Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-26 @ 12:04 PM
Study NCT ID:
NCT00924456
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2009-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of the Transcendental Meditation (TM) Program on Blood Pressure, Psychological Distress, and Coping
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2009-06-18', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinic systolic and diastolic blood pressure', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'psychological distress (anxiety, depression, anger/hostility) and coping (constructive thinking)', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transcendental Meditation', 'blood pressure', 'psychological distress', 'high psychological distress'], 'conditions': ['High-normal Blood Pressure', 'Psychological Stress']}, 'referencesModule': {'references': [{'pmid': '19798037', 'type': 'RESULT', 'citation': 'Nidich SI, Rainforth MV, Haaga DA, Hagelin J, Salerno JW, Travis F, Tanner M, Gaylord-King C, Grosswald S, Schneider RH. A randomized controlled trial on effects of the Transcendental Meditation program on blood pressure, psychological distress, and coping in young adults. Am J Hypertens. 2009 Dec;22(12):1326-31. doi: 10.1038/ajh.2009.184. Epub 2009 Oct 1.'}, {'pmid': '18854202', 'type': 'RESULT', 'citation': 'Travis F, Haaga DA, Hagelin J, Tanner M, Nidich S, Gaylord-King C, Grosswald S, Rainforth M, Schneider RH. Effects of Transcendental Meditation practice on brain functioning and stress reactivity in college students. Int J Psychophysiol. 2009 Feb;71(2):170-6. doi: 10.1016/j.ijpsycho.2008.09.007. Epub 2008 Sep 30.'}, {'pmid': '21559213', 'type': 'RESULT', 'citation': 'Haaga DA, Grosswald S, Gaylord-King C, Rainforth M, Tanner M, Travis F, Nidich S, Schneider RH. Effects of the Transcendental Meditation Program on Substance Use among University Students. Cardiol Res Pract. 2011 Mar 21;2011:537101. doi: 10.4061/2011/537101.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to show that the Transcendental Meditation program can decrease blood pressure in young adults (college students) and is associated with decreased psychological distress and coping ability.', 'detailedDescription': 'Psychological distress contributes to the development of hypertension in young adults. This was a randomized controlled trial of 296 university students randomly allocated to either the Transcendental Meditation® program or wait-list control. At baseline and after three months posttest, systolic and diastolic blood pressure, psychological distress (total mood disturbance, anxiety, depression, anger/hostility) and coping ability (global constructive thinking) were measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female\n* currently enrolled in an undergraduate or graduate program through August 2006\n\nExclusion Criteria:\n\n* history of:\n\n * hypertension\n * hypoglycemia\n * chronic fainting\n * coronary heart disease\n * current systolic/diastolic blood pressure above 140/90 mm Hg or below 90/60 mm Hg'}, 'identificationModule': {'nctId': 'NCT00924456', 'acronym': 'AU', 'briefTitle': 'A Clinical Trial of the Transcendental Meditation (TM) Program on Blood Pressure, Psychological Distress, and Coping', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi International University'}, 'officialTitle': 'A Randomized Controlled Trial of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults', 'orgStudyIdInfo': {'id': 'AF-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcendental Meditation program', 'description': 'a natural effortless mental technique practiced sitting quietly 20 minutes twice a day', 'interventionNames': ['Behavioral: Transcendental Meditation program']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Wait list control', 'description': 'student subjects on wait list control', 'interventionNames': ['Behavioral: Transcendental Meditation program']}], 'interventions': [{'name': 'Transcendental Meditation program', 'type': 'BEHAVIORAL', 'otherNames': ['TM'], 'description': 'a natural effortless mental technique', 'armGroupLabels': ['Transcendental Meditation program', 'Wait list control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'American University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Robert H Schneider, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maharishi International University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maharishi International University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American University', 'class': 'OTHER'}, {'name': 'Abramson Family Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Dean', 'investigatorFullName': 'Robert Schneider, MD', 'investigatorAffiliation': 'Maharishi International University'}}}}