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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523766
• Other study ID #: IRB_00135443
• Status: Completed
• Phase: N/A
• Start date: June 29, 2021
• Est. completion date: September 18, 2023

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: September 18, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use
• Pain, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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