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NCT06148324Recruiting

MENTOR Wellness Program

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

Source: ClinicalTrials.gov · Last updated 28 Jan 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
138 (estimated)
First submitted
20 Nov 2023
Start date
11 Apr 2024
Primary completion date
Mar 2027
Lead sponsor
NYU Langone Health
NCT number
NCT06148324

What you commit to

  • Study type: Interventional
  • Planned participants: 138
  • From 11 Apr 2024 to the primary completion date, Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

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

Other

  • Less than 12 months post-TBI
  • In minimally conscious or vegetative state

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.