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| ID | Type | Description | Link |
|---|---|---|---|
| 1IK1RX004813 | U.S. NIH Grant/Contract | View source |
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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.
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 2: Explore the feasibility and acceptability of delivering VA CALM-SCI over a Virtual Reality platform for Veterans with SCI and chronic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VA CALM | Experimental | This group will receive the VA CALM mindfulness programming. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum. | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mindfulness- Five Facet Mindfulness Questionnaire (FFMQ) | Minimum Score: 1 Maximum Score: 5 Score Interpretation: Items are aggregated and averaged. Higher scores indicate greater mindfulness. | Baseline to 2 weeks post completion (Approx 14 weeks). |
| Pain- PROMIS-Pain Numeric Rating Scale (NRS) | Minimum Score: 0 Maximum Score: 10 Score Interpretation: Single item measure, higher scores indicate greater pain intensity. | Baseline to 2 weeks post completion (Approx 14 weeks). |
| Mindfulness- Mindfulness Attention Awareness Scale (MAAS) | Minimum Score: 1 Maximum Score: 6 Score Interpretation: Items are aggregated and averaged. Higher scores indicate greater mindfulness | Baseline to 2 weeks post completion (Approx 14 weeks). |
| Pain Interference- PROMIS-Pain Interference (PROMIS-PI, SF8a) | 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. | Baseline to 2 weeks post completion (Approx 14 weeks). |
| Pain Acceptance- Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) | 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. | Baseline to 2 weeks post completion (Approx 14 weeks). |
| Pain Catastrophizing- Pain Catastrophizing Scale (PCS) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life- World Health Organization Quality of Life-Brief (WHOQOL-BREF) | Minimum Score: 4 Maximum Score: 20 Score interpretation: Measure is comprised of 4 quality of life domains: physical health, psychological health, social relationships, and environment. Items for each domain are aggregated, averaged, then scaled for final scoring. Higher scores indicate higher quality of life. | Baseline to 2 weeks post completion (Approx 14 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
-Individuals unable to consent for research or medical care are ineligible to participate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hilary Touchett, PhD MSN BSN | Contact | (713) 791-1414 | hilary.touchett@va.gov | |
| Felicia Skelton, MD MS | Contact | (713) 794-7128 | Felicia.Skelton2@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Hilary Touchett, PhD MSN BSN | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Recruiting | Houston | Texas | 77030-4211 | United States |
Individual participant data that underlie the results reported in articles to be published after de-identification (text, tables, figures, and appendices) as required by publishers, funding agencies, and or by law.
Further, a Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
Beginning 3 months and ending 36 months following article publication.
Data sharing will be permitted for the purposes of validation of results via replication of analyses with the limited, de-identified database. Individually identifiable information will be removed from any database shared to ensure protection of personal privacy. Further the data will be shared pursuant to a data use agreement which prohibits re-identification.
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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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.
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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.
| Baseline to 2 weeks post completion (Approx 14 weeks). |
| Anxiety- Generalized Anxiety Disorder (GAD-7) | Minimum Score: 0 Maximum Score: 21 Score Interpretation: Higher scores indicate more severe anxiety. 0-4: minimal anxiety, 5-9: mild anxiety, 10-14: moderate anxiety, 15-21: severe anxiety. | Baseline to 2 weeks post completion (Approx 14 weeks). |
| Depression- Patient Health Questionnaire-9 (PHQ-9) | Minimum Score: 0 Maximum Score: 27 Score Interpretation: Item scores are aggregated. Higher scores indicate greater depression severity. 0: no depression, 1-4: minimal depression, 5-9: mild depression, 10-14: moderate depression, 15-19: moderately severe depression, 20-27: severe depression. | Baseline to 2 weeks post completion (Approx 14 weeks). |
| Virtual Reality Embodiment- One-Item Presence Scale | Minimum Score: 1 Maximum Score: 10 Score Interpretation: Single item. Higher score indicates greater virtual presence. | After completion of 2nd VR session (One time point at completion of study, approximately week 12). |
| Virtual Reality Embodiment- Virtual Embodiment Questionnaire | Minimum Score:1 Maximum Score: 7 Scoring interpretation: Measures 3 domains: Acceptance (ownership), Control (agency), and Change (perceived change in the body scheme). Item scores are aggregated then averaged for each domain. Higher scores indicate greater embodiment. | After completion of 2nd VR session (One time point at completion of study, approximately week 12). |
| Acceptability of Virtual Reality- System Usability Scale (SUS) | Minimum Score: 0 Maximum Score: 100 Score interpretation: Items aggregated. Higher scores indicate greater usability. | 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) | Raw component Minimum Score: 1 Raw component Maximum Score: 5 Percentile Minimum Score: 0 Percentile Minimum Score: 100 Score interpretation: Two scores are generated and evaluated: Raw component score (1-5) which is aggregated and then averaged and percentile score (0-100). Higher scores indicate better user experience for both scales. | After completion of 2nd VR session (One time point at completion of study, approximately week 12). |
| Acceptability of Program- Acceptability of Intervention Measure (AIM) | Minimum Score: 1 Maximum Score: 5 Score interpretation: Items aggregated then averaged. Higher scores indicate greater acceptability. | After completion of 2nd VR session (One time point at completion of study, approximately week 12). |
| Acceptability of Program- Intervention Appropriateness Measure (IAM) | Minimum Score: 1 Maximum Score: 5 Score interpretation: Items aggregated then averaged. Higher scores indicate greater appropriateness. | After completion of 2nd VR session (One time point at completion of study, approximately week 12). |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |