Pain, Chronic, Opioid Use
Conditions
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.
Interventions
BEHAVIORALMindfulness 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.
BEHAVIORALMindful 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.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Change in Pleasant Sensation Ratios | 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. |
| Longer-Term Change in Pleasant Sensation Ratios | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Opioid Medication Desire | 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. |
| Change in Pain Intensity | 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. |
| Change in Opioid Use | At baseline and 1-month follow-up, approximately 3 months | Opioid Use will be assessed with a timeline follow-back procedure. |
| Change in Pain Functional Interference | At pretreatment and 1-month follow-up, approximately 3 months | Pain functional interference will be assessed with the Brief Pain Inventory. |
Countries
United States
Outcome results
None listed