Mindfulness Training for Spinal Cord Injury

Overseen By Hilary Touchett, PhD MSN BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Unable to consent, others

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

Compensation: Varies

Number of Visits: 2

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mindfulness program called the VA Compassionate Awareness Learning Module (VA CALM) for Veterans with spinal cord injuries (SCI). The goal is to adapt the program to better suit those with SCI and determine if virtual reality enhances its effectiveness. Participants must be Veterans with a spinal cord injury experiencing chronic pain for over three months, have internet access, and be comfortable using a computer. As an unphased trial, this study offers Veterans a unique opportunity to contribute to innovative research that could improve pain management techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mindfulness program is safe for Veterans with spinal cord injuries?

Research has shown that mindfulness programs like the VA Compassionate Awareness Learning Module (VA CALM) are generally safe. A review of 26 studies found that mindfulness training can improve patient safety and treatment outcomes. Mindfulness reduces stress, alleviates anxiety and depression, and increases self-awareness. These findings suggest that mindfulness practices are well-tolerated and positively impact well-being. Although specific safety data for VA CALM in individuals with spinal cord injuries is lacking, mindfulness programs are generally considered low-risk and offer many potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VA Compassionate Awareness Learning Module (VA CALM) for spinal cord injury because it offers a unique approach through mindfulness training. Unlike traditional treatments that focus on physical rehabilitation or pain management through medications, VA CALM aims to enhance well-being by helping individuals develop greater awareness and emotional regulation. This mindfulness programming encourages patients to engage with their thoughts and feelings in a non-judgmental way, potentially leading to improved mental health and quality of life. The novelty of integrating mindfulness into spinal cord injury recovery is what sets VA CALM apart from existing options.

What evidence suggests that the VA CALM program is effective for spinal cord injury?

Research has shown that mindfulness training, such as the VA Compassionate Awareness Learning Module (VA CALM), can boost mental well-being. Studies on mindfulness programs have found improvements in stress levels, self-kindness, and mindfulness skills. In this trial, participants will receive the VA CALM mindfulness programming, which aims to make mindfulness more accessible and beneficial for veterans with spinal cord injuries. Although specific data on VA CALM for spinal cord injuries is limited, mindfulness training has proven beneficial in other areas, suggesting it might help with pain and emotional health. The program also explores the use of virtual reality to assess its practicality and reception. ^{1 2 3 6 7}

Who Is on the Research Team?

Hilary Touchett, PhD MSN BSN

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

This trial is for Veterans with spinal cord injuries (SCI) who are experiencing chronic pain. The study aims to adapt a mindfulness program, VA CALM, to better suit their needs. Participants will help identify necessary changes by first trying the unmodified version.

Inclusion Criteria

Access to high-speed internet

Endorse being (at least) minimally proficient on the computer (eg, able to check emails, read the news, etc.); be able, either independently or with caregiver support, to get online for virtual meetings and don/doff VR equipment

I can speak clearly and by myself in group discussions.

Exclusion Criteria

I am able to give consent for research and medical care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Formative Evaluation

Deliver the VA CALM program to 10 Veterans with SCI over telehealth to conduct a formative evaluation of the VA CALM curriculum to tailor for SCI contextual needs.

6 weeks

Telehealth sessions

Steering Committee

Assemble a Steering Committee of SCI stakeholders to develop appropriate strategies, accommodations, and recommended tools to support the delivery of VA CALM-SCI.

4 weeks

Virtual Reality Delivery

Deliver 2 VA CALM-SCI modules over VR to Veterans with SCI to assess the feasibility and acceptability of using VR in this population to deliver mindfulness training.

2 weeks

2 VR sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VA Compassionate Awareness Learning Module (VA CALM)

Trial Overview The intervention being tested is the VA Compassionate Awareness Learning Module (VA CALM), a mindfulness curriculum tailored for Veterans. This study tests its delivery through virtual reality to make it more accessible and suitable for those with SCI.

How Is the Trial Designed?

Group I: VA CALM Experimental Treatment 1 Intervention

This group will receive the VA CALM mindfulness programming.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a pilot study involving 6 participants with spinal cord injuries, an 8-week community exercise program that included inspiratory muscle training (IMT) led to significant improvements in functional measures such as transfer times and trunk strength.

Participants reported positive impacts from the program, suggesting that combining IMT with community exercise may help reduce respiratory complications and improve overall health outcomes for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community exercise for individuals with spinal cord injury with inspiratory muscle training: A pilot study. Leathem, JM., Macht-Sliwinski, M., Boak, S., et al.[2022]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06587607

VR Mindfulness Training for Veterans With SCI | ... The long-term goals and significance of this study include studying the efficacy of VA CALM-SCI for the treatment of chronic pain and examining the comparative ...

2. trialstoday.org trialstoday.org/trial/NCT06587607

VR Mindfulness Training for Veterans With SCI This study involves delivering a mindfulness program that was developed for Veterans called VA Compassionate Awareness Learning Module (VA CALM) ...

3. va.gov va.gov/wholehealth/professional-resources/clinician-tools/library-research-articles/Veteran-Caregiver.asp

Veteran Caregiver & VA Employee Well-being - Whole ... Outcomes from standardized measures included burnout, competence, mindfulness, self-compassion, and stress. Participant self-efficacy was also assessed. RESULTS.

4. research.va.gov research.va.gov/topics/sci.cfm

Spinal Cord Injury The study demonstrates that it may be possible to use stem cells to form a “bridge” around an injury to restore both movement and feeling in people with SCIs.

5. va.gov va.gov/wholehealthlibrary/passport/chapter-4.asp

Chapter 4. Mindful Awareness - Passport to Whole Health A 2019 review of 26 studies of mindfulness training for health care providers found moderate evidence that it improved patient safety, led to better treatment ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04807764?tab=table

Transspinal Stimulation Plus Locomotor Training for SCI Fifteen people with spinal cord injury will receive 40 daily sessions of 30 minutes of sham transspinal stimulation during standing at an intensity where ...

7. va.gov va.gov/WHOLEHEALTH/features/Reduce_Stress_Through_Mindfulness.asp

Reduce Stress Through Mindfulness - Whole Health Mindfulness has been shown to be effective for reducing stress, improving resilience, increasing self-awareness, helping with anxiety and depression.