Spinal Cord InjuryNCT06587607
VR Mindfulness Training for Veterans With SCI
A study testing VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum. in people with Spinal Cord Injury and Chronic Pain, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Chronic Pain
- What is being tested?
- VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -Individuals unable to consent for research or medical care are ineligible to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Suzette Stine, MBA BS, (713) 794-8654, suzette.stine@va.gov
Jan A Lindsay, PhD, (713) 440-4482, Jan.Lindsay2@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injury, Chronic Pain
- Being tested
- VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum.
- Keywords
- Spinal Cord Injuries, Chronic Pain, Virtual Reality, Mindfulness
- Medical subject headings
- Spinal Cord Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum.Behavioural
Also called VA CALM
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.
| Study group | Role | What they receive |
|---|---|---|
| VA CALM | Experimental | This group will receive the VA CALM mindfulness programming. Receives: Behavioral: VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness- Five Facet Mindfulness Questionnaire (FFMQ)
Minimum Score: 1 Maximum Score: 5 Score Interpretation: Items are aggregated and averaged. Higher scores indicate greater mindfulness.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 2 weeks post completion (Approx 14 weeks).
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After completion of 2nd VR session (One time point at completion of study, approximately week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Hilary Touchett, PhD MSN BSN, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587607
- Sponsor's protocol ID
- B4813-M
- Other IDs
- 1IK1RX004813
- Status last verified
- Feb 2026
- First submitted
- 4 Sep 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Virtual Reality Mindfulness Training for Veterans With SCI and Chronic Pain
- ClinicalTrials.gov ID
- NCT06587607
- Acronym / sponsor ID
- B4813-M
- Conditions
- Spinal Cord Injury, Chronic Pain
- Keywords
- Spinal Cord Injuries, Chronic Pain, Virtual Reality, Mindfulness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VA CALM | Experimental | Behavioral: VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum.This group will receive the VA CALM mindfulness programming. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- -Individuals unable to consent for research or medical care are ineligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum.Also: VA CALMVA 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. | Behavioural | VA CALM |
Primary outcome
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.
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.
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
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.
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.
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.
9 secondary outcomes
Quality of Life- World Health Organization Quality of Life-Brief (WHOQOL-BREF)
Time frame: 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).
Depression- Patient Health Questionnaire-9 (PHQ-9)
Time frame: 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).
Virtual Reality Embodiment- Virtual Embodiment Questionnaire
Time frame: 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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hilary Touchett, PhD MSN BSN principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VA Compassionate Awareness Learning Module (VA CALM) a mindfulness curriculum. in people with Spinal Cord Injury and Chronic Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilary Touchett, PhD MSN BSN ((713) 791-1414, hilary.touchett@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness- Five Facet Mindfulness Questionnaire (FFMQ) (time frame: Baseline to 2 weeks post completion (Approx 14 weeks).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.