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Completed

NCT Number: NCT03104465

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Womack Army Medical Center at Ft. Bragg

Fort Bragg, North Carolina, 28301, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Training

Behavioral

interactive. web-based mindfulness training complemented with mobile application

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Chronic Pain

    Time frame: Baseline

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

  6. Chronic Pain

    Time frame: 6 - 8 weeks post-treatment

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Co-Occurring Conditions - Alcohol Use

    Time frame: Baseline

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

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. Self-Regulation - Pain Catastrophizing Scale

    Time frame: Baseline

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

  20. Self-Regulation - Pain Catastrophizing Scale

    Time frame: 6 - 8 weeks post-treatment

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

  21. Self-Regulation - Chronic Pain Acceptance Scale

    Time frame: Baseline

    Assess behavioral aspects of chronic pain acceptance

  22. Self-Regulation - Chronic Pain Acceptance Scale

    Time frame: 6 - 8 weeks post-treatment

    Assess behavioral aspects of chronic pain acceptance

  23. 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

  24. 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

  25. Mindfulness

    Time frame: Baseline

    Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)

  26. Mindfulness

    Time frame: 6 - 8 weeks post-treatment

    Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 7, 2017
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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