Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 12:05 PM
Study NCT ID:
NCT01524133
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2012-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PROlonGed ExpoSure Sertraline
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sheila.rauch@va.gov', 'phone': '404-321-6111', 'title': 'Sheila Rauch', 'phoneExt': '3122', 'organization': 'Atlanta VAMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)', 'description': 'Individual descriptions were summarized to organ class', 'eventGroups': [{'id': 'EG000', 'title': 'Sertraline + Enhanced Medication Management (SERT/EMM)', 'description': '24 weeks of sertraline + enhanced medication management\n\nSertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 69, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prolonged Exposure + Sertraline (PE/SERT)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline\n\nSertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.\n\nProlonged Exposure Therapy: up to 13 sessions of prolonged exposure', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 61, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Prolonged Exposure + Placebo (PE/PLB)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo\n\nProlonged Exposure Therapy: up to 13 sessions of prolonged exposure', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 46, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 94, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 68, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 39, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 36, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 25, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muskuloskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 38, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 40, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 36, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 25, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Increased Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline + Enhanced Medication Management (SERT/EMM)', 'description': '24 weeks of sertraline + enhanced medication management\n\nSertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.'}, {'id': 'OG001', 'title': 'Prolonged Exposure + Sertraline (PE/SERT)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline\n\nSertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.\n\nProlonged Exposure Therapy: up to 13 sessions of prolonged exposure'}, {'id': 'OG002', 'title': 'Prolonged Exposure + Placebo (PE/PLB)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo\n\nProlonged Exposure Therapy: up to 13 sessions of prolonged exposure'}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '43.3', 'spread': '27.2', 'groupId': 'OG001'}, {'value': '51.5', 'spread': '25.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Total Score; Range 0-136 with increasing PTSD severity as scores increase', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who received treatment'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire-15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline + Enhanced Medication Management (SERT/EMM)', 'description': '24 weeks of sertraline + enhanced medication management\n\nSertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.'}, {'id': 'OG001', 'title': 'Prolonged Exposure + Sertraline (PE/SERT)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline\n\nSertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.\n\nProlonged Exposure Therapy: up to 13 sessions of prolonged exposure'}, {'id': 'OG002', 'title': 'Prolonged Exposure + Placebo (PE/PLB)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo\n\nProlonged Exposure Therapy: up to 13 sessions of prolonged exposure'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '5.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized patients who received treatment and had the measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sertraline + Enhanced Medication Management (SERT/EMM)', 'description': '24 weeks of sertraline + enhanced medication management\n\nSertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.'}, {'id': 'FG001', 'title': 'Prolonged Exposure + Sertraline (PE/SERT)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline\n\nSertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.\n\nProlonged Exposure Therapy: up to 13 sessions of prolonged exposure'}, {'id': 'FG002', 'title': 'Prolonged Exposure + Placebo (PE/PLB)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo\n\nProlonged Exposure Therapy: up to 13 sessions of prolonged exposure'}], 'periods': [{'title': 'Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed Both Assigned treatment', 'groupId': 'FG000', 'numSubjects': '52'}, {'comment': 'Completed Both Assigned Treatments', 'groupId': 'FG001', 'numSubjects': '37'}, {'comment': 'Completed both assigned treatments', 'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Overall Study 52 Weeks', 'milestones': [{'type': 'STARTED', 'comment': 'Treatment occurred weeks 0-24 and naturalistic follow-up continued through to week 52.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}]}], 'preAssignmentDetails': 'Patients were informed of assignment at first treatment visit. Only those randomized patients who started treatment are included below (16 patients never started treatment. They did not know condition assignment.).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sertraline + Enhanced Medication Management (SERT/EMM)', 'description': '24 weeks of sertraline + enhanced medication management\n\nSertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.'}, {'id': 'BG001', 'title': 'Prolonged Exposure + Sertraline (PE/SERT)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline\n\nSertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.\n\nProlonged Exposure Therapy: up to 13 sessions of prolonged exposure'}, {'id': 'BG002', 'title': 'Prolonged Exposure + Placebo (PE/PLB)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo\n\nProlonged Exposure Therapy: up to 13 sessions of prolonged exposure'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.7', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '35.1', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '8.3', 'groupId': 'BG002'}, {'value': '34.5', 'spread': '8.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}, {'title': 'African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-30', 'studyFirstSubmitDate': '2012-01-27', 'resultsFirstSubmitDate': '2017-12-06', 'studyFirstSubmitQcDate': '2012-01-27', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-30', 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)', 'timeFrame': '24 weeks', 'description': 'Total Score; Range 0-136 with increasing PTSD severity as scores increase'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire-15', 'timeFrame': '24 weeks', 'description': 'PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['combat-related PTSD', 'Posttraumatic stress disorder', 'prolonged exposure therapy', 'sertraline', 'military', 'veterans', 'VA hospital', 'mental illness'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '34147766', 'type': 'DERIVED', 'citation': 'Allard CB, Norman SB, Straus E, Kim HM, Stein MB, Simon NM, Rauch SAM; PROGrESS Study Team. Reductions in guilt cognitions following prolonged exposure and/or sertraline predict subsequent improvements in PTSD and depression. J Behav Ther Exp Psychiatry. 2021 Dec;73:101666. doi: 10.1016/j.jbtep.2021.101666. Epub 2021 Jun 1.'}, {'pmid': '34133087', 'type': 'DERIVED', 'citation': 'Rauch SAM, Kim HM, Lederman S, Sullivan G, Acierno R, Tuerk PW, Simon NM, Venners MR, Norman SB, Allard CB, Porter KE, Martis B, Bui E, Baker AW; PROGrESS Team. Predictors of Response to Prolonged Exposure, Sertraline, and Their Combination for the Treatment of Military PTSD. J Clin Psychiatry. 2021 Jun 15;82(4):20m13752. doi: 10.4088/JCP.20m13752.'}, {'pmid': '32668087', 'type': 'DERIVED', 'citation': 'Sheynin J, Duval ER, King AP, Angstadt M, Phan KL, Simon NM, Rauch SAM, Liberzon I. Associations between resting-state functional connectivity and treatment response in a randomized clinical trial for posttraumatic stress disorder. Depress Anxiety. 2020 Oct;37(10):1037-1046. doi: 10.1002/da.23075. Epub 2020 Jul 15.'}, {'pmid': '32446108', 'type': 'DERIVED', 'citation': 'Rauch SAM, King A, Kim HM, Powell C, Rajaram N, Venners M, Simon NM, Hamner M, Liberzon I. Cortisol awakening response in PTSD treatment: Predictor or mechanism of change. Psychoneuroendocrinology. 2020 Aug;118:104714. doi: 10.1016/j.psyneuen.2020.104714. Epub 2020 May 15.'}, {'pmid': '32306485', 'type': 'DERIVED', 'citation': 'Duval ER, Sheynin J, King AP, Phan KL, Simon NM, Martis B, Porter KE, Norman SB, Liberzon I, Rauch SAM. Neural function during emotion processing and modulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder. Depress Anxiety. 2020 Jul;37(7):670-681. doi: 10.1002/da.23022. Epub 2020 Apr 19.'}, {'pmid': '32278278', 'type': 'DERIVED', 'citation': 'Joshi SA, Duval ER, Sheynin J, King AP, Phan KL, Martis B, Porter KE, Liberzon I, Rauch SAM. Neural correlates of emotional reactivity and regulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder. Psychiatry Res Neuroimaging. 2020 May 30;299:111062. doi: 10.1016/j.pscychresns.2020.111062. Epub 2020 Mar 5.'}, {'pmid': '32216142', 'type': 'DERIVED', 'citation': 'Goetter EM, Hoeppner SS, Khan AJ, Charney ME, Wieman S, Venners MR, Avallone KM, Rauch SAM, Simon NM. Combat-Related Posttraumatic Stress Disorder and Comorbid Major Depression in U.S. Veterans: The Role of Deployment Cycle Adversity and Social Support. J Trauma Stress. 2020 Jun;33(3):276-284. doi: 10.1002/jts.22496. Epub 2020 Mar 26.'}, {'pmid': '30516797', 'type': 'DERIVED', 'citation': 'Rauch SAM, Kim HM, Powell C, Tuerk PW, Simon NM, Acierno R, Allard CB, Norman SB, Venners MR, Rothbaum BO, Stein MB, Porter K, Martis B, King AP, Liberzon I, Phan KL, Hoge CW. Efficacy of Prolonged Exposure Therapy, Sertraline Hydrochloride, and Their Combination Among Combat Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Feb 1;76(2):117-126. doi: 10.1001/jamapsychiatry.2018.3412.'}, {'pmid': '29081351', 'type': 'DERIVED', 'citation': 'Rauch SAM, Simon NM, Kim HM, Acierno R, King AP, Norman SB, Venners MR, Porter K, Phan KL, Tuerk PW, Allard C, Liberzon I, Rothbaum BO, Martis B, Stein MB, Hoge CW. Integrating biological treatment mechanisms into randomized clinical trials: Design of PROGrESS (PROlonGed ExpoSure and Sertraline Trial). Contemp Clin Trials. 2018 Jan;64:128-138. doi: 10.1016/j.cct.2017.10.013. Epub 2017 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'The current research study aims to compare the effectiveness of two proven treatments for posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their combination. In addition, the investigators are examining predictors of response to these two treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such treatments. Biological mechanisms of change are also examined including emotion processing and regulation in fMRI, HPA axis function, and genetics and genomics. In addition, the investigators will examine acceptability of each treatment and reasons for ending treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is an Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) combat veteran with chronic posttraumatic stress disorder (PTSD) or significant PTSD symptoms (Clinician Administered Posttraumatic Stress Disorder Scale \\[CAPS\\] \\>= 50) of at least 3 months duration\n\nExclusion Criteria:\n\n* Current, imminent risk of suicide (as indicated on C-SSRS)\n* Active psychosis\n* Alcohol or substance dependence in the past 8 weeks\n* Unable to attend regular appointments\n* Prior intolerance or failure of adequate trial of prolonged exposure (PE) or sertraline (SERT) (defined as at least 2 months of SERT at least 100mg/day)\n* Medical illness likely to result in hospitalization or for which treatments are contraindicated (based on lab results, medical history and physical exam)\n* Serious cognitive impairment (as evidenced by cognitive impairment felt likely to interfere with the ability to participate meaningfully in the study)\n* Concurrent antidepressants or antipsychotics\n* Pregnant females'}, 'identificationModule': {'nctId': 'NCT01524133', 'acronym': 'PROGrESS', 'briefTitle': 'PROlonGed ExpoSure Sertraline', 'organization': {'class': 'FED', 'fullName': 'VA Ann Arbor Healthcare System'}, 'officialTitle': 'Randomized Trial of Sertraline, Prolonged Exposure, and Their Combination for Post-traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF).', 'orgStudyIdInfo': {'id': 'PROGrESS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sertraline + enhanced medication management (SERT/EMM)', 'description': '24 weeks of sertraline + enhanced medication management', 'interventionNames': ['Drug: Sertraline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prolonged Exposure + sertraline (PE/SERT)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline', 'interventionNames': ['Drug: Sertraline', 'Behavioral: Prolonged Exposure Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prolonged Exposure + placebo (PE/PLB)', 'description': 'Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo', 'interventionNames': ['Behavioral: Prolonged Exposure Therapy']}], 'interventions': [{'name': 'Sertraline', 'type': 'DRUG', 'otherNames': ['Zoloft'], 'description': 'Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.', 'armGroupLabels': ['Prolonged Exposure + sertraline (PE/SERT)', 'Sertraline + enhanced medication management (SERT/EMM)']}, {'name': 'Prolonged Exposure Therapy', 'type': 'BEHAVIORAL', 'description': 'up to 13 sessions of prolonged exposure', 'armGroupLabels': ['Prolonged Exposure + placebo (PE/PLB)', 'Prolonged Exposure + sertraline (PE/SERT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Veterans Affairs Ann Arbor Healthcare System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Sheila Rauch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Ann Arbor Healthcare System', 'class': 'FED'}, 'collaborators': [{'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Director of Wounded Warrior Project and Associate Professor at Emory University, Principal Investigator', 'investigatorFullName': 'Sheila Rauch', 'investigatorAffiliation': 'Atlanta VA Medical Center'}}}}