Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-02-03
2027-01-31
Brief Summary
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Detailed Description
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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 effectiveness between VR and video telehealth modalities to build evidence for the modified intervention. This work has the potential to improve care for Veterans with SCI who are at risk of being left out of innovative clinical advancements that improve quality of life and well-being, due to the complexity of their medical condition.
Aim 1: Conduct a formative evaluation of the VA CALM program to develop accommodations to improve program accessibility and acceptability for Veterans with SCI and chronic pain (VA CALM-SCI).
* Aim 1a: 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.
* Aim 1b: Assemble a Steering Committee of SCI stakeholders (10 members) to develop appropriate strategies, accommodations, and recommended tools to support the delivery of VA CALM-SCI.
Aim 2: Explore the feasibility and acceptability of delivering VA CALM-SCI over a Virtual Reality platform for Veterans with SCI and chronic pain.
* Aim 2a: Assess potential VR applications and settings for delivery and testing of VA CALM-SCI.
* Aim 2b: 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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VA CALM
This group will receive the VA CALM mindfulness programming.
VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum.
VA CALM is a 9 week mindfulness curriculum typically delivered at a once/week module pace in group settings during sessions that last approximately 60-90 minutes. Module topics include: Program Introduction, Why mindfulness, Perception, What Makes Something a Pleasant Experience?, Being Stuck, Getting Unstuck, Communication, Mindfulness in Daily Life, and Today is the First Dat of the Rest of Your Life.
Interventions
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VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum.
VA CALM is a 9 week mindfulness curriculum typically delivered at a once/week module pace in group settings during sessions that last approximately 60-90 minutes. Module topics include: Program Introduction, Why mindfulness, Perception, What Makes Something a Pleasant Experience?, Being Stuck, Getting Unstuck, Communication, Mindfulness in Daily Life, and Today is the First Dat of the Rest of Your Life.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of spinal cord injury with incomplete or complete tetraplegia based on AIS score OR incomplete or complete paraplegia based on AIS score.
* Endorses chronic pain lasting 3 months;
* age 18+ years
* 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
* Able to speak clearly and independently to participate in focus group interviews.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Hilary Touchett, PhD MSN BSN
Role: PRINCIPAL_INVESTIGATOR
Michael E. DeBakey VA Medical Center, Houston, TX
Locations
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Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B4813-M
Identifier Type: -
Identifier Source: org_study_id
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