Traumatic Brain Injury Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Fatima Imdad
Fatima.Imdad@nyulangone.org
917-376-2270
Backup
Michelle Michelle.Smith@nyulangone.org
Michelle.Smith@nyulangone.org
646-501-9162
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2027-08
Participants
Target number of participants: 138
Treatments
Experimental: Immediate treatment (IT)
Participants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period.
Experimental: Delayed treatment (DT)
Participants randomized to the DT arm will have an 8-week waitlist period prior to starting the 8-week MENTOR program, followed by an 8-week retention period.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research, University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov