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MENTOR Wellness Program for TBI

N/A
Recruiting
Led By Tamara Bushnik, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Speak and understand English or Spanish
Have a medically-documented complicated-mild, moderate, or severe TBI requiring admission to an acute inpatient rehabilitation unit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-retention period assessment (week 16 for it; week 24 for dt)
Awards & highlights

Study Summary

This trial will assess the effectiveness of a virtual wellness intervention program in helping individuals with TBI with emotional, physical and nutritional outcomes, taking into account social determinants of health.

Who is the study for?
The MENTOR Wellness Program is for individuals who have had a traumatic brain injury (TBI) at least 12 months ago, can speak English or Spanish, and are medically cleared to participate. They must have internet access and not be in a minimally conscious state or starting new treatments that could affect the study.Check my eligibility
What is being tested?
This trial tests the MENTOR virtual wellness program's effectiveness on emotional, physical, and nutritional outcomes for TBI patients. Participants are randomly assigned to either start treatment immediately or after a delay, considering social health factors.See study design
What are the potential side effects?
Since this is a non-medical intervention focusing on wellness through virtual means, traditional side effects associated with medications are not expected. However, participants may experience varying levels of engagement or psychological impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can speak and understand either English or Spanish.
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I was admitted to a hospital for a serious brain injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12-Item Short Form Survey (SF-12) Score at Baseline
12-Item Short Form Survey (SF-12) Score at Post-Retention Assessment
Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Baseline
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Immediate treatment (IT)Experimental Treatment1 Intervention
Participants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period.
Group II: Delayed treatment (DT)Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Alabama at Birmingham (UAB) Wellness, Health and Research Facility (WHARF)UNKNOWN
NYU Langone HealthLead Sponsor
1,373 Previous Clinical Trials
840,982 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
72 Previous Clinical Trials
9,003 Total Patients Enrolled
~92 spots leftby Jan 2027
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