Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

Chronic Pain Clinical Trial

Official title:

Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104465
• Other study ID #: R34AT008423-01
• Status: Completed
• Phase: N/A
• Start date: April 30, 2017
• Est. completion date: June 11, 2018

Study information

• Verified date: July 2018
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 11, 2018
• Est. primary completion date: June 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Womack Army Medical Center at Ft. Bragg	Fort Bragg	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Chronic Pain	Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire	Baseline
Primary	Chronic Pain	Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire	6 - 8 weeks post-treatment
Secondary	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
Secondary	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
Secondary	Co-Occurring Conditions - Anxiety	Assess anxiety using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 - Emotional Distress- Anxiety 6a	Baseline
Secondary	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
Secondary	Co-Occurring Conditions - Alcohol Use	Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT)	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of Life - Fatigue	Assess fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Fatigue 8a	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Self-Regulation - Pain Catastrophizing Scale	Assess experience of pain through sub-scales of rumination, magnification and helplessness	Baseline
Secondary	Self-Regulation - Pain Catastrophizing Scale	Assess experience of pain through sub-scales of rumination, magnification and helplessness	6 - 8 weeks post-treatment
Secondary	Self-Regulation - Chronic Pain Acceptance Scale	Assess behavioral aspects of chronic pain acceptance	Baseline
Secondary	Self-Regulation - Chronic Pain Acceptance Scale	Assess behavioral aspects of chronic pain acceptance	6 - 8 weeks post-treatment
Secondary	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
Secondary	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
Secondary	Mindfulness	Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)	Baseline
Secondary	Mindfulness	Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)	6 - 8 weeks post-treatment