Mindfulness Meditation for Brain Injury

CA
Overseen ByClinical Associate Professor, OTD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Saint Joseph's University, Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mindfulness meditation program delivered through telehealth can improve sleep quality and reduce anxiety in people with brain injuries. Participants will attend eight sessions over four to five weeks, focusing on guided meditation and educational discussion. The trial suits those with an acquired brain injury who experience sleep or anxiety issues and have internet access for telehealth sessions. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance well-being for individuals with similar conditions.

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 prior data suggests that this mindfulness meditation program is safe for individuals with brain injury?

Research has shown that mindfulness meditation is generally safe for most people. In past studies, participants, including those with brain injuries, have handled mindfulness programs well. For instance, a small study with veterans who had mild brain injuries found that mindfulness-based stress reduction did not cause any negative effects.

Moreover, researchers have tested mindfulness practices in many different situations, and they have consistently been well-tolerated without major side effects. This makes mindfulness meditation a promising and safe choice for people wanting to improve their sleep and reduce anxiety.12345

Why are researchers excited about this trial?

Researchers are excited about mindfulness meditation for brain injury because it offers a non-pharmaceutical approach to healing. Unlike standard treatments that often involve medication and physical therapy, this method utilizes guided meditation to potentially improve cognitive and emotional outcomes. By focusing on mindfulness, it aims to enhance mental clarity and reduce stress, which could be especially beneficial for individuals with brain injuries. This approach is unique because it empowers patients to actively participate in their recovery process through meditation sessions, potentially leading to improved quality of life.

What evidence suggests that mindfulness meditation is effective for improving sleep quality and reducing anxiety in individuals with brain injury?

Research shows that mindfulness meditation, which participants in this trial will engage in, can aid recovery from brain injuries. It effectively reduces mental fatigue and enhances cognitive skills. Studies have found that mindfulness activities support recovery from mild brain injuries by clearing the mind and reducing stress. These activities also increase awareness and acceptance, potentially leading to improved mental health. These benefits suggest that mindfulness meditation might enhance sleep and reduce anxiety for those with brain injuries. Although direct evidence for this specific program is limited, the general success of mindfulness in similar areas is encouraging.678910

Who Is on the Research Team?

CA

Clinical Associate Professor, OTD

Principal Investigator

Saint Joseph's University

Are You a Good Fit for This Trial?

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.
See 1 more

Exclusion Criteria

I have been diagnosed with aphasia.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Eight- session of mindfulness meditationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Saint Joseph's University, Philadelphia

Lead Sponsor

Trials
4
Recruited
240+

Published Research Related to This Trial

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.
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]
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.
Adverse events in meditation practices and meditation-based therapies: a systematic review.Farias, M., Maraldi, E., Wallenkampf, KC., et al.[2021]
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.
Mindfulness-based cognitive therapy: benefits in reducing depression following a traumatic brain injury.Bédard, M., Felteau, M., Marshall, S., et al.[2022]

Citations

Mindfulness-based stress reduction as perceived by ...Mindfulness-based stress reduction (MBSR) has shown promising results in quantitative studies as a complementary treatment for pathological mental fatigue (PMF ...
“Hidden Gains”? Measuring the Impact of Mindfulness ...Mindfulness-based interventions can support recovery from mild traumatic brain injury (mTBI). Although measurement is a key determinant of outcomes, ...
The Effects of Mindfulness-Based Interventions on ...Research shows that MBSR mainly reduces mental fatigue symptoms in mTBI patients, and GOALS tend to improve their cognitive function.
Mindfulness-Based Cognitive Therapy Intervention to Treat ...A Multi-site, Randomized, Controlled Trial of a Mindfulness-based Cognitive Therapy Intervention for Treating Depression in a Traumatic Brain Injury Population.
EFFICACY OF ADAPTED MINDFULNESS-BASED ...However, the researchers suspect that this MBSR treatment used was effective at improving the participants' awareness and acceptance of their ...
Mindfulness-based stress reduction as perceived by ...Pilot evaluation of a mindfulness-based intervention to improve quality of life among individuals who sustained traumatic brain injuries.
Yoga, Meditation, and Mindfulness for Treatment of ...Outcome measures used to determine efficacy of treatment were primarily quality of life, followed by cognitive function and depression. Most ...
A Pilot Study of Mindfulness-Based Stress Reduction | Military ...In a pre-post mixed methods design pilot study, nine Veterans with post-traumatic stress disorder (PTSD) and a history of mild traumatic brain ...
A Pilot Study Examining the Effect of Mindfulness-Based ...Objective: To evaluate the effectiveness of the mindfulness-based stress reduction (MBSR) program tailored to.
Neurobiological Changes Induced by Mindfulness and ...Key outcomes include changes in brain structure and function, neuroplasticity, and alterations in stress-related biomarkers. 2.3. Inclusion ...
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