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Completed

NCT Number: NCT04523766

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

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.

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Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Immediate Change in Pleasant Sensation Ratios

    Time frame: 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.

  2. Longer-Term Change in Pleasant Sensation Ratios

    Time frame: 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 outcomes

  1. Change in Opioid Medication Desire

    Time frame: 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.

  2. Change in Pain Intensity

    Time frame: 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.

  3. Change in Opioid Use

    Time frame: At baseline and 1-month follow-up, approximately 3 months

    Opioid Use will be assessed with a timeline follow-back procedure.

  4. Change in Pain Functional Interference

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

    Pain functional interference will be assessed with the Brief Pain Inventory.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2020
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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