VR Mindfulness Training for Veterans With SCI
Purpose
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.
Conditions
- Spinal Cord Injury
- Chronic Pain
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Veteran - 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
- Individuals unable to consent for research or medical care are ineligible to participate.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single non-randomized group will be used to gather evaluation data on needed modifications to enhance program fit to the SCI population needs to develop a tailored curriculum for SCI. Outcomes will involve pre-post evaluation of measures to determine if there are any direct or indirect impacts of the mindfulness program as a preliminary feasibility study.
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VA CALM |
This group will receive the VA CALM mindfulness programming. |
|
Recruiting Locations
Houston 4699066, Texas 4736286 77030-4211
More Details
- NCT ID
- NCT06587607
- Status
- Recruiting
- Sponsor
- VA Office of Research and Development
Detailed Description
The objectives of this study are to explore the feasibility and acceptability of a spinal cord injury (SCI) tailored, evidence-based mindfulness group known as VA Compassionate Awareness Learning Module (VA CALM) when delivered via virtual reality (VR) The project will first assess modification needs for SCI and then explore the feasibility and acceptability of delivering VA CALM-SCI over VR. 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.