Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587607
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
VR Mindfulness Training for Veterans With SCI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploring Virtual Reality Mindfulness Training for Veterans With SCI and Chronic Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None