Comparing the Impact of Mindful Interoceptive Mapping and Mindful Breathing on Pain and Opioid Use

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Chronic, Opioid Use

Intervention / Treatment
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* Behavioral: Mindfulness of Breath
* Behavioral: Mindful Interoceptive Mapping


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness of Breath<br> | Behavioral: Mindfulness of Breath<br>* The Mindful Breathing intervention will be adapted from a validated, brief mindfulness training model. Participants will be instructed to focus on the sensations of the breath (i.e., at the tip of the nose and in the nostrils, abdomen and back) and, if a pain arises in the body, acknowledge it without judgement and return attention to the breath.<br>|
| Experimental: Mindful Interoceptive Mapping<br> | Behavioral: Mindful Interoceptive Mapping<br>* The MIM intervention will be adapted from the core MORE meditation practice. Participants will be instructed to (1) zoom in to deconstruct pain into its constituent affectively-valenced physical sensations and precisely map each sensation's spatial location, (2) zoom out to broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that are absent of sensation and pleasant sensations), and (3) savor any pleasant sensations or experiences occurring during the mindfulness practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate Change in Pleasant Sensation Ratios | 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. | Immediately before and immediately after the final mindfulness training session, approximately 30 minutes | 
| Longer-Term Change in Pleasant Sensation Ratios | 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. | At baseline and posttreatment, approximately 1.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Opioid Medication Desire | Single-item Numeric Rating Scale (0-10), with 0 indicating no desire for opioid medication and 10 representing the an intense desire for opioid medication. | Immediately before and immediately after the final mindfulness training session, approximately 30 minutes | 
| Change in Pain Intensity | Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the an most intense pain imaginable. | Immediately before and immediately after the final mindfulness training session, approximately 30 minutes | 
| Change in Opioid Use | Opioid Use will be assessed with a timeline follow-back procedure. | At baseline and 1-month follow-up, approximately 3 months | 
| Change in Pain Functional Interference | Pain functional interference will be assessed with the Brief Pain Inventory. | At pretreatment and 1-month follow-up, approximately 3 months |