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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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)

Study details
    Mild Traumatic Brain Injury
    Alexithymia

NCT07436754

Hackensack Meridian Health

27 June 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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