Recruiting

MENTOR

Sponsor:

NYU Langone Health

Code:

NCT06148324

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

MENTOR Program

Study Details

Brief summary:

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).

Conditions

Traumatic Brain Injury

Study ID

NCT06148324

Start date

Apr 11, 2024

Status verified date

Jan, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate treatment (IT)

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

experimental: Delayed treatment (DT)

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.

Interventions

MENTOR Program

MENTOR is an online wellness program covering 11 wellness modules: Exercise; Nutrition; Mindfulness; Spiritual Practice; Self-Care; Arts \& Leisure; Rest \& Relaxation; Outdoors in Nature; Relationships; Core Values; and Contribution to Others.

The 8-week cycle comprises 40 hours of online group-based instruction and discussion, meeting up to five times per week.

Primary outcome measure

  • Freiburg Mindfulness Inventory (FMI) Score at Baseline [ Time Frame: Baseline ]
  • Freiburg Mindfulness Inventory (FMI) Score at Post-Intervention Assessment [ Time Frame: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT) ]
  • International Physical Activity Questionnaire (IPAQ) Score at Baseline [ Time Frame: Baseline ]
  • International Physical Activity Questionnaire Score at Post-Intervention Assessment [ Time Frame: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT) ]
  • Health Promoting Lifestyle Profile II (HPLP-II) Score at Baseline [ Time Frame: Baseline ]
  • Health Promoting Lifestyle Profile II (HPLP-II) Score at Post-Intervention Assessment [ Time Frame: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT) ]
  • Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Baseline [ Time Frame: Baseline ]
  • Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Post-Retention Assessment [ Time Frame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT) ]
  • Perceived Stress Scale (PSS) Score at Baseline [ Time Frame: Baseline ]
  • Perceived Stress Scale (PSS) Score at Post-Retention Assessment [ Time Frame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT) ]
  • Participation Assessment with Recombined Tools - Objective (PART-O) Score at Baseline [ Time Frame: Baseline ]
  • Participation Assessment with Recombined Tools - Objective (PART-O) Score at Post-Retention Assessment [ Time Frame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT) ]
  • Quality of Life after Brain Injury (QOLIBRI) Score at Baseline [ Time Frame: Baseline ]
  • Quality of Life after Brain Injury (QOLIBRI) Score at Post-Retention Assessment [ Time Frame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT) ]
  • 12-Item Short Form Survey (SF-12) Score at Baseline [ Time Frame: Baseline ]
  • 12-Item Short Form Survey (SF-12) Score at Post-Retention Assessment [ Time Frame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT) ]
  • WHO-Quality of Life - Spirituality, Religious and Personal Beliefs module (WHOQOL-SRPB BREF) Score at Baseline [ Time Frame: Baseline ]
  • WHO-Quality of Life - Spirituality, Religious and Personal Beliefs module (WHOQOL-SRPB BREF) Score at Post-Retention Assessment [ Time Frame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT) ]
  • Flourishing Scale Score at Baseline [ Time Frame: Baseline ]
  • Flourishing Scale Score at Post-Retention Assessment [ Time Frame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT) ]

Central Contacts and Locations

Central contacts

Fatima Imdad

917-376-2270Fatima.Imdad@nyulangone.org

Michelle Michelle.Smith@nyulangone.org

646-501-9162Michelle.Smith@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • traumatic brain injury
  • TBI
  • brain injury
  • wellness
  • physical activity
  • nutrition
  • chronic
  • mindfulness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-01-28.