Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07351305

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carl R Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

Location status: Recruiting

Location contact

Scot D Engel, PsyD

CONTACT

254-419-4703

About this study

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).

Aim1:

Conduct 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.

Aim2:

Establish the acceptability and feasibility of the non-trauma intervention in service members and veterans.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: T3 PTSD

Primary outcomes

  1. PTSD Checklist-DSM-5 (PCL-5)

    Time frame: Baseline to 6 months post treatment (approximately 8 months)

    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.

Secondary outcomes

  1. Credibility and Expectancy Questionnaire

    Time frame: Baseline to 2 weeks post treatment (approximately 10 weeks)

    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.

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

    Time frame: Baseline to 6 months post treatment (approximately 8 months)

    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.

  3. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline to 6 months post treatment (approximately 8 months)

    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.

  4. Patient Global Impressions (PGI) Scale

    Time frame: 2 weeks post treatment to 6 months post treatment

    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

  5. Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: Baseline to 6 months post treatment (approximately 8 months)

    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.

  6. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline to 6 months post treatment (approximately 8 months)

    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

  7. Depressive Symptom Index-Suicide Subscale (DSI-SS)

    Time frame: Baseline to 6 months post treatment (approximately 8 months)

    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.

  8. Insomnia Severity Index (ISI)

    Time frame: Baseline to 6 months post treatment (approximately 8 months)

    A 7 item scale scored from 0-4 for each item. Total scores range from 0-28 with a higher score indicating worse insomnia.

  9. Life Events Checklist-5 (LEC-5)

    Time frame: Baseline to 6 months post treatment (approximately 8 months)

    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.

  10. Satisfaction with Therapy and Therapist Scale (STTS)

    Time frame: 2 weeks post treatment (approximately 10 weeks after the first treatment)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cindy McGeary, PhD

CONTACT

[email protected]

210-567-5497

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Non-Trauma Intervention to Treat Posttraumatic Stress Disorder (PTSD) for Veterans and Service Members Suffering From a Traumatic Brain Injury (TBI)

Acronym: T3 for PTSD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.