MENTOR Wellness Program

Description

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).

Conditions

Traumatic Brain Injury

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Study Overview

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Study Details

Study overview

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).

Promoting Wellness in Individuals With Traumatic Brain Injury: A Randomized Trial Assessing the Effectiveness of the Mindfulness, Exercise, Nutrition to Optimize Resilience (MENTOR) Program

MENTOR Wellness Program

Condition
Traumatic Brain Injury
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have a medically-documented (e.g., EMS report, hospital record, physician record) or per medical monitor review complicated-mild, moderate, or severe TBI requiring admission 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 in the study
  • * 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 can influence study findings in the judgment of the principal investigator and/or medical monitor (participants whose treatment regimens are stable will be eligible)
  • * In the judgment of the principal investigator, medical monitor, and/or study team member, 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 team member, significant or major disabling medical condition sufficient to preclude meaningful informed consent and/or data collection

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Tamara Bushnik, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2027-08