Recruiting

VR Mindfulness

Sponsor:

VA Office of Research and Development

Code:

NCT06587607

Conditions

Spinal Cord Injury

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06587607

Start date

Jul 1, 2025

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: VA CALM

This group will receive the VA CALM mindfulness programming.

Interventions

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.

Primary outcome measure

  • Mindfulness- Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 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). ]
  • Mindfulness- Mindfulness Attention Awareness Scale (MAAS) [ Time Frame: 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). ]
  • Pain Acceptance- Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Hilary Touchett, PhD MSN BSN

(713) 791-1414hilary.touchett@va.gov

Felicia Skelton, MD MS

(713) 794-7128Felicia.Skelton2@va.gov

Locations

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Suzette Stine, MBA BS

(713) 794-8654suzette.stine@va.gov

Jan A Lindsay, PhD

(713) 440-4482Jan.Lindsay2@va.gov

Principal Investigator:

Hilary Touchett, PhD MSN BSN

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Spinal Cord Injuries
  • Chronic Pain
  • Virtual Reality
  • Mindfulness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-03-02.