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NCT Number: NCT06148324

MENTOR Wellness 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).

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Key information

Conditions

Traumatic Brain Injury Behavior Brain Diseases Brain Injuries Brain Injuries, Traumatic Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Central Nervous System Diseases Craniocerebral Trauma Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Nervous System Diseases Organizing Pneumonia Respiratory Tract Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MENTOR Program

Behavioral

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.

Primary outcomes

  1. Freiburg Mindfulness Inventory (FMI) Score at Baseline

    Time frame: 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.

  2. Freiburg Mindfulness Inventory (FMI) Score at Post-Intervention Assessment

    Time frame: 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.

  3. International Physical Activity Questionnaire (IPAQ) Score at Baseline

    Time frame: 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).

  4. International Physical Activity Questionnaire Score at Post-Intervention Assessment

    Time frame: 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).

  5. Health Promoting Lifestyle Profile II (HPLP-II) Score at Baseline

    Time frame: 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.

  6. Health Promoting Lifestyle Profile II (HPLP-II) Score at Post-Intervention Assessment

    Time frame: 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.

  7. Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Baseline

    Time frame: 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.

  8. Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Post-Retention Assessment

    Time frame: 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.

  9. Perceived Stress Scale (PSS) Score at Baseline

    Time frame: 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.

  10. Perceived Stress Scale (PSS) Score at Post-Retention Assessment

    Time frame: 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.

  11. Participation Assessment with Recombined Tools - Objective (PART-O) Score at Baseline

    Time frame: 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.

  12. Participation Assessment with Recombined Tools - Objective (PART-O) Score at Post-Retention Assessment

    Time frame: 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.

  13. Quality of Life after Brain Injury (QOLIBRI) Score at Baseline

    Time frame: 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.

  14. Quality of Life after Brain Injury (QOLIBRI) Score at Post-Retention Assessment

    Time frame: 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.

  15. 12-Item Short Form Survey (SF-12) Score at Baseline

    Time frame: 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.

  16. 12-Item Short Form Survey (SF-12) Score at Post-Retention Assessment

    Time frame: 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.

  17. WHO-Quality of Life - Spirituality, Religious and Personal Beliefs module (WHOQOL-SRPB BREF) Score at Baseline

    Time frame: 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.

  18. WHO-Quality of Life - Spirituality, Religious and Personal Beliefs module (WHOQOL-SRPB BREF) Score at Post-Retention Assessment

    Time frame: 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.

  19. Flourishing Scale Score at Baseline

    Time frame: 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.

  20. Flourishing Scale Score at Post-Retention Assessment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatima Imdad

CONTACT

[email protected]

917-376-2270

Michelle [email protected]

CONTACT

[email protected]

646-501-9162

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research
  • University of Alabama at Birmingham

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 28, 2023
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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