MENTOR Wellness Program

Sponsor

NYU Langone Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06148324

Collaborator

National Institute on Disability, Independent Living, and Rehabilitation Research (U.S. Fed), University of Alabama at Birmingham (UAB) Wellness, Health and Research Facility (WHARF) (Other)

138

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Behavioral: MENTOR Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health
National Institute on Disability, Independent Living, and Rehabilitation Research
University of Alabama at Birmingham (UAB) Wellness, Health and Research Facility (WHARF)