Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

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 Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Mindfulness Training

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Fort Bragg, North Carolina, United States, 28301
      • Womack Army Medical Center at Ft. Bragg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Shari Miller, PhD, RTI International

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2017
• Primary Completion (Actual): June 11, 2018
• Study Completion (Actual): June 11, 2018

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Quality of Life; Chronic Pain; Mindfulness; Behavioral Health
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: R34AT008423-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No