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

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

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 Overview

• Status: Completed
• Conditions: Opioid Use; Pain, Chronic
• Intervention / Treatment: Behavioral: Mindfulness of Breath; Behavioral: Mindful Interoceptive Mapping

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam W. Hanley; Phone Number: 801-213-4191; Email: adam.hanley@utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mindfulness of Breath	Behavioral: Mindfulness of Breath; 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.
Experimental: Mindful Interoceptive Mapping	Behavioral: Mindful Interoceptive Mapping; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Actual): March 9, 2023
• Study Completion (Actual): April 18, 2023

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: IRB_00135443

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No