Chemically-Induced Disorders, Chronic Pain, Mental Disorders, Narcotic-Related Disorders, Neurologic Manifestations, Opioid-Related Disorders, Pain, Prescription Opioid Misuse, Substance-Related Disorders
Conditions
Brief summary
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.
Interventions
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.
BEHAVIORALPatient-Centered Chronic Pain Management Visits
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).
Sponsors
University of Utah
Rutgers University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigators, study staff, and statistician will be blinded to treatment condition.
Intervention model description
Hybrid implementation-effectiveness trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 + * Current chronic pain diagnosis (pain for ≥3 months) determined by physician assessment * Prescribed long-term opioid therapy (≥3 months) * Score \>=3 on the Pain Enjoyment General Activity scale * Score \>=9 on the Current Opioid Misuse Measure OR lifetime psychiatric or substance use disorder diagnosis OR benzodiazepine use OR history of overdose OR patient or physician determination that risks of opioid use may outweigh the benefits of opioid use
Exclusion criteria
* Chronic pain due to a cancer diagnosis * Active suicidal intent, schizophrenia, psychotic disorder * Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, Mindfulness-Based Relapse Prevention, or Mindfulness-Oriented Recovery Enhancement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pain | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) | 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: 1. A total sum score from 0 to 30, with higher scores indicating more severe pain and pain-related interference with life and activities 2. Dividing the sum of responses to all three items by 3 to get the mean score on a scale of 0-10, with higher scores indicating more severe pain and pain-related interference with life and activities. |
| Opioid Misuse | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) | 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. |
| Opioid Dosing | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) | 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. |
| Opioid Craving | Daily from baseline through month 4 | Opioid craving will be assessed with validated numeric rating scale items (Garland et. al, 2022) delivered by ecological momentary assessment. |
| PTSD Symptoms | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) | 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. |
| Depression | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) | 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. |
| Generalized Anxiety | Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) | 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. |
Countries
United States
Contacts
CONTACTHannah Pfeffer, MSW
CONTACTThanusha Puvananayagam, MPH
Outcome results
None listed