Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

RTI International14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

Mindfulness TrainingBEHAVIORAL

interactive. web-based mindfulness training complemented with mobile application

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Womack Army Medical Center at Ft. Bragg

Fort Bragg, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 6 - 8 weeks post-treatment

Chronic Pain

Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire

Time frame: Baseline

Chronic Pain

Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire

Time frame: 6 - 8 weeks post-treatment

Secondary Outcomes

Co-Occurring Conditions - Depression

Assess depression using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional Distress - Depression 8a

Time frame: Baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Co-Occurring Conditions - Depression

Assess depression using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional Distress - Depression 8a

Time frame: 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

Time frame: Baseline

Co-Occurring Conditions - Anxiety

Assess anxiety using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 - Emotional Distress- Anxiety 6a

Time frame: 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)

Time frame: Baseline

Co-Occurring Conditions - Alcohol Use

Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline

Quality of Life - Fatigue

Assess fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Fatigue 8a

Time frame: 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

Time frame: 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

Time frame: 6 - 8 weeks post-treatment

Self-Regulation - Pain Catastrophizing Scale

Assess experience of pain through sub-scales of rumination, magnification and helplessness

Time frame: Baseline

Self-Regulation - Pain Catastrophizing Scale

Assess experience of pain through sub-scales of rumination, magnification and helplessness

Time frame: 6 - 8 weeks post-treatment

Self-Regulation - Chronic Pain Acceptance Scale

Assess behavioral aspects of chronic pain acceptance

Time frame: Baseline

Self-Regulation - Chronic Pain Acceptance Scale

Assess behavioral aspects of chronic pain acceptance

Time frame: 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

Time frame: 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

Time frame: 6 - 8 weeks post-treatment

Mindfulness

Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)

Time frame: Baseline

Mindfulness

Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)

Time frame: 6 - 8 weeks post-treatment