Not provided
Not provided
Not provided
Not provided
Not provided
Lack of funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The University of Texas Health Science Center, Houston | OTHER |
| TIRR Memorial Hermann | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Meditation (MM) App | Experimental | 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. |
|
| Engagement and Distraction (ED) App | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Meditation App | Behavioral | Listening to audio-guided meditation sessions using a mobile app. |
|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-2 item | Depressive Symptoms; scores range from 0-6 with higher scores indicating greater depression symptoms | Assessed weekly during the 6-week intervention |
| Generalized Anxiety Disorder Questionnaire-2 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TIRR Memorial Hermann | Houston | Texas | 77030 | United States |
There is no plan to make IDP available to other researchers, aside from those directly involved in the project (i.e., listed on the study's IRB protocol at Baylor College of Medicine and the collaborating site, The University of Texas Health Science Center at Houston).
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Engagement and Distraction App | Behavioral | Listening to engaging and distracting videos of interest to the participant using a mobile app. |
|
| 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) |
Anxiety Symptoms; scores range from 0-6 with higher scores indicating greater anxiety symptoms
| Assessed weekly during the 6-week intervention |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |