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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health

About this trial

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

Qualifiers

Mild TBI

≥18 years old

≥6 months post-TBI

Elevated alexithymia and emotion dysregulation

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Program 1
  • Program 2

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hackensack Meridian Health

Lead sponsor

United States Department of Defense

Collaborator