NCT06891989Not yet recruitingNot Applicable
Effects of a Mobile App-Based Mindfulness Intervention in Persons With Spinal Cord Injury and Chronic Pain: A Randomized Controlled Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 282
- Locations
- 1
- Primary Endpoint
- Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Mindfulness meditation (MM)
Experimental
Intervention: Mindfulness meditation (MM) Intervention (Other)
Active Control (AC)
Active Comparator
Intervention: Health Education Active Control Intervention (Other)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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))
- Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)(baseline , post-intervention (6 weeks after baseline))
- Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD-7)(baseline , post-intervention (6 weeks after baseline))
Investigators
Radha Korupolu
Principal Investigator
Mayo Clinic
Study Sites (1)
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