Brain Health & Wellness Classes for Veterans with Concussion-Related Issues

Overseen By Juliana Baldo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: East Bay Institute for Research and Education

Disqualifiers: Neurologic disease, Brain surgery, Severe TBI, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of classes might improve mental well-being for Veterans with ongoing issues from past concussions. The Brain Health Education class focuses on brain health, teaching about brain function and aging. The Mindfulness-based Stress Reduction class uses mindfulness techniques, such as meditation and yoga, to reduce stress. Veterans who have experienced mild traumatic brain injuries (concussions) for more than six months, suffer from PTSD, and notice cognitive issues like memory problems may be well-suited for this study. As an unphased trial, this study offers Veterans a unique opportunity to explore innovative approaches to enhancing mental well-being.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these Brain Health & Wellness classes are safe for veterans with concussion-related issues?

Studies have shown that both Brain Health Education and Mindfulness-based Stress Reduction (MBSR) classes are safe and well-tolerated by participants. Research indicates that MBSR has been used with veterans to improve mental health, leading to better psychological well-being and reduced stress levels. Most participants handle it well, though a small percentage might not experience significant improvements.

Specific safety studies for the Brain Health Education class are not available. However, since it involves lectures and discussions, it is generally considered low-risk. Such classes focus on learning and discussion, which typically do not cause harm.

Overall, both treatments appear safe for participants, with MBSR having more data supporting its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these classes for veterans with concussion-related issues because they offer non-pharmaceutical approaches to improving brain health and reducing stress. The Brain Health Education class provides veterans with a deep understanding of how their brains work and the concept of neuroplasticity, empowering them with knowledge that could enhance their cognitive resilience. Meanwhile, the Mindfulness-based Stress Reduction class introduces veterans to mindfulness, meditation, and yoga, which are practices known to help manage stress and improve mental well-being. Unlike traditional treatments that might focus on medications or physical therapy, these classes aim to engage veterans in actively improving their brain health and managing their stress through education and mindfulness.

What evidence suggests that these classes could be effective for veterans with concussion-related issues?

Research has shown that Mindfulness-Based Stress Reduction (MBSR), one of the treatments in this trial, can reduce mental tiredness and improve thinking skills in people with mild traumatic brain injuries (mTBI). Studies have also found that MBSR can lessen PTSD symptoms in veterans. In a study of 960 veterans, most participants benefited from MBSR.

Meanwhile, the Brain Health Education class, another treatment option in this trial, involves cognitive rehabilitation activities that have assisted those with mild-to-moderate traumatic brain injuries. This includes learning about how the brain functions and changes with age, which supports mental recovery and adjustment. Both treatments in this trial aim to enhance mental health and thinking abilities in veterans with concussion-related issues. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for veterans aged 18-75 with a history of mild traumatic brain injuries (mTBIs) over 6 months old, currently diagnosed with PTSD, and experiencing cognitive symptoms. It's not open to those with other neurological diseases, major brain surgeries, moderate/severe TBI, recent substance abuse, severe psychotic disorders or current severe suicidal risks.

Inclusion Criteria

At least one self-reported cognitive symptom

I have been diagnosed with PTSD.

I have had one or more mild traumatic brain injuries for over 6 months.

Exclusion Criteria

I have never had a moderate or severe traumatic brain injury.

I have no history of serious brain or nerve conditions.

I do not have any severe illnesses that need treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend either a 9-week Mindfulness-based Stress Reduction class or a Brain Health Education class, each meeting 2.5 hours per week

9 weeks

Post-intervention Assessment

Standardized psychological and cognitive measures are administered to assess change in response to the intervention

Within 2 weeks post-intervention

Follow-up

Participants are monitored for lasting changes with an additional assessment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Brain Health Education class
• Mindfulness-based Stress Reduction class

Trial Overview

The study examines the effectiveness of two classes aimed at improving mental health in veterans who have suffered concussions: Brain Health Education and Mindfulness-based Stress Reduction. Participants will attend these wellness classes designed specifically for their needs.

How Is the Trial Designed?

Group I: Mindfulness-based Stress Reduction class Experimental Treatment 1 Intervention

Mindfulness-based Stress Reduction (MBSR) is a 9-week class that meets 2.5 hours/week and involves training in mindfulness (being present in the moment), meditation, and yoga. The MBSR course is taught by a certified MBSR instructor.

Group II: Brain Health Education Class Active Control 1 Intervention

the Brain Health Education Class is a 9-week class that meets 2.5 hours/week and involves lectures/discussion about how the brain works, how the brain ages, neuroplasticity, and other topics on the brain.

Who Is Running the Clinical Trial?

East Bay Institute for Research and Education

Lead Sponsor

Trials

9

Recruited

570+

Published Research Related to This Trial

Mindfulness-based stress reduction (MBSR) significantly improved depression, well-being, and perceived stress among Brazilian college faculty and students, as shown by questionnaire results before and after the intervention.

In contrast, a control group of teachers who did not participate in MBSR experienced either no change or worsening in their stress and well-being, highlighting the effectiveness of the MBSR program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based intervention for college faculties and students in Brazil. Cunha Paiva, SP., Campos Nunes, FF., Marinho Couto, BRG., et al.[2022]

The mindfulness-based stress reduction (MBSR) program, adapted for individuals with mild traumatic brain injury (mTBI), showed clinically meaningful improvements in quality of life and perceived self-efficacy after a 10-week intervention involving 22 participants.

Participants experienced enhanced awareness and acceptance of their symptoms, which may help reduce the negative impact of mTBI on their daily lives, suggesting that MBSR could be a beneficial therapeutic approach for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study examining the effect of mindfulness-based stress reduction on symptoms of chronic mild traumatic brain injury/postconcussive syndrome. Azulay, J., Smart, CM., Mott, T., et al.[2019]

An 8-week mindfulness-based group therapy significantly reduced chronic stress and depressive symptoms in individuals with mild-to-moderate traumatic brain injury (TBI) compared to an active control group.

The study indicates that mindfulness therapy is a feasible and effective intervention for managing chronic symptoms after TBI, suggesting its potential as a cost-effective self-management approach for early therapy post-injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Versus Health Promotion Group Therapy After Traumatic Brain Injury. Bay, E., Chan, RR.[2019]

A mindfulness-based stress reduction program significantly improved the quality of life in individuals with mild to moderate traumatic brain injuries, with a mean improvement of 15.40 points on the SF-36 scale compared to a decline in controls.

Participants also showed improvements in the cognitive-affective domain of depression, indicating that mindfulness techniques can be beneficial for psychological well-being after traditional treatments have been exhausted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot evaluation of a mindfulness-based intervention to improve quality of life among individuals who sustained traumatic brain injuries. Bédard, M., Felteau, M., Mazmanian, D., et al.[2015]

A study involving 79 veterans showed that a 9-week mindfulness-based stress reduction (MBSR) program significantly reduced symptoms of anxiety, depression, and suicidal ideation, while also improving mental health functioning.

Increased mindfulness during the MBSR program was linked to these improvements, highlighting the potential of mindfulness practices as a complementary approach for mental health issues among veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction (MBSR) reduces anxiety, depression, and suicidal ideation in veterans. Serpa, JG., Taylor, SL., Tillisch, K.[2014]

A pilot Mindfulness-Based Stress Reduction (MBSR) program was explored at a university, revealing that students face high levels of stress due to workload and a culture of perfectionism.

Participants reported that MBSR helped them gain perspective on their stressors and provided effective techniques for managing stress, suggesting that such programs could enhance student well-being and create a more supportive learning environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There Is No Performance, There Is Just This Moment: The Role of Mindfulness Instruction in Promoting Health and Well-Being Among Students at a Highly-Ranked University in the United States. Kerrigan, D., Chau, V., King, M., et al.[2019]

Mindfulness-based stress reduction (MBSR) training significantly improves psychological well-being and self-compassion among medical students, while also reducing stress and psychological distress, based on a review of nine studies.

Despite the positive effects on well-being, the impact of MBSR on empathy was inconsistent, and there was no evidence of a reduction in burnout, highlighting the need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for medical students: a narrative review. Polle, E., Gair, J.[2022]

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

The author provides a personal account of the development of mindfulness-based stress reduction (MBSR) teacher education at the University of Massachusetts Medical School, highlighting the foundational principles that shaped the Oasis Institute.

The narrative emphasizes how the educational trajectory and pedagogy of the Oasis Institute were influenced by the experiences and intentions of its founder, reflecting the importance of personal experience in shaping effective mindfulness education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building an ark: creating a vessel for the education of MBSR teachers. Santorelli, SF.[2020]

A school-based mindfulness-based stress reduction (MBSR) program significantly reduced anxiety and rumination in 7th and 8th grade boys compared to a health education program, indicating its effectiveness in improving mental health.

MBSR participants showed stable cortisol levels during academic stress, while those in the health education group experienced a trend towards increased cortisol, suggesting that MBSR may help mitigate physiological stress responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based mindfulness instruction for urban male youth: a small randomized controlled trial. Sibinga, EM., Perry-Parrish, C., Chung, SE., et al.[2022]

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