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

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Pain, Chronic; Opioid Use

Treatments: Behavioral: Mindfulness of Breath; Behavioral: Mindful Interoceptive Mapping

Study type: Interventional

Funder types: Other

Identifiers

NCT04523766

IRB_00135443

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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149 participants in 2 patient groups

Mindfulness of Breath

Active Comparator group

Treatment:

Behavioral: Mindfulness of Breath

Mindful Interoceptive Mapping

Experimental group

Treatment:

Behavioral: Mindful Interoceptive Mapping