Traumatic Brain InjuryNCT06148324
MENTOR Wellness Program
A study testing MENTOR Program in people with Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- MENTOR Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
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
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).
- Conditions
- Traumatic Brain Injury
- Being tested
- MENTOR Program
- Keywords
- traumatic brain injury, TBI, brain injury, wellness, physical activity, nutrition, chronic, mindfulness
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries, Motor Activity, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MENTOR ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment (IT) | Experimental | Participants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period. Receives: Behavioral: MENTOR Program |
| Delayed treatment (DT) | Experimental | 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. Receives: Behavioral: MENTOR Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start11 Apr 2024
- Primary completionMar 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Tamara Bushnik, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148324
- Sponsor's protocol ID
- 23-00826
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06148324
- Acronym / sponsor ID
- 23-00826
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, TBI, brain injury, wellness, physical activity, nutrition, chronic, mindfulness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, University of Alabama at Birmingham
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment (IT) | Experimental | Behavioral: MENTOR ProgramParticipants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period. |
| Delayed treatment (DT) | Experimental | Behavioral: MENTOR ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MENTOR ProgramMENTOR 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. | Behavioural | Delayed treatment (DT), Immediate treatment (IT) |
Primary outcome
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: 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.
Related trials for Traumatic Brain Injury
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Not yet recruitingObservational study
Description of Clinicians' Predictive Abilities Before and After a Diffusion Tensor Imaging (DTI)
Diffusion Tensor Imaging Prognosis, Brain Injury, Traumatic
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamara Bushnik, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MENTOR Program in people with Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatima Imdad (917-376-2270, Fatima.Imdad@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freiburg Mindfulness Inventory (FMI) Score at Baseline (time frame: Baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.