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NCT06148324 | RECRUITING | Traumatic Brain Injury

MENTOR Wellness Program
Sponsor:

NYU Langone Health

Brief 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).

Condition or disease

Traumatic Brain Injury

Intervention/treatment

MENTOR Program

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 138 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Promoting Wellness in Individuals With Traumatic Brain Injury: A Randomized Trial Assessing the Effectiveness of the Mindfulness, Exercise, Nutrition to Optimize Resilience (MENTOR) Program
Actual Study Start Date : 2024-04-11
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2027-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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
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 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
MENTOR Wellness Program

Location Details

NCT06148324

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016