VR Mindfulness Training for Veterans With SCI

February 26, 2026 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030-4211
        • Recruiting
        • Michael E. DeBakey VA Medical Center, Houston, TX
        • Contact:
        • Principal Investigator:
          • Hilary Touchett, PhD MSN BSN
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VA CALM
This group will receive the VA CALM mindfulness programming.
Behavioral: 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.
Other Names:
  • VA CALM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life- World Health Organization Quality of Life-Brief (WHOQOL-BREF)
Time Frame: Baseline to 2 weeks post completion (Approx 14 weeks).
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).
Anxiety- Generalized Anxiety Disorder (GAD-7)
Time Frame: Baseline to 2 weeks post completion (Approx 14 weeks).
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)
Time Frame: Baseline to 2 weeks post completion (Approx 14 weeks).
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
Time Frame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
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
Time Frame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
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)
Time Frame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
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)
Time Frame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).

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)
Time Frame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
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)
Time Frame: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Hilary Touchett, PhD MSN BSN, Michael E. DeBakey VA Medical Center, Houston, TX

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

September 4, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B4813-M
  • 1IK1RX004813 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 3 months and ending 36 months following article publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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