therapy for Insomnia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Tai ChiParticipants 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. | Behavioural | Online Tai Chi |
| Digital Cognitive Behavioral Therapy for InsomniaParticipants 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. | Behavioural | Digital Cognitive Behavioral Therapy for Insomnia |
Primary outcome
Change in Insomnia Severity Index Score From Baseline to Week 6
Time frame: Baseline (end of the 7-day run-in period) 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.
2 secondary outcomes
Change in ISI Score From Baseline to Week 30
Time frame: Baseline to Week 30
Change in ISI Score From Baseline to Week 3
Time frame: Baseline to Week 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Tai Chi and Digital Cognitive Behavioral Therapy for Insomnia in people with Chronic Insomnia Disorder, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinze Wu (+86 13548671685, 602587@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index Score From Baseline to Week 6 (time frame: Baseline (end of the 7-day run-in period) to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.