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NCT07436754NARecruiting

Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury

Hackensack Meridian Health

Start Date

5/20/2026

Completion Date

3/1/2031

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

BEHAVIORAL

Program 1

BEHAVIORAL

Program 2

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Conditions

Mild Traumatic Brain InjuryAlexithymia

Locations

Indiana University

Indianapolis, Indiana 46202

United States

National Intrepid Center Of Excellence

Bethesda, Maryland 20889

United States

Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

Edison, New Jersey 08820

United States