[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07351305":3,"trial-entities:NCT07351305":117,"trial-summary:NCT07351305":122},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":42,"secondary_outcomes":47,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":84,"eligibility_criteria":85,"std_ages":89,"locations":92,"central_contacts":107,"overall_officials":112,"references":115,"see_also_links":116},"NCT07351305","STUDY00001920","Non-Trauma Intervention to Treat PTSD for Veterans and Service Members Suffering From a TBI","Non-Trauma Intervention to Treat Posttraumatic Stress Disorder (PTSD) for Veterans and Service Members Suffering From a Traumatic Brain Injury (TBI)","RECRUITING","2027-08","2026-01","2026-08-28","2026-03-05","The University of Texas Health Science Center at San Antonio","OTHER",true,"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.","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.",[19,20,21],"PTSD","Post Traumatic Stress Disorder","Traumatic Brain Injury",[23,24,25],"Non-trauma intervention","Veterans","Service Members","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},30,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":40},"BEHAVIORAL","Non-Trauma Treatment for TBI and PTSD","The treatment includes 8 sessions with each session lasting approximately 45-75 minutes. Sessions will cover relaxation training, identifying stress, stress management, and problem solving.",[39],"Active duty service members and veterans seeking clinical care for TBI",[41],"T3 PTSD",[43],{"measure":44,"description":45,"timeFrame":46},"PTSD Checklist-DSM-5 (PCL-5)","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.","Baseline to 6 months post treatment (approximately 8 months)",[48,52,55,58,62,65,68,71,74,77],{"measure":49,"description":50,"timeFrame":51},"Credibility and Expectancy Questionnaire","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.","Baseline to 2 weeks post treatment (approximately 10 weeks)",{"measure":53,"description":54,"timeFrame":46},"Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders Version 5 (DSM-5)","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":56,"description":57,"timeFrame":46},"Generalized Anxiety Disorder-7 (GAD-7)","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":59,"description":60,"timeFrame":61},"Patient Global Impressions (PGI) Scale","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","2 weeks post treatment to 6 months post treatment",{"measure":63,"description":64,"timeFrame":46},"Alcohol Use Disorders Identification Test (AUDIT)","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":66,"description":67,"timeFrame":46},"Patient Health Questionnaire-9 (PHQ-9)","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":69,"description":70,"timeFrame":46},"Depressive Symptom Index-Suicide Subscale (DSI-SS)","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":72,"description":73,"timeFrame":46},"Insomnia Severity Index (ISI)","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":75,"description":76,"timeFrame":46},"Life Events Checklist-5 (LEC-5)","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":78,"description":79,"timeFrame":80},"Satisfaction with Therapy and Therapist Scale (STTS)","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.","2 weeks post treatment (approximately 10 weeks after the first treatment)","ALL","18 Years",null,false,{"inclusion":86,"exclusion":87,"raw_text":88},[],[],"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\u002Fbenefit based on interviewer assessment and clinical judgement.",[90,91],"ADULT","OLDER_ADULT",[93],{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":104},"Carl R Darnall Army Medical Center","Fort Hood","Texas","76544","United States",[100],{"name":101,"role":102,"phone":103},"Scot D Engel, PsyD","CONTACT","254-419-4703",{"lat":105,"lon":106},31.25483,-97.70913,[108],{"name":109,"role":102,"phone":110,"email":111},"Cindy McGeary, PhD","210-567-5497","mcgearyc@uthscsa.edu",[113],{"name":109,"affiliation":13,"role":114},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":118,"biomarkers":121},[119,120],"Post-Traumatic Stress Disorder","Traumatic Encephalopathy",[],{"nct_id":4,"found":15,"summary":123,"prompt_version":133},{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This study is an interventional study, meaning it tests a specific treatment. It aims to enroll 30 participants.","completed","Non-Trauma Treatment for PTSD and TBI in Veterans","This study is testing a new approach called \"Non-Trauma Treatment for TBI and PTSD\" for military veterans and service members who have both post-traumatic stress disorder (PTSD) and a mild or moderate traumatic brain injury (TBI). This treatment involves 8 individual counseling sessions, each lasting about an hour, focusing on relaxation, stress management, and problem-solving. Researchers want to see if this treatment helps reduce PTSD symptoms. You might be able to join if you are a veteran or active duty service member, at least 18 years old, and have been diagnosed with mild or moderate TBI. The study is currently unclear on its recruitment status and plans to enroll 30 participants.","Participants will be followed for approximately 6 months after completing treatment.",111,"You would attend 8 individual sessions, each lasting about 60 minutes. Your PTSD symptoms will be measured at the beginning of the study and again 6 months after treatment.","Not stated in the trial record.",[36],"v2"]