Clinical trial NCT06587607: VR Mindfulness Training for Veterans With SCI
Official title: Exploring Virtual Reality Mindfulness Training for Veterans With SCI and Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Chronic Pain
Keywords: Spinal Cord Injuries
Chronic Pain
Virtual Reality
Mindfulness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mindfulness- Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline to 2 weeks post completion (Approx 14 weeks).
measure: Pain- PROMIS-Pain Numeric Rating Scale (NRS)
timeFrame: Baseline to 2 weeks post completion (Approx 14 weeks).
measure: Mindfulness- Mindfulness Attention Awareness Scale (MAAS)
timeFrame: Baseline to 2 weeks post completion (Approx 14 weeks).
measure: Pain Interference- PROMIS-Pain Interference (PROMIS-PI, SF8a)
timeFrame: Baseline to 2 weeks post completion (Approx 14 weeks).
measure: Pain Acceptance- Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
timeFrame: Baseline to 2 weeks post completion (Approx 14 weeks).
measure: Pain Catastrophizing- Pain Catastrophizing Scale (PCS)
timeFrame: Baseline to 2 weeks post completion (Approx 14 weeks).
Secondary outcomes:
measure: Quality of Life- World Health Organization Quality of Life-Brief (WHOQOL-BREF)
timeFrame: Baseline to 2 weeks post completion (Approx 14 weeks).
measure: Anxiety- Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline to 2 weeks post completion (Approx 14 weeks).
measure: Depression- Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline to 2 weeks post completion (Approx 14 weeks).
measure: Virtual Reality Embodiment- One-Item Presence Scale
timeFrame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
measure: Virtual Reality Embodiment- Virtual Embodiment Questionnaire
timeFrame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
measure: Acceptability of Virtual Reality- System Usability Scale (SUS)
timeFrame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
measure: Acceptability of Virtual Reality- Standardized User Experience Percentile Rank Questionnaire (SUPRQ)
timeFrame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
measure: Acceptability of Program- Acceptability of Intervention Measure (AIM)
timeFrame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
measure: Acceptability of Program- Intervention Appropriateness Measure (IAM)
timeFrame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Hilary Touchett, PhD MSN BSN
role: PRINCIPAL_INVESTIGATOR
References: