[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621356":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":45,"interventions":51,"overallOfficials":57,"centralContacts":38,"locations":61,"responsibleParty":88,"collaborators":91,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":38,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":38,"studyType":110,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":64,"whyStopped":38,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Medical University of South Carolina","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":38},[9,13],{"measure":10,"description":11,"timeFrame":12},"Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate)","Proportion of participants who complete all mandatory guided practice on each of the five aiTBS treatment days. Calculated as: number completing all five days ÷ total enrolled. Higher values indicate better feasibility.","Day 0 to Day 5",{"measure":14,"description":15,"timeFrame":12},"Tolerability of Guided Mindfulness Practice During aiTBS (Adverse Events)","Number and severity of meditation-related adverse events recorded via participant report and study staff observation. Higher values indicate worse tolerability.",[17,20,23,26,30,34],{"measure":18,"description":19,"timeFrame":12},"Change in State Mindfulness (Toronto Mindfulness Scale Total Score)","Change in Toronto Mindfulness Scale (TMS) total score from baseline to Day 5. Higher scores indicate greater state mindfulness.",{"measure":21,"description":22,"timeFrame":12},"Change in Hedonic Tone (Snaith-Hamilton Pleasure Scale Total Score)","Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to Day 5. Lower scores indicate improved hedonic tone.",{"measure":24,"description":25,"timeFrame":12},"Change in Perceived Ease of Meditation (0-10 Rating)","Change in meditation ease rating on a 0-10 numeric scale (0 = not at all easy; 10 = extremely easy). Higher scores indicate greater perceived ease.",{"measure":27,"description":28,"timeFrame":29},"Change in Trait Mindfulness (CAMS-R Total Score)","Change in Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) total score from baseline to Week 12. Higher scores indicate greater trait mindfulness.","Baseline to Week 12 (with Week-4 assessment)",{"measure":31,"description":32,"timeFrame":33},"Durability of Antidepressant Response (Percent Change in PHQ-9)","Percent change in PHQ-9 total score from baseline to Week 4. Lower scores indicate improvement","Baseline to Week 4",{"measure":35,"description":36,"timeFrame":37},"Meditation Engagement (App Analytics and Self-Report)","Engagement with the Waking Up app measured by total minutes practiced, number of Foundations completed, and cumulative meditation minutes. Higher values indicate greater engagement.","Day 0 to Week 12",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"NA","SINGLE_GROUP","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":38},"NONE",[46],{"label":47,"type":48,"description":38,"interventionNames":49},"Mindfulness Training during aiTBS","EXPERIMENTAL",[50],"Behavioral: Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app",[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":38},"BEHAVIORAL","Guided Mindfulness Practice using a study created web app that links to the commercially available Waking Up app","5-15 minutes of mindfulness exercises during aiTBS inter-session intervals (9 total per day) for five consecutive treatment days; optional additional practices allowed. App analytics (with permission) and self-reports quantify engagement.",[47],[58],{"name":59,"affiliation":5,"role":60},"Clayton Olash, MD","PRINCIPAL_INVESTIGATOR",[62,82],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"IOP","RECRUITING","Charleston","South Carolina","29407","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-79.93275,32.77632,{"lat":74,"lon":73},[77],{"name":78,"role":79,"phone":80,"phoneExt":38,"email":81},"Danyal Smani, MD","CONTACT","1 843 243 7306","claytonolash@gmail.com",{"facility":83,"status":84,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":85,"geoPoint":87,"contacts":38},"Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry","NOT_YET_RECRUITING",{"type":71,"coordinates":86},[73,74],{"lat":74,"lon":73},{"type":60,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Clayton Olash","Medical\u002FDental Resident",[92,94],{"name":93,"class":6},"University of Wisconsin, Madison",{"name":95,"class":96},"National Institute on Drug Abuse (NIDA)","NIH","100621356","mindfulness-training-during-accelerated-tms-for-depression-100621356",false,"NCT07369557","Mindfulness Training During Accelerated TMS for Depression","MB-TBS: Mindfulness-Based Theta-Burst Stimulation-A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression","Inclusion Criteria:\n\n* Clinical diagnosis of MDD and eligible for aiTBS at MUSC\n* Already enrolled in aiTBS course at MUSC\n* English proficiency\n* Smartphone or willingness to use study-provided device\n\nExclusion Criteria:\n\n* TMS contraindications (e.g., seizure history, implants, pregnancy)\n* Concurrent neuromodulation (ECT, VNS)\n* Psychotic disorder, bipolar disorder, active substance use disorder, high suicide risk\n* Unable\u002Funwilling to engage in mindfulness or complete questionnaires","ALL","18 Years","80 Years",{"count":108,"type":109},20,"ESTIMATED","INTERVENTIONAL",[40],"This NIH-funded single-arm pilot tests the feasibility, acceptability, and preliminary effects of embedding brief guided mindfulness practice (via the Waking Up smartphone app) into the inter-session intervals of clinically administered accelerated intermittent theta-burst stimulation (aiTBS) for major depressive disorder (MDD). Participants receive aiTBS as standard clinical care at MUSC; the research intervention is daily guided mindfulness practice during the aiTBS course. Outcomes include feasibility\u002Facceptability, changes in state mindfulness and hedonic tone (Day 0 to Day 5), perceived ease of meditation, trait mindfulness at 4 and 12 weeks, and durability of antidepressant response (PHQ-9) at 4 and 12 weeks.",[114],"Depression",[116,117,118,119,120,121],"Major Depressive Disorder","Transcranial Magnetic Stimulation","Theta-Burst Stimulation","Mindfulness","Positive Affect","Hedonic Tone","2026-10-05",{"date":124,"type":125},"2026-10-06","ACTUAL",{"date":127,"type":125},"2026-04-13",{"date":129,"type":109},"2027-04-30",{"name":5,"class":6},2]