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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
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The overall aim of this study is to test the acceptability and feasibility of an interactive, web-based mindfulness training with active duty soldiers being treated for chronic pain.
The overall aim of study is to test the acceptability and feasibility of an interactive, web-based mindfulness training with active duty soldiers being treated for chronic pain. We will adapt the evidence-based Mindfulness-based Stress Reduction (MBSR) training for use with this population. The adapted training will be enhanced by mobile applications (apps) for skills practice, using an existing apps platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness training | Experimental | 6 90-minute sessions interactive, web-based mindfulness training complemented with mobile application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Training | Behavioral | interactive. web-based mindfulness training complemented with mobile application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Pain - Pain Intensity | Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Intensity 3a | Baseline |
| Chronic Pain - Pain Intensity | Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Intensity 3a | 6 - 8 weeks post-treatment |
| Chronic Pain - Pain Interference | Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Interference 8a | Baseline |
| Chronic Pain - Pain Interference | Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Interference 8a | 6 - 8 weeks post-treatment |
| Chronic Pain | Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire | Baseline |
| Chronic Pain | Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire | 6 - 8 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Co-Occurring Conditions - Depression | Assess depression using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional Distress - Depression 8a | Baseline |
| Co-Occurring Conditions - Depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shari Miller, PhD | RTI International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Womack Army Medical Center at Ft. Bragg | Fort Bragg | North Carolina | 28301 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Assess depression using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional Distress - Depression 8a
| 6 - 8 weeks post-treatment |
| Co-Occurring Conditions - Anxiety | Assess anxiety using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 - Emotional Distress- Anxiety 6a | Baseline |
| Co-Occurring Conditions - Anxiety | Assess anxiety using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 - Emotional Distress- Anxiety 6a | 6 - 8 weeks post-treatment |
| Co-Occurring Conditions - Alcohol Use | Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT) | Baseline |
| Co-Occurring Conditions - Alcohol Use | Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT) | 6 - 8 weeks post-treatment |
| Co-Occurring Conditions - Post Traumatic Stress Disorder | Assess trauma symptoms in response to stressful experiences using the Post Traumatic Stress Disorder (PTSD) Checklist - Civilian version (PCL-C) | Baseline |
| Co-Occurring Conditions - Post Traumatic Stress Disorder | Assess trauma symptoms in response to stressful experiences using the Post Traumatic Stress Disorder (PTSD) Checklist - Civilian version (PCL-C) | 6 - 8 weeks post-treatment |
| Co-Occurring Conditions - Prescription drug misuse | Assess use of drugs not prescribed, or use of more than recommended dose, to feel good/get high/buzzed | Baseline |
| Co-Occurring Conditions - Prescription drug misuse | Assess use of drugs not prescribed, or use of more than recommended dose, to feel good/get high/buzzed | 6 - 8 weeks post-treatment |
| Quality of Life - Physical Functioning | Assess physical functioning using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Physical Function 12a | Baseline |
| Quality of Life - Physical Functioning | Assess physical functioning using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Physical Function 12a | 6 - 8 weeks post-treatment |
| Quality of Life - Sleep disturbance | Assess sleep quality, depth and restoration using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Sleep Disturbance 8a | Baseline |
| Quality of Life - Sleep disturbance | Assess sleep quality, depth and restoration using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Sleep Disturbance 8a | 6 - 8 weeks post-treatment |
| Quality of Life - Fatigue | Assess fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Fatigue 8a | Baseline |
| Quality of Life - Fatigue | Assess fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Fatigue 8a | 6 - 8 weeks post-treatment |
| Quality of Life - Role satisfaction | Assess social satisfaction using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Ability to Participate in Social Roles & Activities 8a | Baseline |
| Quality of Life - Role satisfaction | Assess social satisfaction using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Ability to Participate in Social Roles & Activities 8a | 6 - 8 weeks post-treatment |
| Self-Regulation - Pain Catastrophizing Scale | Assess experience of pain through sub-scales of rumination, magnification and helplessness | Baseline |
| Self-Regulation - Pain Catastrophizing Scale | Assess experience of pain through sub-scales of rumination, magnification and helplessness | 6 - 8 weeks post-treatment |
| Self-Regulation - Chronic Pain Acceptance Scale | Assess behavioral aspects of chronic pain acceptance | Baseline |
| Self-Regulation - Chronic Pain Acceptance Scale | Assess behavioral aspects of chronic pain acceptance | 6 - 8 weeks post-treatment |
| Self-Regulation - Emotional Behavioral Dysregulation | Assess emotional behavioral dysregulation using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional and Behavioral Dyscontrol | Baseline |
| Self-Regulation - Emotional Behavioral Dysregulation | Assess emotional behavioral dysregulation using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional and Behavioral Dyscontrol | 6 - 8 weeks post-treatment |
| Mindfulness | Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ) | Baseline |
| Mindfulness | Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ) | 6 - 8 weeks post-treatment |