Training Program for Mild Brain Injuries in Veterans
Mild TBI Assessment & Rehabilitation
Recruiting
N/AInterventional Study
Brain Injuries, Traumatic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
65 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for veterans with mild brain injuries and some ongoing problems caused by them. Participants will take part in training activities designed to improve daily living and cognitive functions.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I have a history of mild brain injury
I am more than 6 months past my last injury
I have ongoing memory or thinking difficulties that affect my daily life
I am willing to take part in training and assessments
I am stable on any psychoactive medications for at least 30 days
You may not be able to join if
I have a history of moderate or severe brain injury
I have unstable medical, neurological, or psychiatric conditions
I abuse drugs or alcohol
I have psychosis
I have severe depression, anxiety, or PTSD that prevents me from participating
I do not understand English well
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for …
One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive/behavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.
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Eligibility Criteria
Inclusion Criteria:
For TBI-positive veteran participants, to be randomized to either GOALS or TAU:
* Ages 18+
* A history of mild TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument)
* Chronic, stable phase of recovery (\>6 months from last…
Inclusion Criteria:
For TBI-positive veteran participants, to be randomized to either GOALS or TAU:
* Ages 18+
* A history of mild TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument)
* Chronic, stable phase of recovery (\>6 months from last post-concussive event)
* Report of residual cognitive difficulties (1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI)) that interfere(s) with daily function
* Able and willing to commit to participate in training and assessments
* If on psychoactive medications, must be stable on medications (\> 30 days)
For the TBI-negative healthy veteran control group:
* Ages 18+
* No history of any (mild to severe) TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument)
* Able and willing to commit to participate in assessments
* If on psychoactive medications, must be stable on medications (\> 30 days)
Exclusion Criteria:
For the TBI-positive veteran participants, to be randomized to either GOALS or TAU:
* A history of moderate or severe TBI
* Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g., contraindications to MRI)
* Ongoing illicit drug or alcohol abuse (AUDIT\>8)
* Psychosis
* Severe depression, anxiety or PTSD that precludes participation in research activities
* Poor English comprehension
* Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD
* There will be no restriction in regard to gender, race and socioeconomic status
For the TBI-negative healthy veteran control group:
* A history of any mild, moderate, or severe TBI
* Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g. contraindications to MRI)
* Ongoing illicit drug or alcohol abuse (AUDIT\>8)
* Psychosis
* Severe depression, anxiety or PTSD that precludes participation in research activities
* Poor English comprehension
* Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD.
* There will be no restriction in regard to gender, race and socioeconomic status
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