Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-29 @ 7:44 AM
Study NCT ID:
NCT01270568
Status:
COMPLETED
Last Update Posted:
2011-01-21
First Post:
2011-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mind-body Interventions in Cardiac Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-10-03', 'releaseDate': '2014-09-25'}, {'resetDate': '2019-06-27', 'releaseDate': '2019-04-02'}], 'estimatedResultsFirstSubmitDate': '2014-09-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080032', 'term': 'Psychology, Positive'}], 'ancestors': [{'id': 'D011584', 'term': 'Psychology'}, {'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-20', 'studyFirstSubmitDate': '2011-01-03', 'studyFirstSubmitQcDate': '2011-01-03', 'lastUpdatePostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasiblity', 'timeFrame': '8 weeks', 'description': 'Percentage of exercises completed in the 8 week period'}], 'secondaryOutcomes': [{'measure': 'Optimism', 'timeFrame': '8 weeks', 'description': 'Self-report (on Likert scale) of optimism'}, {'measure': 'Happiness', 'timeFrame': '8 week', 'description': 'Score on Subjective Happiness Scale Score on Happiness subscale of CES-D'}, {'measure': 'Depression', 'timeFrame': '8 weeks', 'description': 'Center for Epidemiologic Studies Depression Scale (CES-D)'}, {'measure': 'Anxiety', 'timeFrame': '8 weeks', 'description': 'Hospital Anxiety and Depression Scale--Anxiety subscale'}, {'measure': 'Mental-health related quality of life', 'timeFrame': '8 weeks', 'description': 'SF-12 Mental Component Score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['positive psychology', 'cardiovascular disease'], 'conditions': ['Acute Coronary Syndrome', 'Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': "This study is investigating whether a series of psychological exercises, called positive psychology, provides benefit to patients who have been hospitalized for heart disease (an 'acute coronary syndrome' or heart failure).\n\nIn this study, subjects are randomly assigned to complete 8 positive psychology exercises over 8 weeks, or to complete different exercises in control groups.\n\nWe hypothesize that patients who are assigned to the positive psychology tasks will be able to complete the exercises at a high rate, will feel that the exercises were easy to perform, and will have greater improvements of optimism, anxiety, mood, and health-related quality of life than subjects in the control conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalization at Massachusetts General Hospital for an acute coronary syndrome or congestive heart failure\n* Able to read/write in English\n* Have working home or cellular phone\n\nExclusion Criteria:\n\n* Cognitive disorder\n* Medical condition likely to lead to death within 6 months\n* Illness leading to inabilty to consent or complete study exercises\n* Current or prior participation in positive psychology interventions'}, 'identificationModule': {'nctId': 'NCT01270568', 'briefTitle': 'Mind-body Interventions in Cardiac Patients', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'orgStudyIdInfo': {'id': '2009P002386'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positive Psychology', 'description': '8 weekly positive psychology exercises', 'interventionNames': ['Other: Positive Psychology']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation Response', 'description': 'Meditation-based treatment', 'interventionNames': ['Behavioral: Relaxation Response']}, {'type': 'SHAM_COMPARATOR', 'label': 'Recollection', 'description': 'Recollection of daily events, recorded weekly', 'interventionNames': ['Behavioral: Recollection']}], 'interventions': [{'name': 'Positive Psychology', 'type': 'OTHER', 'description': 'Weekly exercises focused on optimism, gratitude, altruism, and other positive affective states', 'armGroupLabels': ['Positive Psychology']}, {'name': 'Relaxation Response', 'type': 'BEHAVIORAL', 'description': 'Daily practice of relaxation response, reviewed on a weekly basis', 'armGroupLabels': ['Relaxation Response']}, {'name': 'Recollection', 'type': 'BEHAVIORAL', 'description': 'Subjects record daily events on a weekly basis for 8 weeks', 'armGroupLabels': ['Recollection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'oldNameTitle': 'Jeff C. Huffman, M.D.', 'oldOrganization': 'Massachusetts General Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-09-25', 'type': 'RELEASE'}, {'date': '2014-10-03', 'type': 'RESET'}, {'date': '2019-04-02', 'type': 'RELEASE'}, {'date': '2019-06-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jeff C. Huffman, MD, Principal Investigator, Massachusetts General Hospital'}}}}