RECRUITING

MENTOR Wellness Program

Conditions

Traumatic Brain Injury TBI brain injury wellness physical activity nutrition chronic mindfulness

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2024-04-11

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06148324

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Tamara Bushnik, PhD

CONTACT

212-263-6547

Tamara.Bushnik@nyulangone.org

Olga Garduno-Ortega

CONTACT

917-376-2270

Olga.Garduno-Ortega@nyulangone.org

Principal Investigator

Tamara Bushnik, PhD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Tamara Bushnik, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-11

Study Completion Date2027-08

Study Record Updates

Study Start Date2024-04-11

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

traumatic brain injury
TBI
brain injury
wellness
physical activity
nutrition
chronic
mindfulness

Additional Relevant MeSH Terms

Traumatic Brain Injury