Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

Not Applicable

Completed

• Conditions: Chronic Pain

• Registration Number: NCT03104465
• Lead Sponsor: RTI International

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.

Study Timeline

• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-07
• Study Start: 2017-04-30
• Primary Completion: 2018-06-11
• Study Completion: 2018-06-11
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Chronic Pain - Pain Interference	6 - 8 weeks post-treatment	Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Interference 8a
Chronic Pain	6 - 8 weeks post-treatment	Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire
Chronic Pain - Pain Intensity	6 - 8 weeks post-treatment	Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Intensity 3a

Secondary Outcome Measures

Name	Time	Method
Co-Occurring Conditions - Post Traumatic Stress Disorder	6 - 8 weeks post-treatment	Assess trauma symptoms in response to stressful experiences using the Post Traumatic Stress Disorder (PTSD) Checklist - Civilian version (PCL-C)
Co-Occurring Conditions - Prescription drug misuse	6 - 8 weeks post-treatment	Assess use of drugs not prescribed, or use of more than recommended dose, to feel good/get high/buzzed
Co-Occurring Conditions - Anxiety	6 - 8 weeks post-treatment	Assess anxiety using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 - Emotional Distress- Anxiety 6a
Quality of Life - Physical Functioning	6 - 8 weeks post-treatment	Assess physical functioning using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Physical Function 12a
Co-Occurring Conditions - Alcohol Use	6 - 8 weeks post-treatment	Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT)
Quality of Life - Sleep disturbance	6 - 8 weeks post-treatment	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	6 - 8 weeks post-treatment	Assess fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Fatigue 8a
Self-Regulation - Pain Catastrophizing Scale	6 - 8 weeks post-treatment	Assess experience of pain through sub-scales of rumination, magnification and helplessness
Self-Regulation - Chronic Pain Acceptance Scale	6 - 8 weeks post-treatment	Assess behavioral aspects of chronic pain acceptance
Co-Occurring Conditions - Depression	6 - 8 weeks post-treatment	Assess depression using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional Distress - Depression 8a
Quality of Life - Role satisfaction	6 - 8 weeks post-treatment	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
Self-Regulation - Emotional Behavioral Dysregulation	6 - 8 weeks post-treatment	Assess emotional behavioral dysregulation using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional and Behavioral Dyscontrol
Mindfulness	6 - 8 weeks post-treatment	Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)

Trial Locations

Locations (1)

Womack Army Medical Center at Ft. Bragg; 🇺🇸 Fort Bragg, North Carolina, United States