Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT01033851
Status:
COMPLETED
Last Update Posted:
2014-06-04
First Post:
2009-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ehoge@partners.org', 'phone': '6177240859', 'title': 'Dr. Elizabeth Hoge', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 months', 'description': 'A validated questionnaire was used to assess adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Mindfulness Based Stress Reduction', 'description': 'Weekly 2 hour class, given for 8 weeks total.', 'otherNumAtRisk': 48, 'otherNumAffected': 1, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stress Management Education', 'description': 'Weekly 2 hour class, given for 8 weeks total.', 'otherNumAtRisk': 41, 'otherNumAffected': 1, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'muscle soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sleep disruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Active Symptoms of Generalized Anxiety Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Based Stress Reduction', 'description': 'Weekly 2 hour class, given for 8 weeks total.'}, {'id': 'OG001', 'title': 'Stress Management Education', 'description': 'Weekly 2 hour class, given for 8 weeks total.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.65', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '16.27', 'spread': '7.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 months', 'description': 'The Hamilton Anxiety Scale (HAMA) was defined as the primary anxiety outcome variable. This scale has 14 items describing symptoms of anxiety, each answered on a 0-4 scale, with 0 for a single question generally representing no symptoms, and 4 representing severe levels of the symptom. The total score is calculated by adding all the items together, for a possible total score of 0 to 56.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included all participants who attended at least one class of an intervention.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Based Stress Reduction', 'description': 'Weekly 2 hour class, given for 8 weeks total.'}, {'id': 'OG001', 'title': 'Stress Management Education', 'description': 'Weekly 2 hour class, given for 8 weeks total.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.15', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '3.58', 'spread': '1.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0366', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'A repeated measure ANOVA, with time as the repeated measure, treatment arm as between-subjects factor and CGI-S score as the dependent variable, found a main effect of time (F(1,84)=62.19, p\\<0.001) and a significant treatment arm X time interaction (F(1,84)=4.51, p=0.0366).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 months', 'description': 'This is an overal clinical measure of anxiety symptoms after examining and interviewing the patient. The scale is one global item, that scores from 1 (1= not ill at all) to 7 (7= among the most extremely ill).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included all participants attending at least one class of an intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mindfulness Based Stress Reduction', 'description': 'Weekly 2 hour class, given for 8 weeks total.'}, {'id': 'FG001', 'title': 'Stress Management Education', 'description': 'Weekly 2 hour class, given for 8 weeks total.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Participants were recruited by media advertisement and referral between December 2008 and February 2011.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindfulness Based Stress Reduction', 'description': 'Weekly 2 hour class, given for 8 weeks total.'}, {'id': 'BG001', 'title': 'Stress Management Education', 'description': 'Weekly 2 hour class, given for 8 weeks total.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '14', 'groupId': 'BG000'}, {'value': '37', 'spread': '12', 'groupId': 'BG001'}, {'value': '39', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-29', 'studyFirstSubmitDate': '2009-12-09', 'resultsFirstSubmitDate': '2013-02-21', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-07', 'studyFirstPostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Active Symptoms of Generalized Anxiety Disorder', 'timeFrame': '2 months', 'description': 'The Hamilton Anxiety Scale (HAMA) was defined as the primary anxiety outcome variable. This scale has 14 items describing symptoms of anxiety, each answered on a 0-4 scale, with 0 for a single question generally representing no symptoms, and 4 representing severe levels of the symptom. The total score is calculated by adding all the items together, for a possible total score of 0 to 56.'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.', 'timeFrame': '2 months', 'description': 'This is an overal clinical measure of anxiety symptoms after examining and interviewing the patient. The scale is one global item, that scores from 1 (1= not ill at all) to 7 (7= among the most extremely ill).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Generalized Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '28314552', 'type': 'DERIVED', 'citation': 'Hoge EA, Guidos BM, Mete M, Bui E, Pollack MH, Simon NM, Dutton MA. Effects of mindfulness meditation on occupational functioning and health care utilization in individuals with anxiety. J Psychosom Res. 2017 Apr;95:7-11. doi: 10.1016/j.jpsychores.2017.01.011. Epub 2017 Jan 23.'}, {'pmid': '23541163', 'type': 'DERIVED', 'citation': 'Hoge EA, Bui E, Marques L, Metcalf CA, Morris LK, Robinaugh DJ, Worthington JJ, Pollack MH, Simon NM. Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J Clin Psychiatry. 2013 Aug;74(8):786-92. doi: 10.4088/JCP.12m08083.'}]}, 'descriptionModule': {'briefSummary': 'Current therapies for Generalized Anxiety Disorder (GAD) have limited effectiveness. This study measures the efficacy of two different approaches to reducing anxiety and stress. One approach uses education, nutrition, exercise, and time management training, and another uses mindfulness meditation and yoga, which is taught as part of the Mindfulness-based stress reduction (MBSR) course, an 8-week manualized mindfulness intervention. We hypothesize that the two approaches will reduce anxiety in individuals with GAD in different ways. We will measure changes in stress hormones associated with these changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with generalized anxiety disorder\n* medically healthy\n\nExclusion Criteria:\n\n* substance abuse\n* history of other psychiatric diagnoses such as psychosis, Obsessive Compulsive Disorder, PTSD\n* use of certain types of psychotherapy, meditation training, yoga\n* pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01033851', 'briefTitle': 'Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects', 'orgStudyIdInfo': {'id': '2008-P-000275'}, 'secondaryIdInfos': [{'id': '5K23AT004432', 'link': 'https://reporter.nih.gov/quickSearch/5K23AT004432', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness Based Stress Reduction', 'description': 'Mindfulness Based Stress Reduction (MBSR) is an 8-week group intervention that trains participants in mindfulness meditation techniques.', 'interventionNames': ['Behavioral: Mindfulness Based Stress Reduction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stress Management Education', 'description': 'Stress Management Education (SME) is an 8-week group intervention that educates participants about stress physiology and health lifestyle changes.', 'interventionNames': ['Behavioral: Stress Management Education']}], 'interventions': [{'name': 'Mindfulness Based Stress Reduction', 'type': 'BEHAVIORAL', 'description': '8 week course', 'armGroupLabels': ['Mindfulness Based Stress Reduction']}, {'name': 'Stress Management Education', 'type': 'BEHAVIORAL', 'description': '8 week course', 'armGroupLabels': ['Stress Management Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Elizabeth A Hoge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Psychiatrist', 'investigatorFullName': 'Elizabeth A. Hoge, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}