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

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: East Bay Institute for Research and Education

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is testing the usefulness of two types of Brain Health \& Wellness classes for Veterans with a history of concussion to improve mental health.

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 data supports the effectiveness of this treatment for veterans with concussion-related issues?

Research shows that mindfulness-based stress reduction (MBSR) can improve quality of life and reduce symptoms in individuals with traumatic brain injuries, suggesting it may help veterans with concussion-related issues. ^{1 2 3 4 5}

Is Mindfulness-Based Stress Reduction (MBSR) safe for humans?

Mindfulness-Based Stress Reduction (MBSR) has been used in various settings, including universities and schools, to help reduce stress and improve mental health. The research suggests that MBSR is generally safe for humans and can contribute to better well-being. ^{3 5 6 7 8}

How is the Brain Health & Wellness Classes treatment different from other treatments for concussion-related issues?

This treatment is unique because it uses mindfulness-based stress reduction (MBSR), which is a meditation program that helps improve mental health and reduce stress, anxiety, and depression. Unlike standard medical treatments, MBSR is a complementary approach that focuses on self-management and has shown benefits for mood disorders and pain, making it appealing to veterans. ^{1 2 5 9 10}

Research Team

Eligibility Criteria

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

I have been diagnosed with PTSD.

At least one self-reported cognitive symptom

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.

Trial Timeline

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

Treatment Details

Interventions

• Brain Health Education class (Behavioral Intervention)
• Mindfulness-based Stress Reduction class (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pilot evaluation of a mindfulness-based intervention to improve quality of life among individuals who sustained traumatic brain injuries. [2015]

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2019]

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

School-based mindfulness instruction for urban male youth: a small randomized controlled trial. [2022]

6. United States 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. [2019]

7. Canada pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for medical students: a narrative review. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Mindfulness-based intervention for college faculties and students in Brazil. [2022]

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

Mindfulness-based stress reduction (MBSR) reduces anxiety, depression, and suicidal ideation in veterans. [2014]

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

Mindfulness-Based Versus Health Promotion Group Therapy After Traumatic Brain Injury. [2019]