← Back to Search

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

Must not have

History of complicated-mild, moderate, or severe TBI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-retention period assessment (week 16 for it; week 24 for dt)

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I can speak and understand either English or Spanish.

Select...

I was admitted to a hospital for a serious brain injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a traumatic 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met