MENTOR Wellness Program for TBI

Overseen By Fatima Imdad

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Recent TBI, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

138 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a virtual wellness program designed to assist individuals who have experienced a traumatic brain injury (TBI). The goal is to determine if this program can enhance emotional, physical, and nutritional health, while also examining the influence of social factors on recovery. Participants will either begin the MENTOR Program immediately or wait eight weeks before starting. The trial seeks individuals who had a TBI over a year ago, are medically stable, and have internet access for the program. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve recovery for others with TBI.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants should not be starting a new treatment regimen that could affect the study. If your current treatment is stable, you may be eligible to participate.

What prior data suggests that the MENTOR Program is safe for individuals with TBI?

Research shows that the MENTOR Program is a digital health wellness initiative focusing on mindfulness, exercise, and nutrition to enhance overall well-being. Studies indicate that this program effectively boosts wellness and resilience for individuals with brain injuries.

The program offers a virtual wellness approach, meaning it doesn't involve drugs or medical procedures, thus minimizing the risk of harmful side effects. Past participants reported positive experiences without major negative effects.

Designed to be safe and easy to follow, the program promotes healthy lifestyle habits that benefit emotional, physical, and nutritional health. For those considering participation, the MENTOR Program appears to be a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MENTOR Wellness Program for traumatic brain injury (TBI) is unique because it's designed to address the condition through a structured, non-pharmacological approach. Unlike standard treatments that often focus on medication to manage symptoms, the MENTOR Program emphasizes cognitive and emotional rehabilitation through an 8-week regimen, followed by a retention period. This approach is particularly exciting for researchers because it provides a holistic and potentially more sustainable way to enhance recovery and quality of life for TBI patients without relying on drugs. By focusing on wellness and retention, the program may offer lasting benefits that current treatments don't typically achieve.

What evidence suggests that the MENTOR Program is effective for TBI?

Research has shown that the MENTOR Program, which stands for Mindfulness, Exercise, and Nutrition To Optimize Recovery, may benefit people with traumatic brain injury (TBI). In this trial, participants will be randomized into two groups: the Immediate Treatment (IT) arm, where they receive the 8-week MENTOR program immediately, and the Delayed Treatment (DT) arm, where they start the program after an 8-week waitlist period. Studies have found that participants experienced better overall wellness, including improved emotional and physical health. The program includes mindfulness activities, physical exercises, and nutrition, all aimed at boosting recovery. Early findings suggest that the program can enhance quality of life by focusing on different areas of wellness. While more research is needed, these initial results are promising for those with TBI. ^{2 5 6 7 8}

Who Is on the Research Team?

Tamara Bushnik, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

The MENTOR Wellness Program is for individuals who have had a traumatic brain injury (TBI) at least 12 months ago, can speak English or Spanish, and are medically cleared to participate. They must have internet access and not be in a minimally conscious state or starting new treatments that could affect the study.

Inclusion Criteria

It has been over a year since my traumatic brain injury.

I can speak and understand either English or Spanish.

You are willing to take part in the study.

Exclusion Criteria

I had a traumatic brain injury less than a year ago.

I have had a traumatic brain injury.

Beginning a new treatment regimen 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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Treatment

Participants in the IT group receive the 8-week MENTOR program

8 weeks

Virtual sessions

Delayed Treatment

Participants in the DT group have an 8-week waitlist period before starting the MENTOR program

8 weeks

Virtual sessions

Retention

Participants undergo an 8-week retention period after completing the MENTOR program

8 weeks

Follow-up

Participants are monitored for outcomes such as stress, resilience, and quality of life

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MENTOR Program

Trial Overview This trial tests the MENTOR virtual wellness program's effectiveness on emotional, physical, and nutritional outcomes for TBI patients. Participants are randomly assigned to either start treatment immediately or after a delay, considering social health factors.

How Is the Trial Designed?

Group I: Immediate treatment (IT) Experimental Treatment 1 Intervention

Participants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period.

Group II: Delayed treatment (DT) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

University of Alabama at Birmingham (UAB) Wellness, Health and Research Facility (WHARF)

Collaborator

Trials

1

Recruited

140+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

A new wellness check-in process for first-year psychiatry residents was implemented, where chief residents met regularly with interns to discuss their experiences and wellness, based on individual preferences gathered from a baseline questionnaire.

All eight interns participated in the check-ins, which were tailored to their needs, indicating a positive step towards enhancing support and mentorship in residency programs, though further research is needed to measure the impact on intern wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting intern wellness within a psychiatry residency training program: A process of regular check-ins by chief residents. Yung, J., Kim, B.[2022]

Physicians, especially those in training, are facing high rates of burnout and depression, highlighting the urgent need for wellness programs in medical education.

Successful wellness programs should involve both organizational and individual strategies, requiring collaboration among leadership, faculty, and trainees, along with ongoing assessment and targeted interventions to effectively reduce burnout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trainee Wellness: Why It Matters, and How to Promote It. Sharp, M., Burkart, KM.[2018]

A 12-week health and wellness group intervention for individuals with moderate to severe traumatic brain injury (TBI) showed no significant efficacy compared to a wait-list control group, based on a study involving 74 participants.

The lack of effectiveness may be attributed to the variability in individual health goals, the structure of the intervention, and the chosen outcome measures, suggesting that a more tailored approach might be necessary for future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A health and wellness intervention for those with moderate to severe traumatic brain injury: a randomized controlled trial. Brenner, LA., Braden, CA., Bates, M., et al.[2015]

The Workplace Managed Care Cooperative Agreement project aims to enhance substance abuse prevention programs for 3,300 healthcare professionals in New Mexico, focusing on reducing risky drinking and improving employee wellness.

Project WISE, a key component of this initiative, includes affordable strategies like substance abuse training and motivational counseling, with evaluations planned to assess its effectiveness through various methods including health records and focus groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance abuse intervention for health care workers: a preliminary report. Lapham, SC., Chang, I., Gregory, C.[2019]

The peer-based physical activity program for adults with moderate-to-severe traumatic brain injury (TBI) was found to significantly improve participants' daily lives, leading to positive psychological, physical, and social outcomes.

Key factors for the program's success included strong leadership, accessibility, and social inclusion, which are essential for its sustainability and effectiveness in promoting health-related behaviors post-TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring a peer-based physical activity program in the community for adults with moderate-to-severe traumatic brain injury. Quilico, E., Sweet, S., Duncan, L., et al.[2023]

The Mentoring Program for medical residents significantly improved their feelings of support, confidence, and satisfaction after one year, indicating its effectiveness in helping them cope with the demands of residency.

Both residents and attending physicians benefited from the program, which has now become a key component of departmental teaching and communication, enhancing professional growth and empowerment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[MENTORING PROGRAM - ANOTHER FACET OF RESIDENT EDUCATION]. Fishman, A., Kenet, R., Biron-Shental, T.[2015]

Burnout and depression among healthcare providers are rising, highlighting the urgent need for effective wellness programs to foster resiliency and well-being in future healthcare professionals.

The article outlines a residency wellness program with four core components—concrete resources, positive conversations, curriculum, and control—aimed at creating a culture of wellness, and mentions early efforts to empirically assess its impact across residency programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating a culture of wellness: conversations, curriculum, concrete resources, and control. Place, S., Talen, M.[2022]

The Accreditation Council for Graduate Medical Education has mandated initiatives to improve resident wellness due to rising burnout rates among medical residents, highlighting the importance of addressing mental health in medical training.

The literature review emphasizes the need for both individual-level interventions, such as personal wellness strategies, and systemic organizational changes to effectively combat burnout and promote overall wellness in residency education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Interventions that Promote Resident Wellness from the Council of Emergency Residency Directors. Parsons, M., Bailitz, J., Chung, AS., et al.[2020]

The Heart Transplant Mentor Programme (HTMP) was positively received by mentored patients, with average ratings of 3.8 for information and 4.0 for support, indicating its effectiveness in enhancing patient care.

To improve satisfaction, the program should introduce mentors earlier and match them more closely with patients based on demographics and clinical experiences, as some patients reported dissatisfaction due to late contact and differing clinical courses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a mentorship program for heart transplant patients. Wright, L., Pennington, JJ., Abbey, S., et al.[2019]

The mobile version of the Bruin Health Improvement Program (BHIP mobile) showed promising results, with participants experiencing significant reductions in body weight and body mass index after a 10-week program, indicating its efficacy in promoting weight loss.

Participants reported high acceptability of the program due to its flexibility and convenience, although challenges like inconsistent internet connections were noted, suggesting areas for improvement in future iterations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Efficacy and Acceptability of an Online Exercise and Nutrition Workplace Wellness Program: A Brief Report. SantaBarbara, N., Rezai, R., Terry, E., et al.[2022]

The LoveYourBrain Mindset program, a six-week online intervention combining yoga, mindfulness, and psychoeducation, was found to be feasible and acceptable for individuals with traumatic brain injury (TBI), with 71% of the 1539 participants attending at least one class.

Participants showed significant improvements in quality of life, resilience, emotional regulation, cognition, and overall well-being after the program, indicating its potential effectiveness in supporting recovery from TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LoveYourBrain Mindset: Feasibility, Acceptability, Usability, and Effectiveness of an Online Yoga, Mindfulness, and Psychoeducation Intervention for People with Traumatic Brain Injury. Callahan, CE., Beisecker, L., Zeller, S., et al.[2023]

Physical activity (PA) interventions for individuals with mild traumatic brain injury (mTBI) can improve various health-related outcomes, suggesting that incorporating PA into rehabilitation programs is beneficial.

The review identified 35 articles and 14 gray literature records, highlighting a need for higher-quality research and better reporting on intervention details to enhance the effectiveness and replicability of these PA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Interventions for Individuals With a Mild Traumatic Brain Injury:: A Scoping Review. Alarie, C., Gagnon, I., Quilico, E., et al.[2023]

The WIRE curriculum is a comprehensive wellness program for residents in plastic surgery, featuring six formal lectures and additional informal events aimed at promoting personal and professional wellness.

The program not only enhances camaraderie among residents but also provides networking opportunities with field leaders, highlighting its potential for improving overall resident education and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating and Implementing a Novel Wellness-Inspired Resident Educational RG (WIRE) Curriculum. Guest, RA., Miller, MA., Bergman, H., et al.[2023]

A peer-mentoring program for individuals with traumatic brain injury (TBI) and their caregivers showed significant benefits, with 88% of participants reporting positive experiences over a 2-year period.

Mentored individuals exhibited better behavioral control, reduced alcohol use, and improved quality of life compared to those who did not receive mentoring, highlighting the program's effectiveness in enhancing emotional well-being and community integration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of peer mentoring for individuals with traumatic brain injury and their significant others. Hanks, RA., Rapport, LJ., Wertheimer, J., et al.[2012]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06148324/mentor-wellness-program

MENTOR Wellness Program | Clinical Research Trial Listing This randomized trial aims to determine the effectiveness a virtual wellness intervention program in individuals with traumatic brain injury (TBI).

2. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/2376/promoting-wellness-individuals-traumatic/

Promoting wellness in individuals with traumatic brain injury This randomized trial aims to determine the effectiveness of an online wellness intervention program focused on mindfulness, physical activity, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10805275/

Mindfulness, Exercise, and Nutrition To Optimize ... We evaluated the MENTOR 2.0 program and reported improvements in multiple areas of wellness ... Traumatic brain injury, 7 (6.0). Cerebral palsy, 5 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9397963/

Qualitative Evaluation of a Comprehensive Online ... These preliminary findings demonstrate that MENTOR may benefit the wellbeing of people with SCI and warrant further study. Keywords: wellness, ...

5. ctv.veeva.com ctv.veeva.com/study/a-health-and-wellness-lifestyle-program-to-support-community-dwelling-persons-with-traumatic-brain-i

A Health and Wellness Lifestyle Program to Support ... The purpose of this study is to evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program (POWERS-TBI) on ...

6. trialx.com trialx.com/clinical-trials/listings/304490/mentor-wellness-program/

MENTOR Wellness Program | Clinical Research Trial ... This randomized trial aims to determine the effectiveness a virtual wellness intervention program in individuals with traumatic brain injury ( ...

7. jprm.scholasticahq.com jprm.scholasticahq.com/article/141307

Two Brains Are Better Than One: Incorporating Peer Mentors ... Individuals with acquired brain injury (ABI), including traumatic brain injury (TBI) and stroke, are at an increased risk for obesity and obesity-related ...

8. cdc.gov cdc.gov/pcd/issues/2024/23_0181.htm

Mindfulness, Exercise, and Nutrition To Optimize ... Research shows that the MENTOR (Mindfulness, Exercise, and Nutrition To Optimize Resilience) digital health wellness program is effective in improving wellness ...