Effects of live-online, group mindfulness training on opioid use and anxiety during buprenorphine treatment: A comparative effectiveness RCT.

BACKGROUND: Office-based opioid treatment with buprenorphine has emerged as a popular evidence-based treatment for opioid use disorder. Unfortunately, psychosocial stress, anxiety, pain, and co-morbid substance use increase patients' risk for relapse. We designed this study to compare the effects of complementing buprenorphine treatment with 24 weeks of a live-online Mindful Recovery Opioid Care Continuum (M-ROCC) group to a time and attention-matched, live-online Recovery Support Group (RSG) active control condition. METHODS: We plan to enroll a maximum of N = 280 and randomize at least N = 192 patients prescribed buprenorphine through referrals from office-based and telemedicine buprenorphine treatment providers and social media advertisements. Participants will be randomly assigned to M-ROCC or RSG and will be blinded to their treatment condition. The primary outcome for this study will be biochemically confirmed periods of abstinence from illicit opioids, as measured by self-reported use and randomly collected, video-observed oral fluid toxicology testing during the final 12 weeks of study participation. Secondary outcomes include changes in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and pain interference scores between baseline and week 24. RESULTS: The trial was funded by the National Institutes of Health, HEAL Initiative through NCCIH (R33AT010125). Data collection is projected to end by September 2023, and we expect publication of results in 2024. CONCLUSION: If the M-ROCC intervention is found to be effective in this format, it will demonstrate that live-online mindfulness groups can improve outcomes and address common co-morbidities like anxiety and pain during buprenorphine treatment.

Impact of warm mindfulness on emotion regulation: A randomized controlled effectiveness trial.

OBJECTIVE: To determine the effects of mindfulness training for primary care (MTPC), an integrated warm mindfulness training program, on emotion regulation and its relationship with health behavior change. Interventions that improve self-regulation, particularly emotion regulation, are needed for the self-management of comorbid chronic physical and mental illnesses. Mindfulness-based interventions (MBIs) may impact self-regulation and facilitate health behavior change. METHOD: A randomized controlled comparative effectiveness trial was conducted in a population of adult primary care patients to evaluate the impact of MTPC versus a low-dose mindfulness comparator (LDC) on self-reported difficulties in emotion regulation (DERS) total score and other assays of self-regulation at baseline, Weeks 8 and 24. Self-reported action plan initiation was reported between Weeks 8 and 10. Participants had diagnoses of anxiety, depression, or stress-related disorders. MTPC is an 8-week insurance-reimbursable warm MBI designed to cultivate mindfulness and self-compassion and to catalyze chronic illness self-management related health behavior change. RESULTS: Compared to LDC, MTPC participants had statistically significant reductions in DERS total score at 8 weeks (d = -0.59, ß = -12.98, 95% CI [-23.3 to -2.6]; p = .01) and 24 weeks (d = -0.61, ß = -13.35, [-24.3, -2.4]; p = .02). Compared to 38% for LDC, 63% of MTPC participants successfully initiated their action plan within 3 weeks (OR = 2.87, [1.1, 7.9]; p = .04). CONCLUSIONS: This randomized controlled trial demonstrated MTPC enhanced emotion regulation and facilitated initiation of chronic illness self-management and health behavior change among primary care patients with anxiety, depression, and stress-related disorders, replicating previous reports. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Mindfulness Training for Primary Care for Portuguese-Speaking Immigrants: A Pilot Study.

Background: Portuguese-speaking immigrants are a growing underserved population in the Unites States who experience high levels of psychological distress and increased vulnerability to mental health disorders such as depression and anxiety. Current evidence shows that mindfulness-based interventions (MBIs) are effective to promote physical and mental health among educated English speakers; nonetheless, the lack of diversity in the mindfulness literature is a considerable limitation. To our knowledge, the feasibility and acceptability of MBIs among Portuguese-speaking immigrants have not yet been investigated. Methods: This single-arm pilot study (N = 30) explored the feasibility, acceptability, and cultural aspects of Mindfulness Training for Primary Care (MTPC)-Portuguese among Portuguese-speaking immigrants in the Boston area. MTPC is an 8-week, primary care-adapted, referral-based, insurance-reimbursable, trauma-informed MBI that is fully integrated into a healthcare system. The study also examined intervention preliminary effectiveness on mental health outcomes (depression and anxiety symptoms) and self-regulation (emotional regulation, mindfulness, self-compassion, interoceptive awareness), and initiation of health behavior was explored. Results: Primary care providers referred 129 patients from 2018 to 2020. Main DSM-5 primary diagnoses were depression (76.3%) and anxiety disorders (6.7%). Participants (N = 30) attended a mean of 6.1 (SD 1.92) sessions and reported a mean of 213.7 (SD = 124.3) min of practice per week. All survey finishers would recommend the program to a friend, found the program helpful, and rated the overall program as "very good" or "excellent," and 93% would participate again, with satisfaction mean scores between 4.6 and 5 (Likert scale 0-5). Participants and group leaders provided feedback to refine MTPC-Portuguese culturally responsiveness regarding materials language, settings, time, food, and community building. Patients exhibited reductions in depression (d = 0.67; p < 0.001) and anxiety (d = 0.48; p = 0.011) symptoms, as well as enhanced emotional regulation (d = 0.45; p = 0.009), and among survey finishers, 50% initiated health behavior change through action plan initiation. Conclusion: This pilot study suggests that MTPC-Portuguese is feasible, acceptable, and culturally appropriate among Portuguese-speaking patients in the Boston area. Furthermore, the intervention might potentially decrease depression and anxiety symptoms, facilitate health behavior change, and improve emotional regulation. MTPC-Portuguese investigation with larger samples in controlled studies is warranted to support its dissemination and implementation in the healthcare system. Clinical Trial Registration: Identifier: NCT04268355.