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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Non-Trauma Treatment for TBI and PTSD

    Behavioral

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Active duty service members and veterans seeking clinical care for TBIExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

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

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.

Time frame
Baseline to 6 months post treatment (approximately 8 months)
3

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.

Time frame
Baseline to 6 months post treatment (approximately 8 months)
4

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

Time frame
2 weeks post treatment to 6 months post treatment

Other outcomes

Sponsors and contacts

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