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This study will be a single-site, two-arm randomized controlled trial conducted among chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually via a HIPAA compliant virtual meeting platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One MORE | Experimental |
| |
| Waitlist Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One MORE | Behavioral | One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into four, 30-minute segments. In the first segment, participants will be introduced to mindfulness and guided though a body scan practice, which directs participants to systematically shift attention from one part of the body to the next. Mindful pain management will be the focus of the second segment and participants will be guided through a mindfulness of pain practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The third segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, and the fourth segment will focus on increasing the positive emotions that can attenuate pain with mindful savoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing | Change in pain catastrophizing from baseline through 3-month follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing. | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Change in pain intensity from baseline through 3-month follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain intensity. | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function | Change in physical function from baseline through 3-month follow-up will be assessed with the PROMIS Physical Functioning Short Form. Scores range from 6 to 30, with higher scores reflecting greater physical function. | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. |
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38588552 | Derived | Hanley AW, Lingard A, Garland EL. A Single-Session, 2-Hour Version of Mindfulness-Oriented Recovery Enhancement (One MORE) Improves Chronic Pain Patients' Pain-Related Outcomes Through 3-Month Follow-Up in a Randomized Controlled Trial. J Integr Complement Med. 2024 Sep;30(9):869-877. doi: 10.1089/jicm.2023.0501. Epub 2024 Apr 8. |
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| 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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| Pain Interference |
Change in pain interference from baseline through 3-month follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 20, with higher scores reflecting greater pain interference. |
| Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. |
| Sleep |
Change in sleep from baseline through 3-month follow-up will be assessed with the PROMIS Sleep Disturbance Short Form. Scores range from 6 to 30, with higher scores reflecting worse sleep. |
| Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. |
| Depression | Change in depression from baseline through 3-month follow-up will be assessed with the Patient Health Questionnaire-2. Scores range from 0 to 6, with higher scores reflecting greater depression. | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. |
| Anxiety | Change in anxiety from baseline through 3-month follow-up will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety. | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. |
| Prescription Pain Medication Misuse | Change in prescription pain medication misuse from baseline through 3-month follow-up will be assessed with the PROMIS Prescription Pain Medication Misuse Short Form. Scores range from 7 to 35, with higher scores reflecting greater medication misuse. | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. |
| Trait Mindfulness | Change in trait mindfulness from baseline through 3-month follow-up will be assessed with the Toronto Mindfulness Scale - Trait Version. Scores range from 0 to 52, with higher scores reflecting greater trait mindfulness. | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. |
| Trait Self-Transcendence | Change in trait self-transcendence from baseline through 3-month follow-up will be assessed with the Nondual Awareness Dimensional Assessment - Trait Version. Scores range from 0 to 52, with higher scores reflecting greater trait self-transcendence. | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. |
| Acute Pain | Change in acute pain will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain. | Will be completed immediately before and after the 2-hour, One MORE intervention. |
| Decentering | Change in decentering will be measured with the state version of the Metacognitive Processes of Decentering scale. Scores range from 0 to 10, with higher scores reflecting greater decentering. | Will be completed immediately before and after the 2-hour, One MORE intervention. |
| Self-Transcendent State | Change in self-transcendent state will be measured with the Nondual Awareness Dimensional Assessment - State Version. Scores range from 0 to 10, with higher scores reflecting greater self-transcendence. | Will be completed immediately before and after the 2-hour, One MORE intervention. |