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. 2022 Feb 28;e220033.
doi: 10.1001/jamainternmed.2022.0033. Online ahead of print.

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

Eric L Garland  1   2 , Adam W Hanley  1 , Yoshio Nakamura  3 , John W Barrett  4 , Anne K Baker  5 , Sarah E Reese  6 , Michael R Riquino  7 , Brett Froeliger  8 , Gary W Donaldson  3
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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

Eric L Garland et al. JAMA Intern Med. .
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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.

Conflict of interest statement

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.

Figures

Figure 1.
Figure 1.. CONSORT Flow Diagram
Follow-up was affected by the onset of the COVID-19 pandemic.
Figure 2.
Figure 2.. Opioid Outcomes Through 9-Month Follow-up Period for Mindfulness-Oriented Recovery Enhancement and Supportive Psychotherapy
A, Measured by the Drug Misuse Index (with 1 indicating a positive rating and 0 indicating a negative rating). B, Measured in morphine-equivalent daily dose. Error bars represent SEs. MORE indicates Mindfulness-Oriented Recovery Enhancement; and Support, supportive psychotherapy.
Figure 3.
Figure 3.. Standardized Estimates of Between-Group and Within-Group Differences
A, Standardized point estimate of between-group differences (baseline adjusted and averaged over all follow-up visits) with 95% CIs (represented by horizontal line lengths), with positive directional effect indicating an improvement in the Mindfulness-Oriented Recovery Enhancement (MORE) group relative to the supportive psychotherapy (support) group. B, Standardized point estimate of within-group change from baseline to 9-month follow-up (standardized mean differences) with 95% CIs (represented by horizontal line lengths). Standardized estimates are interpretable in terms of Cohen d small (0.2), moderate (0.5), and large (0.8) effect sizes. BPI indicates Brief Pain Inventory; DASS, Depression Anxiety Stress Scale; DMI, Drug Misuse Index; and MEDD, morphine-equivalent daily dose.
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