Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

Study Overview
=================
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.

Official Title
-----------------
Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Training


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness training<br>6 90-minute sessions interactive, web-based mindfulness training complemented with mobile application | Behavioral: Mindfulness Training<br>* interactive. web-based mindfulness training complemented with mobile application<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Chronic Pain, Mindfulness, Behavioral Health