Mindfulness for Spinal Cord Injury

Overseen By Kayla Samimi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Chronotropic, Pressor

Disqualifiers: Pregnancy, Cardiovascular disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness breathing exercises can improve the health of people with spinal cord injuries (SCI). Participants will join a one-month program to practice these exercises. It suits individuals with SCI between the C5 and T10 levels who do not have acute illnesses or cardiovascular diseases. The goal is to determine if mindfulness can enhance overall well-being for people in this situation. As an unphased study, this trial offers participants a unique opportunity to contribute to innovative research that could improve the quality of life for those with SCI.

Will I have to stop taking my current medications?

If you are taking medications that affect heart rate or blood pressure, you will not be eligible to participate in this trial.

What prior data suggests that mindfulness is safe for individuals with spinal cord injury?

Research has shown that mindfulness practices are generally safe and manageable for most people. Studies have found that mindfulness can enhance the quality of life and mental health for those with spinal cord injuries. For instance, programs like mindfulness-based stress reduction (MBSR), similar to the exercises in this study, have been used without causing serious side effects.

Mindfulness has been compared to other treatments like cognitive behavioral therapy (CBT) and has demonstrated positive effects on health and well-being. These findings suggest that mindfulness practices are safe for people with spinal cord injuries, with few reported negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mindfulness for spinal cord injury because it offers a non-invasive, mind-body approach that differs from traditional treatments like medication and physical therapy. Mindfulness focuses on breathing exercises that can enhance mental well-being and potentially reduce pain perception. This approach is appealing since it empowers individuals to manage their symptoms actively and could complement existing therapies to improve overall quality of life.

What evidence suggests that mindfulness could be effective for spinal cord injury?

Research has shown that practicing mindfulness benefits the health and well-being of adults with spinal cord injuries (SCI). In this trial, participants will join a mindfulness exercise group, engaging in a one-month mindfulness breathing-exercise program. Studies have found that mindfulness exercises may improve the quality of life for people with SCI. These exercises can also help manage pain and lead to better mental health and daily functioning. Overall, mindfulness appears promising in enhancing life quality and reducing pain for those with SCI. ^{2 3 4 5 6}

Who Is on the Research Team?

Eduard Tiozzo, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with spinal cord injuries from C5 to T10 levels, who can consent and are in good health without acute illnesses or cardiovascular disease. Pregnant individuals or those on certain medications affecting heart rate and blood pressure cannot join.

Inclusion Criteria

Self-reported American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A-D

I understand the study and am in good health without any acute illness or heart disease.

I am between 18 and 70 years old with a spinal cord injury between C5 and T10.

Exclusion Criteria

I am not on medication that affects my heart rate or blood pressure.

I am not pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness Breathing Exercise Program

Subjects participate in a one-month mindfulness breathing-exercise program

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in metabolism, heart rate, blood pressure, and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness

Trial Overview The study explores whether mindfulness breathing exercises improve the overall quality of life for people living with spinal cord injuries. Participants will practice these exercises to see if there's a positive effect.

How Is the Trial Designed?

Group I: Mindfulness Exercise Group Experimental Treatment 1 Intervention

Subjects will participate in a one-month mindfulness breathing-exercise program

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

Mindfulness-Based Stress Reduction (MBSR) has been shown to improve mental health in 11 studies compared to waitlist controls or treatment as usual, demonstrating its efficacy as a therapeutic intervention.

Mindfulness-Based Cognitive Therapy (MBCT) effectively reduces the risk of depressive relapse, showing similar efficacy to treatment as usual in two studies, indicating its potential as a preventive measure for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Fjorback, LO., Arendt, M., Ornbøl, E., et al.[2022]

Mindfulness-based interventions (MBIs) are effective in reducing symptom severity in major depressive disorder and lowering relapse rates during maintenance treatment, based on a review of 52 studies.

MBIs, particularly mindfulness-based stress reduction, have shown effectiveness in improving symptoms and quality of life in veterans with PTSD, and they are considered safe and cost-effective adjuncts to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. Khusid, MA., Vythilingam, M.[2018]

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]

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]

In a study of 159 individuals with spinal cord injury, key components of Acceptance and Commitment Therapy (ACT) such as acceptance, values pursuit, and defusion were found to significantly reduce anxiety levels.

The overall ACT processes also contributed to lower perceived stress, suggesting that tailored ACT-based interventions could be effective in managing anxiety and stress for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Acceptance and Commitment Therapy Core Processes on Anxiety and Stress in Persons With Spinal Cord Injury: A Cross-sectional Study. Dorenkamp, MA., Waldron-Perrine, B., Hanks, R.[2023]

Citations

1. tandfonline.com tandfonline.com/doi/full/10.1080/10790268.2024.2374130

Mindfulness for health and wellbeing in adults with spinal ... Mindfulness and mindfulness-based interventions appear to positively impact health and well-being in adults with SCI.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9620601/

The role of mindfulness in quality of life of persons ... This study aimed to identify the direct and indirect effect of mindfulness on the quality of life of persons living with spinal cord injury.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846725001222

Evaluation of Mindfulness-based Interventions for Pain ... The results of this study trend positively towards the treatment groups, showing possible benefits in utilizing MBI for patients with SCI suffering from pain ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04972773

Spinal Cord Injury Mental Health Functional Outcomes ... This research will isolate SCI patients to understand the effects of MM. Research focuses on programs like mindfulness-based stress reduction (MBSR), an 8-week ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2504811

Effect of Mindfulness-Based Stress Reduction vs Cognitive ... Treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11900371/

Mindfulness-Based Cognitive Therapy in Clinical Practice MBCT is a clinical intervention that integrates cognitive therapy with mindfulness practices to prevent depression relapses and improve mental health.