MENTOR Wellness Program

NYU Langone Health

Status: Enrolling

Conditions: Traumatic Brain Injury

Treatments: Behavioral: MENTOR Program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06148324

23-00826

Details and patient eligibility

About

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).

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Immediate treatment (IT)

Experimental group

Description:

Participants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period.

Treatment:

Behavioral: MENTOR Program

Delayed treatment (DT)

Experimental group

Description:

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.

Treatment:

Behavioral: MENTOR Program