Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

January 30, 2026 updated by: Eric Garland, University of Utah
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers University Primary Care Clinics
        • Contact:
        • Principal Investigator:
          • Nina Cooperman, PsyD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah Primary Care Clinics
        • Principal Investigator:
          • Eric L Garland, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid Misuse
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
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Chronic Pain
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:

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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
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.
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Opioid Dosing
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.
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Opioid Craving
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.
Daily from baseline through month 4
PTSD Symptoms
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.
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Depression
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.
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Generalized Anxiety
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.
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Decentering
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.
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
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 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
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.
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Reappraisal
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.
Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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