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Compares treatment options for Mild Traumatic Brain Injury
Official title Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury
ClinicalTrials.gov ID: NCT07436754
What this study is testing
- What it's testing
- The purpose of the study is to test two different training programs to find out which is better at helping people with a concussion or mild TBI (mTBI) improve their emotional health and well-being. Study participation is completely remote and will last approximately 8 months total, involving 4 assessment visits and 8 sessions of brain training via a secure video-conferencing platform.
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
- Mild TBI
- ≥18 years old
- ≥6 months post-TBI
- Elevated alexithymia and emotion dysregulation
- Capacity to consent
You likely can't join if
- Premorbid neurological disorder other than TBI
- Degenerative neurologic condition
- Active or uncontrolled major psychiatric disorder
- Conditions that pose safety concern to self or others, such as suicide risk
- Previous psychiatric hospitalization
- Visual, hearing, communication, or cognitive impairments that would impede participation
See the full eligibility criteria
- Mild TBI
- ≥18 years old
- ≥6 months post-TBI
- Elevated alexithymia and emotion dysregulation
- Capacity to consent
- Speaks and understands English
- Personal device capable of video conferencing and internet
- Premorbid neurological disorder other than TBI
- Degenerative neurologic condition
- Active or uncontrolled major psychiatric disorder
- Conditions that pose safety concern to self or others, such as suicide risk
- Previous psychiatric hospitalization
- Visual, hearing, communication, or cognitive impairments that would impede participation
- Unstable medications (e.g., started \< 6 weeks prior to enrollment) or anticipated medication changes that will influence mood/ affect during study participation
- Active involvement in an intensive rehabilitation program
- Individuals who recently started psychotherapy and/or mental health counseling (e.g., \<3 months prior)
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Bethesda, Maryland, United States
- Edison, New Jersey, 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 Indianapolis, Indiana, United States; Bethesda, Maryland, United States; Edison, New Jersey, 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.