Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-24 @ 2:53 AM
Study NCT ID:
NCT00624520
Status:
TERMINATED
Last Update Posted:
2014-12-22
First Post:
2008-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mental Stress Reduction in Defibrillator Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010353', 'term': 'Patient Education as Topic'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Dcrussel@facstaff.wisc.edu', 'phone': '608-256-1901', 'title': 'Dr Douglas C Russell', 'organization': 'Department of Veterans Affairs'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination of study after 12 month study extension and interim data analysis, due to high drop-out rate and exhaustion of population pool, 9 subjects short of revised target enrollment.'}}, 'adverseEventsModule': {'timeFrame': '6 to 12 months, from enrollment to study completion', 'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions', 'otherNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.', 'otherNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'seriousNumAffected': 12}], 'seriousEvents': [{'term': 'Death', 'notes': 'Cardiomyopathy, sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter', 'notes': 'Includes Ablation procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'notes': 'Tachycardia unknown origin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Includes syncope, dizziness, hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Implantable Defibrillator malfunction', 'notes': 'Includes admissions for inappropriate device firings, lead revisions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophageal stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'notes': 'Includes colonoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Carotid artery disease', 'notes': 'Includes carotid artery surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'notes': 'includes respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal polyps', 'notes': 'Includes nasal polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mental Stress Induced Elevation in "Double Product" by Math Stress Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'OG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}], 'classes': [{'title': '6 months post', 'categories': [{'measurements': [{'value': '1693', 'spread': '343', 'groupId': 'OG000'}, {'value': '1137', 'spread': '228', 'groupId': 'OG001'}]}]}, {'title': '3 months post', 'categories': [{'measurements': [{'value': '1399', 'spread': '201', 'groupId': 'OG000'}, {'value': '1063', 'spread': '158', 'groupId': 'OG001'}]}]}, {'title': 'Immediate post', 'categories': [{'measurements': [{'value': '1514', 'spread': '246', 'groupId': 'OG000'}, {'value': '1538', 'spread': '224', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '891', 'pValueComment': 'Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post', 'groupDescription': 'Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in "Double Product" response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediate to 6 months post intervention', 'description': 'Maximum Mental Stress induced elevation in "Double Product" , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress task of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect.', 'unitOfMeasure': 'mmHg x beats/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Response to Mental Stress by Math Stress Task.'}, {'type': 'SECONDARY', 'title': 'State Anger', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'OG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '2', 'groupId': 'OG000'}, {'value': '19', 'spread': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediate post intervention', 'description': 'Psychosocial score of negative mood derived from self-report questionnaires. Scale range was 15-45. Lower values represent better outcome, and higher values represent worse outcome..', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Serial psychometric scores up to 6 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.'}, {'type': 'SECONDARY', 'title': 'Tension/Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'OG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '4', 'groupId': 'OG000'}, {'value': '12', 'spread': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediate post intervention', 'description': 'Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.'}, {'type': 'SECONDARY', 'title': 'Perceived Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'OG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '6', 'groupId': 'OG000'}, {'value': '14', 'spread': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediate post intervention', 'description': 'Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.'}, {'type': 'SECONDARY', 'title': 'Depression/Dejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'OG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '6', 'groupId': 'OG000'}, {'value': '24', 'spread': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 months post intervention', 'description': 'Psychometric score from self-report questionnaire Scale range is 9 to 60. Lower values represent better outcome, and higher values represent worse outcome..', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up,with inclusion only of participants having accurate and appropriate data.'}, {'type': 'SECONDARY', 'title': 'Low Frequency Heart Rate Variability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'OG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '19', 'groupId': 'OG000'}, {'value': '70', 'spread': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-11', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months post intervention', 'description': 'Heart Rate Variability measure of cardiac autonomic activity, believed to reflect a combination of cardiac sympathetic and parasympathetic activity.\n\nData are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Low frequency heart rate variability correlates with cardiac sympathetic and parasympathetic activity. Increased sympathetic activity and/or decreased parasympathetic activity occur in this study population at high risk for cardiac arrhythmia. Normalized units are used, reflecting percentage of total frequency power.', 'unitOfMeasure': 'percentage of spectral power', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 months post intervention, from ECG recordings during mental stress tasks Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for HRV analyses during follow-up, with inclusion only of participants having accurate and appropriate data.'}, {'type': 'SECONDARY', 'title': 'High Frequency Heart Rate Variability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'OG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '19', 'groupId': 'OG000'}, {'value': '26', 'spread': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '15', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months post intervention', 'description': 'Heart Rate Variability measure of Cardiac Parasympathetic activity. Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Increased High Frequency heart rate variability correlates with increased cardiac parasympathetic activity. Normalized units are used, reflecting percentage of total frequency power.', 'unitOfMeasure': 'percentage of spectral power', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reduced participant numbers reflect drop-outs and exclusion of participants with non-diagnostic recordings for HRV analyses, with inclusion only of participants having accurate and appropriate data.'}, {'type': 'SECONDARY', 'title': 'Low Frequency/High Frequency Ratio of Heart Rate Variability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'OG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '4.01', 'spread': '3.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.02', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months post intervention', 'description': 'Heart Rate Variability measure of cardiac autonomic activity Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Decreased Low/High Frequency ratio reflects Increased High Frequency heart rate variability which correlates with increased cardiac parasympathetic activity, which may be beneficial in this patient population. Normalized units are used, reflecting percentage of total frequency power.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for heart rate variability analyses during follow-up, with inclusion only of participants having accurate and appropriate data.\n\nData are shown for Ratios of Low and High Frequency power shown above.'}, {'type': 'SECONDARY', 'title': 'Cardioverter-DefibrillatorTherapies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'OG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months post intervention', 'description': 'Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cardioverter-defibrillator interrogation data between 3 and 6 months post intervention'}, {'type': 'PRIMARY', 'title': 'Mental Stress Induced Elevation in Double Product by Math Stress Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}], 'classes': [{'title': 'Pre intervention', 'categories': [{'measurements': [{'value': '1915', 'spread': '263', 'groupId': 'OG000'}]}]}, {'title': '3 months post intervention', 'categories': [{'measurements': [{'value': '1399', 'spread': '201', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000'], 'paramType': "Effect size (Cohen's d)", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.38', 'pValueComment': 'P-value refers to a repeated measures within-group comparison in the CBSM group using ANCOVA with baseline DP elevation as covariate from baseline to 3 months post.', 'estimateComment': "Range of Cohen's d for small effect is 0.20 - 0.50", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 months post intervention', 'description': 'Maximum Mental Stress induced elevation in "Double Product" , DP, (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress tasks of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect.', 'unitOfMeasure': 'mmHg x beats/minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Response to mental stress by math task testing at 3 months post intervention, compared with pre-intervention. Within-group comparison is shown for matched pair data. The lower number of participants analyzed than at study entry is due to patient drop-outs during follow-up post-intervention.'}, {'type': 'PRIMARY', 'title': 'Mental Stress Induced Elevation in "Double Product" by Anger-recall Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'OG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}], 'classes': [{'title': '6 months post intervention', 'categories': [{'measurements': [{'value': '711', 'spread': '232', 'groupId': 'OG000'}, {'value': '631', 'spread': '292', 'groupId': 'OG001'}]}]}, {'title': '3 months post intervention', 'categories': [{'measurements': [{'value': '353', 'spread': '167', 'groupId': 'OG000'}, {'value': '548', 'spread': '308', 'groupId': 'OG001'}]}]}, {'title': 'Immediate post intervention', 'categories': [{'measurements': [{'value': '406', 'spread': '93', 'groupId': 'OG000'}, {'value': '681', 'spread': '244', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '80', 'pValueComment': 'Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post', 'groupDescription': 'Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in "Double Product" response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediate to 6 months post intervention', 'description': 'Maximum Mental Stress induced elevation in "Double Product" , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress of anger-recall task. Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The anger-recall test was applied for 25 minutes with 10 minutes monitoring post-test. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect', 'unitOfMeasure': 'mmHg x beats/minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Response to Mental Stress by Anger-Recall Stress Task'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'FG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment commenced October 2009, completed December 2011 Recruitment from Cardiology Clinics W S Middleton Veterans Hospital, Madison, and Zablocki VA Medical Center, Milwaukee', 'preAssignmentDetails': 'Some enrolled participants were excluded from the trial if determined to have severe mental illness after administration of an SCID-I questionnaire and/or interview by a clinical psychologist. Others were excluded as drop-outs due to travel issues, weather, family issues, and illness. 2 subjects died before group assignment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions\n\nCognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions'}, {'id': 'BG001', 'title': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions\n\nPatient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '66.2', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '65.7', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'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': '32', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Madison and Milwaukee study sites, US', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects randomized , including drop-outs before commencement of intervention.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'whyStopped': 'Exhaustion of subject population pool, greater than expected drop-out rates . Data analysis approved by DMC for study completions', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-15', 'studyFirstSubmitDate': '2008-02-14', 'resultsFirstSubmitDate': '2014-11-19', 'studyFirstSubmitQcDate': '2008-02-15', 'lastUpdatePostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-15', 'studyFirstPostDateStruct': {'date': '2008-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mental Stress Induced Elevation in "Double Product" by Math Stress Task', 'timeFrame': 'Immediate to 6 months post intervention', 'description': 'Maximum Mental Stress induced elevation in "Double Product" , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress task of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect.'}, {'measure': 'Mental Stress Induced Elevation in Double Product by Math Stress Task', 'timeFrame': '3 months post intervention', 'description': 'Maximum Mental Stress induced elevation in "Double Product" , DP, (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress tasks of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect.'}, {'measure': 'Mental Stress Induced Elevation in "Double Product" by Anger-recall Task', 'timeFrame': 'Immediate to 6 months post intervention', 'description': 'Maximum Mental Stress induced elevation in "Double Product" , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress of anger-recall task. Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The anger-recall test was applied for 25 minutes with 10 minutes monitoring post-test. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect'}], 'secondaryOutcomes': [{'measure': 'State Anger', 'timeFrame': 'Immediate post intervention', 'description': 'Psychosocial score of negative mood derived from self-report questionnaires. Scale range was 15-45. Lower values represent better outcome, and higher values represent worse outcome..'}, {'measure': 'Tension/Anxiety', 'timeFrame': 'Immediate post intervention', 'description': 'Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..'}, {'measure': 'Perceived Stress', 'timeFrame': 'Immediate post intervention', 'description': 'Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..'}, {'measure': 'Depression/Dejection', 'timeFrame': '3 months post intervention', 'description': 'Psychometric score from self-report questionnaire Scale range is 9 to 60. Lower values represent better outcome, and higher values represent worse outcome..'}, {'measure': 'Low Frequency Heart Rate Variability', 'timeFrame': '6 months post intervention', 'description': 'Heart Rate Variability measure of cardiac autonomic activity, believed to reflect a combination of cardiac sympathetic and parasympathetic activity.\n\nData are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Low frequency heart rate variability correlates with cardiac sympathetic and parasympathetic activity. Increased sympathetic activity and/or decreased parasympathetic activity occur in this study population at high risk for cardiac arrhythmia. Normalized units are used, reflecting percentage of total frequency power.'}, {'measure': 'High Frequency Heart Rate Variability', 'timeFrame': '6 months post intervention', 'description': 'Heart Rate Variability measure of Cardiac Parasympathetic activity. Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Increased High Frequency heart rate variability correlates with increased cardiac parasympathetic activity. Normalized units are used, reflecting percentage of total frequency power.'}, {'measure': 'Low Frequency/High Frequency Ratio of Heart Rate Variability', 'timeFrame': '6 months post intervention', 'description': 'Heart Rate Variability measure of cardiac autonomic activity Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Decreased Low/High Frequency ratio reflects Increased High Frequency heart rate variability which correlates with increased cardiac parasympathetic activity, which may be beneficial in this patient population. Normalized units are used, reflecting percentage of total frequency power.'}, {'measure': 'Cardioverter-DefibrillatorTherapies', 'timeFrame': '6 months post intervention', 'description': 'Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stress, Psychological', 'Tachycardia, Ventricular', 'Defibrillators, Implantable', 'Death, Sudden Cardiac', 'Cognitive Therapy', 'Anger'], 'conditions': ['Cardiomyopathy, Dilated', 'Arrhythmia', 'Anger', 'Stress']}, 'referencesModule': {'references': [{'pmid': '26010524', 'type': 'DERIVED', 'citation': 'Russell DC, Smith TL, Krahn DD, Graskamp P, Singh D, Kolden GG, Sigmund H, Zhang Z. Effects of Cognitive Behavioral Stress Management on Negative Mood and Cardiac Autonomic Activity in ICD Recipients. Pacing Clin Electrophysiol. 2015 Aug;38(8):951-65. doi: 10.1111/pace.12668. Epub 2015 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable Cardioverter-Defibrillators', 'detailedDescription': 'The study is a randomized controlled small clinical trial designed to determine whether a 10-week program of group cognitive-behavioral stress management (CBSM) versus a control "Patient Education" program can improve hemodynamic responses to mental stress testing in patients with Implantable Cardioverter Defibrillators. Comparison will be made between groups of heart rate and blood pressure responses to mental arithmetic and anger-recall mental stress, psychometric profiles, arrhythmia frequency and implantable cardioverter defibrillator firings before, immediately and up to 6 months after intervention. If benefit of CBSM is proven, study findings could lead to wider use of stress management programs, with increased life expectancy for implantable cardioverter-defibrillator patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>21 years,\n* ICD Implantation,\n* \\> 3 months following ICD implantation,\n* willingness to give informed consent\n\nExclusion Criteria:\n\n* Episodes within prior 3 months of: acute coronary syndrome, myocardial infraction, Coronary Artery By-pass Graft surgery, percutaneous coronary intervention, hospital admission any cause,\n* severe mental illness,\n* life expectancy \\< 1 year,\n* hyperkalemia,\n* hypokalemia,\n* hypomagnesemia,\n* hypermagnesemia,\n* unwillingness to give informed consent'}, 'identificationModule': {'nctId': 'NCT00624520', 'briefTitle': 'Mental Stress Reduction in Defibrillator Patients', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Effectiveness of Mental Stress Reduction in Defibrillator Patients', 'orgStudyIdInfo': {'id': 'CLIN-008-07F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioral Stress Management', 'description': '10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions', 'interventionNames': ['Behavioral: Cognitive Behavioral Stress Management (CBSM)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patient Education', 'description': '10 week program of once weekly Patient Education group sessions', 'interventionNames': ['Other: Patient Education']}], 'interventions': [{'name': 'Cognitive Behavioral Stress Management (CBSM)', 'type': 'BEHAVIORAL', 'description': '10 week program of weekly CBSM therapy group sessions', 'armGroupLabels': ['Cognitive Behavioral Stress Management']}, {'name': 'Patient Education', 'type': 'OTHER', 'description': '10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.', 'armGroupLabels': ['Patient Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wlliam S. Middleton Memorial Veterans Hospital, Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53295-1000', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Zablocki VA Medical Center, Milwaukee', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Douglas Russell, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wlliam S. Middleton Memorial Veterans Hospital, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}