Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-29 @ 5:35 PM
Study NCT ID:
NCT03962504
Status:
COMPLETED
Last Update Posted:
2024-07-18
First Post:
2019-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial
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': 'denise.sloan@va.gov', 'phone': '857-364-6333', 'title': 'Dr. Denise Sloan', 'organization': 'National Center for PTSD at VA Boston Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study focused on veteran participants and thus findings may not generalize to the general population. The study also primarily took place during COVID-19 global pandemic, including the height of the initial lockdown, which was a period of increased stress and anxiety.'}}, 'adverseEventsModule': {'timeFrame': '30 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Written Exposure Therapy', 'description': 'The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.\n\ntrauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 6, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Prolonged Exposure', 'description': 'Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures\n\ntrauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 5, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'contracted COVID-19', 'notes': 'physical symptoms from contracting COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'medical hospitalization', 'notes': 'hospitalization due to medical surgery unrelated to study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'medical hospitalization', 'notes': 'hospitalized due to severe dehydration due to vomiting during flu.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'psychiatric hospitalization', 'notes': 'increased suicidal risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Written Exposure Therapy', 'description': 'The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.\n\ntrauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.'}, {'id': 'OG001', 'title': 'Prolonged Exposure', 'description': 'Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures\n\ntrauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.17', 'groupId': 'OG000', 'lowerLimit': '23.88', 'upperLimit': '28.46'}, {'value': '24.78', 'groupId': 'OG001', 'lowerLimit': '22.29', 'upperLimit': '27.27'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change score baseline to 20 weeks', 'description': 'The CAPS-5 is a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. Psychometric properties indicate high criterion and construct validity and high agreement with a self-report measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to administer.\n\nScores can range from 0-80, with higher scores indicating greater severity.', 'unitOfMeasure': 'CAPS-5 total score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'World Health Organization Quality of Life BREF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Written Exposure Therapy', 'description': 'The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.\n\ntrauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.'}, {'id': 'OG001', 'title': 'Prolonged Exposure', 'description': 'Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures\n\ntrauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.21', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change score baseline to 20 weeks', 'description': 'The World Health Organization Quality of Life BREF (WHOQOL-BREF; WHO, 1998) instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that is more convenient for use in large research studies or clinical trials. This measure requires 5-10 minutes to complete.\n\nTotal score 0-100, with higher scores indicate greater quality of life.', 'unitOfMeasure': 'change score; score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The sample size is substantially less than the number randomized because the self-report measure was mailed to the study team due to COVID-19 pandemic and response rate for self-report measures was much lower than clinician-administered interviews (i.e., CAPS-5). Accordingly, the planned analysis is not conducted as it is underpowered.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Written Exposure Therapy', 'description': 'The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.\n\ntrauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.'}, {'id': 'FG001', 'title': 'Prolonged Exposure', 'description': 'Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures\n\ntrauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '32'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Written Exposure Therapy', 'description': 'The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.\n\ntrauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.'}, {'id': 'BG001', 'title': 'Prolonged Exposure', 'description': 'Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures\n\ntrauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.17', 'spread': '13.33', 'groupId': 'BG000'}, {'value': '43.79', 'spread': '13.96', 'groupId': 'BG001'}, {'value': '44.97', 'spread': '13.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', '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': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-28', 'size': 432493, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-12T12:54', 'hasProtocol': True}, {'date': '2021-10-18', 'size': 257554, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-01-06T16:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors will be unaware of participant conditions. Assessors will not have access to any study materials in which unmasking could occur. Participants will be instructed to not reveal their treatment condition to the assessors.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a non-inferiority design to examine if a brief intervention for PTSD is non-inferior to a more time-intensive intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2019-05-22', 'resultsFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-16', 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5)', 'timeFrame': 'change score baseline to 20 weeks', 'description': 'The CAPS-5 is a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. Psychometric properties indicate high criterion and construct validity and high agreement with a self-report measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to administer.\n\nScores can range from 0-80, with higher scores indicating greater severity.'}], 'secondaryOutcomes': [{'measure': 'World Health Organization Quality of Life BREF', 'timeFrame': 'change score baseline to 20 weeks', 'description': 'The World Health Organization Quality of Life BREF (WHOQOL-BREF; WHO, 1998) instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that is more convenient for use in large research studies or clinical trials. This measure requires 5-10 minutes to complete.\n\nTotal score 0-100, with higher scores indicate greater quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD', 'psychosocial treatment', 'cognitive behavioral treatment', 'veterans', 'quality of life'], 'conditions': ['PTSD']}, 'referencesModule': {'references': [{'pmid': '37610727', 'type': 'DERIVED', 'citation': 'Sloan DM, Marx BP, Acierno R, Messina M, Muzzy W, Gallagher MW, Litwack S, Sloan C. Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Nov 1;80(11):1093-1100. doi: 10.1001/jamapsychiatry.2023.2810.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to examine whether a brief, exposure-based treatment (Written Exposure Therapy) approach is just as effective in the treatment of posttraumatic stress disorder (PTSD) compared with a more commonly used time-intensive approach called Prolonged Exposure. One hundred and fifty Veterans diagnosed with PTSD will be randomly assigned to either Written Exposure therapy or Prolonged Exposure. Veteran participants will be assessed at pre-treatment, and 10-, 20-, and 30- weeks post first treatment session. Primary outcome measure will be PTSD symptom severity. The secondary outcome measure will be quality of life. In addition, treatment dropout during the first five sessions will be examined. WET is expected to have a lower treatment dropout rate relative to PE.', 'detailedDescription': 'Although Written Exposure Therapy (WET) is listed in the upcoming VA/DoD PTSD Practice Guidelines as an evidence-based, recommended PTSD treatment, there are limited data supporting the use of WET with Veterans suffering from PTSD. Additional research is needed to support the use of WET for the treatment of Veterans diagnosed with PTSD. The goal of this study is to investigate whether WET is non-inferior in the treatment of PTSD in a sample of Veterans diagnosed with PTSD. Men and women Veterans diagnosed with PTSD will be randomly assigned to either WET (n = 88) or Prolonged Exposure (PE; n = 90). PTSD symptom severity will serve as the primary outcome. Quality of life will serve as a secondary outcome measure. Assessments will be conducted by independent evaluators at baseline, 10-, 20-, and 20-week post first treatment session. WET is expected to be non-inferior to PE in reducing PTSD symptom severity and functioning. In addition, WET is expected to have significantly lower treatment dropout rate relative to the first five sessions of PE (i.e., better treatment engagement). If WET is found to be non-inferior to the more time intensive PE treatment then the VA will have evidence to support the use of a brief PTSD treatment, which will assist in addressing the high demand for PTSD clinical services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veteran status\n* Current DSM-5 diagnosis of PTSD (assessed with the Clinician Administered PTSD Scale for DSM-5; CAPS-5)\n* If taking psychotropic medication, on a stable dose for at least 30 days prior to study entry\n\nExclusion Criteria:\n\n* Current engagement psychosocial treatment for PTSD\n* Current diagnosis of substance dependence\n\n * abuse will not be excluded; determined with severe combined immunodeficiency (SCID)\n* Current psychosis or unstable bipolar disorder diagnosis\n\n * determined with the Mini International Neuropsychiatric Interview (MINI)clinician-administered interview\n* High suicidal risk\n\n * i.e., intent with a plan; assessed with the MINI suicide module\n* Significant cognitive impairment (assessed with the Montreal Cognitive Assessment \\[MoCA\\] and clinical judgment)'}, 'identificationModule': {'nctId': 'NCT03962504', 'briefTitle': 'Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'An Efficient, Exposure-based Treatment for PTSD Compared to Prolonged Exposure: A Non-inferiority Randomized Trial', 'orgStudyIdInfo': {'id': 'MHBB-005-18F'}, 'secondaryIdInfos': [{'id': 'CX001967-01', 'type': 'OTHER_GRANT', 'domain': 'Department of Veterans Affairs'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'written exposure therapy', 'description': 'The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.', 'interventionNames': ['Behavioral: trauma-focused treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prolonged Exposure', 'description': 'Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures', 'interventionNames': ['Behavioral: trauma-focused treatment']}], 'interventions': [{'name': 'trauma-focused treatment', 'type': 'BEHAVIORAL', 'description': 'cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.', 'armGroupLabels': ['Prolonged Exposure', 'written exposure therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02130-4817', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '29401-5799', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H. Johnson VA Medical Center, Charleston, SC', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'William S. Middleton Memorial Veterans Hospital, Madison, WI', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Denise M Sloan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'one year', 'ipdSharing': 'YES', 'description': 'Datasets meeting VA standards for disclosure to the public will be made available within 1 year after publication. Prior to distribution, a local privacy officer will certify that all datasets contains no protected health information (PHI). Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by Office of Research and Development (ORD). Those requesting data will be asked to sign a Letter of Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}