MENTOR Wellness Program for Traumatic Brain Injury

This study is testing an online wellness program called MENTOR for people who have had a traumatic brain injury (TBI). The MENTOR program includes 11 modules covering topics like exercise, nutrition, mindfulness, and relationships. The goal is to see how well this virtual program helps with emotional, physical, and nutritional well-being after a TBI. You might be able to join if you are between 18 and 70 years old, had a complicated-mild, moderate, or severe TBI at least 12 months ago, and have internet access. The study will measure success by looking at changes in mindfulness (using the Freiburg Mindfulness Inventory) and physical activity (using the International Physical Activity Questionnaire) scores.

Study design: This is a randomized study with 138 planned participants. You would be assigned to either start the MENTOR program right away or after a delay.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Your mindfulness and physical activity will be assessed at the beginning of the study and again after 8 or 16 weeks, depending on when you start the program.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

MENTOR Wellness Program

Recruiting

NAAges 18–70InterventionalTreatment

NYU Langone Health

~138 participants

Updated 2026-01-28 on ClinicalTrials.gov

What's tested:MENTOR Program

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Freiburg Mindfulness Inventory (FMI) Score at Baseline

Measured over Baseline

+19 more outcomes measured

Conditions

Traumatic Brain Injury

Where it's being run

1 sites across 1 states

New York1

Study leadership

Tamara Bushnik, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Fatima Imdad

[email protected]

917-376-2270

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Freiburg Mindfulness Inventory (FMI) Score at BaselineBaseline
14-item scale measuring mindfulness. Items are rated on a scale from 1 (rarely) to 4 (almost always); the total score is the sum of responses and ranges from 14 to 56; higher scores indicate greater levels of mindfulness.
Freiburg Mindfulness Inventory (FMI) Score at Post-Intervention AssessmentPost-Intervention Assessment (Week 8 for IT; Week 16 for DT)
14-item scale measuring mindfulness. Items are rated on a scale from 1 (rarely) to 4 (almost always); the total score is the sum of responses and ranges from 14 to 56; higher scores indicate greater levels of mindfulness.
International Physical Activity Questionnaire (IPAQ) Score at BaselineBaseline
The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. The following formula is used to calculate the MET: MET=8(vigorous activity) (minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes).
International Physical Activity Questionnaire Score at Post-Intervention AssessmentPost-Intervention Assessment (Week 8 for IT; Week 16 for DT)
The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. The following formula is used to calculate the MET: MET=8(vigorous activity) (minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes).
Health Promoting Lifestyle Profile II (HPLP-II) Score at BaselineBaseline
53-item self-assessment of nutritional and health-related habits. Items are rated on a scale from 1 (never) to 4 (routinely); the total score is the sum of responses and ranges from 52 to 208. Higher scores indicate nutritional and health-related habits that are more closely associated with good health outcomes.
Health Promoting Lifestyle Profile II (HPLP-II) Score at Post-Intervention AssessmentPost-Intervention Assessment (Week 8 for IT; Week 16 for DT)
53-item self-assessment of nutritional and health-related habits. Items are rated on a scale from 1 (never) to 4 (routinely); the total score is the sum of responses and ranges from 52 to 208. Higher scores indicate nutritional and health-related habits that are more closely associated with good health outcomes.
Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at BaselineBaseline
10-item assessment of how participants feel when faced with various difficult situations. Each item is rated on a scale from 0 (not true at all) to (true nearly all the time). The total score is the sum of responses and ranges from 0 to 40; higher scores indicate greater resilience.
Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Post-Retention AssessmentPost-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
10-item assessment of how participants feel when faced with various difficult situations. Each item is rated on a scale from 0 (not true at all) to (true nearly all the time). The total score is the sum of responses and ranges from 0 to 40; higher scores indicate greater resilience.
Perceived Stress Scale (PSS) Score at BaselineBaseline
10-item assessment of perceived stress. Each item is rated on a scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 40; higher scores indicate higher perceived stress.
Perceived Stress Scale (PSS) Score at Post-Retention AssessmentPost-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
10-item assessment of perceived stress. Each item is rated on a scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 40; higher scores indicate higher perceived stress.
Participation Assessment with Recombined Tools - Objective (PART-O) Score at BaselineBaseline
10-item assessment of participation in the community. Each item is rated on a scale from 0-5; the total score is the sum of responses and ranges from 0 to 50; higher scores indicate greater community participation.
Participation Assessment with Recombined Tools - Objective (PART-O) Score at Post-Retention AssessmentPost-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
10-item assessment of participation in the community. Each item is rated on a scale from 0-5; the total score is the sum of responses and ranges from 0 to 50; higher scores indicate greater community participation.
Quality of Life after Brain Injury (QOLIBRI) Score at BaselineBaseline
37-item assessment of quality of life following brain injury. Items rated on a scale from 1 (not at all) to 5 (very). The total score is the sum of responses and ranges from 37 to 185; higher scores indicate greater quality of life.
Quality of Life after Brain Injury (QOLIBRI) Score at Post-Retention AssessmentPost-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
37-item assessment of quality of life following brain injury. Items rated on a scale from 1 (not at all) to 5 (very). The total score is the sum of responses and ranges from 37 to 185; higher scores indicate greater quality of life.
12-Item Short Form Survey (SF-12) Score at BaselineBaseline
12-item assessment of general health. The raw score is the sum of responses; the raw score is transformed to a summary t-score with a mean of 50 and standard deviation of 10; higher scores indicate greater overall health.
12-Item Short Form Survey (SF-12) Score at Post-Retention AssessmentPost-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
12-item assessment of general health. The raw score is the sum of responses; the raw score is transformed to a summary t-score with a mean of 50 and standard deviation of 10; higher scores indicate greater overall health.
WHO-Quality of Life - Spirituality, Religious and Personal Beliefs module (WHOQOL-SRPB BREF) Score at BaselineBaseline
32-item assessment of how beliefs have affected different aspects of a participant's quality of life over the past two weeks. Items are rated on a scale from 1 (not at all) to 5 (an extreme amount). The total score is the sum of responses and ranges from 32 to 160; higher scores indicate beliefs have a greater impact on the participant's quality of life.
WHO-Quality of Life - Spirituality, Religious and Personal Beliefs module (WHOQOL-SRPB BREF) Score at Post-Retention AssessmentPost-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
32-item assessment of how beliefs have affected different aspects of a participant's quality of life over the past two weeks. Items are rated on a scale from 1 (not at all) to 5 (an extreme amount). The total score is the sum of responses and ranges from 32 to 160; higher scores indicate beliefs have a greater impact on the participant's quality of life.
Flourishing Scale Score at BaselineBaseline
8-item assessment of general prosperity. Each item is rated on a scale from 1 (strongly disagree) to 7 (strongly agree). The total score is the sum of responses and ranges from 8-56; higher scores indicate greater prosperity.
Flourishing Scale Score at Post-Retention AssessmentPost-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
8-item assessment of general prosperity. Each item is rated on a scale from 1 (strongly disagree) to 7 (strongly agree). The total score is the sum of responses and ranges from 8-56; higher scores indicate greater prosperity.

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