Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-18 @ 3:38 AM
Study NCT ID:
NCT02004158
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2013-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhuffman@partners.org', 'phone': '617-724-2910', 'title': 'Jeff Huffman', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '11 months (duration of study)', 'eventGroups': [{'id': 'EG000', 'title': 'Positive Psychology', 'description': 'Positive psychology intervention', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Exercise Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Positive psychology intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Rate of exercise completion will be measured by the number of participants who have a good rate of completion of exercises. There are 8 exercises in total. A good rate of completion will be defined as an average of 5 or more exercises completed per subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ease of Exercises', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Positive psychology intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Ease of exercises will be measured by a self-report 10-point Likert scale (0=not easy to complete, 10=very easy to complete). Ease will be defined as an average score of 6 or more on this scale.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Self-reported Psychological Impact of Exercises', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Positive psychology intervention'}], 'classes': [{'title': 'Optimism', 'categories': [{'measurements': [{'value': '7.9', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Happiness', 'categories': [{'measurements': [{'value': '8.0', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Psychological impact of exercises will be measured by two self-reported 10-point Likert scales. One scale measures optimism after completing the exercise (0=not optimistic, 10=very optimistic), and the other scale measures happiness after completing the exercise (0=not happy, 10=very happy). Psychological impact will be defined as an average score of 6 or more on both of these scales.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Objective Psychological Impact of Exercises', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Positive psychology intervention (Baseline data)'}, {'id': 'OG001', 'title': 'Positive Psychology', 'description': 'Positive psychology intervention (8 week data)'}], 'classes': [{'title': 'LOT-R', 'categories': [{'measurements': [{'value': '23.5', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'PANAS', 'categories': [{'measurements': [{'value': '35.1', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '38.2', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'HADS', 'categories': [{'measurements': [{'value': '13.4', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '5.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Object psychological impact of exercises will be measured by clinician-administered questionnaires given at baseline and again at 8 weeks. These questionnaires include:\n\n1. Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism)\n2. Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect)\n3. Hospital Anxiety and Depression Scale (scores range from 0-42; a high score means higher depression and anxiety).\n\nObjective psychological impact will be defined as having significantly improved scores at 8 weeks as compared to scores at baseline.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Positive Psychology', 'description': 'Positive psychology intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Positive Psychology', 'description': 'Positive psychology intervention'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '11.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2013-12-03', 'resultsFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-02', 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Exercise Completion', 'timeFrame': '8 weeks', 'description': 'Rate of exercise completion will be measured by the number of participants who have a good rate of completion of exercises. There are 8 exercises in total. A good rate of completion will be defined as an average of 5 or more exercises completed per subject.'}, {'measure': 'Ease of Exercises', 'timeFrame': '8 weeks', 'description': 'Ease of exercises will be measured by a self-report 10-point Likert scale (0=not easy to complete, 10=very easy to complete). Ease will be defined as an average score of 6 or more on this scale.'}, {'measure': 'Self-reported Psychological Impact of Exercises', 'timeFrame': '8 weeks', 'description': 'Psychological impact of exercises will be measured by two self-reported 10-point Likert scales. One scale measures optimism after completing the exercise (0=not optimistic, 10=very optimistic), and the other scale measures happiness after completing the exercise (0=not happy, 10=very happy). Psychological impact will be defined as an average score of 6 or more on both of these scales.'}], 'secondaryOutcomes': [{'measure': 'Objective Psychological Impact of Exercises', 'timeFrame': '8 weeks', 'description': 'Object psychological impact of exercises will be measured by clinician-administered questionnaires given at baseline and again at 8 weeks. These questionnaires include:\n\n1. Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism)\n2. Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect)\n3. Hospital Anxiety and Depression Scale (scores range from 0-42; a high score means higher depression and anxiety).\n\nObjective psychological impact will be defined as having significantly improved scores at 8 weeks as compared to scores at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute coronary syndrome', 'Health behavior', 'Mental health'], 'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'In this proof-of-concept study, the investigators will assess the ease and usefulness of a positive psychology program in patients with acute coronary syndrome and less-than-optimal adherence to health behaviors. The investigators believe that positive psychology (a field that studies boosting positive emotions rather than simply reducing negative emotions) will help this cardiac population to be more healthy. The investigators want to determine whether this positive psychology program has the potential to be an adjunctive treatment for cardiac populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients admitted to one of three cardiac inpatient units at Massachusetts General Hospital.\n* Primary diagnosis of acute coronary syndrome (myocardial infarction or unstable angina).\n* Less-than-optimal adherence to health behaviors. This will be defined as a mean score of less than 15 on the Medical Outcomes Study Specific Adherence Scale (scores range from 3-18, with higher scores indicating better adherence).\n\nExclusion Criteria:\n\n* Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.\n* Patients not prescribed aspirin at discharge.\n* Inability to communicate in English.\n* Inability to participate in physical activity.'}, 'identificationModule': {'nctId': 'NCT02004158', 'acronym': 'PEACE II', 'briefTitle': 'Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Study of a Positive Psychology Program to Improve Healthy Behaviors After an Acute Coronary Syndrome: Proof of Concept Study', 'orgStudyIdInfo': {'id': '2013P001961'}, 'secondaryIdInfos': [{'id': '1R01HL113272-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL113272-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positive psychology', 'description': 'Positive psychology intervention', 'interventionNames': ['Behavioral: Positive psychology intervention']}], 'interventions': [{'name': 'Positive psychology intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Positive psychology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jeff Huffman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Cardiac Psychiatry Research Program', 'investigatorFullName': 'Jeff C. Huffman, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}