Virtual wellness program for individuals with traumatic brain injury
Promoting Wellness in Individuals With Traumatic Brain Injury: A Randomized Trial Assessing the Effectiveness of the Mindfulness, Exercise, Nutrition to Optimize Resilience (MENTOR) Program
This study is testing a virtual wellness program to see if it can help people with traumatic brain injury improve their emotional, physical, and nutritional health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06148324 on ClinicalTrials.gov |
What this trial studies
This randomized trial evaluates the effectiveness of a virtual wellness intervention program for individuals with traumatic brain injury (TBI). Participants will be divided into two groups: one receiving immediate treatment and the other receiving delayed treatment. The study aims to assess the impact of various components of the intervention on emotional, physical, and nutritional outcomes, while considering social determinants of health. The program is designed for individuals at least 12 months post-TBI who have access to the internet and are medically cleared to participate.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 and older who are at least 12 months post-TBI and have access to the internet.
Not a fit: Patients who are in a minimally conscious or vegetative state or those who have not experienced a complicated form of TBI will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the emotional and physical well-being of individuals recovering from traumatic brain injury.
How similar studies have performed: Other studies have shown promise in using virtual interventions for rehabilitation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Tamara Bushnik, PhD — NYU Langone Health
- Study coordinator: Fatima Imdad
- Email: Fatima.Imdad@nyulangone.org
- Phone: 917-376-2270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.