MENTOR Wellness Program for TBI

Overseen by Tamara Bushnik, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NYU Langone Health

Disqualifiers: Recent TBI, Cognitive impairment, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the MENTOR Wellness Program for TBI treatment?

The MENTOR Wellness Program may be effective because similar mentorship programs have shown to increase feelings of support, confidence, and satisfaction in medical residents, and a mentorship program for heart transplant patients was positively received, suggesting that mentorship can enhance patient care and well-being. ^{1 2 3 4 5}

Is the MENTOR Wellness Program safe for humans?

The available research on programs similar to the MENTOR Wellness Program, such as peer mentoring and physical activity interventions for traumatic brain injury (TBI), does not report any safety concerns, suggesting they are generally safe for humans. ^{6 7 8 9 10}

How is the MENTOR Wellness Program for TBI different from other treatments?

The MENTOR Wellness Program for TBI is unique because it focuses on wellness and lifestyle interventions rather than traditional medical treatments. It likely incorporates elements such as exercise, nutrition, and mental health support, which are not standard in typical TBI treatments that often focus on medication or surgery. ^{1 11 12 13 14}

Research Team

Tamara Bushnik, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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)

Trial Timeline

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

Treatment Details

Interventions

• MENTOR Program (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

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

Collaborator

Trials

1

Recruited

140+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Dr. Kristi Hill

National Institute on Disability, Independent Living, and Rehabilitation Research

Acting Director since 2012

PhD in Neuroscience from the Medical College of Virginia

Dr. Phillip Beatty

National Institute on Disability, Independent Living, and Rehabilitation Research

Director of the Office of Research Sciences since 2019

PhD in Rehabilitation Sciences

Findings from Research

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]

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]

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 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 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]

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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Trainee Wellness: Why It Matters, and How to Promote It. [2018]

2. Israel pubmed.ncbi.nlm.nih.gov

[MENTORING PROGRAM - ANOTHER FACET OF RESIDENT EDUCATION]. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a mentorship program for heart transplant patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Evidence-Based Interventions that Promote Resident Wellness from the Council of Emergency Residency Directors. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Exploring a peer-based physical activity program in the community for adults with moderate-to-severe traumatic brain injury. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A health and wellness intervention for those with moderate to severe traumatic brain injury: a randomized controlled trial. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of peer mentoring for individuals with traumatic brain injury and their significant others. [2012]

9. England 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Physical Activity Interventions for Individuals With a Mild Traumatic Brain Injury:: A Scoping Review. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Creating and Implementing a Novel Wellness-Inspired Resident Educational RG (WIRE) Curriculum. [2023]

12. India pubmed.ncbi.nlm.nih.gov

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

13. United States pubmed.ncbi.nlm.nih.gov

Substance abuse intervention for health care workers: a preliminary report. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Preliminary Efficacy and Acceptability of an Online Exercise and Nutrition Workplace Wellness Program: A Brief Report. [2022]