Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT00847132
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2009-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhuffman@partners.org', 'phone': '617-724-2910', 'title': 'Dr. Jeff Huffman', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Collaborative Care', 'description': 'A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations\n\nCollaborative care vs. usual care: depression education, treatment recommendations, coordination of care', 'otherNumAtRisk': 90, 'otherNumAffected': 0, 'seriousNumAtRisk': 90, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Primary medical providers are informed that the patient has depression and that treatment is recommended.\n\nCollaborative care vs. usual care: depression education, treatment recommendations, coordination of care', 'otherNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rates of Adequate Depression Treatment at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Care', 'description': 'A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations\n\nCollaborative Care Treatment: depression education, treatment recommendations, coordination of care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Primary medical providers are informed that the patient has depression and that treatment is recommended.\n\nUsual Care Treatment: treatment as usual, providers are notified of diagnoses'}], 'classes': [{'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 days after enrollment', 'description': 'Adequate treatment was defined a priori as either: (1) discharge prescription of an antidepressant at a clinically effective dose based on manufacturers\' package labeling and treatment guidelines for the treatment of depression or (2) referral to a mental health treatment provider for psychotherapy (unless pre-planned as less than six sessions).\n\nTimeframe of "5 days after enrollment" was determined by calculating the median length of hospitalization for all subjects.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Depression Symptoms From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collaborative Care', 'description': 'A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations\n\nCollaborative Care Treatment: depression education, treatment recommendations, coordination of care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Primary medical providers are informed that the patient has depression and that treatment is recommended.\n\nUsual Care Treatment: treatment as usual, providers are notified of diagnoses'}], 'classes': [{'title': 'Baseline to 6 weeks', 'categories': [{'measurements': [{'value': '-8.98', 'groupId': 'OG000', 'lowerLimit': '-10.26', 'upperLimit': '-7.70'}, {'value': '-5.95', 'groupId': 'OG001', 'lowerLimit': '-7.40', 'upperLimit': '-4.50'}]}]}, {'title': '6 weeks to 12 weeks', 'categories': [{'measurements': [{'value': '-8.73', 'groupId': 'OG000', 'lowerLimit': '-10.06', 'upperLimit': '-7.38'}, {'value': '-5.30', 'groupId': 'OG001', 'lowerLimit': '-6.75', 'upperLimit': '-3.85'}]}]}, {'title': '12 weeks to 6 months', 'categories': [{'measurements': [{'value': '-8.67', 'groupId': 'OG000', 'lowerLimit': '-10.17', 'upperLimit': '-7.16'}, {'value': '-6.90', 'groupId': 'OG001', 'lowerLimit': '-8.20', 'upperLimit': '-5.59'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 6 months', 'description': 'Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Collaborative Care', 'description': 'A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations\n\nCollaborative care vs. usual care: depression education, treatment recommendations, coordination of care'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Primary medical providers are informed that the patient has depression and that treatment is recommended.\n\nCollaborative care vs. usual care: depression education, treatment recommendations, coordination of care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Collaborative Care', 'description': 'A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations\n\nCollaborative Care Treatment: depression education, treatment recommendations, coordination of care'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Primary medical providers are informed that the patient has depression and that treatment is recommended.\n\nUsual Care Treatment: treatment as usual, providers are notified of diagnoses'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '62.35', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': 'Not White', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Patient Health Questionnaire-9 (PHQ-9)', 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '17.3', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '17.6', 'spread': '3.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Medical Outcomes Study Short Form-12 Mental Component Score (SF-12 MCS)', 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '8', 'groupId': 'BG000'}, {'value': '32.5', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '31.7', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The SF-12 Mental Component Score is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)', 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '9.7', 'spread': '4', 'groupId': 'BG001'}, {'value': '10.3', 'spread': '4.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The HADS-A is a 7-item scale used to measure anxiety severity. Each question asks about a specific symptom of anxiety and offers four answers: 0 = Never / Not at all, 1 = A little / Time to time, 2 = Quite often / Usually, 3 = Most of the time / Very often. Scores are totaled and range from 0-21. A higher score means more anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)', 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '25.4', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '25.7', 'spread': '4.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The MGH CPFQ is a 7-item scale that assesses cognitive and executive function in mood and anxiety disorders. The MGH CPFQ asks about patients' abilities in different areas of cognition and executive function. Each question includes the following response options: 1 = greater than normal ability, 2 = normal ability, 3 = minimally diminished ability, 4 = moderately diminished ability, 5 = markedly diminished ability, 6 = totally absent ability. Scores are added and range from 7 to 42. Higher scores mean lower functioning abilities.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Women and Ischemia Syndrome Evaluation-Severity (WISE)', 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '11.7', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '11.9', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The WISE is a 10-item scale that assesses the number and severity of cardiac symptoms. Each question offers 4 responses: 0 = None (no symptom), 1 = Mild, 2 = Moderate, 3 = Severe.\n\nThe "Severity" score represents the severity of cardiac illness. It\'s derived by adding all scores together. The Severity score can range from 0-30. A lower score means less severity of symptoms.\n\nThe "Number" score represents the number of symptoms of cardiac illness. It\'s derived by counting the number of symptoms that scored 1 or more. The Number score can range from 0-10. A lower score means fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Medical Outcomes Study Short Form-12 Physical Component Score (SF-12 PCS)', 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '31.3', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '31.8', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The SF-12 Physical Component Score is a 6-item scale that assesses physical health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average physical health-related quality of life. Higher scores represent higher than average physical health-related quality of life, and lower scores represent lower physical health-related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Women and Ischemia Syndrome Evaluation-Number (WISE)', 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '6.0', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The WISE is a 10-item scale that assesses the number and severity of cardiac symptoms. Each question offers 4 responses: 0 = None (no symptom), 1 = Mild, 2 = Moderate, 3 = Severe.\n\nThe "Severity" score represents the severity of cardiac illness. It\'s derived by adding all scores together. The Severity score can range from 0-30. A lower score means less severity of symptoms.\n\nThe "Number" score represents the number of symptoms of cardiac illness. It\'s derived by counting the number of symptoms that scored 1 or more. The Number score can range from 0-10. A lower score means fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2009-02-17', 'resultsFirstSubmitDate': '2014-08-14', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-21', 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of Adequate Depression Treatment at Discharge', 'timeFrame': '5 days after enrollment', 'description': 'Adequate treatment was defined a priori as either: (1) discharge prescription of an antidepressant at a clinically effective dose based on manufacturers\' package labeling and treatment guidelines for the treatment of depression or (2) referral to a mental health treatment provider for psychotherapy (unless pre-planned as less than six sessions).\n\nTimeframe of "5 days after enrollment" was determined by calculating the median length of hospitalization for all subjects.'}], 'secondaryOutcomes': [{'measure': 'Change in Depression Symptoms From Baseline to 6 Months', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 6 months', 'description': 'Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Collaborative Care'], 'conditions': ['Coronary Artery Disease', 'Congestive Heart Failure', 'Arrhythmia', 'Depression']}, 'referencesModule': {'references': [{'pmid': '23747159', 'type': 'DERIVED', 'citation': 'Sowden GL, Mastromauro CA, Seabrook RC, Celano CM, Rollman BL, Huffman JC. Baseline physical health-related quality of life and subsequent depression outcomes in cardiac patients. Psychiatry Res. 2013 Aug 15;208(3):288-90. doi: 10.1016/j.psychres.2013.05.019. Epub 2013 Jun 5.'}, {'pmid': '22325974', 'type': 'DERIVED', 'citation': 'Bauer LK, Caro MA, Beach SR, Mastromauro CA, Lenihan E, Januzzi JL, Huffman JC. Effects of depression and anxiety improvement on adherence to medication and health behaviors in recently hospitalized cardiac patients. Am J Cardiol. 2012 May 1;109(9):1266-71. doi: 10.1016/j.amjcard.2011.12.017. Epub 2012 Feb 9.'}, {'pmid': '22210240', 'type': 'DERIVED', 'citation': 'Celano CM, Mastromauro CA, Lenihan EC, Januzzi JL, Rollman BL, Huffman JC. Association of baseline anxiety with depression persistence at 6 months in patients with acute cardiac illness. Psychosom Med. 2012 Jan;74(1):93-9. doi: 10.1097/PSY.0b013e31823d38bc. Epub 2011 Dec 30.'}, {'pmid': '21386067', 'type': 'DERIVED', 'citation': 'Huffman JC, Mastromauro CA, Sowden G, Fricchione GL, Healy BC, Januzzi JL. Impact of a depression care management program for hospitalized cardiac patients. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):198-205. doi: 10.1161/CIRCOUTCOMES.110.959379. Epub 2011 Mar 8.'}]}, 'descriptionModule': {'briefSummary': "Depression in cardiac patients is common, persistent, and deadly. However, the vast majority of cardiac patients with depression go unrecognized and untreated, despite the existence of treatments that clearly improve depressive symptoms and may favorably impact survival. Our research group and others have found that depression recognition and treatment appears particularly limited among patients with acute cardiac illness, though this population may be the most vulnerable to the deleterious effects of depression. We propose a project, building on successful collaborative care depression management programs in outpatient settings, to address this important issue.\n\nThe specific hypotheses behind the proposed research are that a collaborative care depression management program can be successfully adapted to inpatient cardiac units, and that such a program will lead to greater rates of adequate depression treatment and improvements in secondary outcomes.\n\nThe following specific aims capture the stepwise goals of this program:\n\n1. To determine whether a collaborative care depression management program ('Enhanced Care') leads to significantly increased rates of adequate depression treatment compared to usual care (screening and feedback) (Primary Aim).\n2. To assess whether this Enhanced Care program has a lasting impact on adequate depression treatment, depressive symptoms, health-related quality of life, and adherence to medical recommendations at 6 weeks, 12 weeks, and 6 months, compared to usual care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatient admission for cardiac diagnosis\n* Positive depression evaluation (PHQ-2\\>2, PHQ-9\\>9)\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Active suicidal ideation\n* Bipolar disorder, psychotic disorder, active substance use disorder'}, 'identificationModule': {'nctId': 'NCT00847132', 'briefTitle': 'A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients', 'orgStudyIdInfo': {'id': '2007P-001152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collaborative Care', 'description': 'Collaborative Care Treatment: A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations', 'interventionNames': ['Behavioral: Collaborative Care Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Usual Care Treatment: Primary medical providers are informed that the patient has depression and that treatment is recommended.', 'interventionNames': ['Behavioral: Usual Care Treatment']}], 'interventions': [{'name': 'Collaborative Care Treatment', 'type': 'BEHAVIORAL', 'description': 'Depression education, treatment recommendations, coordination of care', 'armGroupLabels': ['Collaborative Care']}, {'name': 'Usual Care Treatment', 'type': 'BEHAVIORAL', 'description': 'Treatment as usual, providers are notified of diagnoses', 'armGroupLabels': ['Usual Care']}]}, '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 C Huffman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jeff C. Huffman, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}