MENTOR Wellness Program

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06148324
• Other study ID #: 23-00826
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2024
• Est. completion date: August 2027

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Tamara Bushnik, PhD
• Phone: 212-263-6547
• Email: Tamara.Bushnik[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: August 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)