Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury
Recruiting now · Not applicable
Conditions studied: Mild Traumatic Brain Injury, Alexithymia
In brief
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. The 4 assessment visits (about 30-90 minutes each) include surveys and questionnaires about participant's emotional health. These assessment visits will take place before the training, immediately after the training, 3 months after training and 6 months after training. The 8 sessions of 1-on-1 training (about 60-90 minutes each) will be completed over the course of approximately 1 month.
Key facts
- Study ID
- NCT07436754
- Run by
- Hackensack Meridian Health
- People needed
- 300
- Starts
- 2026-05-20
- Expected to finish
- 2031-03-01
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify 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
- 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 is running
- Indiana University — Indianapolis, Indiana, United States (enrolling)
- Hackensack Meridian Health - JFK Johnson Rehabilitation Institute — Edison, New Jersey, United States (enrolling)
- National Intrepid Center Of Excellence — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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