30 Participants Needed

Psychotherapy for PTSD and Traumatic Brain Injury

(T3 for PTSD Trial)

CM
Overseen ByCindy McGeary, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special therapy designed to help military veterans and active service members with PTSD (posttraumatic stress disorder) and mild traumatic brain injuries (mTBI). The treatment involves individual therapy sessions focused on managing PTSD symptoms. It suits those diagnosed with mTBI, experiencing PTSD symptoms, and who haven't recently changed medications. The trial aims to improve mental health and quality of life for those affected. As an unphased trial, it offers participants a unique opportunity to contribute to valuable research that could enhance treatment options for PTSD and mTBI.

Will I have to stop taking my current medications?

The trial requires that participants be stable on their medications, meaning you should not have any changes in your medication prescriptions in the 4 weeks before starting the trial.

What prior data suggests that this psychotherapy treatment is safe for military veterans and service members with mTBI and PTSD?

Research has shown that individual talk therapy for PTSD in people with mild traumatic brain injury (mTBI) can be safe and helpful. Participants, regardless of a history of TBI, demonstrated significant improvements in PTSD and depression symptoms during therapy. This indicates that talk therapy is well-tolerated and effective for these conditions.

Although specific safety data for this exact treatment is lacking, the focus on non-invasive talk therapy is promising. Talk therapy typically avoids the physical side effects that medications might cause. However, individuals may still experience some emotional discomfort as they work through their experiences. Overall, this type of therapy is generally considered safe for treating PTSD and mTBI.12345

Why are researchers excited about this trial?

Researchers are excited about this treatment because it takes a novel approach to addressing mild Traumatic Brain Injury (mTBI) and PTSD. Unlike traditional treatments that often focus on trauma-specific therapies or medications, this non-trauma-focused psychotherapy provides an alternative by potentially offering relief without revisiting traumatic events. This approach could be especially appealing for patients who find trauma-focused therapy daunting or emotionally taxing. Additionally, the treatment is specifically tailored for active duty service members and veterans, addressing their unique needs and experiences, which makes it a promising option for this specific population.

What evidence suggests that this treatment might be an effective treatment for PTSD and TBI?

Research has shown that therapy can effectively reduce PTSD symptoms, even for people with mild traumatic brain injury (mTBI). Studies have found that therapy helps manage PTSD symptoms, regardless of a history of mTBI. Early results suggest that people with mTBI can still benefit from PTSD treatments. Participating in cognitive rehabilitation, a component of therapy, may improve emotional control and daily life skills. Overall, this treatment offers hope for those dealing with both PTSD and mTBI.36789

Who Is on the Research Team?

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Cindy McGeary, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for military veterans and service members who have mild traumatic brain injuries (TBI) along with PTSD. Specific eligibility criteria are not provided, but typically participants would need to meet diagnostic criteria for both conditions.

Inclusion Criteria

My medications have not changed in the last 4 weeks.
Ability to read, write, and speak English based on interviewer assessment and clinical judgement
I understand the study and agree to participate.
See 2 more

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
I have been assessed to have significant cognitive issues affecting my treatment adherence.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive individual psychotherapy sessions to manage PTSD

8 weeks
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Non-Trauma Treatment for mTBI and PTSD

Trial Overview

The study is testing a specialized psychotherapy treatment tailored for individuals with both mild TBI and PTSD. The therapy involves individual sessions aimed at managing the symptoms of PTSD in this specific population.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Active duty service members and veterans seeking clinical care for mTBIExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

Non-Trauma Intervention to Treat PTSD for Veterans and ...

The objective of this study is to test a non-trauma intervention for PTSD tailored to military veterans and service members with mTBI called ...

Effectiveness of Psychotherapy for Post-Traumatic Stress ...

Results: Both psychotherapies were equally effective in reducing PTSD symptoms, regardless of TBI status. The early initiation of treatment ...

Research Review on PTSD and TBI

Engaging in cognitive rehabilitation may also have a positive impact on other outcomes including emotional regulation and functional performance ...

Mild traumatic brain injury characteristics do not negatively ...

However, research suggests that those with a history of mTBI can benefit from evidence-based PTSD treatment. To extend these findings, we examined whether ...

Outcomes in Patients With Mild Traumatic Brain Injury ...

This study found that most participants with a GCS score of 15 and negative head CT scan reported incomplete recovery at 2 weeks and 6 months after their ...

The Influence of Traumatic Brain Injury on Treatment ...

Participants with and without TBI history demonstrated significant improvements in PTSD and depression symptoms during the course of treatment. However, ...

Research Review on Mild Traumatic Brain Injury and Post- ...

The purpose of this research review is to provide an overview of the topic of comorbid mild traumatic brain injury and posttraumatic stress ...

Genetic vulnerability and adverse mental health outcomes ...

A prospective cohort study of civilians who sustained traumatic injuries found that individuals with mTBI were more likely to develop PTSD, with an odds ratio ...

NCT03796936 | 3MDR to Treat PTSD With mTBI (3MDR)

There is no proven treatment for mTBI, and standard treatments for PTSD frequently achieve only transient, modest impact. Motion-assisted, Multi-modular Memory ...