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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness of Breath | Active Comparator |
| |
| Mindful Interoceptive Mapping | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness of Breath | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Pain Intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 8, 2024 | |
| Reset | Nov 26, 2024 | |
| Release | Nov 26, 2024 | |
| Reset | Dec 18, 2024 | |
| Release | Dec 18, 2024 | |
| Reset | Jan 9, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 8, 2024 | Nov 26, 2024 | |||
| Nov 26, 2024 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Mindful Interoceptive Mapping | Behavioral | 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. |
|
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 |
| 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 |
| 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 |
| Dec 18, 2024 |
| Dec 18, 2024 | Jan 9, 2025 |