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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

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.

0 / 2Eligibility criteria met

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

1,369 Previous Clinical Trials

840,460 Total Patients Enrolled

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED

71 Previous Clinical Trials

8,991 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me if there are any vacancies open for this experiment?

"This specific clinical trial is not currently seeking participants, as evidenced on its listing on clinicaltrials.gov which was last updated in November 2023. Despite this study being inactive, there are still 1002 other trials that are actively recruiting participants."

Answered by AI

Is the eligibility for this clinical trial inclusive of those over 55 years old?

"This trial's requisites necessitate that participants must be aged 18-70. For those outside this range, there are 178 trials for minors and 784 clinical studies dedicated to seniors."

Answered by AI