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Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Training
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain focused on measuring Chronic Pain, Mindfulness, Behavioral Health, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Womack Army Medical Center at Ft. Bragg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness training

Arm Description

6 90-minute sessions interactive, web-based mindfulness training complemented with mobile application

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Co-Occurring Conditions - Depression
Assess depression using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional Distress - Depression 8a
Co-Occurring Conditions - Depression
Assess depression using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional Distress - Depression 8a
Co-Occurring Conditions - Anxiety
Assess anxiety using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 - Emotional Distress- Anxiety 6a
Co-Occurring Conditions - Anxiety
Assess anxiety using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 - Emotional Distress- Anxiety 6a
Co-Occurring Conditions - Alcohol Use
Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT)
Co-Occurring Conditions - Alcohol Use
Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT)
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)
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)
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
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
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
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
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
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
Quality of Life - Fatigue
Assess fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Fatigue 8a
Quality of Life - Fatigue
Assess fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Fatigue 8a
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
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
Self-Regulation - Pain Catastrophizing Scale
Assess experience of pain through sub-scales of rumination, magnification and helplessness
Self-Regulation - Pain Catastrophizing Scale
Assess experience of pain through sub-scales of rumination, magnification and helplessness
Self-Regulation - Chronic Pain Acceptance Scale
Assess behavioral aspects of chronic pain acceptance
Self-Regulation - Chronic Pain Acceptance Scale
Assess behavioral aspects of chronic pain acceptance
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
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
Mindfulness
Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)
Mindfulness
Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)

Full Information

First Posted
April 3, 2017
Last Updated
July 30, 2018
Sponsor
RTI International
Collaborators
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT03104465
Brief Title
Adaptation of Mindfulness Training to Treat Chronic Pain in the Military
Official Title
Adaptation of Mindfulness Training to Treat Chronic Pain in the Military
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 30, 2017 (Actual)
Primary Completion Date
June 11, 2018 (Actual)
Study Completion Date
June 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain, Mindfulness, Behavioral Health, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness training
Arm Type
Experimental
Arm Description
6 90-minute sessions interactive, web-based mindfulness training complemented with mobile application
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training
Intervention Description
interactive. web-based mindfulness training complemented with mobile application
Primary Outcome Measure Information:
Title
Chronic Pain - Pain Intensity
Description
Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Intensity 3a
Time Frame
Baseline
Title
Chronic Pain - Pain Intensity
Description
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
Title
Chronic Pain - Pain Interference
Description
Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Interference 8a
Time Frame
Baseline
Title
Chronic Pain - Pain Interference
Description
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
Title
Chronic Pain
Description
Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire
Time Frame
Baseline
Title
Chronic Pain
Description
Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire
Time Frame
6 - 8 weeks post-treatment
Secondary Outcome Measure Information:
Title
Co-Occurring Conditions - Depression
Description
Assess depression using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional Distress - Depression 8a
Time Frame
Baseline
Title
Co-Occurring Conditions - Depression
Description
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
Title
Co-Occurring Conditions - Anxiety
Description
Assess anxiety using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 - Emotional Distress- Anxiety 6a
Time Frame
Baseline
Title
Co-Occurring Conditions - Anxiety
Description
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
Title
Co-Occurring Conditions - Alcohol Use
Description
Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT)
Time Frame
Baseline
Title
Co-Occurring Conditions - Alcohol Use
Description
Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT)
Time Frame
6 - 8 weeks post-treatment
Title
Co-Occurring Conditions - Post Traumatic Stress Disorder
Description
Assess trauma symptoms in response to stressful experiences using the Post Traumatic Stress Disorder (PTSD) Checklist - Civilian version (PCL-C)
Time Frame
Baseline
Title
Co-Occurring Conditions - Post Traumatic Stress Disorder
Description
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
Title
Co-Occurring Conditions - Prescription drug misuse
Description
Assess use of drugs not prescribed, or use of more than recommended dose, to feel good/get high/buzzed
Time Frame
Baseline
Title
Co-Occurring Conditions - Prescription drug misuse
Description
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
Title
Quality of Life - Physical Functioning
Description
Assess physical functioning using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Physical Function 12a
Time Frame
Baseline
Title
Quality of Life - Physical Functioning
Description
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
Title
Quality of Life - Sleep disturbance
Description
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
Title
Quality of Life - Sleep disturbance
Description
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
Title
Quality of Life - Fatigue
Description
Assess fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Fatigue 8a
Time Frame
Baseline
Title
Quality of Life - Fatigue
Description
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
Title
Quality of Life - Role satisfaction
Description
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
Title
Quality of Life - Role satisfaction
Description
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
Title
Self-Regulation - Pain Catastrophizing Scale
Description
Assess experience of pain through sub-scales of rumination, magnification and helplessness
Time Frame
Baseline
Title
Self-Regulation - Pain Catastrophizing Scale
Description
Assess experience of pain through sub-scales of rumination, magnification and helplessness
Time Frame
6 - 8 weeks post-treatment
Title
Self-Regulation - Chronic Pain Acceptance Scale
Description
Assess behavioral aspects of chronic pain acceptance
Time Frame
Baseline
Title
Self-Regulation - Chronic Pain Acceptance Scale
Description
Assess behavioral aspects of chronic pain acceptance
Time Frame
6 - 8 weeks post-treatment
Title
Self-Regulation - Emotional Behavioral Dysregulation
Description
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
Title
Self-Regulation - Emotional Behavioral Dysregulation
Description
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
Title
Mindfulness
Description
Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)
Time Frame
Baseline
Title
Mindfulness
Description
Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)
Time Frame
6 - 8 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari Miller, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Womack Army Medical Center at Ft. Bragg
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28301
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

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