MENTOR Wellness Program

Promoting Wellness in Individuals With Traumatic Brain Injury: A Randomized Trial Assessing the Effectiveness of the Mindfulness, Exercise, Nutrition to Optimize Resilience (MENTOR) Program

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).

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: MENTOR Program

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamara Bushnik, PhD; Phone Number: 212-263-6547; Email: Tamara.Bushnik@nyulangone.org
• Study Contact Backup: Name: Olga Garduno-Ortega; Phone Number: 917-376-2270; Email: Olga.Garduno-Ortega@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate treatment (IT); Participants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period.	Behavioral: 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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research; University of Alabama at Birmingham (UAB) Wellness, Health and Research Facility (WHARF)
• Investigators: Principal Investigator: Tamara Bushnik, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; nutrition; mindfulness; TBI; brain injury; chronic; traumatic brain injury; wellness
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 23-00826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved protocol. The request may be submitted beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the researchers execute a data use agreement with NYU Langone Health. Requests may be directed to: Tamara.Bushnik@nyulangone.org. After 36 months, the data will be available in NYU Langone's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at ICPSR Data Excellence Research Impact (umich.edu). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Requests should be directed to Tamara.Bushnik@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in NYU Langone's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at ICPSR Data Excellence Research Impact (umich.edu).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No