Recruiting

Psychotherapy

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07351305

Conditions

PTSD

Post Traumatic Stress Disorder

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Trauma Treatment for TBI and PTSD

Study Details

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

PTSD

Post Traumatic Stress Disorder

Traumatic Brain Injury

Study ID

NCT07351305

Start date

Mar 5, 2026

Status verified date

Jan, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Ability of participant to understand and the willingness to sign a written informed consent document based on interviewer assessment and clinical judgement.
2. 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
3. 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.
4. Ability to read, write, and speak English based on interviewer assessment and clinical judgement.

Exclusion Criteria:

1. Participant is actively engaged in a behavioral intervention primarily targeting PTSD.
2. 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.
3. Participant demonstrates significant cognitive impairment that could impact treatment adherence/benefit based on interviewer assessment and clinical judgement.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active duty service members and veterans seeking clinical care for TBI

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

Interventions

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.

Primary outcome measure

  • PTSD Checklist-DSM-5 (PCL-5) [ Time Frame: Baseline to 6 months post treatment (approximately 8 months) ]

Central Contacts and Locations

Central contacts

Locations

Carl R Darnall Army Medical Center

Recruiting

Fort Hood, Texas, United States, 76544

Contacts

Scot D Engel, PsyD

254-419-4703

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Aug 28, 2026

Last verified

Jan, 2026

Keywords

  • Non-trauma intervention
  • Veterans
  • Service Members

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-08-28.