Chronic Pain
Conditions
Keywords
Chronic Pain, Mindfulness, Behavioral Health, Quality of Life
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindfulness Training
interactive. web-based mindfulness training complemented with mobile application
Sponsors
University of North Carolina, Chapel Hill
RTI International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients who have experienced chronic pain for at least 6 months
Exclusion criteria
* Do not have any of the following conditions: substance abuse or dependence, psychosis, suicidal ideation in the last 2 months, high levels of trauma symptoms, * plans to have a permanent change of station or deploy in the coming 6 months, or * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pain - Pain Intensity | Baseline | Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Intensity 3a |
| Chronic Pain - Pain Interference | Baseline | Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Interference 8a |
| Chronic Pain | Baseline | Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mindfulness | Baseline | Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ) |
| Co-Occurring Conditions - Depression | Baseline | Assess depression using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional Distress - Depression 8a |
| Co-Occurring Conditions - Anxiety | Baseline | Assess anxiety using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 - Emotional Distress- Anxiety 6a |
| Co-Occurring Conditions - Alcohol Use | Baseline | Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT) |
| Co-Occurring Conditions - Post Traumatic Stress Disorder | Baseline | Assess trauma symptoms in response to stressful experiences using the Post Traumatic Stress Disorder (PTSD) Checklist - Civilian version (PCL-C) |
| Self-Regulation - Pain Catastrophizing Scale | Baseline | Assess experience of pain through sub-scales of rumination, magnification and helplessness |
| Quality of Life - Physical Functioning | Baseline | Assess physical functioning using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Physical Function 12a |
| Quality of Life - Sleep disturbance | Baseline | Assess sleep quality, depth and restoration using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Sleep Disturbance 8a |
| Quality of Life - Fatigue | Baseline | Assess fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Fatigue 8a |
| Quality of Life - Role satisfaction | Baseline | 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 |
| Co-Occurring Conditions - Prescription drug misuse | Baseline | Assess use of drugs not prescribed, or use of more than recommended dose, to feel good/get high/buzzed |
| Self-Regulation - Chronic Pain Acceptance Scale | Baseline | Assess behavioral aspects of chronic pain acceptance |
| Self-Regulation - Emotional Behavioral Dysregulation | Baseline | Assess emotional behavioral dysregulation using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional and Behavioral Dyscontrol |
Countries
United States
Outcome results
None listed