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Behavioral Intervention
Mindfulness Training for Spinal Cord Injury
N/A
Waitlist Available
Led By Hilary Touchett, PhD MSN BSN
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of spinal cord injury with incomplete or complete tetraplegia based on AIS score OR incomplete or complete paraplegia based on AIS score
Age 18+ years
Must not have
Individuals unable to consent for research or medical care are ineligible to participate.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 weeks post completion (approx 14 weeks).
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to adapt a mindfulness program called VA CALM for Veterans with spinal cord injuries. The study will involve delivering the program in its original form to a group of Veterans with SCI to identify areas
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves mindfulness training via virtual reality, side effects may include discomfort from VR use such as dizziness or nausea but are generally minimal compared to medical or drug interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a spinal cord injury resulting in tetraplegia or paraplegia.
Select...
I am 18 years old or older.
Select...
I have been experiencing chronic pain for at least 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am able to give consent for research and medical care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 2 weeks post completion (approx 14 weeks).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 weeks post completion (approx 14 weeks).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mindfulness- Five Facet Mindfulness Questionnaire (FFMQ)
Mindfulness- Mindfulness Attention Awareness Scale (MAAS)
Pain Acceptance- Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
+3 moreSecondary study objectives
Acceptability of Program- Acceptability of Intervention Measure (AIM)
Acceptability of Program- Intervention Appropriateness Measure (IAM)
Acceptability of Virtual Reality- Standardized User Experience Percentile Rank Questionnaire (SUPRQ)
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: VA CALMExperimental Treatment1 Intervention
This group will receive the VA CALM mindfulness programming.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,656 Total Patients Enrolled
42 Trials studying Chronic Pain
5,162 Patients Enrolled for Chronic Pain
Hilary Touchett, PhD MSN BSNPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX