SCI Pain App Intervention Study

Study Overview
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Brief Summary
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The purpose of this study is to find out if using an app is a feasible and acceptable treatment for chronic pain in persons with spinal cord injury. Participants will have a 50% chance of being asked to listen to 10 minutes of audio-guided meditations using an app each day for six weeks, and a 50% chance of being asked to listen to 10 minutes of engaging and distracting presentations about topics of interest to the individual (TED Talks) for six weeks. All participants will be asked to complete three online surveys about their emotional and physical health lasting 20-30 minutes (one when the participant first enters the study, one six weeks later, and another six weeks later). Additionally, participants will be asked to complete brief (<5 minute) online surveys once a week during the first six weeks of their participation. Participation in this study is very low risk, and participants may not experience any personal benefit from their participation. Participation in this study is entirely voluntary.

Official Title
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SCI Pain App Intervention Study

Conditions
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Spinal Cord Injuries, Chronic Pain

Intervention / Treatment
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* Behavioral: Mindfulness Meditation App
* Behavioral: Engagement and Distraction App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are at least 18 years of age have a traumatic SCI of at least 6 months duration have 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 understand the goals, procedures, time involved, and the time involved in participation, participate in the intervention and complete study surveys. Exclusion Criteria: have a significant visual or hearing impairment that limits their ability to participate in the app/computer-based intervention lack access to and the ability to use a smart phone or smart tablet (e.g., iPad) are unable to provide or obtain an email address for communication practiced any kind of meditation more than once a week in the past 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Meditation (MM) App<br>Participants randomized to the MM condition will be asked to download and use the free Mindfulness Coach app (available for iOS and Android platforms) developed by the Veteran Affairs National Center for PTSD. The app offers written information about mindfulness as well as 12 audio-guided meditations each lasting 8-13 minutes. Participants will attend a live videochat orientation to the study with the research coordinator (RC) to receive assistance in downloading and using the app. Participants will be asked to listen to at least one, and ideally two, audio-guided meditation exercises using the app daily for six weeks. The RC will ask participants to complete weekly logs of their MM app use via a Qualtrics survey sent via email. | Behavioral: Mindfulness Meditation App<br>* Listening to audio-guided meditation sessions using a mobile app.<br>|
| Active Comparator: Engagement and Distraction (ED) App<br>Participants randomized to the Engagement and Distraction condition will be asked to download and use the free TED Talk app (available for iOS and Android platforms). The app offers many videos of engaging and distracting presentations about technology, entertainment, and design. The research coordinator will work with the participant to create a customized list of Ted Talk videos, each lasting 6-12 minutes, based on participants' personal interests. Participants will be asked to listen to or watch at least one, and ideally two, presentations using the app daily for six weeks. The research coordinator will ask participants to complete weekly logs of their TED Talk app use via a Qualtrics survey sent via email. | Behavioral: Engagement and Distraction App<br>* Listening to engaging and distracting videos of interest to the participant using a mobile app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed | proportion of assigned home practice completed by participants | Immediately post-intervention (i.e., 6-weeks post-baseline) | 
| Feasibility of Immediate Post-Intervention Follow-Up Assessment as assessed by the proportion of participants who complete immediate post-intervention follow up assessment | proportion of participants who complete immediate post-intervention follow up assessment | Immediately post-intervention (i.e., 6-weeks post-baseline) | 
| Feasibility of 6-Week Follow-Up Assessment as assessed by the proportion of participants who complete 6 weeks post-intervention follow up assessment | proportion of participants who complete 6 weeks post-intervention follow up assessment | 6 weeks post-intervention (i.e., 12-weeks post-baseline) | 
| Participant Satisfaction as assessed by a satisfaction questionnaire adapted from the Client Satisfaction Questionnaire for Internet-based Interventions (CSQ-I) | participant reported satisfaction with their assigned condition; scores range from 12-48, with higher scores indicating greater satisfaction | Immediately post-intervention (i.e., 6-weeks post-baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International SCI Pain Basic Data Subset Questionnaire | Self-reported pain intensity and interference on a 0-10 scale with higher scores indicating greater pain intensity and interference | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) | 
| Chronic Pain Acceptance Questionnaire | Self-reported acceptance of pain; scores range from 0-156 with higher scores indicating greater acceptance of pain | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) | 
| Five Facet Mindfulness Questionnaire-Short Form | Self-reported mindfulness; scores range from 24-120 with higher scores indicating greater mindfulness | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) | 
| Patient Health Questionnaire-8 item | Depressive Symptoms; scores range from 0-24 with higher scores indicating greater depression symptoms | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) | 
| Generalized Anxiety Disorder Questionnaire-7 | Anxiety Symptoms; scores range from 0-21 with higher scores indicating greater anxiety symptoms | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) | 
| SCI-QOL Positive Affect and Wellbeing Questionnaire | Self-reported Quality of Life; scores range from 10-50 with higher scores indicating greater quality of life | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) |