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

Trial Summary

What is the purpose of this trial?

This study involves delivering a mindfulness program that was developed for Veterans called VA Compassionate Awareness Learning Module (VA CALM) to Veterans with spinal cord injuries (SCI) to develop accommodations to make the VA CALM program more accessible for those with SCI. It will involve delivering the unmodified curriculum to a group of Veterans with SCI first to determine what areas need accommodations, working with a group of stakeholders to develop appropriate accommodations, and then delivering 1-2 modified modules via virtual reality to evaluate whether using virtual reality was feasible and acceptable for this program.

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 data supports the effectiveness of the treatment VA Compassionate Awareness Learning Module (VA CALM) for spinal cord injury?

Research shows that mindfulness-based interventions, which are similar to VA CALM, can help improve pain, depression, anxiety, and quality of life in people with spinal cord injuries. Additionally, mindfulness has been found to play a role in improving the quality of life by reducing pain and enhancing social support and functional independence. ^{1 2 3 4 5}

Is mindfulness training safe for people with spinal cord injury?

The research does not report any negative effects from mindfulness training for people with spinal cord injury, suggesting it is generally safe. ^{1 2 3 5 6}

How is the VA CALM treatment different from other treatments for spinal cord injury?

The VA CALM treatment is unique because it focuses on mindfulness training, which helps individuals become more aware of their thoughts and feelings in a non-judgmental way. This approach is different from traditional physical therapies or medications, as it aims to improve mental well-being and reduce stress, which can be particularly beneficial for managing the psychological aspects of living with a spinal cord injury. ^{1 2 5 7 8}

Research Team

Hilary Touchett, PhD MSN BSN

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Eligibility Criteria

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

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.

I have a spinal cord injury resulting in tetraplegia or paraplegia.

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Pilot clinical trial of a clinical meditation and imagery intervention for chronic pain after spinal cord injury. [2022]

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

Pain and quality of life in persons with spinal cord injury: Mediating effects of mindfulness, self-efficacy, social support, and functional independence. [2023]

4. 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]

5. 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]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Case Study of Hypnosis Enhanced Cognitive Therapy for Pain in a Ventilator Dependent Patient during Inpatient Rehabilitation for Spinal Cord Injury. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Is inspiratory muscle training effective for individuals with cervical spinal cord injury? A qualitative systematic review. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Community exercise for individuals with spinal cord injury with inspiratory muscle training: A pilot study. [2022]