BridgeMD
New treatment option for Brain Injuries, Traumatic
Official title Mild TBI Assessment & Rehabilitation
ClinicalTrials.gov ID: NCT02920788
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For TBI-positive veteran participants, to be assigned by chance 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...
You likely can't join if
- For the TBI-positive veteran participants, to be assigned by chance 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...
- Ongoing illicit drug or alcohol abuse (AUDIT\>8)
- Psychosis
- Severe depression, anxiety or PTSD that precludes participation in research activities
See the full eligibility criteria
- For TBI-positive veteran participants, to be assigned by chance 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)
- For the TBI-positive veteran participants, to be assigned by chance 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.