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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
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.
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).
UCSD Health
La Jolla, California, United States
RECRUITINGRutgers University Primary Care Clinics
New Brunswick, New Jersey, United States
RECRUITINGUniversity of Utah Primary Care Clinics
Salt Lake City, Utah, United States
RECRUITINGOpioid 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
Time frame: 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: 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.
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
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