Clinical trial NCT03104465: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Mindfulness
Behavioral Health
Quality of Life
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2017-04-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Chronic Pain - Pain Intensity
timeFrame: Baseline
measure: Chronic Pain - Pain Intensity
timeFrame: 6 - 8 weeks post-treatment
measure: Chronic Pain - Pain Interference
timeFrame: Baseline
measure: Chronic Pain - Pain Interference
timeFrame: 6 - 8 weeks post-treatment
measure: Chronic Pain
timeFrame: Baseline
measure: Chronic Pain
timeFrame: 6 - 8 weeks post-treatment
Secondary outcomes:
measure: Co-Occurring Conditions - Depression
timeFrame: Baseline
measure: Co-Occurring Conditions - Depression
timeFrame: 6 - 8 weeks post-treatment
measure: Co-Occurring Conditions - Anxiety
timeFrame: Baseline
measure: Co-Occurring Conditions - Anxiety
timeFrame: 6 - 8 weeks post-treatment
measure: Co-Occurring Conditions - Alcohol Use
timeFrame: Baseline
measure: Co-Occurring Conditions - Alcohol Use
timeFrame: 6 - 8 weeks post-treatment
measure: Co-Occurring Conditions - Post Traumatic Stress Disorder
timeFrame: Baseline
measure: Co-Occurring Conditions - Post Traumatic Stress Disorder
timeFrame: 6 - 8 weeks post-treatment
measure: Co-Occurring Conditions - Prescription drug misuse
timeFrame: Baseline
measure: Co-Occurring Conditions - Prescription drug misuse
timeFrame: 6 - 8 weeks post-treatment
measure: Quality of Life - Physical Functioning
timeFrame: Baseline
measure: Quality of Life - Physical Functioning
timeFrame: 6 - 8 weeks post-treatment
measure: Quality of Life - Sleep disturbance
timeFrame: Baseline
measure: Quality of Life - Sleep disturbance
timeFrame: 6 - 8 weeks post-treatment
measure: Quality of Life - Fatigue
timeFrame: Baseline
measure: Quality of Life - Fatigue
timeFrame: 6 - 8 weeks post-treatment
measure: Quality of Life - Role satisfaction
timeFrame: Baseline
measure: Quality of Life - Role satisfaction
timeFrame: 6 - 8 weeks post-treatment
measure: Self-Regulation - Pain Catastrophizing Scale
timeFrame: Baseline
measure: Self-Regulation - Pain Catastrophizing Scale
timeFrame: 6 - 8 weeks post-treatment
measure: Self-Regulation - Chronic Pain Acceptance Scale
timeFrame: Baseline
measure: Self-Regulation - Chronic Pain Acceptance Scale
timeFrame: 6 - 8 weeks post-treatment
measure: Self-Regulation - Emotional Behavioral Dysregulation
timeFrame: Baseline
measure: Self-Regulation - Emotional Behavioral Dysregulation
timeFrame: 6 - 8 weeks post-treatment
measure: Mindfulness
timeFrame: Baseline
measure: Mindfulness
timeFrame: 6 - 8 weeks post-treatment
Other outcomes:
Locations:
city: Fort Bragg
country: United States
facility: Womack Army Medical Center at Ft. Bragg
state: North Carolina
Study officials:
affiliation: RTI International
name: Shari Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: