Mindfulness Meditation for Brain Injury

Overseen By Clinical Associate Professor, OTD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Saint Joseph's University, Philadelphia

Disqualifiers: Aphasia

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

Compensation: Varies

Number of Visits: 2

Duration: 4-5 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to learn the effect of a telehealth mindfulness meditation program on sleep quality and anxiety in individuals with brain injury living in the community. The main questions it aims to answer are: * Does an eight-session mindfulness meditation program change sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in individuals with acquired brain injury? * Does an eight-session mindfulness meditation program change anxiety levels as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form in individuals with acquired brain injury? Participants will: * Complete eight sessions of mindfulness meditation over 4 to 5 weeks * Complete two mindfulness meditation sessions per week. * Complete two additional sessions for pre- and post-test measurements.

Do I have to stop taking my current medications for the trial?

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

What data supports the effectiveness of the treatment Mindfulness Meditation for Brain Injury?

Research shows that mindfulness-based group therapy can significantly reduce stress and symptoms in people with traumatic brain injuries, making it a promising and cost-effective approach for managing these conditions. ^{1 2 3 4 5}

Is mindfulness meditation generally safe for humans?

Mindfulness meditation is generally considered safe, but some people may experience anxiety, pain, or more severe reactions like psychosis, especially if they have a history of mental health issues. These reactions are often linked to the intensity and duration of meditation practices, and programs like Mindfulness-Based Stress Reduction are designed to be adaptable to avoid such issues. ^{5 6 7 8 9}

How is the treatment Mindfulness Meditation unique for brain injury?

Mindfulness Meditation is unique for brain injury because it focuses on reducing stress and improving emotional well-being through practices like meditation and awareness, rather than using medication or traditional therapy. This approach can help address psychological and emotional issues that are often overlooked in standard treatments for brain injury. ^{5 10 11 12 13}

Research Team

Clinical Associate Professor, OTD

Principal Investigator

Saint Joseph's University

Eligibility Criteria

This trial is for individuals with brain injuries who are living in the community. They should be interested in participating in a telehealth mindfulness meditation program to potentially improve their sleep and reduce anxiety.

Inclusion Criteria

Can speak and comprehend English

Score 19 or below on the Short Orientation-Memory-Concentration Test of Cognitive Impairment (SOMC)

I have been diagnosed with a brain injury that occurred after birth.

Exclusion Criteria

I have been diagnosed with aphasia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants complete eight sessions of mindfulness meditation over 4 to 5 weeks

4-5 weeks

2 sessions per week (virtual)

Follow-up

Participants are monitored for changes in sleep quality and anxiety levels after treatment

4 weeks

Treatment Details

Interventions

• Mindfulness Meditation

Trial Overview The study tests if an eight-session mindfulness meditation program delivered via telehealth can improve sleep quality, using the Pittsburgh Sleep Quality Index, and decrease anxiety levels, measured by PROMIS Anxiety Short Form, among those with acquired brain injury.

Participant Groups

Group I: Eight- session of mindfulness meditation Experimental Treatment 1 Intervention

Each mindfulness meditation session will be 30 minutes long, consisting of a 5-minute introduction, 15 minutes of guided mindfulness meditation, and 10 minutes of educational discussion. Participants are required to complete two mindfulness meditation sessions per week. Participants must complete a minimum of 8 sessions over 4 to 5 weeks.

Who Is Running the Clinical Trial?

Saint Joseph's University, Philadelphia

Lead Sponsor

Trials

4

Recruited

240+

Findings from Research

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]

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]

Mindfulness meditation programs have been shown to significantly reduce stress, anxiety, depression, and burnout among nurses and nursing students, enhancing their overall well-being and empathy.

The review included 16 studies, but most were small-scale, which limits the generalizability of the findings; larger and more rigorous studies are needed to confirm these benefits in broader nursing populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness meditation for nurses and nursing students: An integrated literature review. van der Riet, P., Levett-Jones, T., Aquino-Russell, C.[2022]

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]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

Mindfulness meditation, particularly through programs like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), is widely used to treat various conditions such as stress, depression, and chronic pain, but concerns about its safety have emerged due to reported adverse events.

The viewpoint argues that many reported negative experiences during mindfulness meditation, such as anxiety or discomfort, are not true adverse events but rather expected reactions that can occur as individuals learn to manage their mental and physical states; severe outcomes like psychosis are often influenced by external factors rather than the meditation itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Are Adverse Events in Mindfulness Meditation? Binda, DD., Greco, CM., Morone, NE.[2022]

A systematic review of 83 studies involving 6703 participants found that 8.3% experienced adverse events (AEs) related to meditation, with higher prevalence in observational studies (33.2%) compared to experimental studies (3.7%).

The most common adverse events included anxiety (33%), depression (27%), and cognitive anomalies (25%), indicating that meditation can lead to negative effects, even in individuals without prior mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in meditation practices and meditation-based therapies: a systematic review. Farias, M., Maraldi, E., Wallenkampf, KC., et al.[2021]

Mindfulness meditation (MM) can have side effects, particularly related to mental health, physical health, and spiritual well-being, highlighting the need for safety considerations in research.

The paper provides practical tools for researchers, including screening procedures to assess participant contraindications and guidelines for MM training, based on a review of 17 primary studies and 5 secondary reports on meditation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. Lustyk, MK., Chawla, N., Nolan, RS., 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]

Mindfulness-based cognitive therapy (MBCT) significantly reduced depression symptoms in individuals with traumatic brain injury (TBI) after an 8-week intervention, with medium to large effect sizes observed across all depression measures.

Participants also reported reduced pain intensity and increased energy levels following MBCT, highlighting its potential benefits beyond just alleviating depression in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: benefits in reducing depression following a traumatic brain injury. Bédard, M., Felteau, M., Marshall, S., et al.[2022]

References

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

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

2. 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]

3. Scotland pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness meditation for nurses and nursing students: An integrated literature review. [2022]

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

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

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

Mindfulness-Based Teaching Competency Assessment: Comparing Self-Assessment With Expert Evaluation in the Veterans Administration - Compassionate Awareness Learning Module Program. [2023]

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

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

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

What Are Adverse Events in Mindfulness Meditation? [2022]

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

Adverse events in meditation practices and meditation-based therapies: a systematic review. [2021]

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

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. [2022]

10. 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]

11. England pubmed.ncbi.nlm.nih.gov

Mindful Creativity Scale (MCS): Validation of a German version of the Langer Mindfulness Scale with patients with severe TBI and controls. [2019]

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

The use of relaxation training to enhance functional outcomes in adults with traumatic head injuries. [2019]

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

Mindfulness-based cognitive therapy: benefits in reducing depression following a traumatic brain injury. [2022]