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| Name | Class |
|---|---|
| Rutgers University | OTHER |
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The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visits | Experimental | Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks, in addition to patient-centered chronic pain management visits led by their primary care provider. |
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| Patient-centered chronic pain management visits | Active Comparator | Participants will attend patient-centered chronic pain management visits led by their primary care provider. |
|
| 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 therapeutic approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Misuse | Opioid misuse as evidenced by triangulated aggregate of self-reported Current Opioid Misuse Measure and/or interview via Addiction Behaviors Checklist and/or urine screen | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) |
| Chronic Pain | Change in Chronic pain will be measured from baseline through study completion using the Pain, Enjoyment of Life, and General Activity Scale (PEG). Scoring can be determined in one of two ways:
| Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Change in Quality of Life will be measured from baseline through study completion using the Patient Reported Outcomes Measurement Information System (PROMIS-29) to assess physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. Scores range from 4-20 in each domain, with higher scores indicating more impairment in that domain. |
| Measure | Description | Time Frame |
|---|---|---|
| Decentering | Change in Decentering from baseline through study completion will be measured with the Metacognitive Processes of Decentering (MPODS) scale. Scores range from 15 to 75, with higher scores indicating more decentering. | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Pfeffer, MSW | Contact | 619-500-4668 | hapfeffer@health.ucsd.edu | |
| Thanusha Puvananayagam, MPH | Contact | 732.235.4341 | puvanath@rwjms.rutgers.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Health | Recruiting | La Jolla | California | 92037 | United States |
Data sharing will conform to National Institutes of Health (NIH) regulations and our resource sharing plan
At the time with publication of the primary outcome results
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Hybrid implementation-effectiveness trial
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Investigators, study staff, and statistician will be blinded to treatment condition.
| Patient-Centered Chronic Pain Management Visits | Behavioral | Participant will meet with their primary care provider for patient-centered care and shared decision making while discussing their chronic pain management strategy (e.g., opioid analgesics). |
|
| Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) |
| Opioid Dosing | Opioid dose will be assessed from baseline through study completion by Timeline Follow Back (TLFB) interview. Opioid dose will be converted to morphine-equivalent using equianalgesic conversions. | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) |
| Opioid Craving | Opioid craving will be assessed with validated numeric rating scale items (Garland et. al, 2022) delivered by ecological momentary assessment. | Daily from baseline through month 4 |
| PTSD Symptoms | PTSD Symptoms will be measured from baseline through study completion using the Posttraumatic Stress Disorder Checklist (PCL-5). Scores range from 0-80, with higher scores indicating overall higher PTSD symptom severity. | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) |
| Depression | Depression symptoms will be measured from baseline through study completion using the nine-item Patient Health Questionnaire (PHQ-9). Scores range from 0-27, with higher scores indicating more severe symptoms of depression. | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) |
| Generalized Anxiety | Generalized Anxiety will be measured from baseline through study completion using the Generalized Anxiety Disorder 7 (GAD-7). Scores range from 0-21, with higher scores indicating more severe symptoms of anxiety. | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) |
| Mindful Reappraisal of Pain Sensations |
Change in Mindful Reappraisal of Pain Sensations from baseline through study completion will be assessed with the Mindful Reappraisal of Pain Sensations (MRPS) Scale. Scores range from 0 to 54, with higher scores indicating greater mindful reappraisal of pain sensations. |
| Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) |
| Savoring | Change in savoring measured by the Brief Savoring Inventory, range from 4 to 20, higher scores indicating more use of savoring. | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) |
| Reappraisal | Change in reappraisal measured by the Emotion Regulation Questionnaire, range from 6 to 42, with a higher score indicating more use of reappraisal. | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) |
| Rutgers University Primary Care Clinics | Recruiting | New Brunswick | New Jersey | 08901 | United States |
|
| University of Utah Primary Care Clinics | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| D010146 | Pain |
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
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