Spinal Cord Injuries
Conditions
Brief 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.
Interventions
OTHERMindfulness meditation (MM) Intervention
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.
OTHERHealth Education Active Control Intervention
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS). | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain interference as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference scale | baseline , post-intervention (6 weeks after baseline) | 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. |
| Change in depression as assessed by the Patient Health Questionnaire (PHQ-9) | baseline , post-intervention (6 weeks after baseline) | 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 |
| Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) | baseline , post-intervention (6 weeks after baseline) | 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 |
Countries
United States
Contacts
CONTACTDepartment Physical Medicine & Rehab
PRINCIPAL_INVESTIGATORRadha Korupolu, MBBS, MD
Mayo Clinic
Outcome results
None listed