Enhancing Pain Management and Preventing Opioid Misuse by Optimizing Mindfulness Based Interventions for Opioid-Treated Chronic Pain Patients: A Comparison of Mindful Interoceptive Mapping and Mindful Breathing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 149
- Locations
- 2
- Primary Endpoint
- Immediate Change in Pleasant Sensation Ratios
Study Overview
Brief Summary
This is a single site, two-arm, parallel group randomized clinical trial comparing the effect of two mindfulness-based interventions (Mindful Interoceptive Mapping vs. Mindfulness of the Breath) on opioid-treated chronic pain patients' pleasant/unpleasant sensation reports and opioid use.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1) men/women ≥18 years of age,
- •(2) current chronic low back pain condition determined by physician assessment (e.g., ICD-10 codes M54.5, M54.4, M54.3),
- •(3) reporting pain ≥3 on 0-10 scale with opioid medication, and
- •(4) long-term opioid pharmacotherapy (>3 months of use).
Exclusion Criteria
- •(1) formal mindfulness training (e.g., MBSR/MBRP),
- •(2) current cancer diagnosis,
- •(3) psychosis, suicidality, and moderate/severe substance use disorder in the past year as assessed with the MINI, and
- •(4) unstable illness, as judged by a physician, that may interfere with treatment.
Outcomes
Primary Outcomes
Immediate Change in Pleasant Sensation Ratios
Time Frame: Immediately before and immediately after the final mindfulness training session, approximately 30 minutes
The Multidimensional Assessment of Pleasant and Painful Sensations (MAPPS) is an outline of a human body overlaid by a grid of 786 sensation pixels that was developed using the Qualtrics online survey platform, which can be recreated on any device capable of supporting a web-browser. Mouse clicks allow respondents to identify locations (i.e., grid pixels) on the manikin where they feel both pleasant and unpleasant sensations. Clicking once in any grid pixel turns that location blue, indicating a pleasant sensation. Clicking twice in any grid pixel turns that location red, indicating an unpleasant sensation. A ratio of pleasant to unpleasant sensations is derived from MAPPS.
Longer-Term Change in Pleasant Sensation Ratios
Time Frame: At baseline and posttreatment, approximately 1.5 months
The Multidimensional Assessment of Pleasant and Painful Sensations (MAPPS) is an outline of a human body overlaid by a grid of 786 sensation pixels that was developed using the Qualtrics online survey platform, which can be recreated on any device capable of supporting a web-browser. Mouse clicks allow respondents to identify locations (i.e., grid pixels) on the manikin where they feel both pleasant and unpleasant sensations. Clicking once in any grid pixel turns that location blue, indicating a pleasant sensation. Clicking twice in any grid pixel turns that location red, indicating an unpleasant sensation. A ratio of pleasant to unpleasant sensations is derived from MAPPS.
Secondary Outcomes
- Change in Opioid Medication Desire(Immediately before and immediately after the final mindfulness training session, approximately 30 minutes)
- Change in Pain Functional Interference(At pretreatment and 1-month follow-up, approximately 3 months)
- Change in Pain Intensity(Immediately before and immediately after the final mindfulness training session, approximately 30 minutes)
- Change in Opioid Use(At baseline and 1-month follow-up, approximately 3 months)
Investigators
Adam Hanley
Assistant Professor
University of Utah