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

Not Applicable

Completed

• Conditions: Pain, Chronic; Opioid Use
• Interventions: Behavioral: Mindfulness of Breath; Behavioral: Mindful Interoceptive Mapping

• Registration Number: NCT04523766
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-24
• Study Start: 2021-06-29
• Primary Completion: 2023-08-09
• Study Completion: 2023-09-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness of Breath	Mindfulness of Breath	-
Mindful Interoceptive Mapping	Mindful Interoceptive Mapping	-

Primary Outcome Measures

Name	Time	Method
Immediate Change in Pleasant Sensation Ratios	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	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 Outcome Measures

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

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States