Non-Trauma Intervention to Treat PTSD for Veterans and Service Members Suffering From a TBI

NCT07351305 | Recruiting DMC

• 2 other identifiers: STUDY00001920HT94252411015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; PTSD; Post Traumatic Stress Disorder

Keywords

Non-trauma intervention; Veterans; Service Members

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (10)

• Credibility and Expectancy Questionnaire

  Baseline to 2 weeks post treatment (approximately 10 weeks)

• Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders Version 5 (DSM-5)

  Baseline to 6 months post treatment (approximately 8 months)

• Generalized Anxiety Disorder-7 (GAD-7)

  Baseline to 6 months post treatment (approximately 8 months)

• Patient Global Impressions (PGI) Scale

  2 weeks post treatment to 6 months post treatment

• Alcohol Use Disorders Identification Test (AUDIT)

  Baseline to 6 months post treatment (approximately 8 months)

Study Arms (1)

Active duty service members and veterans seeking clinical care for TBI

EXPERIMENTAL

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

Behavioral: Non-Trauma Treatment for TBI and PTSD

Interventions

Non-Trauma Treatment for TBI and PTSD BEHAVIORAL

The treatment includes 8 sessions with each session lasting approximately 60 minutes. Sessions will cover relaxation training, identifying stress, stress management, and problem solving.

Also known as: T3 PTSD

Active duty service members and veterans seeking clinical care for TBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability of participant to understand and the willingness to sign a written informed consent document based on interviewer assessment and clinical judgement.
• 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
• 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.
• Ability to read, write, and speak English based on interviewer assessment and clinical judgement.

You may not qualify if:

• Participant is actively engaged in a behavioral intervention primarily targeting PTSD.
• 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.
• Participant demonstrates significant cognitive impairment that could impact treatment adherence/benefit based on interviewer assessment and clinical judgement.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• United States Department of Defense: collaborator

Study Sites (1)

Carl R Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Interventions

Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Investigative Techniques

Study Officials

• Cindy McGeary, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy McGeary, PhD

CONTACT

210-567-5497; mcgearyc@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a single group pilot test

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 20, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Public data will be shared at the end of the study after the data is analyzed.

Locations

US (1)