MENTOR Wellness Program

Last updated: March 6, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Traumatic Brain Injury

Memory Loss

Treatment

MENTOR Program

Clinical Study ID

NCT06148324
23-00826
  • Ages 18-70
  • All Genders

Study Summary

This randomized trial aims to determine the effectiveness a virtual wellness intervention program in individuals with traumatic brain injury (TBI). Participants will be randomized at enrollment into two groups: immediate treatment (IT) and delayed treatment (DT) group. This study will also provide insights into the impact of these intervention's components in helping emotional, physical, and nutritional outcomes post-injury in the context of social determinants of health (SDOH).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a medically-documented (e.g., EMS report, hospital record, physician record) orper medical monitor review complicated-mild, moderate, or severe TBI requiringadmission to an acute inpatient rehabilitation unit

  • Be at least 12 months post-TBI

  • Have access to the internet on a computer, tablet, and/or smartphone.

  • Speak and understand English or Spanish

  • Agree to participate

  • Are medically cleared by their primary physician, physiatrist, neurologist,rehabilitation therapist, or other recognized health professional to participate inthe study

Exclusion

Exclusion Criteria:

  • No history of complicated-mild, moderate, or severe TBI

  • Less than 12 months post-TBI

  • In minimally conscious or vegetative state

  • Beginning a new treatment regimen (e.g., physical therapy, occupational therapy,vestibular therapy, psychotherapy, and/or medication) at study start that caninfluence study findings in the judgment of the principal investigator and/ormedical monitor (participants whose treatment regimens are stable will be eligible)

  • In the judgment of the principal investigator, medical monitor, and/or study teammember, presence of significant cognitive impairment (i.e. delirium or dementia)sufficient to preclude meaningful informed consent and/or data collection

  • In the judgment of the principal investigator, medical monitor, and/or study teammember, significant or major disabling medical condition sufficient to precludemeaningful informed consent and/or data collection

Study Design

Total Participants: 138
Treatment Group(s): 1
Primary Treatment: MENTOR Program
Phase:
Study Start date:
April 11, 2024
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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