NCT Number: NCT06387290
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
UCSD Health, La Jolla, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 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
Time frame: 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:
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
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.
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
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.
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Change in savoring measured by the Brief Savoring Inventory, range from 4 to 20, higher scores indicating more use of savoring.
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Change in reappraisal measured by the Emotion Regulation Questionnaire, range from 6 to 42, with a higher score indicating more use of reappraisal.
Contact information is provided by the study sponsor or research team.
Hannah Pfeffer, MSW
CONTACT
Thanusha Puvananayagam, MPH
CONTACT
University of Utah
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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