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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04523766
Other study ID # IRB_00135443
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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