Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 11, 2018

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

  • Behavioral: Mindfulness Training
    • interactive. web-based mindfulness training complemented with mobile application

Arms, Groups and Cohorts

  • Experimental: Mindfulness training
    • 6 90-minute sessions interactive, web-based mindfulness training complemented with mobile application

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RTI International
  • Collaborator
    • University of North Carolina, Chapel Hill
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shari Miller, PhD, Principal Investigator, RTI International

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