Exploring Virtual Reality Mindfulness Training for Veterans With SCI and Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mindfulness- Five Facet Mindfulness Questionnaire (FFMQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Individuals unable to consent for research or medical care are ineligible to participate.
研究组 & 干预措施
VA CALM
This group will receive the VA CALM mindfulness programming.
干预措施: VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum. (Behavioral)
结局指标
主要结局
Mindfulness- Five Facet Mindfulness Questionnaire (FFMQ)
时间窗: Baseline to 2 weeks post completion (Approx 14 weeks).
Minimum Score: 1 Maximum Score: 5 Score Interpretation: Items are aggregated and averaged. Higher scores indicate greater mindfulness.
Pain- PROMIS-Pain Numeric Rating Scale (NRS)
时间窗: Baseline to 2 weeks post completion (Approx 14 weeks).
Minimum Score: 0 Maximum Score: 10 Score Interpretation: Single item measure, higher scores indicate greater pain intensity.
Mindfulness- Mindfulness Attention Awareness Scale (MAAS)
时间窗: Baseline to 2 weeks post completion (Approx 14 weeks).
Minimum Score: 1 Maximum Score: 6 Score Interpretation: Items are aggregated and averaged. Higher scores indicate greater mindfulness
Pain Interference- PROMIS-Pain Interference (PROMIS-PI, SF8a)
时间窗: Baseline to 2 weeks post completion (Approx 14 weeks).
Minimum Score: 8 Maximum Score: 40 Score Interpretation: Scores are converted into a T-score which rescales the score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate greater pain interference.
Pain Acceptance- Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
时间窗: Baseline to 2 weeks post completion (Approx 14 weeks).
Minimum Score: 0 Maximum Score: 6 Score Interpretation: Generates scores for two domains: Activity Engagement and Pain Willingness. Scores for each item in a domain are aggregated. Higher scores indicate higher levels of acceptance.
Pain Catastrophizing- Pain Catastrophizing Scale (PCS)
时间窗: Baseline to 2 weeks post completion (Approx 14 weeks).
Minimum Score: 0 Maximum Score: 52 Score Interpretation: Generates a total score PCS-T and three subscale scores: Rumination, Magnification, and Helplessness. Total score above 30 indicates clinically relevant level of catastrophizing.
次要结局
- Quality of Life- World Health Organization Quality of Life-Brief (WHOQOL-BREF)(Baseline to 2 weeks post completion (Approx 14 weeks).)
- Anxiety- Generalized Anxiety Disorder (GAD-7)(Baseline to 2 weeks post completion (Approx 14 weeks).)
- Depression- Patient Health Questionnaire-9 (PHQ-9)(Baseline to 2 weeks post completion (Approx 14 weeks).)
- Virtual Reality Embodiment- One-Item Presence Scale(After completion of 2nd VR session (One time point at completion of study, approximately week 12).)
- Virtual Reality Embodiment- Virtual Embodiment Questionnaire(After completion of 2nd VR session (One time point at completion of study, approximately week 12).)
- Acceptability of Virtual Reality- System Usability Scale (SUS)(After completion of 2nd VR session (One time point at completion of study, approximately week 12).)
- Acceptability of Virtual Reality- Standardized User Experience Percentile Rank Questionnaire (SUPRQ)(After completion of 2nd VR session (One time point at completion of study, approximately week 12).)
- Acceptability of Program- Acceptability of Intervention Measure (AIM)(After completion of 2nd VR session (One time point at completion of study, approximately week 12).)
- Acceptability of Program- Intervention Appropriateness Measure (IAM)(After completion of 2nd VR session (One time point at completion of study, approximately week 12).)