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

NCT04523766 | Completed

• 1 other identifier: IRB_00135443
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Opioid Use

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Opioid Medication Desire

  Immediately before and immediately after the final mindfulness training session, approximately 30 minutes

• 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

• Change in Pain Functional Interference

  At pretreatment and 1-month follow-up, approximately 3 months

Study Arms (2)

Mindfulness of Breath

ACTIVE COMPARATOR

Behavioral: Mindfulness of Breath

Mindful Interoceptive Mapping

EXPERIMENTAL

Behavioral: Mindful Interoceptive Mapping

Interventions

Mindfulness of Breath BEHAVIORAL

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.

Mindfulness of Breath

Mindful Interoceptive Mapping BEHAVIORAL

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.

Mindful Interoceptive Mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: June 29, 2021
• Primary Completion: August 9, 2023
• Study Completion: September 18, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)