VR Mindfulness Training for Veterans With SCI

NCT06587607 | Recruiting

• 2 other identifiers: B4813-M1IK1RX004813
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Chronic Pain

Keywords

Spinal Cord Injuries; Chronic Pain; Virtual Reality; Mindfulness

Outcome Measures

Primary Outcomes (6)

• 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)

  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).

Secondary Outcomes (9)

• 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).

Study Arms (1)

VA CALM

EXPERIMENTAL

This group will receive the VA CALM mindfulness programming.

Behavioral: VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum.

Interventions

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.

Also known as: VA CALM

VA CALM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Individuals unable to consent for research or medical care are ineligible to participate.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Chronic Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hilary Touchett, PhD MSN BSN

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 36 months following article publication.
• Access Criteria: 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.

Locations

US (1)