Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

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 Overview

• Status: Not yet recruiting
• Conditions: Substance-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Pain; Neurologic Manifestations; Chronic Pain; Opioid-Related Disorders; Narcotic-Related Disorders; Prescription Opioid Misuse
• Intervention / Treatment: Behavioral: Mindfulness Oriented Recovery Enhancement; Behavioral: Patient-Centered Chronic Pain Management Visits

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thanusha Puvananayagam, MPH; Phone Number: 732-235-4341; Email: puvanath@rwjms.rutgers.edu
• Study Contact Backup: Name: Taylor Scott, MSW; Phone Number: 732-235-7453; Email: taylor.m.scott@rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers University Primary Care Clinics
      • Contact: Thanusha Puvananayagam, MPH; Phone Number: 732-235-4341; Email: puvanath@rwjms.rutgers.edu
      • Contact: Taylor Scott, MSW; Phone Number: 732-235-7453; Email: taylor.m.scott@rutgers.edu
      • Principal Investigator: Nina Cooperman, PsyD
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Primary Care Clinics
      • Contact: Kelly A Hendrickson, MS; Phone Number: 801-585-6354; Email: kelly.hendrickson@utah.edu
      • Contact: Layla Lincoln, BA; Phone Number: 801-581-7508; Email: layla.lincoln@utah.edu
      • Principal Investigator: Eric L Garland, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 +
• Current chronic pain diagnosis (pain for ≥3 months) determined by physician assessment
• Current use of opioids for ≥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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visits; 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.	Behavioral: Mindfulness Oriented Recovery Enhancement; 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.; Behavioral: Patient-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).
Active Comparator: Patient-centered chronic pain management visits; Participants will attend patient-centered chronic pain management visits led by their primary care provider.	Behavioral: Patient-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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: A total sum score from 0 to 30, with higher scores indicating more severe pain and pain-related interference with life and activities; 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.	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

Secondary Outcome Measures

Outcome Measure	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.	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)

Other Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Rutgers University

Study record dates

Study Major Dates

• Study Start (Estimated): May 6, 2024
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Substance-Related Disorders; Chronic Pain; Mental Disorders; Opioid-Related Disorders; Neurologic Manifestations; Chemically-Induced Disorders; Narcotic-Related Disorders
• Other Study ID Numbers: 00172836

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing will conform to National Institutes of Health (NIH) regulations and our resource sharing plan
• IPD Sharing Time Frame: At the time with publication of the primary outcome results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No