NCT07436754 Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury
| NCT ID | NCT07436754 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hackensack Meridian Health |
| Condition | Mild Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-05-20 |
| Primary Completion | 2031-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2026-05-20 with a primary completion date of 2031-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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)
Contact & Investigator
Dawn Neumann, PhD, FACRM
PRINCIPAL INVESTIGATOR
Hackensack Meridian Health
Frequently Asked Questions
Who can join the NCT07436754 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mild Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07436754 currently recruiting?
Yes, NCT07436754 is actively recruiting participants. Contact the research team at grace.wells1@hmhn.org for enrollment information.
Where is the NCT07436754 trial being conducted?
This trial is being conducted at Indianapolis, United States, Bethesda, United States, Edison, United States.
Who is sponsoring the NCT07436754 clinical trial?
NCT07436754 is sponsored by Hackensack Meridian Health. The principal investigator is Dawn Neumann, PhD, FACRM at Hackensack Meridian Health. The trial plans to enroll 300 participants.