Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-31 @ 2:33 PM
Study NCT ID:
NCT01338506
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2011-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003130', 'term': 'Combat Disorders'}, {'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}], 'ancestors': [{'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'backs@musc.edu', 'phone': '843-792-9383', 'title': 'Dr. Sudie Back', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'COPE Therapy', 'description': 'Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Treatment as Usual', 'description': "Current standard treatment available through the Department of Veteran's Affairs.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).", 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Attempted suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hospitalization', 'notes': 'Hospitalized for suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Post-traumatic Stress Disorder Symptomatology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE Therapy', 'description': 'Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'CBT for substance use disorder.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).'}], 'classes': [{'title': 'Clinician Administered PTSD Sore', 'categories': [{'measurements': [{'value': '-51.2', 'groupId': 'OG000', 'lowerLimit': '-59.7', 'upperLimit': '-42.8'}, {'value': '-35.9', 'groupId': 'OG001', 'lowerLimit': '-48.8', 'upperLimit': '-23'}]}]}, {'title': 'The PTSD Checklist for DSM-5 PTSD Diagnosis', 'categories': [{'measurements': [{'value': '-22.3', 'groupId': 'OG000', 'lowerLimit': '-29.3', 'upperLimit': '-15.3'}, {'value': '-10.9', 'groupId': 'OG001', 'lowerLimit': '-18', 'upperLimit': '-3.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Following 12 weeks of therapy.', 'description': 'The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing Change in Post-traumatic Stress Disorder symptoms as measured by a reduction of 25 points or more in scores for the Clinician Administered Post-traumatic Stress Disorder Scale (CAPS).\n\nA lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes.\n\nA negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes).\n\nClinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms\n\n≥80: extreme PTSD symptoms\n\nPost-traumatic Stress Disorder Checklist: score range 17-85.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Drinks Per Drinking Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE Therapy', 'description': 'Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': "Current standard treatment available through the Department of Veteran's Affairs.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Following 12 weeks of therapy.', 'description': 'Number of standard drinks reported during drinking day', 'unitOfMeasure': 'Number of drinks per drinking day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-traumatic Stress Disorder Symptomatology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE Therapy', 'description': 'Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': "Current standard treatment available through the Department of Veteran's Affairs.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."}], 'classes': [{'title': 'Clinician Administered PTSD Scale (CAPS)', 'categories': [{'measurements': [{'value': '27.2', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '49.7', 'spread': '25.3', 'groupId': 'OG001'}]}]}, {'title': 'PTSD Checklist for DSM-4 PTSD Diagnosis (PCL-5)', 'categories': [{'measurements': [{'value': '37.6', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '53.1', 'spread': '14.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Following 12 weeks of therapy.', 'description': 'Score of PTSD from Clinician Administered PTSD Scale (CAPS) and self-administered PTSD Checklist for DSM-5 PTSD Diagnosis (PCL-5).\n\nLower scores on CAPS and PCL would indicate less severe PTSD. A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes.\n\nA negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes).\n\nClinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms\n\n≥80: extreme PTSD symptoms\n\nPost-traumatic Stress Disorder Checklist: score range 17-85.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Clinician Administered PTSD Scale Itemized Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE Therapy', 'description': 'Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': "Current standard treatment available through the Department of Veteran's Affairs.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."}], 'classes': [{'title': 'Clinician Administered PTSD Scale- Re-experiencing', 'categories': [{'measurements': [{'value': '5.6', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '10.7', 'groupId': 'OG001'}]}]}, {'title': 'Clinician Admin PTSD Scale - Avoidance/Numbing', 'categories': [{'measurements': [{'value': '10.8', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '24', 'spread': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'Clinician Administered PTSD Scale - Hyperarousal', 'categories': [{'measurements': [{'value': '11.7', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '6.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 12 weeks of treatment', 'description': 'Clinician Administered PTSD Scale Itemized Scores Within the assessment there are 20 symptoms of PTSD, each with an individual score.\n\nA lower score would represent a better outcome (ie less severe symptom). The three itemized symptoms listed below represent hallmark traits/symptoms of PTSD.\n\nOverall score range 0-136 Reexperiencing Symptoms range 0-40 Avoidance/Numbing range 0-56 Hyperarousal range 0-40', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Report Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual', 'description': 'Relapse Prevention (RP) for substance use disorders.\n\nIncluded 12 sessions of RP matched for time.'}, {'id': 'OG001', 'title': 'COPE Therapy', 'description': 'Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Following 12 weeks of therapy.', 'description': 'The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing substance use as measured by decreases in percent days using and increased abstinence rates.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Reported rate of abstinence'}, {'type': 'SECONDARY', 'title': 'Beck Depression Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE Therapy', 'description': 'Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': "Current standard treatment available through the Department of Veteran's Affairs.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '11', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '12.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Following 12 weeks of therapy.', 'description': 'Measure of depression. A lower score would indicate less severe depression. Scores range 0-30', 'unitOfMeasure': 'units on a scale (BDI)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COPE Therapy', 'description': 'Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).'}, {'id': 'FG001', 'title': 'Treatment as Usual', 'description': "Current standard treatment available through the Department of Veteran's Affairs.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment as Usual', 'description': 'Relapse Prevention (RP) for substance use disorders.\n\nIncluded 12 sessions of RP matched for time.'}, {'id': 'BG001', 'title': 'COPE Therapy', 'description': 'Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.\n\nConcurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '39.7', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '40.4', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participants were asked their age at baseline visit using a demographic form.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '78', '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': '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': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '27', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2011-04-08', 'resultsFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2011-04-18', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-04', 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Post-traumatic Stress Disorder Symptomatology', 'timeFrame': 'Following 12 weeks of therapy.', 'description': 'The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing Change in Post-traumatic Stress Disorder symptoms as measured by a reduction of 25 points or more in scores for the Clinician Administered Post-traumatic Stress Disorder Scale (CAPS).\n\nA lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes.\n\nA negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes).\n\nClinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms\n\n≥80: extreme PTSD symptoms\n\nPost-traumatic Stress Disorder Checklist: score range 17-85.'}, {'measure': 'Drinks Per Drinking Day', 'timeFrame': 'Following 12 weeks of therapy.', 'description': 'Number of standard drinks reported during drinking day'}, {'measure': 'Post-traumatic Stress Disorder Symptomatology', 'timeFrame': 'Following 12 weeks of therapy.', 'description': 'Score of PTSD from Clinician Administered PTSD Scale (CAPS) and self-administered PTSD Checklist for DSM-5 PTSD Diagnosis (PCL-5).\n\nLower scores on CAPS and PCL would indicate less severe PTSD. A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes.\n\nA negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes).\n\nClinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms\n\n≥80: extreme PTSD symptoms\n\nPost-traumatic Stress Disorder Checklist: score range 17-85.'}, {'measure': 'Clinician Administered PTSD Scale Itemized Scores', 'timeFrame': 'After 12 weeks of treatment', 'description': 'Clinician Administered PTSD Scale Itemized Scores Within the assessment there are 20 symptoms of PTSD, each with an individual score.\n\nA lower score would represent a better outcome (ie less severe symptom). The three itemized symptoms listed below represent hallmark traits/symptoms of PTSD.\n\nOverall score range 0-136 Reexperiencing Symptoms range 0-40 Avoidance/Numbing range 0-56 Hyperarousal range 0-40'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Report Abstinence', 'timeFrame': 'Following 12 weeks of therapy.', 'description': 'The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing substance use as measured by decreases in percent days using and increased abstinence rates.'}, {'measure': 'Beck Depression Index', 'timeFrame': 'Following 12 weeks of therapy.', 'description': 'Measure of depression. A lower score would indicate less severe depression. Scores range 0-30'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Military', 'Posttraumatic Stress Disorder', 'PTSD', 'PostTraumatic Stress Disorders', 'Combat', 'Psychological Treatment', 'Psychotherapy', 'Trauma', 'Posttraumatic Stress', 'Prolonged Exposure', 'Exposure therapy', 'Behavior Therapy', 'Cognitive Behavior Therapy', 'Stress Disorders', 'Drug Abuse', 'Drug Dependence', 'Alcohol Abuse', 'Alcohol Dependence', 'Substance Use Disorders', 'Alcoholism'], 'conditions': ['Posttraumatic Stress Disorders', 'Combat Disorders', 'Alcohol Dependence', 'Drug Dependence']}, 'referencesModule': {'references': [{'pmid': '28460246', 'type': 'BACKGROUND', 'citation': 'Szafranski DD, Snead A, Allan NP, Gros DF, Killeen T, Flanagan J, Pericot-Valverde I, Back SE. Integrated, exposure-based treatment for PTSD and comorbid substance use disorders: Predictors of treatment dropout. Addict Behav. 2017 Oct;73:30-35. doi: 10.1016/j.addbeh.2017.04.005. Epub 2017 Apr 4.'}, {'pmid': '28329434', 'type': 'BACKGROUND', 'citation': 'Mills AC, Badour CL, Korte KJ, Killeen TK, Henschel AV, Back SE. Integrated Treatment of PTSD and Substance Use Disorders: Examination of Imaginal Exposure Length. J Trauma Stress. 2017 Apr;30(2):166-172. doi: 10.1002/jts.22175. Epub 2017 Mar 22.'}, {'pmid': '28098747', 'type': 'BACKGROUND', 'citation': 'Korte KJ, Bountress KE, Tomko RL, Killeen T, Moran-Santa Maria M, Back SE. Integrated Treatment of PTSD and Substance Use Disorders: The Mediating Role of PTSD Improvement in the Reduction of Depression. J Clin Med. 2017 Jan 13;6(1):9. doi: 10.3390/jcm6010009.'}, {'pmid': '31010449', 'type': 'BACKGROUND', 'citation': 'Lancaster CL, Gros DF, Mullarkey MC, Badour CL, Killeen TK, Brady KT, Back SE. Does trauma-focused exposure therapy exacerbate symptoms among patients with comorbid PTSD and substance use disorders? Behav Cogn Psychother. 2020 Jan;48(1):38-53. doi: 10.1017/S1352465819000304. Epub 2019 Apr 23.'}, {'pmid': '30529244', 'type': 'RESULT', 'citation': 'Back SE, Killeen T, Badour CL, Flanagan JC, Allan NP, Ana ES, Lozano B, Korte KJ, Foa EB, Brady KT. Concurrent treatment of substance use disorders and PTSD using prolonged exposure: A randomized clinical trial in military veterans. Addict Behav. 2019 Mar;90:369-377. doi: 10.1016/j.addbeh.2018.11.032. Epub 2018 Nov 27.'}, {'pmid': '28221062', 'type': 'RESULT', 'citation': 'Badour CL, Flanagan JC, Gros DF, Killeen T, Pericot-Valverde I, Korte KJ, Allan NP, Back SE. Habituation of distress and craving during treatment as predictors of change in PTSD symptoms and substance use severity. J Consult Clin Psychol. 2017 Mar;85(3):274-281. doi: 10.1037/ccp0000180.'}]}, 'descriptionModule': {'briefSummary': 'In comparison to the general population, U.S. military and Veterans are at an increased risk for developing both substance use disorders (SUD) and Post Traumatic Stress Disorder (PTSD). Current research has shown that there is a high comorbidity of SUD and PTSD, and although there are a number of treatments for SUD and PTSD independently, there are very few effective methods to simultaneously treat both disorders. Because of this substantial gap in the treatment of both SUDs and PTSD, it has become essential to develop a combined treatment that would address and treat both disorders. Individuals, specifically U.S. military and Veterans, with SUD/PTSD have unique needs that require a specialized treatment approach. This designed approach would employ cognitive-behavioral therapy (CBT) to treat the SUD, in conjunction with Prolonged Exposure therapy to treat the PTSD. Prolonged Exposure (PE) is an empirically supported and evidence-based treatment that is currently regarded as the "gold standard" psychosocial treatment for PTSD. In combination with CBT, this treatment would address both disorders in hopes of reducing substance use and PTSD symptomatology.', 'detailedDescription': 'As a result of sustained operations in Afghanistan and Iraq, there are an increasing number of U.S. military personnel and Veterans at risk of developing both substance use disorders (SUDs) and Post Traumatic Stress Disorder (PTSD). If left untreated, individuals with SUDs and/or PTSD are at risk for other mental health problems (e.g., depression), suicidal ideation and attempts, physical health problems, reduced resiliency, lost productivity, and family/relationship impairment. While mental health services are in place for U.S. military personnel, substantial gaps in the treatment of co-occurring SUDs and PTSD exist and there is little scientific evidence available to guide the provision of care. The proposed study directly addresses this knowledge gap by testing the feasibility and preliminary efficacy of an integrative behavioral intervention for the treatment of co-occurring SUDs and PTSD modified for use among U.S. military personnel (including National Guard and Reservists) who have served in Operation Enduring Freedom and/or Operation Iraqi Freedom (OEF/OIF). The intervention, called "Concurrent Treatment with Prolonged exposure" or "COPE," represents a novel treatment that integrates cognitive-behavioral therapy for SUDs with prolonged exposure therapy for PTSD. In earlier studies with civilians, COPE has demonstrated efficacy in reducing alcohol and drug use severity, PTSD symptoms, and associated mental health problems (e.g., depression, anxiety). In this hybrid Stage Ib/Stage II study, we will (1) use a manualized, well-tolerated behavioral treatment for SUDs and PTSD (COPE); (2) employ a two-arm randomized between-groups experimental design (COPE versus a modified treatment-as usual (TAU); and (3) examine standardized, repeated dependent measures of clinical outcomes and process variables at 5 time points (pre-, mid-, and post-treatment; 3 and 6 month follow-up). The proposed project is directly responsive to the mission of the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in that it seeks to enhance and accelerate research on the prevention and treatment of alcohol and drug use disorders (including illicit and prescription drugs) and comorbid conditions (e.g., PTSD, depression, sleep disturbances, HIV risk behaviors). The findings of this study will provide empirical evidence to inform policies and programs to better serve the needs of U.S. military personnel, Veterans, and their families.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male and female active-duty OIF/OEF military personnel and separated OIF/OEF veterans ages 18-65.\n* Diagnosis of PTSD determined by a clinician-administered study interview.\n\nExclusion Criteria:\n\n* Current bipolar disorder or other psychotic disorder (as determined by the evaluator conducting the patient interview and medical record review)\n* subjects with a current eating disorder or with dissociative identity disorder\n* currently in ongoing therapy for SUDs or PTSD, who are not willing to discontinue these therapies for the duration of the trial\n* recently prescribed maintenance anxiolytic, antidepressant, or mood stabilizing medications (must be stabilized for four weeks on meds before entry into study)\n* Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)'}, 'identificationModule': {'nctId': 'NCT01338506', 'acronym': 'COPE', 'briefTitle': 'Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Integrated Treatment of Operation Enduring Freedom/Operation Iraqi Freedom Veterans With Post-traumatic Stress Disorder and Substance Use Disorders', 'orgStudyIdInfo': {'id': 'R01DA030143-01', 'link': 'https://reporter.nih.gov/quickSearch/R01DA030143-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'HR20279', 'type': 'OTHER', 'domain': 'MUSC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COPE Therapy', 'description': 'Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.', 'interventionNames': ['Behavioral: Concurrent Treatment with Prolonged Exposure (COPE)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'CBT for substance use disorder.', 'interventionNames': ['Behavioral: Concurrent Treatment with Prolonged Exposure (COPE)']}], 'interventions': [{'name': 'Concurrent Treatment with Prolonged Exposure (COPE)', 'type': 'BEHAVIORAL', 'otherNames': ['Prolonged Exposure'], 'description': '12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).', 'armGroupLabels': ['COPE Therapy', 'Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Sudie E Back, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sudie E. Back', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}