Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-22 @ 1:17 PM
Study NCT ID:
NCT02956434
Status:
COMPLETED
Last Update Posted:
2021-12-08
First Post:
2016-11-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment
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': 'johanna.thompson-hollands@va.gov', 'phone': '857-364-2311', 'title': 'Dr. Johanna Thompson-Hollands', 'organization': 'VA Boston Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'description': 'No difference in definitions', 'eventGroups': [{'id': 'EG000', 'title': 'Brief Family Intervention - Veterans', 'description': "Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.\n\nTheir chosen family member will receive the BFI as an adjunctive treatment to the veteran's CPT/PE.", 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual-care CPT/PE - Veterans', 'description': 'Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.\n\nTheir chosen family member will NOT receive the BFI.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Brief Family Intervention - Family Members', 'description': "Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.\n\nBrief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.", 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'No Intervention - Family Members', 'description': 'Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Medication overdose', 'notes': 'Participant took more of their (non-study) psychiatric medication than was prescribed. No intervention was required.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10}, {'groupId': 'EG003', 'numAtRisk': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Participant was involuntarily hospitalized following an aggressive episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10}, {'groupId': 'EG003', 'numAtRisk': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinician-Administered PTSD Scale, 5th Edition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Family Intervention', 'description': "Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.\n\nBrief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."}, {'id': 'OG001', 'title': 'No Intervention', 'description': 'Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.60', 'spread': '10.98', 'groupId': 'OG000'}, {'value': '21.21', 'spread': '9.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only Veterans'}, {'type': 'PRIMARY', 'title': 'Treatment Attendance/Dropout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Family Intervention', 'description': "Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.\n\nBrief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."}, {'id': 'OG001', 'title': 'No Intervention', 'description': 'Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': "A measure of Veterans' treatment attendance or premature dropout. Data represents the Veterans who dropped out of their standard-care PTSD treatment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only veterans'}, {'type': 'SECONDARY', 'title': "Significant Others' Responses to Trauma Scale (SORTS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Family Intervention', 'description': "Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.\n\nBrief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."}, {'id': 'OG001', 'title': 'No Intervention', 'description': 'Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.82', 'spread': '11.16', 'groupId': 'OG000'}, {'value': '29.88', 'spread': '24.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'A measure of self-reported family accommodation of PTSD symptoms. Min value = 0, max value = 112. Higher scores mean worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only family members'}, {'type': 'SECONDARY', 'title': 'Revised Dyadic Adjustment Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Family Intervention', 'description': "Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.\n\nBrief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."}, {'id': 'OG001', 'title': 'No Intervention', 'description': 'Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.60', 'spread': '8.38', 'groupId': 'OG000'}, {'value': '51.00', 'spread': '7.681', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only family members'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brief Family Intervention - Veterans', 'description': "The family members of these veterans will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.\n\nBrief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."}, {'id': 'FG001', 'title': 'No Intervention - Veterans', 'description': 'The family members of these veterans will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.'}, {'id': 'FG002', 'title': 'Brief Family Intervention - Family Members', 'description': "Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.\n\nBrief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."}, {'id': 'FG003', 'title': 'No Intervention - Family Members', 'description': 'These family members will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Brief Family Intervention - Veterans', 'description': "Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.\n\nTheir chosen family member will receive the BFI as an adjunctive treatment to the veteran's CPT/PE."}, {'id': 'BG001', 'title': 'Usual-care CPT/PE - Veterans', 'description': 'Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.\n\nTheir chosen family member will NOT receive the BFI.'}, {'id': 'BG002', 'title': 'Brief Family Intervention - Family Members', 'description': "Family members will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.\n\nBrief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals."}, {'id': 'BG003', 'title': 'No Intervention - Family Members', 'description': 'Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '49.40', 'spread': '18.12', 'groupId': 'BG000'}, {'value': '38.70', 'spread': '10.02', 'groupId': 'BG001'}, {'value': '45.70', 'spread': '17.25', 'groupId': 'BG002'}, {'value': '38.30', 'spread': '11.44', 'groupId': 'BG003'}, {'value': '43.02', 'spread': '14.852', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CAPS-5', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '37.80', 'spread': '8.81', 'groupId': 'BG000'}, {'value': '42.40', 'spread': '8.81', 'groupId': 'BG001'}, {'value': '40.10', 'spread': '9.341', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Min value = 0, max value = 80. Higher scores mean worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only Veterans were administered the CAPS-5'}, {'title': 'SORTS', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '33.30', 'spread': '21.79', 'groupId': 'BG002'}, {'value': '45.40', 'spread': '27.24', 'groupId': 'BG003'}, {'value': '39.35', 'spread': '26.061', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Min value = 0, max value = 112. Higher scores mean worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only family members completed the SORTS'}], 'populationDescription': 'Individuals (Veterans or family members) assigned to each group. The arms are paired -- the two Brief Family Intervention groups are paired dyad members, and the Usual-care CPT/PE Veterans and the No Intervention Family Members are also paired dyad members.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-02', 'size': 320825, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-07T10:11', '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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2016-11-02', 'resultsFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2016-11-03', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-07', 'studyFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician-Administered PTSD Scale, 5th Edition', 'timeFrame': '16 weeks', 'description': 'A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome.'}, {'measure': 'Treatment Attendance/Dropout', 'timeFrame': '16 weeks', 'description': "A measure of Veterans' treatment attendance or premature dropout. Data represents the Veterans who dropped out of their standard-care PTSD treatment."}], 'secondaryOutcomes': [{'measure': "Significant Others' Responses to Trauma Scale (SORTS)", 'timeFrame': '16 weeks', 'description': 'A measure of self-reported family accommodation of PTSD symptoms. Min value = 0, max value = 112. Higher scores mean worse outcome.'}, {'measure': 'Revised Dyadic Adjustment Scale', 'timeFrame': '16 weeks', 'description': 'A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Posttraumatic Neuroses']}, 'descriptionModule': {'briefSummary': 'This study aims to test a brief family intervention (the BFI) to enhance individually-delivered PTSD treatment for Veterans.', 'detailedDescription': "The investigators will enroll pairs of Veterans and one adult family member who lives with them. Veterans will be beginning a course of PTSD-focused treatment at the Boston VA; Veterans' treatment will not be limited or changed by their participation in this study.\n\nFamily members will receive or not receive (depending on which Phase of the study they are recruited in) the BFI. The BFI consists of 2 sessions in which the family member meets one-on-one with a clinician to discuss PTSD, PTSD treatment, and how families can be most helpful to patients in treatment.\n\nVeterans and family members will also be interviewed about their opinions and experiences regarding family-inclusive treatment for PTSD. Clinicians will be recruited and enrolled to obtain their information and feedback (via qualitative interviews), and to deliver the intervention in Phase II."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans must have a diagnosis of PTSD and be beginning a course of Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT) at the Boston VA.\n* Must also have an eligible family member who is willing to participate.\n\nExclusion Criteria:\n\n* Current diagnosis of unstable bipolar disorder, substance dependence, past or present psychosis, or organic mental disorder\n* Clear and current suicidal risk\n* Current participation in family/couples therapy'}, 'identificationModule': {'nctId': 'NCT02956434', 'briefTitle': 'An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'An Adjunctive Family Intervention for Individual PTSD Treatment', 'orgStudyIdInfo': {'id': 'MHBB-013-16F'}, 'secondaryIdInfos': [{'id': 'IK2CX001589', 'link': 'https://reporter.nih.gov/quickSearch/IK2CX001589', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief family intervention', 'description': 'Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.', 'interventionNames': ['Behavioral: Brief Family Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.'}], 'interventions': [{'name': 'Brief Family Intervention', 'type': 'BEHAVIORAL', 'description': "Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.", 'armGroupLabels': ['Brief family intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02130', '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}}], 'overallOfficials': [{'name': 'Johanna Thompson-Hollands, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Entire study (baseline to 16 weeks)', 'ipdSharing': 'YES', 'description': 'Data may be released to other researchers as VA policy allows.', 'accessCriteria': 'As per VA policy and local IRB approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}