Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:15 AM
Study NCT ID:
NCT07369557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness Training During Accelerated iTBS for Depression (MB-TBS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Guided Mindfulness Practice During aiTBS (Adherence Rate)', 'timeFrame': 'Day 0 to Day 5', 'description': 'Proportion of participants who complete ≥1 Healthy Minds Foundation guided practice on each of the five aiTBS treatment days. Calculated as: number completing all five days ÷ total enrolled. Higher values indicate better feasibility.'}, {'measure': 'Tolerability of Guided Mindfulness Practice During aiTBS (Adverse Events)', 'timeFrame': 'Day 0 to Day 5', 'description': 'Number and severity of meditation-related adverse events recorded via participant report and study staff observation. Higher values indicate worse tolerability.'}], 'secondaryOutcomes': [{'measure': 'Change in State Mindfulness (Toronto Mindfulness Scale Total Score)', 'timeFrame': 'Day 0 to Day 5', 'description': 'Change in Toronto Mindfulness Scale (TMS) total score from baseline to Day 5. Higher scores indicate greater state mindfulness.'}, {'measure': 'Change in Hedonic Tone (Snaith-Hamilton Pleasure Scale Total Score)', 'timeFrame': 'Day 0 to Day 5', 'description': 'Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to Day 5. Lower scores indicate improved hedonic tone.'}, {'measure': 'Change in Perceived Ease of Meditation (0-10 Rating)', 'timeFrame': 'Day 0 to Day 5', 'description': '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': 'Change in Trait Mindfulness (CAMS-R Total Score)', 'timeFrame': 'Baseline to Week 12 (with Week-4 assessment)', 'description': 'Change in Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) total score from baseline to Week 12. Higher scores indicate greater trait mindfulness.'}, {'measure': 'Durability of Antidepressant Response (Percent Change in PHQ-9)', 'timeFrame': 'Baseline to Week 4', 'description': 'Percent change in PHQ-9 total score from baseline to Week 4. Lower scores indicate improvement'}, {'measure': 'Meditation Engagement (App Analytics and Self-Report)', 'timeFrame': 'Day 0 to Week 12', 'description': 'Engagement with the Healthy Minds app measured by total minutes practiced, number of Foundations completed, and cumulative meditation minutes. Higher values indicate greater engagement.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Transcranial Magnetic Stimulation', 'Theta-Burst Stimulation', 'Mindfulness', 'Positive Affect', 'Hedonic Tone'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'This NIH-funded single-arm pilot tests the feasibility, acceptability, and preliminary effects of embedding brief guided mindfulness practice (via the Healthy Minds 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/acceptability, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/unwilling to engage in mindfulness or complete questionnaires'}, 'identificationModule': {'nctId': 'NCT07369557', 'briefTitle': 'Mindfulness Training During Accelerated iTBS for Depression (MB-TBS)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'MB-TBS: Mindfulness-Based Theta-Burst Stimulation-A Pilot Study Integrating Mindfulness Training Into Accelerated Neuromodulation Therapy for Depression', 'orgStudyIdInfo': {'id': 'Pro00148491'}, 'secondaryIdInfos': [{'id': 'R25DA020537', 'link': 'https://reporter.nih.gov/quickSearch/R25DA020537', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness Training during aiTBS', 'interventionNames': ['Behavioral: Guided Mindfulness Practice (Healthy Minds app)']}], 'interventions': [{'name': 'Guided Mindfulness Practice (Healthy Minds app)', 'type': 'BEHAVIORAL', 'description': 'One guided "Foundation" per day (5-30 minutes) during aiTBS inter-session intervals for five consecutive treatment days; optional additional practices allowed. App analytics (with permission) and self-reports quantify engagement.', 'armGroupLabels': ['Mindfulness Training during aiTBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina (MUSC), Brain Stimulation Laboratory Institute of Psychiatry', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Clayton Olash, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Within 12 months of study completion', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical/Dental Resident', 'investigatorFullName': 'Clayton Olash', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}