Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-30 @ 12:46 AM
Study NCT ID:
NCT04676750
Status:
UNKNOWN
Last Update Posted:
2020-12-21
First Post:
2020-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MBSR for Work Active Seniors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-18', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2020-12-18', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'self-perceived stress', 'timeFrame': '2 years', 'description': 'questionnaire'}], 'secondaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': '2 years'}, {'measure': 'blood pressure', 'timeFrame': '2 years'}, {'measure': 'weight', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Promotion and Stress Prevention']}, 'descriptionModule': {'briefSummary': 'Testing Mindfulness-based Stress Reduction (MBSR) in 60-65 year old senior employees.', 'detailedDescription': 'Outcome measures: HRV, blood pressure, weight, structural and functional brain scans, questionnaire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n\nExclusion Criteria:\n\n* psychosis'}, 'identificationModule': {'nctId': 'NCT04676750', 'acronym': 'MBSR6065', 'briefTitle': 'MBSR for Work Active Seniors', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Mindfulness-baseret Forebyggelse og Sundhedsfremme i Den Sidste Del af Arbejdslivet', 'orgStudyIdInfo': {'id': '10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBSR', 'description': 'receives 8-week MBSR course', 'interventionNames': ['Behavioral: Mindfulness-Based Stress Reduction']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'receives intervention after experiment finishes'}], 'interventions': [{'name': 'Mindfulness-Based Stress Reduction', 'type': 'BEHAVIORAL', 'description': 'yoga, meditation and psycho education', 'armGroupLabels': ['MBSR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Brabrand', 'country': 'Denmark', 'facility': 'Dansk Center for Mindfulness', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'VU University of Amsterdam', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}