Back to resultsComparing the Impact of Mindful Interoceptive Mapping and Mindful Breathing on Pain and Opioid Use
Primary Purpose
Pain, Chronic, Opioid Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness of Breath
Mindful Interoceptive Mapping
Sponsored by
About this trial
This is an interventional other trial for Pain, Chronic
Eligibility Criteria
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.
Sites / Locations
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mindfulness of Breath
Mindful Interoceptive Mapping
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Change in Opioid Use
Opioid Use will be assessed with a timeline follow-back procedure.
Change in Pain Functional Interference
Pain functional interference will be assessed with the Brief Pain Inventory.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04523766
Brief Title
Comparing the Impact of Mindful Interoceptive Mapping and Mindful Breathing on Pain and Opioid Use
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Opioid Use
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness of Breath
Arm Type
Active Comparator
Arm Title
Mindful Interoceptive Mapping
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness of Breath
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Interoceptive Mapping
Intervention Description
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 Outcome Measure Information:
Title
Immediate Change in Pleasant Sensation Ratios
Description
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.
Time Frame
Immediately before and immediately after the final mindfulness training session, approximately 30 minutes
Title
Longer-Term Change in Pleasant Sensation Ratios
Description
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.
Time Frame
At baseline and posttreatment, approximately 1.5 months
Secondary Outcome Measure Information:
Title
Change in Opioid Medication Desire
Description
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.
Time Frame
Immediately before and immediately after the final mindfulness training session, approximately 30 minutes
Title
Change in Pain Intensity
Description
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the an most intense pain imaginable.
Time Frame
Immediately before and immediately after the final mindfulness training session, approximately 30 minutes
Title
Change in Opioid Use
Description
Opioid Use will be assessed with a timeline follow-back procedure.
Time Frame
At baseline and 1-month follow-up, approximately 3 months
Title
Change in Pain Functional Interference
Description
Pain functional interference will be assessed with the Brief Pain Inventory.
Time Frame
At pretreatment and 1-month follow-up, approximately 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam W. Hanley
Phone
801-213-4191
Email
adam.hanley@utah.edu
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam W Hanley, PhD
Phone
801-581-6192
Email
adam.hanley@utah.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing the Impact of Mindful Interoceptive Mapping and Mindful Breathing on Pain and Opioid Use
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