Telehealth Mindfulness-Oriented Recovery Enhancement vs Usual Care in Individuals With Opioid Use Disorder and Pain

Abstract

ImportanceMethadone treatment (MT) fails to address the emotion dysregulation, pain, and reward processing deficits that often drive opioid use disorder (OUD). New interventions are needed to address these factors.ObjectiveTo evaluate the efficacy of MT as usual (usual care) vs telehealth Mindfulness-Oriented Recovery Enhancement (MORE) plus usual care among people with an OUD and pain.Design, Setting, and ParticipantsThis study was a randomized clinical trial conducted from August 2020 to June 2022. Participants receiving MT for OUD and experiencing chronic pain were recruited at 5 clinics in New Jersey.InterventionsIn usual care, participants received MT, including medication and counseling. Participants receiving MORE plus usual care attended 8 weekly, 2-hour telehealth groups that provided training in mindfulness, reappraisal, and savoring in addition to usual care.Main Outcomes and MeasurePrimary outcomes were return to drug use and MT dropout over 16 weeks. Secondary outcomes were days of drug use, methadone adherence, pain, depression, and anxiety. Analyses were based on an intention-to-treat approach.ResultsA total of 154 participants (mean [SD] age, 48.5 [11.8] years; 88 female [57%]) were included in the study. Participants receiving MORE plus usual care had significantly less return to drug use (hazard ratio [HR], 0.58; 95% CI, 0.37-0.90; P = .02) and MT dropout (HR, 0.41; 95% CI, 0.18-0.96; P = .04) than those receiving usual care only after adjusting for a priori–specified covariates (eg, methadone dose and recent drug use, at baseline). A total of 44 participants (57.1%) in usual care and 39 participants (50.6%) in MORE plus usual care returned to drug use. A total of 17 participants (22.1%) in usual care and 20 participants (13.0%) in MORE plus usual care dropped out of MT. In zero-inflated models, participants receiving MORE plus usual care had significantly fewer days of any drug use (ratio of means = 0.58; 95% CI, 0.53-0.63; P < .001) than those receiving usual care only through 16 weeks. A significantly greater percentage of participants receiving MORE plus usual care maintained methadone adherence (64 of 67 [95.5%]) at the 16-week follow-up than those receiving usual care only (56 of 67 [83.6%]; χ2 = 4.49; P = .04). MORE reduced depression scores and ecological momentary assessments of pain through the 16-week follow-up to a significantly greater extent than usual care (group × time F2,272 = 3.13; P = .05 and group × time F16,13000 = 6.44; P < .001, respectively). Within the MORE plus usual care group, EMA pain ratings decreased from a mean (SD) of 5.79 (0.29) at baseline to 5.17 (0.30) at week 16; for usual care only, pain decreased from 5.19 (0.28) at baseline to 4.96 (0.29) at week 16. Within the MORE plus usual care group, mean (SD) depression scores were 22.52 (1.32) at baseline and 18.98 (1.38) at 16 weeks. In the usual care–only group, mean (SD) depression scores were 22.65 (1.25) at baseline and 20.03 (1.27) at 16 weeks. Although anxiety scores increased in the usual care–only group and decreased in the MORE group, this difference between groups did not reach significance (group × time unadjusted F2,272 = 2.10; P= .12; Cohen d = .44; adjusted F2,268 = 2.33; P = .09). Within the MORE plus usual care group, mean (SD) anxiety scores were 25.5 (1.60) at baseline and 23.45 (1.73) at 16 weeks. In the usual care–only group, mean (SD) anxiety scores were 23.27 (1.75) at baseline and 24.07 (1.73) at 16 weeks.Conclusions and RelevanceThis randomized clinical trial demonstrated that telehealth MORE was a feasible adjunct to MT with significant effects on drug use, pain, depression, treatment retention, and adherence.Trial RegistrationClinicalTrials.gov Identifier: NCT04491968

Immediate Effects of Mindful Awareness in Body-oriented Therapy as an Adjunct to Medication for Opioid Use Disorder

“…The results of this study are both similar and distinct from other studies to date examining the bene ts of mindfulness-based approaches as an adjunct to MOUD, and for those using or misusing prescribed opioids (Cooperman et al, 2023;Garland, et al, 2022;Garland, et al, 2023;Garland et al, 2024). The MORE and MABT interventions have overlapping components and are both focused on developing mindfulness to promote reappraisal processes that support health and well-being.…”

“…Prior randomized controlled trials of MBI approaches for MOUD with published outcomes involve Mindfulness-Oriented Recovery Enhancement (MORE). MORE studies have demonstrated improvements in pain, opioid use, and other outcomes in chronic pain patients receiving methadone maintenance treatment, primary care patients with opioid misuse, and people with chronic pain on prescribed opioids (Cooperman et al, 2023;Garland et al, 2022;Garland et al, 2023;Garland et al, 2024).…”

Pain Scores as Secondary Outcomes—Opioid Reduction Studies—Reply

“…In Reply In the response from Hogans to our study describing the effects of telehealth Mindfulness-Oriented Recovery Enhancement (MORE), they note that baseline Brief Pain Inventory (BPI) scores differed from the initial ecological momentary assessment (EMA) rating of pain and question whether this discrepancy relates to either a pain spike in the intervention group or excessive variance. It is unlikely that any potential increase in pain was due to MORE, given that MORE significantly reduced pain in our pilot study in the same population of patients with pain and opioid use disorder receiving methadone treatment, and MORE produced significant reductions in pain relative to active control conditions across 10 effect sizes from randomized clinical trials (RCTs) in a recent meta-analysis (standardized mean change = 0.60; 95% CI, −0.83 to −0.37; P < .001) .…”

The Impact of Nonpharmacological Interventions on Opioid Use for Chronic Noncancer Pain: A Scoping Review

“…NPIs may include acupuncture or neurostimulation, mindfulness-based stress reduction, cognitive behavioral therapy, hypnosis, spirituality, tai chi/qigong, yoga, massage therapy, multidisciplinary rehabilitation, self-management programs, educational programs, devices, digital health technology, and manipulative therapies [ 4 , 32 ]. NPIs may address emotion dysregulation, pain, and reward-processing deficits that often drive opioid use, tolerance, and dependence [ 33 ]. NPIs can be complementary to traditional medical treatments for CNCP to reduce the need for higher dosages and to minimize possible side effects associated with medications.…”