Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
Study NCT ID:
NCT00838006
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2009-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeffrey.pyne@va.gov', 'phone': '501-257-1083', 'title': 'Jeff Pyne, MD', 'organization': 'Central Arkansas Veterans Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'HRV Biofeedback', 'description': 'Soldiers randomized to heart rate variability biofeedback training arm', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cognitive Bias Modification Training', 'description': 'Soldiers randomized to Cognitive Bias Modification for Interpretation training arm', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 0, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control', 'description': 'Soldiers randomized to the control arm', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 0, 'seriousNumAtRisk': 142, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The PTSD Checklist - Military Version', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HRV Biofeedback', 'description': 'Soldiers randomized the heart rate variability biofeedback training arm'}, {'id': 'OG001', 'title': 'Cognitive Bias Modification Training', 'description': 'Soldiers randomized to the cognitive bias modification for interpretation training arm'}, {'id': 'OG002', 'title': 'Control', 'description': 'Soldiers randomized to the control arm'}], 'classes': [{'title': 'Pre-deployment', 'categories': [{'measurements': [{'value': '22.2', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '23.8', 'spread': '9.6', 'groupId': 'OG002'}]}]}, {'title': '3-months Post-deployment', 'categories': [{'measurements': [{'value': '25.9', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '28.5', 'spread': '12.7', 'groupId': 'OG002'}]}]}, {'title': '12-month Post-deployment', 'categories': [{'measurements': [{'value': '24.5', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '23.9', 'spread': '9.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-deployment, 3-, and 12-months post-deployment', 'description': 'The Post Traumatic Stress Disorder Checklist is based on Diagnostic Statistical Manual (DSM)-IV symptoms of PTSD. The minimum score is 17 and the maximum score is 85. Higher scores are associated with more severe symptoms and worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants completed baseline and at least one follow-up'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Heart Rate Variability Biofeedback Training', 'description': 'Soldiers randomized the heart rate variability biofeedback training arm'}, {'id': 'OG001', 'title': 'Cognitive Bias Modification Training', 'description': 'Soldiers randomized to the Cognitive Bias Modification for Interpretation training arm'}, {'id': 'OG002', 'title': 'Control', 'description': 'Soldiers randomized to the control arm'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '3.02', 'spread': '3.27', 'groupId': 'OG001'}, {'value': '3.03', 'spread': '3.29', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-deployment, 3-, and 12-month post-deployment', 'description': 'The PHQ-9 is a nine-item depression module that is based on DSM-IV criteria for major depression. The minimum score is 0 and the maximum score is 27. Higher scores indicate more severe depression or worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Heart Rate Variability Biofeedback Training', 'description': 'Heart rate variability biofeedback training and iPod with Breath Pacer app\n\nheart rate variability biofeedback: Heart rate variability biofeedback,1 session plus handheld device'}, {'id': 'FG001', 'title': 'Cognitive Bias Modification Training', 'description': 'Cognitive bias modification training and iPod with cognitive bias training app\n\nCognitive bias modification training: Cognitive bias modification training - 1 session plus handheld device'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'No additional resilience training and iPod with no resilience training apps\n\nSham Comparator: Subjects received iPod without a study app and no additional resilience training'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '142'}]}, {'type': '3-month Post-deployment Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '48'}]}]}], 'preAssignmentDetails': '426 soldiers were enrolled and completed the pre-deployment assessment. Fo these, 342 were randomized and had at least one follow-up assessment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '342', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Bias Modification', 'description': 'Soldiers randomized to Cognitive Bias Modification for Interpretation training arm'}, {'id': 'BG001', 'title': 'Heart Rate Variability Biofeedback', 'description': 'Soldiers randomized to Heart Rate Variability Biofeedback training arm'}, {'id': 'BG002', 'title': 'Control', 'description': 'Soldiers randomly assigned to Control group'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '342', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '29.0', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '28.1', 'spread': '8.2', 'groupId': 'BG002'}, {'value': '28.7', 'spread': '8.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '314', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '342', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '342 participants completed at least one follow-up and were included in the analysis'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 426}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-17', 'studyFirstSubmitDate': '2009-02-04', 'resultsFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2009-02-05', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-17', 'studyFirstPostDateStruct': {'date': '2009-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The PTSD Checklist - Military Version', 'timeFrame': 'pre-deployment, 3-, and 12-months post-deployment', 'description': 'The Post Traumatic Stress Disorder Checklist is based on Diagnostic Statistical Manual (DSM)-IV symptoms of PTSD. The minimum score is 17 and the maximum score is 85. Higher scores are associated with more severe symptoms and worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'pre-deployment, 3-, and 12-month post-deployment', 'description': 'The PHQ-9 is a nine-item depression module that is based on DSM-IV criteria for major depression. The minimum score is 0 and the maximum score is 27. Higher scores indicate more severe depression or worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['post-traumatic stress disorder', 'post-deployment', 'prediction', 'prevention'], 'conditions': ['Post-traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions.', 'detailedDescription': 'The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions. The objective predictors will be based on: 1) physiologic reactivity (heart rate, heart rate variability, eye blink startle, skin conductance) to virtual reality (VR) environments depicting common Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF) combat scenarios and 2) cognitive bias assessment using a recognition memory paradigm. We hypothesize that a model combining physiologic reactivity and cognitive bias predictors will be superior to either the physiologic reactivity or cognitive bias model alone for predicting post-deployment PTSD. We also will test two pre-deployment resiliency interventions: heart rate variability biofeedback and cognitive bias modification training that we have designed to target physiologic and cognitive responses to stress, respectively. We will compare the prevention interventions to a no intervention control group. We hypothesize that the prevalence of post-deployment PTSD will be lower in the intervention groups compared to the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Army National Guard members who are scheduled to deploy for OIF/OEF operations within the next 12 months, age 18 to 60, and willing to provide the name and phone number of at least one person to help locate the member for the follow-up assessments if necessary.\n\nExclusion Criteria:\n\n* Implantable pacemaker or cardiac defibrillator\n* Unable to wear a virtual reality headset'}, 'identificationModule': {'nctId': 'NCT00838006', 'briefTitle': 'Psychophysiologic Predictors of Post-deployment Mental Health Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Biomedical Research Foundation'}, 'officialTitle': 'Identification of and At-Risk Interventions for Pre-deployment Psychophysiologic Predictors of Post-deployment Mental Health Outcomes', 'orgStudyIdInfo': {'id': 'PT074626'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biofeedback training', 'description': 'Heart rate variability biofeedback training and iPod with Breath Pacer app', 'interventionNames': ['Device: heart rate variability biofeedback']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive bias modification training', 'description': 'Cognitive bias modification training and iPod with cognitive bias training app', 'interventionNames': ['Device: Cognitive bias modification training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'No additional resilience training and iPod with no resilience training apps', 'interventionNames': ['Device: Sham Comparator']}], 'interventions': [{'name': 'heart rate variability biofeedback', 'type': 'DEVICE', 'description': 'Heart rate variability biofeedback, 3 session plus handheld device', 'armGroupLabels': ['Biofeedback training']}, {'name': 'Cognitive bias modification training', 'type': 'DEVICE', 'description': 'Cognitive bias modification training - 3 session plus handheld device', 'armGroupLabels': ['Cognitive bias modification training']}, {'name': 'Sham Comparator', 'type': 'DEVICE', 'description': 'Subjects received iPod without a study app and no additional resilience training', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23824', 'city': 'Blackstone', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Army National Guard', 'geoPoint': {'lat': 37.08043, 'lon': -77.99723}}], 'overallOfficials': [{'name': 'Jeffrey M Pyne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Arkansas Veterans Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomedical Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Jeffrey Pyne', 'investigatorAffiliation': 'Biomedical Research Foundation'}}}}