PTSDT3 for PTSDNCT07351305
Non-Trauma Intervention to Treat PTSD for Veterans and Service Members Suffering From a TBI
A study testing Non-Trauma Treatment for TBI and PTSD in people with PTSD and Post Traumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder, Traumatic Brain Injury
- What is being tested?
- Non-Trauma Treatment for TBI and PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Carl R Darnall Army Medical Center
Fort Hood, Texas, 76544
Scot D Engel, PsyD, 254-419-4703
About this study
Official title: Non-Trauma Intervention to Treat Posttraumatic Stress Disorder (PTSD) for Veterans and Service Members Suffering From a Traumatic Brain Injury (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.
Read the detailed description
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.
- Conditions
- PTSD, Post Traumatic Stress Disorder, Traumatic Brain Injury
- Being tested
- Non-Trauma Treatment for TBI and PTSD
- Keywords
- Non-trauma intervention, Veterans, Service Members
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Trauma Treatment for TBI and PTSDBehavioural
Also called T3 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Non-Trauma Treatment for TBI and PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months post treatment (approximately 8 months)
Secondary outcomes (10)
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.
Measured: 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)
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.
Measured: Baseline to 6 months post treatment (approximately 8 months)
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.
Measured: Baseline to 6 months post treatment (approximately 8 months)
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
Measured: 2 weeks post treatment to 6 months post treatment
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.
Measured: Baseline to 6 months post treatment (approximately 8 months)
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
Measured: Baseline to 6 months post treatment (approximately 8 months)
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.
Measured: Baseline to 6 months post treatment (approximately 8 months)
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.
Measured: Baseline to 6 months post treatment (approximately 8 months)
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.
Measured: Baseline to 6 months post treatment (approximately 8 months)
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.
Measured: 2 weeks post treatment (approximately 10 weeks after the first treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start5 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single group pilot test
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Cindy McGeary, The University of Texas Health Science Center at San Antonio
- Investigators
- Cindy McGeary, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351305
- Sponsor's protocol ID
- STUDY00001920
- Other IDs
- HT94252411015
- Acronym
- T3 for PTSD
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Trauma Intervention to Treat Posttraumatic Stress Disorder (PTSD) for Veterans and Service Members Suffering From a Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT07351305
- Acronym / sponsor ID
- T3 for PTSD / STUDY00001920
- Conditions
- PTSD, Post Traumatic Stress Disorder, Traumatic Brain Injury
- Keywords
- Non-trauma intervention, Veterans, Service Members
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single group pilot test
| Arm | Type | Receives |
|---|---|---|
| Active duty service members and veterans seeking clinical care for TBI | Experimental | Behavioral: Non-Trauma Treatment for TBI and PTSDMale 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Trauma Treatment for TBI and PTSDAlso: T3 PTSDThe treatment includes 8 sessions with each session lasting approximately 45-75 minutes. Sessions will cover relaxation training, identifying stress, stress management, and problem solving. | Behavioural | Active duty service members and veterans seeking clinical care for TBI |
Primary outcome
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.
10 secondary outcomes
Credibility and Expectancy Questionnaire
Time frame: 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)
Time frame: Baseline to 6 months post treatment (approximately 8 months)
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline to 6 months post treatment (approximately 8 months)
Patient Global Impressions (PGI) Scale
Time frame: 2 weeks post treatment to 6 months post treatment
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Baseline to 6 months post treatment (approximately 8 months)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline to 6 months post treatment (approximately 8 months)
Depressive Symptom Index-Suicide Subscale (DSI-SS)
Time frame: Baseline to 6 months post treatment (approximately 8 months)
Insomnia Severity Index (ISI)
Time frame: Baseline to 6 months post treatment (approximately 8 months)
Life Events Checklist-5 (LEC-5)
Time frame: Baseline to 6 months post treatment (approximately 8 months)
Satisfaction with Therapy and Therapist Scale (STTS)
Time frame: 2 weeks post treatment (approximately 10 weeks after the first treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cindy McGeary, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Trauma Treatment for TBI and PTSD in people with PTSD and Post Traumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cindy McGeary, PhD (210-567-5497, mcgearyc@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist-DSM-5 (PCL-5) (time frame: Baseline to 6 months post treatment (approximately 8 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.