Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

• Sponsor: RTI International (Other)
• Overall Status: Completed
• CT.gov ID: NCT03104465
• Collaborator: University of North Carolina, Chapel Hill (Other)
• Enrollment: 14
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.4
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: Mindfulness Training	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Adaptation of Mindfulness Training to Treat Chronic Pain in the Military
• Actual Study Start Date: Apr 30, 2017
• Actual Primary Completion Date: Jun 11, 2018
• Actual Study Completion Date: Jun 11, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Chronic Pain - Pain Intensity [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 [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 [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 [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 [Baseline]

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

6. Chronic Pain [6 - 8 weeks post-treatment]

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

Secondary Outcome Measures

1. Co-Occurring Conditions - Depression [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 [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 [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 [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 [Baseline]

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

6. Co-Occurring Conditions - Alcohol Use [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline]

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

16. Quality of Life - Fatigue [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 [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 [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 [Baseline]

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

20. Self-Regulation - Pain Catastrophizing Scale [6 - 8 weeks post-treatment]

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

21. Self-Regulation - Chronic Pain Acceptance Scale [Baseline]

    Assess behavioral aspects of chronic pain acceptance

22. Self-Regulation - Chronic Pain Acceptance Scale [6 - 8 weeks post-treatment]

    Assess behavioral aspects of chronic pain acceptance

23. Self-Regulation - Emotional Behavioral Dysregulation [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 [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 [Baseline]

    Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)

26. Mindfulness [6 - 8 weeks post-treatment]

    Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Womack Army Medical Center at Ft. Bragg	Fort Bragg	North Carolina	United States	28301

Sponsors and Collaborators

• RTI International
• University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Shari Miller, PhD, RTI International

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RTI International
• ClinicalTrials.gov Identifier: NCT03104465
• Other Study ID Numbers: R34AT008423-01
• First Posted: Apr 7, 2017
• Last Update Posted: Aug 1, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by RTI International: Chronic Pain; Mindfulness; Behavioral Health; Quality of Life
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Aug 1, 2018