An interventional study of MENTOR Program in Traumatic Brain Injury, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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).
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
This study's planned enrollment of 138 is above the median of 56 across 1,133 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period.
Behavioral: MENTOR Program
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.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
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