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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness meditation (MM) | Experimental |
| |
| Active Control (AC) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness meditation (MM) Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS). | Pain will be measured on Numeric Rating Scale (NRS) from 0(no pain) to 10(pain as bad as you can imagine) | baseline , post-intervention (6 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain interference as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference scale | 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. | baseline , post-intervention (6 weeks after baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radha Korupolu, MD | Contact | 713-797-5233 | Radha.Korupolu@uth.tmc.edu | |
| Shrasti Lohiya | Contact | 713-797-7132 | Shrasti.Lohiya@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Radha Korupolu, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| Health Education Active Control Intervention | Other | 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. |
|
| Change in depression as assessed by the Patient Health Questionnaire (PHQ-9) | 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 | baseline , post-intervention (6 weeks after baseline) |
| Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) | 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 | baseline , post-intervention (6 weeks after baseline) |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D008722 | Methods |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D008919 | Investigative Techniques |
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