Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 11:57 AM
Study NCT ID:
NCT07351305
Status:
RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Trauma Intervention to Treat PTSD for Veterans and Service Members Suffering From a TBI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014916', 'term': 'Whole-Body Irradiation'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study is a single group pilot test'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-01-09', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Checklist-DSM-5 (PCL-5)', 'timeFrame': 'Baseline to 6 months post treatment (approximately 8 months)', 'description': 'The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. The scoring involves summing the responses to 20 items (0 to 80) with higher scores indicating more severe PTSD.'}], 'secondaryOutcomes': [{'measure': 'Credibility and Expectancy Questionnaire', 'timeFrame': 'Baseline to 2 weeks post treatment (approximately 10 weeks)', 'description': 'A 6-item measure that was designed to assess treatment expectancy and rationale credibility for use in clinical outcomes studies. The measure is scored on an 8-point scale with higher scores indicating higher credibility and expectancy.'}, {'measure': 'Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders Version 5 (DSM-5)', 'timeFrame': 'Baseline to 6 months post treatment (approximately 8 months)', 'description': 'The CAPS-5 contains 20-items measuring PTSD symptoms, scored on a 5-point scale with scores ranging from 0-80. Higher scores indicate greater PTSD severity.'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Baseline to 6 months post treatment (approximately 8 months)', 'description': 'This 7-item measure asks participants to rate the frequency with which they have been bothered by anxiety symptoms within the past 2 weeks. Scores range from 0=not at all to 3=nearly every day, with totals from 0-21, with a higher score indicating greater anxiety.'}, {'measure': 'Patient Global Impressions (PGI) Scale', 'timeFrame': '2 weeks post treatment to 6 months post treatment', 'description': 'A 2-item survey where each item is scored out of 7. Total score is 0-14, where a lower score indicates less feeling of illness and greater improvement'}, {'measure': 'Alcohol Use Disorders Identification Test (AUDIT)', 'timeFrame': 'Baseline to 6 months post treatment (approximately 8 months)', 'description': 'A self report, 10-item survey with items scored from 0-4. Total scores range from 0-40, with a higher score indication greater alcohol consumption.'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Baseline to 6 months post treatment (approximately 8 months)', 'description': 'The PHQ-9 is a widely used and well-validated 9-item instrument for measuring the severity of depressive symptoms. Each item is scored from 0=not at all to 3=nearly every day giving a possible range of score from 0-27. A lower score indicates better health and well-being'}, {'measure': 'Depressive Symptom Index-Suicide Subscale (DSI-SS)', 'timeFrame': 'Baseline to 6 months post treatment (approximately 8 months)', 'description': 'This 4-item self-report measure of suicidal ideation has excellent internal consistency and concurrent validity. Items are scored 0-3, giving a total range of 0-12, with a higher score indicating more severe suicidal ideation.'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Baseline to 6 months post treatment (approximately 8 months)', 'description': 'A 7 item scale scored from 0-4 for each item. Total scores range from 0-28 with a higher score indicating worse insomnia.'}, {'measure': 'Life Events Checklist-5 (LEC-5)', 'timeFrame': 'Baseline to 6 months post treatment (approximately 8 months)', 'description': "The LEC-5 includes a list of 16 potentially traumatic life events commonly associated with PTSD symptoms, along with an additional item (17) that allows respondents to describe any other stressful events or experience. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3= learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). Total scores range from 6-102, with a higher score indicating less traumatic events."}, {'measure': 'Satisfaction with Therapy and Therapist Scale (STTS)', 'timeFrame': '2 weeks post treatment (approximately 10 weeks after the first treatment)', 'description': 'A 12-item self-report measure with strong psychometric properties used to assess the patient\'s satisfaction with the therapy provided and the therapist. Even number items assess satisfaction with therapy and odd number items assess satisfaction with therapist. Scores range between 5-60 with higher scores reflective of greater satisfaction. Items are on a 5-point Likert scale that ranges from 1 = "Strong disagree" to 5 = "Strongly Agree\'. Additionally, a 13th item provides an independent assessment of the patient\'s global improvement.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-trauma intervention', 'Veterans', 'Service Members'], 'conditions': ['PTSD', 'Post Traumatic Stress Disorder', 'Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The investigators want to test a treatment for posttraumatic stress disorder (PTSD) especially designed for military veterans and service members with mild or moderate traumatic brain injuries (TBI) and PTSD. The treatment will include individual psychotherapy sessions to manage PTSD.', 'detailedDescription': 'The objective of this study is to test a non-trauma intervention for PTSD tailored to military veterans and service members with TBI called Non-Trauma Treatment for TBI and comorbid PTSD (T3 PTSD).\n\nAim1:\n\nConduct a pilot study of the non-trauma intervention for comorbid TBI and PTSD in a sample of n = 20 veterans and service members seeking treatment at Fort Hood, Texas.\n\nAim2:\n\nEstablish the acceptability and feasibility of the non-trauma intervention in service members and veterans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability of participant to understand and the willingness to sign a written informed consent document based on interviewer assessment and clinical judgement.\n2. Any veteran or active duty service member (age 18 or above) diagnosed with mild or moderate TBI as determined by the Ohio State University Brain Injury Identification Method\n3. Participant meets diagnostic criteria for PTSD based on Clinician-Administered PTSD Scale (CAPS-5) interview as described by the National Center for PTSD which includes at least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms as well as meeting Criterions F and G.\n4. Ability to read, write, and speak English based on interviewer assessment and clinical judgement.\n\nExclusion Criteria:\n\n1. Participant is actively engaged in a behavioral intervention primarily targeting PTSD.\n2. Participant has a psychiatric problem that warrants immediate treatment as indicated in the electronic health record, flagged during testing, or confirmed by a clinician through screening or review of clinical notes.\n3. Participant demonstrates significant cognitive impairment that could impact treatment adherence/benefit based on interviewer assessment and clinical judgement.'}, 'identificationModule': {'nctId': 'NCT07351305', 'acronym': 'T3 for PTSD', 'briefTitle': 'Non-Trauma Intervention to Treat PTSD for Veterans and Service Members Suffering From a TBI', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Non-Trauma Intervention to Treat Posttraumatic Stress Disorder (PTSD) for Veterans and Service Members Suffering From a Traumatic Brain Injury (TBI)', 'orgStudyIdInfo': {'id': 'STUDY00001920'}, 'secondaryIdInfos': [{'id': 'HT94252411015', 'type': 'OTHER', 'domain': 'Department of Defense Traumatic Brain Injury and Psychological Health Research Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active duty service members and veterans seeking clinical care for TBI', 'description': 'Male and female active duty service members and veterans at least 18 years of age who are seeking clinical care for mild or moderate Traumatic Brain Injury (TBI) symptoms at the Intrepid Spirit Center located on Fort Hood who also have a co-occurring diagnosis of PTSD', 'interventionNames': ['Behavioral: Non-Trauma Treatment for TBI and PTSD']}], 'interventions': [{'name': 'Non-Trauma Treatment for TBI and PTSD', 'type': 'BEHAVIORAL', 'otherNames': ['T3 PTSD'], 'description': 'The treatment includes 8 sessions with each session lasting approximately 60 minutes. Sessions will cover relaxation training, identifying stress, stress management, and problem solving.', 'armGroupLabels': ['Active duty service members and veterans seeking clinical care for TBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76544', 'city': 'Fort Hood', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scot D Engel, PsyD', 'role': 'CONTACT', 'phone': '254-419-4703'}], 'facility': 'Carl R Darnall Army Medical Center', 'geoPoint': {'lat': 31.25483, 'lon': -97.70913}}], 'centralContacts': [{'name': 'Cindy McGeary, PhD', 'role': 'CONTACT', 'email': 'mcgearyc@uthscsa.edu', 'phone': '210-567-5497'}], 'overallOfficials': [{'name': 'Cindy McGeary, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Public data will be shared at the end of the study after the data is analyzed.', 'ipdSharing': 'YES', 'description': 'Individual Participant data may be shared with the research study team, the IRB, the Department of Defense representatives and state or Federal Government officials where required by law. Only deidentified data will be shared in a peer reviewed journal or in the summary results in ClinicalTrials.gov.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Cindy McGeary', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}