Status:
COMPLETED
Comparing the Impact of Mindful Interoceptive Mapping and Mindful Breathing on Pain and Opioid Use
Lead Sponsor:
University of Utah
Conditions:
Pain, Chronic
Opioid Use
Eligibility:
All Genders
18+ years
Phase:
NA
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 op...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
June 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2023
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT04523766
Start Date
June 29 2021
End Date
September 18 2023
Last Update
April 26 2024
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84112