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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if practicing mindfulness breathing exercises has an effect on the overall health of persons 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 data supports the effectiveness of the treatment Mindfulness for Spinal Cord Injury?

Research shows that mindfulness-based interventions can help improve quality of life and reduce symptoms of depression and anxiety in people with spinal cord injuries. These treatments have also been effective in improving quality of life and reducing depression in individuals with traumatic brain injuries, suggesting potential benefits for similar conditions. ^{1 2 3 4 5}

Is mindfulness safe for humans?

Mindfulness-based interventions are generally considered safe for humans and have been used in various conditions like depression and PTSD. They are seen as a safe, cost-effective addition to standard care. ^{1 6 7 8 9}

How is mindfulness treatment different for spinal cord injury?

Mindfulness treatment for spinal cord injury is unique because it focuses on improving mental health and quality of life by teaching individuals to be present and aware, which can help manage pain, depression, and anxiety. Unlike traditional medical treatments that may focus on physical symptoms, mindfulness addresses psychological well-being and can be delivered through web-based platforms, making it accessible to more people. ^{1 3 4 10 11}

Research Team

Mark Nash, PhD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

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]

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-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 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]

References

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

Mindfulness for pain, depression, anxiety, and quality of life in people with spinal cord injury: a systematic review. [2023]

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

Mindfulness-based cognitive therapy reduces symptoms of depression in people with a traumatic brain injury: results from a randomized controlled trial. [2022]

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

Efficacy of Internet-Delivered Mindfulness for Improving Depression in Caregivers of People With Spinal Cord Injuries and Chronic Neuropathic Pain: A Randomized Controlled Feasibility Trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The role of mindfulness in quality of life of persons with spinal cord injury: a cross-sectional study. [2022]

5. 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]

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. Denmark pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]

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

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. [2022]

9. England 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. [2018]

10. England pubmed.ncbi.nlm.nih.gov

'Trying to bring attention to your body when you're not sure where it is': An interpretative phenomenological analysis of drivers and barriers to mindfulness for people with spinal cord injury. [2021]

11. United States 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. [2023]