Spinal Cord InjuriesNCT06891989
Effects of a Mobile App-Based Mindfulness Intervention in Persons With Spinal Cord Injury and Chronic Pain
A study testing Mindfulness meditation (MM) Intervention in people with Spinal Cord Injuries, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of a 6-week app-guided MM intervention compared to a 6-week app-guided health education AC condition on pain intensity, pain interference, depression, and anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Mindfulness meditation (MM) Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 30 Dec 2029
- 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
- Traumatic SCI of at least 6 months duration
- Chronic pain [defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale]
- Understand spoken and written English sufficiently to provide informed consent, participate in the intervention and complete study surveys
Who cannot join
- Lack of daily internet access
- Inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions about the study
- Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations
- Use of any meditation more than once a week in the last 3 months
- Inability to provide or obtain an email address for registration to the AC intervention and/or communication with study staff
- Inability to provide a phone number for communication with study staff
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
Mayo Clinic
Jacksonville, Florida, 32224
Department Physical Medicine & Rehab, 904-953-2000, Radha.Korupolu@mayo.edu
About this study
Official title: Effects of a Mobile App-Based Mindfulness Intervention in Persons With Spinal Cord Injury and Chronic Pain: A Randomized Controlled Trial
The purpose of this study is to evaluate the efficacy of a 6-week app-guided MM intervention compared to a 6-week app-guided health education AC condition on pain intensity, pain interference, depression, and anxiety.
- Conditions
- Spinal Cord Injuries
- Being tested
- Mindfulness meditation (MM) Intervention, Health Education Active Control Intervention
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditation (MM) InterventionOther
Participants will be asked to download the Mindfulness Coach app that provides simple instructions and brief meditation exercises.This is a a gradual training program of 14 levels which will be completed in the first 2-3 weeks. Each level provides short readings about mindfulness and one or two guided meditations (a silent "seated practice" for increasing lengths of time plus typically an additional 8-13-minute meditation). As participants progress through the levels, they earn "badges" displayed in the app, and an image of a tree on the home screen grows as each successive level is completed.For the remaining weeks of the intervention, participants will select at least one (and ideally two) guided meditation per day from the complete list of available meditations.Participants will track their progress through weekly logs.
Health Education Active Control InterventionOther
Participants will be asked to download and use the free TED Talk app, which will have 50 TED talk videos related to health that range from 3-20 minutes. Participants will be asked to watch or listen to these videos for ≥ 10 minutes daily for 6 days per week and complete weekly logs of the TED Talk app use.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness meditation (MM) | Experimental | Not described Receives: Other: Mindfulness meditation (MM) Intervention |
| Active Control (AC) | Active comparator | Not described Receives: Other: Health Education Active Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS).
Pain will be measured on Numeric Rating Scale (NRS) from 0(no pain) to 10(pain as bad as you can imagine)
Measured: baseline , post-intervention (6 weeks after baseline)
Secondary outcomes (3)
Change in pain interference as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference scale
This is a 10 item questionnaire, each item is typically scored on a 5-point Likert scale from 1 (Not at all) to 5 (Very much), for a maximum raw score of 50, higher scores reflect greater pain interference.
Measured: baseline , post-intervention (6 weeks after baseline)
Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)
This is a 8 item questionnaire , each measured on a 4 point scale from 0(not at all) to 3(nearly every day), for a score range of 0-27, higher score indicating worse outcome
Measured: baseline , post-intervention (6 weeks after baseline)
Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD-7)
This is an 7 item questionnaire, each is scored from 0(not at all) to 3(nearly every day), for a maximum score of 21, a higher score indicating more anxiety
Measured: baseline , post-intervention (6 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study startOct 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radha Korupolu, Mayo Clinic
- Investigators
- Radha Korupolu, MBBS, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891989
- Sponsor's protocol ID
- 26-008634
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mobile App-Based Mindfulness Intervention in Persons With Spinal Cord Injury and Chronic Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06891989
- Acronym / sponsor ID
- 26-008634
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 24 Mar 2025 (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.
The purpose of this study is to evaluate the efficacy of a 6-week app-guided MM intervention compared to a 6-week app-guided health education AC condition on pain intensity, pain interference, depression, and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness meditation (MM) | Experimental | Other: Mindfulness meditation (MM) Intervention |
| Active Control (AC) | Active comparator | Other: Health Education Active Control Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Traumatic SCI of at least 6 months duration
- Chronic pain [defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale]
- Understand spoken and written English sufficiently to provide informed consent, participate in the intervention and complete study surveys
Key exclusion criteria (6 listed)
- Lack of daily internet access
- Inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions about the study
- Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations
- Use of any meditation more than once a week in the last 3 months
- Inability to provide or obtain an email address for registration to the AC intervention and/or communication with study staff
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 |
|---|---|---|
| Mindfulness meditation (MM) InterventionParticipants will be asked to download the Mindfulness Coach app that provides simple instructions and brief meditation exercises.This is a a gradual training program of 14 levels which will be completed in the first 2-3 weeks. Each level provides short readings about mindfulness and one or two guided meditations (a silent "seated practice" for increasing lengths of time plus typically an additional 8-13-minute meditation). As participants progress through the levels, they earn "badges" displayed in the app, and an image of a tree on the home screen grows as each successive level is completed.For the remaining weeks of the intervention, participants will select at least one (and ideally two) guided meditation per day from the complete list of available meditations.Participants will track their progress through weekly logs. | Other | Mindfulness meditation (MM) |
| Health Education Active Control InterventionParticipants will be asked to download and use the free TED Talk app, which will have 50 TED talk videos related to health that range from 3-20 minutes. Participants will be asked to watch or listen to these videos for ≥ 10 minutes daily for 6 days per week and complete weekly logs of the TED Talk app use. | Other | Active Control (AC) |
Primary outcome
Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS).
Time frame: baseline , post-intervention (6 weeks after baseline)
Pain will be measured on Numeric Rating Scale (NRS) from 0(no pain) to 10(pain as bad as you can imagine)
3 secondary outcomes
Change in pain interference as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference scale
Time frame: baseline , post-intervention (6 weeks after baseline)
Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: baseline , post-intervention (6 weeks after baseline)
Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD-7)
Time frame: baseline , post-intervention (6 weeks after baseline)
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
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Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
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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.
Radha Korupolu, MBBS, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation (MM) Intervention in people with Spinal Cord Injuries, run by Mayo Clinic 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Aug 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 Department Physical Medicine & Rehab (904-953-2000, Radha.Korupolu@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS). (time frame: baseline , post-intervention (6 weeks after baseline)). 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 20 Aug 2026.