Non-Trauma Intervention to Treat PTSD for Veterans and Service Members Suffering From a TBI (T3 for PTSD)

The University of Texas System (UT)

Status: Enrolling

Conditions: Post Traumatic Stress Disorder; PTSD; mTBI - Mild Traumatic Brain Injury

Treatments: Behavioral: Non-Trauma Treatment for mTBI and PTSD

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07351305

STUDY00001920

HT94252411015 (Other Identifier)

Details and patient eligibility

About

The investigators want to test a treatment for posttraumatic stress disorder (PTSD) especially designed for military veterans and service members with mild traumatic brain injuries (TBI) and PTSD. The treatment will include individual psychotherapy sessions to manage PTSD.

Full description

The objective of this study is to test a non-trauma intervention for PTSD tailored to military veterans and service members with mTBI called Non-Trauma Treatment for TBI and comorbid PTSD (T3 PTSD).

Aim1:

Conduct a pilot study of the non-trauma intervention for comorbid mTBI 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 mTBI 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 with at least moderate severity (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. Participant is stable on medications at baseline assessment (i.e., no changes in medication prescriptions in the past 4 weeks).
5. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Active duty service members and veterans seeking clinical care for mTBI

Experimental group

Description:

Male and female active duty service members and veterans at least 18 years of age who are seeking clinical care for mild Traumatic Brain Injury (TBI) symptoms at the Intrepid Spirit Center located on Fort Hood who also have a co-occurring diagnosis of PTSD

Treatment:

Behavioral: Non-Trauma Treatment for mTBI and PTSD