MENTOR Wellness Program

Study Overview
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Brief Summary
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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).

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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: MENTOR Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate treatment (IT)<br>Participants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period. | Behavioral: MENTOR Program<br>* 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.<br>|
| Experimental: Delayed treatment (DT)<br>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<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury, TBI, brain injury, wellness, physical activity, nutrition, chronic, mindfulness