Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT04968795
Status:
UNKNOWN
Last Update Posted:
2021-10-08
First Post:
2021-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heartfulness Meditation and Corporate Burnout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-30', 'studyFirstSubmitDate': '2021-07-09', 'studyFirstSubmitQcDate': '2021-07-09', 'lastUpdatePostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in Burnout Scores', 'timeFrame': 'Week 0 & Week 4', 'description': 'Assess the difference in burnout scores between both groups at week 0 and week 4.'}], 'secondaryOutcomes': [{'measure': 'Changes in in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment, using the Maslach Burnout Inventory.', 'timeFrame': 'Week 0 & Week 4', 'description': 'Assess the difference in specific symptoms scores between both groups at week 0 and week 4.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burnout', 'Meditation', 'Stress', 'Heartfulness']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of a 4-week heart-based meditation practice wellness workshop on burnout and emotional wellness in corporate employees. Corporate employees can be defined as individuals who work in large institutions with greater than 300 employees.\n\nThe specific aim of this study is to assess changes in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment using the Maslach Burnout Index. We hypothesize that the meditation wellness practice will be associated with reduction in burnout for those who take part in the meditation program in comparison to the participants who did not meditate and participate in the wellness program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is reflective of the general population, who work in large corporations and have self-identified as having moderate to high levels of stress.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults above 18 years of age willing to participate in the study.\n\nExclusion Criteria:\n\n* Individuals less than 18 years of age, active suicidal ideation, current or past diagnoses of serious psychotic disorders- schizophrenia, personality disorders and post-traumatic stress disorder.'}, 'identificationModule': {'nctId': 'NCT04968795', 'briefTitle': 'Heartfulness Meditation and Corporate Burnout', 'organization': {'class': 'INDUSTRY', 'fullName': 'Resolution Blue Labs Inc'}, 'officialTitle': 'Effect of Heartfulness Corporate Wellness Program on Burnout Inventory Measurements', 'orgStudyIdInfo': {'id': 'RBL-X Wellness_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Participate in filling the questionnaire but NOT the meditation/wellness session (control).'}, {'label': 'Wellness Group', 'description': 'Participate in filling the questionnaire and the meditation/wellness session', 'interventionNames': ['Other: Heartfulness Meditation']}], 'interventions': [{'name': 'Heartfulness Meditation', 'type': 'OTHER', 'description': 'A four-week Heartfulness Wellness seminar, where people are exposed to Heartfulness Meditation and its meditation tools. Participants experience: Heartfulness Guided Relaxation, Heartfulness Meditation and Heartfulness Unwinding/Rejuvenation Technique.', 'armGroupLabels': ['Wellness Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M1T1P2', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Administrator Resolution Blue Labs Inc.', 'role': 'CONTACT', 'email': 'admin@resolutionbluelabs.com'}], 'facility': 'Resolution Blue Labs Inc', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Ankit Bahl', 'role': 'CONTACT', 'email': 'Ankit@resolutionbluelabs.com', 'phone': '204-295-0298'}, {'name': 'Swaraj Aravind', 'role': 'CONTACT', 'email': 'Swaraj@resolutionbluelabs.com', 'phone': '778-908-7839'}], 'overallOfficials': [{'name': 'Andy Kumar, MD/PhD Candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resolution Blue Labs Inc'}, {'name': 'Aravindhan Ravindhran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resolution Blue Labs Inc'}, {'name': 'Arth Patel, MD Candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resolution Blue Labs Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Resolution Blue Labs Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Heartfulness Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}