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
1 other identifier
interventional
138
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2023
CompletedFirst Posted
Study publicly available on registry
November 28, 2023
CompletedStudy Start
First participant enrolled
April 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
January 28, 2026
January 1, 2026
2.9 years
November 20, 2023
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (20)
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)
Study Arms (2)
Immediate treatment (IT)
EXPERIMENTALParticipants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period.
Delayed treatment (DT)
EXPERIMENTALParticipants 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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tamara Bushnik, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2023
First Posted
November 28, 2023
Study Start
April 11, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
January 28, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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).
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.