Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Two online brain-training programs to help emotional health after mild TBI

Official title: Clinical Trial to Evaluate the Efficacy of Building Emotional Self-awareness Teletherapy (BEST) at Improving Psychological Health in Service Members With Brain Injury

Run by Hackensack Meridian Health · NCT07436754 · Data updated 2026-11-12

This study tests two remote brain-training programs to see which better improves emotional health in adults with mild traumatic brain injury and alexithymia.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorHackensack Meridian Health
Academic / other
Locations3 sites (Indianapolis, Indiana and 2 other locations)
StatusRecruiting
StartedMay 20, 2026
Main results expectedMarch 2031
Study endsMarch 2031
Registry record updatedJune 12, 2026
Trial IDNCT07436754 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years or older with mild TBI or concussion, at least 6 months post-injury, showing elevated alexithymia and emotion dysregulation, and able to participate in English via video conferencing.

Probably not a fit

Participants without elevated alexithymia or emotion dysregulation, or those with unstable psychiatric conditions or ongoing intensive rehab, may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares two teletherapy brain-training programs delivered via secure video conferencing for individuals with concussion or mild TBI and emotional dysregulation. Participants engage in 8 one-on-one sessions over about a month and complete four remote assessments to monitor emotional health over roughly eight months. The study follows a neutral, longitudinal design, with evaluations before, immediately after, and at 3- and 6-months post-training. It is sponsored by Hackensack Meridian Health with DoD collaboration and includes multiple sites in Indiana, Maryland, and New Jersey.

Why it matters

Potential benefit: If successful, one program may provide a more effective remote approach to improving emotional well-being after mild TBI.

How similar studies have gone: Previous remote brain-training approaches have shown potential, but results vary; this trial builds on emerging evidence with a direct head-to-head comparison.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion 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

Exclusion Criteria:

* 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)

Where it's running

  • Indiana University
    Indianapolis, Indiana, United States
    Recruiting
  • Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
    Edison, New Jersey, United States
    Recruiting
  • National Intrepid Center Of Excellence
    Bethesda, Maryland, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.