Chronic Pain, Spinal Cord Injuries
Conditions
Brief summary
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.
Interventions
BEHAVIORALMindfulness Meditation App
Listening to audio-guided meditation sessions using a mobile app.
BEHAVIORALEngagement and Distraction App
Listening to engaging and distracting videos of interest to the participant using a mobile app.
Sponsors
The University of Texas Health Science Center, Houston
TIRR Memorial Hermann
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. are at least 18 years of age 2. have a traumatic SCI of at least 6 months duration 3. have chronic pain \[defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale\] 4. 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
1. have a significant visual or hearing impairment that limits their ability to participate in the app/computer-based intervention 2. lack access to and the ability to use a smart phone or smart tablet (e.g., iPad) 3. are unable to provide or obtain an email address for communication 4. practiced any kind of meditation more than once a week in the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of 6-Week Follow-Up Assessment as assessed by the proportion of participants who complete 6 weeks post-intervention follow up assessment | 6 weeks post-intervention (i.e., 12-weeks post-baseline) | proportion of participants who complete 6 weeks post-intervention follow up assessment |
| Participant Satisfaction as assessed by a satisfaction questionnaire adapted from the Client Satisfaction Questionnaire for Internet-based Interventions (CSQ-I) | Immediately post-intervention (i.e., 6-weeks post-baseline) | participant reported satisfaction with their assigned condition; scores range from 12-48, with higher scores indicating greater satisfaction |
| Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed | Immediately post-intervention (i.e., 6-weeks post-baseline) | proportion of assigned home practice completed by participants |
| Feasibility of Immediate Post-Intervention Follow-Up Assessment as assessed by the proportion of participants who complete immediate post-intervention follow up assessment | Immediately post-intervention (i.e., 6-weeks post-baseline) | proportion of participants who complete immediate post-intervention follow up assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-8 item | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) | Depressive Symptoms; scores range from 0-24 with higher scores indicating greater depression symptoms |
| SCI-QOL Positive Affect and Wellbeing Questionnaire | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) | Self-reported Quality of Life; scores range from 10-50 with higher scores indicating greater quality of life |
| Generalized Anxiety Disorder Questionnaire-7 | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) | Anxiety Symptoms; scores range from 0-21 with higher scores indicating greater anxiety symptoms |
| International SCI Pain Basic Data Subset Questionnaire | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) | Self-reported pain intensity and interference on a 0-10 scale with higher scores indicating greater pain intensity and interference |
| Chronic Pain Acceptance Questionnaire | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) | Self-reported acceptance of pain; scores range from 0-156 with higher scores indicating greater acceptance of pain |
| Five Facet Mindfulness Questionnaire-Short Form | Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline) | Self-reported mindfulness; scores range from 24-120 with higher scores indicating greater mindfulness |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-2 item | Assessed weekly during the 6-week intervention | Depressive Symptoms; scores range from 0-6 with higher scores indicating greater depression symptoms |
| Generalized Anxiety Disorder Questionnaire-2 | Assessed weekly during the 6-week intervention | Anxiety Symptoms; scores range from 0-6 with higher scores indicating greater anxiety symptoms |
Countries
United States
Outcome results
None listed