Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-03 @ 8:21 PM
Study NCT ID:
NCT03975595
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2019-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Meditation Effects on Brain Function in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tpx4xe@virginia.edu', 'phone': '(720) 244-1702', 'title': 'Dr. Patrick Finan', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected over the duration of the study, approximately 4-6 weeks per participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Meditation Group A-Savoring', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Intervention A: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.\n\nParticipants in the Savoring Meditation Condition were trained to generate positive emotions through savoring a positive autobiographical memory in a multi-sensory manner.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Meditation Group B-Breathing', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.\n\nParticipants in the Breathing Meditation condition were trained to relax the body and take deep breaths in a self-directed manner.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lateral Orbital Frontal Cortex Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation Group A', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Intervention A: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.'}, {'id': 'OG001', 'title': 'Meditation Group B', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.'}], 'timeFrame': 'Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes.', 'description': 'Activation in the Lateral Orbital Frontal Cortex will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention A in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was not assessed because it was intended for comparison with a treatment arm (mindful breathing) that was dropped from the study due to COVID-19 delays. No data was collected.'}, {'type': 'PRIMARY', 'title': 'Nucleus Accumbens Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation Group A-Savoring', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Intervention A: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.\n\nParticipants in the Savoring Meditation Condition were trained to generate positive emotions through savoring a positive autobiographical memory in a multi-sensory manner.'}, {'id': 'OG001', 'title': 'Meditation Group B-Breathing', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.\n\nParticipants in the Breathing Meditation condition were trained to relax the body and take deep breaths in a self-directed manner.'}], 'classes': [{'categories': [{'measurements': [{'value': '16153.59', 'spread': '1309.90', 'groupId': 'OG000'}, {'value': '15834.56', 'spread': '1681.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes', 'description': 'Activation in the Nucleus Accumbens will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention B in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute (ml/100g/min). There is no normal range for this measure.', 'unitOfMeasure': 'ml/100g/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Meditation Group A-Savoring', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Intervention A: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.\n\nParticipants in the Savoring Meditation Condition were trained to generate positive emotions through savoring a positive autobiographical memory in a multi-sensory manner.'}, {'id': 'FG001', 'title': 'Meditation Group B-Breathing', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.\n\nParticipants in the Breathing Meditation condition were trained to relax the body and take deep breaths in a self-directed manner.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Meditation Group A', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Group A is the Savoring Meditation Condition. Participants in this condition were trained to generate positive emotions through savoring a pleasant autobiographical memory in a multi-sensory manner.\n\nMeditation Intervention A: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.'}, {'id': 'BG001', 'title': 'Meditation Group B', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Group B is the Breathing Meditation Condition. Participants in this condition were trained to relax and body and take deep breaths in a self-directed manner.\n\nMeditation Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '49.8', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White or European American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-28', 'size': 546970, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-10T10:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-10', 'studyFirstSubmitDate': '2019-05-30', 'resultsFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2019-06-03', 'lastUpdatePostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-10', 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lateral Orbital Frontal Cortex Activation', 'timeFrame': 'Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes.', 'description': 'Activation in the Lateral Orbital Frontal Cortex will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention A in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute.'}, {'measure': 'Nucleus Accumbens Activation', 'timeFrame': 'Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes', 'description': 'Activation in the Nucleus Accumbens will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention B in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute (ml/100g/min). There is no normal range for this measure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the neural mechanisms supporting meditation-based pain relief in rheumatoid arthritis (RA) patients. The scientific premise is that RA patients' use of different meditation practices during noxious thermal stimulation will alter neural function in brain areas associated with pain, evaluation, and emotional appraisal. The investigators will randomize RA patients to a brief 4-session course of Intervention A (n=20) or Intervention B (n=20). At post-intervention, participants will undergo functional MRI (fMRI) using a perfusion-based arterial spin labeling (ASL) technique during noxious thermal stimulation to determine if the meditation practices differentially alter neural function during noxious thermal stimulation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Withheld to preserve recruitment integrity.\n\nExclusion Criteria:\n\n* Withheld to preserve recruitment integrity.'}, 'identificationModule': {'nctId': 'NCT03975595', 'briefTitle': 'Meditation Effects on Brain Function in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Meditation Effects on Brain Function in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'IRB00192687'}, 'secondaryIdInfos': [{'id': 'R61AT010134', 'link': 'https://reporter.nih.gov/quickSearch/R61AT010134', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Meditation Group A', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Group A is the Savoring Meditation Condition. Participants in this condition were trained to generate positive emotions through savoring a pleasant autobiographical memory in a multi-sensory manner.', 'interventionNames': ['Behavioral: Meditation Intervention A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meditation Group B', 'description': 'A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).\n\nMeditation Group B is the Breathing Meditation Condition. Participants in this condition were trained to relax and body and take deep breaths in a self-directed manner.', 'interventionNames': ['Behavioral: Meditation Intervention B']}], 'interventions': [{'name': 'Meditation Intervention A', 'type': 'BEHAVIORAL', 'description': 'This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.', 'armGroupLabels': ['Meditation Group A']}, {'name': 'Meditation Intervention B', 'type': 'BEHAVIORAL', 'description': 'This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.', 'armGroupLabels': ['Meditation Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Claudia Campbell, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'University of Utah', 'class': 'OTHER'}, {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}