Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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).

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visitsExperimental treatment 2 interventions
Group B: Patient-centered chronic pain management visitsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
2

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)

Secondary outcomes

1

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)
2

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)
3

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
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)

Other outcomes

1

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.

Time frame
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
2

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.

Time frame
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
3

Savoring

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)
4

Reappraisal

Change in reappraisal measured by the Emotion Regulation Questionnaire, range from 6 to 42, with a higher score indicating more use of reappraisal.

Time frame
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

Rutgers University

Collaborator