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Recruiting NCT07351305

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

No phase Interventional PTSD Post Traumatic Stress Disorder Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Trauma Treatment for TBI and PTSD.
Who it may be relevant to
Registry conditions: PTSD, Post Traumatic Stress Disorder, Traumatic Brain Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Non-Trauma Treatment for TBI and PTSD
    The treatment includes 8 sessions with each session lasting approximately 60 minutes. Sessions will cover relaxation training, identifying stress, stress management, and problem solving.

Primary outcome measures

  • PTSD Checklist-DSM-5 (PCL-5) [Time frame: Baseline to 6 months post treatment (approximately 8 months)]
Secondary outcome measures (10)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Carl R Darnall Army Medical Center — Fort Hood

Identifiers

NCT: NCT07351305 · STUDY00001920 · HT94252411015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗