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The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE), an intervention designed to disrupt the risk chain leading from chronic pain to prescription opioid misuse and addiction. The investigators plan to conduct a full scale clinical trial to determine whether MORE (relative to a support group control condition) can reduce symptoms of chronic pain and opioid misuse among patients who are receiving pain management in primary care via long-term opioid analgesic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M.O.R.E. | Experimental | Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks. |
|
| Support Group | Active Comparator | Participants will attend a support group weekly for eight weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Oriented Recovery Enhancement | Behavioral | Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in opioid misuse | Opioid misuse as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen | Change from baseline through study completion (9 months post-treatment) |
| Change in pain severity and interference | Brief Pain Inventory | Change from baseline through study completion (9 months post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in opioid craving | Opioid craving measure from Wasan et al. 2012 | Change from baseline through study completion (9 months post-treatment) |
| Change in psychological distress | Depression Anxiety Stress Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nonreactivity | subscale on Five Facet Mindfulness Questionnaire | Change from baseline through post-treatment (8 weeks from beginning of treatment) |
| Change in interoceptive awareness | Interoceptive awareness as evidenced by the Multidimensional Assessment of Interoceptive Awareness |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Garland, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Primary Care Clinics | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40305010 | Derived | Garland EL, Hudak J, Hanley AW, Bernat E, Froeliger B. Positive Emotion Dysregulation in Opioid Use Disorder and Normalization by Mindfulness-Oriented Recovery Enhancement: A Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2025 Jul 1;82(7):654-662. doi: 10.1001/jamapsychiatry.2025.0569. | |
| 35226053 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2020 | Aug 31, 2022 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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|
| Support Group | Behavioral | A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist. |
|
| Change from baseline through study completion (9 months post-treatment) |
| Change in opioid dose | Opioid dose converted into morphine equivalents via standardized equianalgesic tables | Change from baseline through study completion (9 months post-treatment) |
| Change from baseline through post-treatment (8 weeks from beginning of treatment) |
| Change in reinterpretation of pain sensations | Reinterpretation of pain sensations subscale on the Coping Strategies Questionnaire | Change from baseline through post-treatment (8 weeks from beginning of treatment) |
| Change in emotion regulation | Emotion regulation as evidenced by responses on the Emotion Regulation Task | Change from baseline through post-treatment (8 weeks from beginning of treatment) |
| Change in positive emotion | Positive emotion as evidenced by the PANAS | Change from baseline through post-treatment (8 weeks from beginning of treatment) |
| Change in cue-reactivity | Cue-reactivity as evidenced by attentional bias and central-autonomic responses during cue-exposure | Change from baseline through post-treatment (8 weeks from beginning of treatment) |
| Change in attention to positive information | Attention to positive information as evidenced by the APNIS | Change from baseline through post-treatment (8 weeks from beginning of treatment) |
| Change in anhedonia | Anhedonia as evidenced by the Snaith Hamilton Anhedonia and Pleasure Scale (SHAPS), from 14 to 56, with lower scores meaning less anhedonia. | Change from baseline through study completion (9 months post-treatment) |
| Garland EL, Hanley AW, Nakamura Y, Barrett JW, Baker AK, Reese SE, Riquino MR, Froeliger B, Donaldson GW. Mindfulness-Oriented Recovery Enhancement vs Supportive Group Therapy for Co-occurring Opioid Misuse and Chronic Pain in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2022 Apr 1;182(4):407-417. doi: 10.1001/jamainternmed.2022.0033. |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |