Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT03033602
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2016-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brief Treatment for Posttraumatic Stress Disorder
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708228', 'term': '2-cyclohexylidenhydrazo-4-phenyl-thiazole'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dsloan@bu.edu', 'phone': '857-364-6333', 'title': 'Dr. Denise Sloan, Professor of Psychiatry', 'organization': 'VA Boston Healthcare System & Boston University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Participants who dropped out prematurely of treatment were less likely to return for subsequent assessments.'}}, 'adverseEventsModule': {'timeFrame': '6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Written Exposure Therapy', 'description': '5 sessions of imaginal exposure therapy.\n\nwritten exposure therapy: five sessions of writing about traumatic experience.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 6, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'CPT, Cognitive Only', 'description': '12 sessions of cognitive therapy.\n\nCPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 7, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'increase in anxiety symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'psychiatric hospitalization', 'notes': 'admitted to psychiatric unit due to suicidality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinician Administered PTSD Scale, 5 (CAPS-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Written Exposure Therapy', 'description': '5 sessions of imaginal exposure therapy.\n\nwritten exposure therapy: five sessions of writing about traumatic experience.'}, {'id': 'OG001', 'title': 'CPT, Cognitive Only', 'description': '12 sessions of cognitive therapy.\n\nCPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.'}], 'classes': [{'title': '10-week assessment', 'categories': [{'measurements': [{'value': '31.55', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '25.12', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': '20 week assessment', 'categories': [{'measurements': [{'value': '29.59', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '25.41', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': '30 week assessment', 'categories': [{'measurements': [{'value': '27.77', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '24.97', 'spread': '1.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 10-, 20-, 30-weeks post first treatment session', 'description': 'The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-inferiority margin'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Written Exposure Therapy', 'description': '5 sessions of imaginal exposure therapy.\n\nwritten exposure therapy: five sessions of writing about traumatic experience.'}, {'id': 'FG001', 'title': 'CPT, Cognitive Only', 'description': '12 sessions of cognitive therapy.\n\nCPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'comment': 'completed treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'discontinued for medical reason or decision by study team', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Written Exposure Therapy', 'description': '5 sessions of imaginal exposure therapy.\n\nwritten exposure therapy: five sessions of writing about traumatic experience.'}, {'id': 'BG001', 'title': 'CPT, Cognitive Only', 'description': '12 sessions of cognitive therapy.\n\nCPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.98', 'spread': '6.86', 'groupId': 'BG000'}, {'value': '33.32', 'spread': '8.22', 'groupId': 'BG001'}, {'value': '33.65', 'spread': '8.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '136', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', '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': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-26', 'size': 261200, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-03T11:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2016-12-02', 'resultsFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-22', 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Administered PTSD Scale, 5 (CAPS-5)', 'timeFrame': 'Change from baseline to 10-, 20-, 30-weeks post first treatment session', 'description': 'The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PTSD']}, 'referencesModule': {'references': [{'pmid': '35015065', 'type': 'BACKGROUND', 'citation': 'Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Straud CL, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911.'}, {'pmid': '31890987', 'type': 'BACKGROUND', 'citation': 'Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial. Contemp Clin Trials Commun. 2019 Dec 10;17:100507. doi: 10.1016/j.conctc.2019.100507. eCollection 2020 Mar.'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to examine whether a brief treatment approach for PTSD is equally efficacious in the treatment of active duty service members relative to a first line treatment approach that requires much greater treatment dose.', 'detailedDescription': 'The goal of this randomized clinical trial is to investigate if a brief, written intervention for posttraumatic stress disorder (PTSD), Written Exposure Therapy (WET), is non-inferior compared to an evidenced-based behavioral therapy, Cognitive Processing Therapy-Cognition only (CPT-C), in the treatment of PTSD in active duty military men and women with a diagnosis of PTSD who have deployed in support of a post-9/11. The primary study outcome is change in symptom severity as assessed by the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 edition (CAPS-5). Independent assessors evaluated participants using the CAPS-5 at baseline, 10-, 20-, and 30-week after the first treatment session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female active duty military personnel who have deployed in support of a post-9/11 conflict seeking treatment for PTSD\n* Diagnosis of PTSD\n* Ability to speak, read and write English\n* Not currently engaged in psychosocial treatment for PTSD\n* Individuals taking psychotropic medications agree to work with their prescriber to remain on stable doses of any prescribed psychotropic medications for the duration of the intervention and through the first follow-up assessment as much as possible and as medically indicated.\n\nExclusion Criteria:\n\n* Current suicide or homicide risk meriting crisis intervention\n* Active psychosis\n* Moderate to severe brain damage'}, 'identificationModule': {'nctId': 'NCT03033602', 'briefTitle': 'Brief Treatment for Posttraumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Boston VA Research Institute, Inc.'}, 'officialTitle': 'Brief Treatment for PTSD: Enhancing Retention and Engagement', 'orgStudyIdInfo': {'id': 'W81WH-15-1-0391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Written exposure therapy', 'description': '5 sessions of imaginal exposure therapy.', 'interventionNames': ['Behavioral: written exposure therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CPT, cognitive only', 'description': '12 sessions of cognitive therapy.', 'interventionNames': ['Behavioral: CPT, cognitive only']}], 'interventions': [{'name': 'written exposure therapy', 'type': 'BEHAVIORAL', 'otherNames': ['WET'], 'description': 'five sessions of writing about traumatic experience.', 'armGroupLabels': ['Written exposure therapy']}, {'name': 'CPT, cognitive only', 'type': 'BEHAVIORAL', 'otherNames': ['CPT-C'], 'description': '12 sessions of cognitive therapy related to traumatic experience.', 'armGroupLabels': ['CPT, cognitive only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Killeen', 'state': 'Texas', 'country': 'United States', 'facility': 'Ft. Hood', 'geoPoint': {'lat': 31.11712, 'lon': -97.7278}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center, San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Denise Sloan, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston VA Research Institute, Inc.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '12 months after publication of the primary outcomes.', 'ipdSharing': 'YES', 'description': 'Data will be made available upon written request to the PI.', 'accessCriteria': 'Written request to the PI describing rationale for why data is needed and what will be done with data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston VA Research Institute, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Texas', 'class': 'OTHER'}, {'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}