[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658798":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":32,"studyPopulation":22,"armGroups":33,"interventions":44,"overallOfficials":22,"centralContacts":52,"locations":58,"responsibleParty":71,"collaborators":22,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":22,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":22,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":22,"overallStatus":94,"whyStopped":22,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"The Third Xiangya Hospital of Central South University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18],{"measure":15,"description":16,"timeFrame":17},"Change in ISI Score From Baseline to Week 30","Change in ISI total score from baseline to Week 30","Baseline to Week 30",{"measure":19,"description":20,"timeFrame":21},"Change in ISI Score From Baseline to Week 3","Change in ISI total score from baseline to Week 3.","Baseline to Week 3",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":22,"timePerspective":22,"maskingInfo":28},"RANDOMIZED","PARALLEL","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).","TREATMENT",{"masking":29,"maskingDescription":22,"whoMasked":30},"SINGLE",[31],"OUTCOMES_ASSESSOR","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 and run-in ISI score (12-14 versus ≥15). 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.",[34,39],{"label":35,"type":36,"description":22,"interventionNames":37},"Online Tai Chi","EXPERIMENTAL",[38],"Behavioral: Online Tai Chi",{"label":40,"type":41,"description":22,"interventionNames":42},"Digital Cognitive Behavioral Therapy for Insomnia","ACTIVE_COMPARATOR",[43],"Behavioral: Digital Cognitive Behavioral Therapy for Insomnia",[45,49],{"type":46,"name":35,"description":47,"armGroupLabels":48,"otherNames":22},"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.",[35],{"type":46,"name":40,"description":50,"armGroupLabels":51,"otherNames":22},"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.",[40],[53],{"name":54,"role":55,"phone":56,"phoneExt":22,"email":57},"Jinze Wu","CONTACT","+86 13548671685","602587@csu.edu.cn",[59],{"facility":60,"status":22,"city":61,"state":62,"zip":22,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":22},"The Third Xiangya Hospital, Central South University","Changsha","Hunan","China","CN",{"type":66,"coordinates":67},"Point",[68,69],112.97087,28.19874,{"lat":69,"lon":68},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","jinze wu","Associate Chief Physician","100658798","online-tai-chi-versus-digital-cbt-i-for-chronic-insomnia-a-multicenter-randomized-noninferiority-trial-100658798",false,"NCT07853651","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","Inclusion Criteria:\n\n1. Age 18 to 65 years, inclusive.\n2. Meet DSM-5 diagnostic criteria for chronic insomnia disorder, confirmed by a trained study physician.\n3. ISI ≥12 at screening and at the end of the 7-day run-in period, with an absolute difference \\\u003C4 points.\n4. Complete at least 5 valid sleep diary days during the run-in period.\n5. Have a suitable smart device and stable internet connection and be able to complete study procedures.\n6. Provide written informed consent.\n7. Be willing to accept randomized assignment, complete the 6-week intervention, and participate through Week 30.\n\nExclusion Criteria:\n\n1. Another untreated or inadequately controlled sleep disorder likely to affect outcomes or safety.\n2. Regular night-shift\u002Frotating shift work or another substantially disruptive sleep-wake schedule.\n3. Severe or unstable medical disease, clinically significant chronic pain interfering with sleep, or physical\u002Fmotor impairment preventing safe participation.\n4. Clinically significant cognitive impairment preventing independent informed consent or reliable participation.\n5. Acute or unstable severe psychiatric illness, clinically significant suicide risk, or active substance use disorder requiring priority treatment.\n6. A condition making sleep restriction\u002Fcompression unsuitable, including uncontrolled epilepsy, current mania\u002Fhypomania or clinically significant triggering risk, hazardous daytime sleepiness, or an inadequately mitigated safety-sensitive occupation.\n7. Regular participation during the previous 3 months in a highly similar mind-body training program likely to affect treatment evaluation.\n8. Current systematic CBT-I, or prior CBT-I with continued regular implementation of core therapeutic strategies likely to affect treatment evaluation.","ALL","18 Years","65 Years",{"count":86,"type":87},172,"ESTIMATED","INTERVENTIONAL",[90],"NA","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.",[93],"Chronic Insomnia Disorder","NOT_YET_RECRUITING","2026-09-26",{"date":97,"type":98},"2026-10-02","ACTUAL",{"date":100,"type":87},"2026-10-10",{"date":102,"type":87},"2028-12-31",{"name":5,"class":6},1]