Идёт набор NCT06587607

VR Mindfulness Training for Veterans With SCI

Без фазы С лечением Spinal Cord Injury Chronic Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum..
Кому может быть актуально: Состояния в реестре: Spinal Cord Injury, Chronic Pain. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Exploring Virtual Reality Mindfulness Training for Veterans With SCI and Chronic Pain

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое 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.

Первичные конечные точки

Mindfulness- Five Facet Mindfulness Questionnaire (FFMQ) [Срок оценки: Baseline to 2 weeks post completion (Approx 14 weeks).]
Pain- PROMIS-Pain Numeric Rating Scale (NRS) [Срок оценки: Baseline to 2 weeks post completion (Approx 14 weeks).]
Mindfulness- Mindfulness Attention Awareness Scale (MAAS) [Срок оценки: Baseline to 2 weeks post completion (Approx 14 weeks).]
Pain Interference- PROMIS-Pain Interference (PROMIS-PI, SF8a) [Срок оценки: Baseline to 2 weeks post completion (Approx 14 weeks).]
Pain Acceptance- Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) [Срок оценки: Baseline to 2 weeks post completion (Approx 14 weeks).]
Pain Catastrophizing- Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline to 2 weeks post completion (Approx 14 weeks).]

Вторичные конечные точки (9)

Quality of Life- World Health Organization Quality of Life-Brief (WHOQOL-BREF) [Срок оценки: Baseline to 2 weeks post completion (Approx 14 weeks).]
Anxiety- Generalized Anxiety Disorder (GAD-7) [Срок оценки: Baseline to 2 weeks post completion (Approx 14 weeks).]
Depression- Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline to 2 weeks post completion (Approx 14 weeks).]
Virtual Reality Embodiment- One-Item Presence Scale [Срок оценки: After completion of 2nd VR session (One time point at completion of study, approximately week 12).]
Virtual Reality Embodiment- Virtual Embodiment Questionnaire [Срок оценки: After completion of 2nd VR session (One time point at completion of study, approximately week 12).]
Acceptability of Virtual Reality- System Usability Scale (SUS) [Срок оценки: 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) [Срок оценки: After completion of 2nd VR session (One time point at completion of study, approximately week 12).]
Acceptability of Program- Acceptability of Intervention Measure (AIM) [Срок оценки: After completion of 2nd VR session (One time point at completion of study, approximately week 12).]
Acceptability of Program- Intervention Appropriateness Measure (IAM) [Срок оценки: After completion of 2nd VR session (One time point at completion of study, approximately week 12).]

Критерии участия

Критерии включения

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.