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      Mindfulness-Oriented Recovery Enhancement vs Supportive Group Therapy for Co-occurring Opioid Misuse and Chronic Pain in Primary Care : A Randomized Clinical Trial

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          Key Points

          Question

          Does a mindfulness-based intervention reduce comorbid chronic pain and opioid misuse in the primary care setting more than supportive psychotherapy?

          Findings

          In this randomized clinical trial that included 250 adults with both chronic pain and opioid misuse, 45.0% of participants receiving Mindfulness-Oriented Recovery Enhancement (MORE) were no longer misusing opioids after 9 months of follow-up compared with 24.4% of participants receiving supportive group psychotherapy. Participants receiving MORE also reported significant improvements in chronic pain symptoms compared with those receiving supportive psychotherapy.

          Meaning

          In this study, MORE appeared to be an efficacious treatment for opioid misuse among adults with chronic pain.

          Abstract

          Importance

          Successful treatment of opioid misuse among people with chronic pain has proven elusive. Guidelines recommend nonopioid therapies, but the efficacy of mindfulness-based interventions for opioid misuse is uncertain.

          Objective

          To evaluate the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE) for the reduction of opioid misuse and chronic pain.

          Design, Setting, and Participants

          This interviewer-blinded randomized clinical trial enrolled patients from primary care clinics in Utah between January 4, 2016, and January 16, 2020. The study included 250 adults with chronic pain receiving long-term opioid therapy who were misusing opioid medications.

          Interventions

          Treatment with MORE (comprising training in mindfulness, reappraisal, and savoring positive experiences) or supportive group psychotherapy (control condition) across 8 weekly 2-hour group sessions.

          Main Outcomes and Measures

          Primary outcomes were (1) opioid misuse assessed by the Drug Misuse Index (self-report, interview, and urine screen) and (2) pain severity and pain-related functional interference, assessed by subscale scores on the Brief Pain Inventory through 9 months of follow-up. Secondary outcomes were opioid dose, emotional distress, and ecological momentary assessments of opioid craving. The minimum intervention dose was defined as 4 or more completed sessions of MORE or supportive group psychotherapy.

          Results

          Among 250 participants (159 women [63.6%]; mean [SD] age, 51.8 [11.9] years), 129 were randomized to the MORE group and 121 to the supportive psychotherapy group. Overall, 17 participants (6.8%) were Hispanic or Latino, 218 (87.2%) were White, and 15 (6.0%) were of other races and/or ethnicities (2 American Indian, 3 Asian, 1 Black, 2 Pacific Islander, and 7 did not specify). At baseline, the mean duration of pain was 14.7 years (range, 1-60 years), and the mean (SD) morphine-equivalent opioid dose was 101.0 (266.3) mg (IQR, 16.0-90.0 mg). A total of 203 participants (81.2%) received the minimum intervention dose (mean [SD], 5.7 [2.2] sessions); at 9 months, 92 of 250 participants (36.8%) discontinued the study. The overall odds ratio for reduction in opioid misuse through the 9-month follow-up period in the MORE group compared with the supportive psychotherapy group was 2.06 (95% CI, 1.17-3.61; P = .01). At 9 months, 36 of 80 participants (45.0%) in the MORE group were no longer misusing opioids compared with 19 of 78 participants (24.4%) in the supportive psychotherapy group. Mixed models demonstrated that MORE was superior to supportive psychotherapy through 9 months of follow-up for pain severity (between-group effect: 0.49; 95% CI, 0.17-0.81; P = .003) and pain-related functional interference (between-group effect: 1.07; 95% CI, 0.64-1.50; P < .001). Participants in the MORE group reduced their opioid dose to a greater extent than those in the supportive psychotherapy group. The MORE group also had lower emotional distress and opioid craving.

          Conclusions and Relevance

          In this randomized clinical trial, among adult participants in a primary care setting, the MORE intervention led to sustained improvements in opioid misuse and chronic pain symptoms and reductions in opioid dosing, emotional distress, and opioid craving compared with supportive group psychotherapy. Despite attrition caused by the COVID-19 pandemic and the vulnerability of the sample, MORE appeared to be efficacious for reducing opioid misuse among adults with chronic pain.

          Trial Registration

          ClinicalTrials.gov Identifier: NCT02602535

          Abstract

          This randomized clinical trial assesses whether Mindfulness-Oriented Recovery Enhancement is more efficacious than supportive group psychotherapy for reducing opioid misuse among adults with chronic pain receiving long-term opioid therapy.

          Related collections

          Most cited references47

          • Record: found
          • Abstract: found
          • Article: not found

          Pain assessment: global use of the Brief Pain Inventory.

          Poorly controlled cancer pain is a significant public health problem throughout the world. There are many barriers that lead to undertreatment of cancer pain. One important barrier is inadequate measurement and assessment of pain. To address this problem, the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care has developed the Brief Pain Inventory (BPI), a pain assessment tool for use with cancer patients. The BPI measures both the intensity of pain (sensory dimension) and interference of pain in the patient's life (reactive dimension). It also queries the patient about pain relief, pain quality, and patient perception of the cause of pain. This paper describes the development of the Brief Pain Inventory and the various applications to which the BPI is suited. The BPI is a powerful tool and, having demonstrated both reliability and validity across cultures and languages, is being adopted in many countries for clinical pain assessment, epidemiological studies, and in studies of the effectiveness of pain treatment.
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            CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016.

            Primary care clinicians find managing chronic pain challenging. Evidence of long-term efficacy of opioids for chronic pain is limited. Opioid use is associated with serious risks, including opioid use disorder and overdose.
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              • Article: not found

              Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.

              A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. Systematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments.
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                Author and article information

                Journal
                JAMA Intern Med
                JAMA Intern Med
                JAMA Internal Medicine
                American Medical Association
                2168-6106
                2168-6114
                28 February 2022
                April 2022
                28 February 2022
                : 182
                : 4
                : 407-417
                Affiliations
                [1 ]Center on Mindfulness and Integrative Health Intervention Development, College of Social Work, University of Utah, Salt Lake City
                [2 ]Veterans Health Care Administration, Veterans Integrated Service Network 19 Whole Health Flagship Site, VA Salt Lake City Health Care System, Salt Lake City, Utah
                [3 ]Pain Research Center, Division of Pain Medicine, Department of Anesthesiology, University of Utah School of Medicine, Salt Lake City
                [4 ]Community Physicians Group, University of Utah School of Medicine, Salt Lake City
                [5 ]Department of Anesthesiology, Duke University, Durham, North Carolina
                [6 ]School of Social Work, University of Montana, Missoula
                [7 ]School of Social Welfare, University of Kansas, Lawrence
                [8 ]Department of Psychology, University of Missouri, Columbia
                Author notes
                Article Information
                Accepted for Publication: January 7, 2022.
                Published Online: February 28, 2022. doi:10.1001/jamainternmed.2022.0033
                Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Garland EL et al. JAMA Internal Medicine.
                Corresponding Author: Eric L. Garland, PhD, Center on Mindfulness and Integrative Health Intervention Development, College of Social Work, University of Utah, 395 S, 1500 E, Salt Lake City, UT 84112 ( eric.garland@ 123456socwk.utah.edu ).
                Author Contributions: Drs Garland and Donaldson had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
                Concept and design: Garland, Nakamura, Barrett, Froeliger.
                Acquisition, analysis, or interpretation of data: Garland, Hanley, Nakamura, Baker, Reese, Riquino, Donaldson.
                Drafting of the manuscript: Garland, Donaldson.
                Critical revision of the manuscript for important intellectual content: Garland, Hanley, Nakamura, Barrett, Baker, Reese, Riquino, Froeliger, Donaldson.
                Statistical analysis: Donaldson.
                Obtained funding: Garland, Nakamura.
                Administrative, technical, or material support: Garland, Hanley, Nakamura, Barrett, Baker, Reese.
                Supervision: Garland.
                Conflict of Interest Disclosures: Dr Garland reported receiving grants from the National Institutes of Health during the conduct of the study; serving as the Director of the Center on Mindfulness and Integrative Health Intervention Development, which provides Mindfulness-Oriented Recovery Enhancement (MORE), mindfulness-based therapy, and cognitive behavioral therapy in the context of research trials for no cost to research participants; receiving honoraria and payment for delivering seminars, lectures, and teaching engagements (related to training clinicians in MORE and mindfulness) sponsored by institutions of higher education, academic teaching hospitals, and medical centers; and receiving royalties from BehaVR and from the sales of books related to MORE outside the submitted work. Dr Nakamura reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Froeliger reported receiving grants from the National Institutes of Health during the conduct of the study. No other disclosures were reported.
                Funding/Support: This work was supported by grant R01DA042033 from the National Institute on Drug Abuse of the National Institutes of Health (Dr Garland).
                Role of the Funder/Sponsor: The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
                Data Sharing Statement: See Supplement 3.
                Additional Contributions: We appreciate the commitment of the participants in this study. We are grateful to the staff and students at the Center on Mindfulness and Integrative Intervention Development (CMIID), who assisted with study coordination, recruitment, and data collection (compensated by the National Institute on Drug Abuse grant). Jania Sommers, MSW, LCSW, of the CMIID, provided clinical support (compensated on a consulting basis); Osman Sanyer, MD, Julie Day, MD, and Susan Terry, MD, of the University of Utah, served as physician champions for the study (not compensated); and Spencer Dorn, MD, of the University of North Carolina at Chapel Hill, provided adverse events review and oversight (compensated by honorarium). We acknowledge the many intellectual contributions of our dear colleague, Matthew O. Howard, Professor, School of Social Work, University of North Carolina at Chapel Hill, who was a coinvestigator on this clinical trial but died in December 2018.
                Article
                ioi220002
                10.1001/jamainternmed.2022.0033
                8886485
                35226053
                c70acae5-4b39-43fc-b429-bc0c5233bd82
                Copyright 2022 Garland EL et al. JAMA Internal Medicine.

                This is an open access article distributed under the terms of the CC-BY License.

                History
                : 19 October 2021
                : 7 January 2022
                Categories
                Research
                Research
                Original Investigation
                Online First

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