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.

Adapted Mindfulness Training for Interoception and Adherence to the DASH Diet: A Phase 2 Randomized Clinical Trial.

Importance: Hypertension is a major cause of cardiovascular disease, and although the Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP), adherence is typically low. Mindfulness training adapted to improving health behaviors that lower BP could improve DASH adherence, in part through improved interoceptive awareness relevant to dietary consumption. Objective: To evaluate the effects of the Mindfulness-Based Blood Pressure Reduction (MB-BP) program on interoceptive awareness and DASH adherence. Design, Setting, and Participants: Parallel-group, phase 2, sequentially preregistered randomized clinical trials were conducted from June 1, 2017, to November 30, 2020. Follow-up was 6 months. Participants with elevated unattended office BP (≥120/80 mm Hg) were recruited from the population near Providence, Rhode Island. Of 348 participants assessed for eligibility, 67 did not meet inclusion criteria, 17 declined, and 63 did not enroll prior to study end date. In total, 201 participants were randomly assigned, 101 to the MB-BP program and 100 to the enhanced usual care control group, with 24 (11.9%) unavailable for follow-up. Outcome assessors and the data analyst were blinded to group allocation. Analyses were performed using intention-to-treat principles from June 1, 2022, to August 30, 2023. Interventions: The 8-week MB-BP program was adapted for elevated BP, including personalized feedback, education, and mindfulness training directed to hypertension risk factors. Both MB-BP and control groups received home BP monitoring devices with instructions and options for referral to primary care physicians. The control group also received educational brochures on controlling high BP. Main Outcomes and Measures: The primary outcome was Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire scores (range 0-5, with higher scores indicating greater interoceptive awareness), and the secondary outcome was DASH adherence scores assessed via a 163-item Food Frequency Questionnaire (range 0-11, with higher scores indicating improved DASH adherence), all compared using regression analyses. Results: Among 201 participants, 118 (58.7%) were female, 163 (81.1%) were non-Hispanic White, and the mean (SD) age was 60.0 (12.2) years. The MB-BP program increased the MAIA score by 0.54 points (95% CI, 0.35-0.74 points; P < .001; Cohen d = 0.45) at 6 months vs control. In participants with poor baseline DASH adherence, the MB-BP program also significantly increased the DASH score by 0.62 points (95% CI, 0.13-1.11 points; P = .01; Cohen d = 0.71) at 6 months vs controls. The intervention was also associated with a 0.34-point improvement in the DASH diet score in all MB-BP participants from baseline (95% CI, 0.09-0.59 points; P = .01; Cohen d = 0.27), while the control group showed a -0.04 point change in DASH diet score from baseline to 6 months (95% CI, -0.31 to 0.24 points; P = .78; Cohen d = -0.03). Conclusions and Relevance: A mindfulness program adapted to improving health behaviors to lower BP improved interoceptive awareness and DASH adherence. The MB-BP program could support DASH dietary adherence in adults with elevated BP. Clinical Trial Registration: ClinicalTrials.gov Identifiers: NCT03859076 and NCT03256890.

When a pandemic and epidemic collide: Lessons learned about how system barriers can interrupt implementation of addiction research.

Background: Telehealth technologies are now featured more prominently in addiction treatment services than prior to the COVID-19 pandemic, but system barriers should be carefully considered for the successful implementation of innovative remote solutions for medication management and recovery coaching support for people with opioid use disorder (OUD). Method: The Centers for Disease Control and Prevention funded a telehealth trial prior to the COVID-19 pandemic with a multi-institution team who attempted to implement an innovative protocol during the height of the pandemic in 2020 in Tampa, Florida. The study evaluated the effectiveness of a mobile device application, called MySafeRx, which integrated remote motivational recovery coaching with daily supervised dosing from secure pill dispensers via videoconference, on medication adherence during buprenorphine treatment. This paper provides a participant case example followed by a reflective evaluation of how the pandemic amplified both an existing research-to-practice gap and clinical system barriers during the implementation of telehealth clinical research intervention for patients with OUD. Findings: Implementation challenges arose from academic institutional requirements, boundaries and role identity, clinical staff burnout and lack of buy-in, rigid clinical protocols, and limited clinical resources, which hampered recruitment and intervention engagement. Conclusions: As the urgency for feasible and effective telehealth solutions continues to rise in response to the growing numbers of opioid-related deaths, the scientific community may use these lessons learned to re-envision the relationship between intervention implementation and the role of clinical research toward mitigating the opioid overdose epidemic.

The COVID-19 pandemic coupled with the opioid overdose epidemic has resulted in compounded challenges to the fields of addiction treatment and clinical research. This manuscript describes a CDC (Centers for Disease Control and Prevention)-funded randomized control trial that was initiated prior to the COVID-19 pandemic and implemented during the height of the pandemic through 2020 in Tampa, Florida. The study evaluated the effectiveness of a mobile device application, called MySafeRx, integrating remote recovery coaching with the option of daily supervised buprenorphine dosing from secure pill dispensers via videoconference to reduce barriers and enhance support for medication adherence during treatment. With the sudden emergence of COVID-19, this research, already challenged by a research-to-practice gap and existing clinical system barriers to medications for opioid use disorder (MOUD) treatment (e.g., siloed service delivery, stigmatized staff and community perceptions of buprenorphine, and high staff burnout/turnover), was amplified by the rapidly changing protocols for standards of care during the implementation of an OUD treatment research intervention in the midst of the start of the pandemic. Lessons learned related to challenges from academic institutional requirements, boundaries and role identity, burnout, staff buy-in, and clinical protocols and resources are discussed, and recommendations for future research are provided. As urgency for feasible and effective solutions continues to rise in response to the growing numbers of opioid-related deaths, the scientific community may use these lessons learned to re-envision the relationship between intervention implementation and the role of clinical research toward mitigating the opioid overdose epidemic.

Participants' Engagement With and Results From a Web-Based Integrative Population Mental Wellness Program (CHAMindWell) During the COVID-19 Pandemic: Program Evaluation Study.

BACKGROUND: The COVID-19 pandemic involved a prolonged period of collective trauma and stress during which substantial increases in mental health concerns, like depression and anxiety, were observed across the population. In this context, CHAMindWell was developed as a web-based intervention to improve resilience and reduce symptom severity among a public health care system's patient population. OBJECTIVE: This program evaluation was conducted to explore participants' engagement with and outcomes from CHAMindWell by retrospectively examining demographic information and mental health symptom severity scores throughout program participation. METHODS: We examined participants' symptom severity scores from repeated, web-based symptom screenings through Computerized Adaptive Testing for Mental Health (CAT-MH) surveys, and categorized participants into symptom severity-based tiers (tier 1=asymptomatic to mild; tier 2=moderate; and tier 3=severe). Participants were provided tier-based mindfulness resources, treatment recommendations, and referrals. Logistic regressions were conducted to evaluate associations between demographic variables and survey completion. The McNemar exact test and paired sample t tests were performed to evaluate changes in the numbers of participants in tier 1 versus tier 2 or 3 and changes in depression, anxiety, and posttraumatic stress disorder severity scores between baseline and follow-up. RESULTS: The program enrolled 903 participants (664/903, 73.5% female; 556/903, 61.6% White; 113/903, 12.5% Black; 84/903, 9.3% Asian; 7/903, 0.8% Native; 36/903, 4% other; and 227/903, 25.1% Hispanic) between December 16, 2020, and March 17, 2022. Of those, 623 (69%) completed a baseline CAT-MH survey, and 196 completed at least one follow-up survey 3 to 6 months after baseline. White racial identity was associated with completing baseline CAT-MH (odds ratio [OR] 1.80, 95% CI 1.14-2.84; P=.01). Participants' odds of having symptom severity below the clinical threshold (ie, tier 1) were significantly greater at follow-up (OR 2.60, 95% CI 1.40-5.08; P=.001), and significant reductions were observed across symptom domains over time. CONCLUSIONS: CHAMindWell is associated with reduced severity of mental health symptoms. Future work should aim to address program engagement inequities and attrition and compare the impacts of CHAMindWell to a control condition to better characterize its effects.

Unfilled prescriptions: Surveying patients' experiences with buprenorphine treatment in Massachusetts before and during the COVID-19 pandemic.

BACKGROUND AND OBJECTIVES: We explored potential challenges to accessing office-based opioid treatment (OBOT) with buprenorphine during the COVID-19 pandemic. METHODS: Using Facebook advertisements, we recruited a sample of N = 72 participants and conducted four repeated-measures analysis of variance comparing ratings of participants' abilities to access aspects of OBOT treatment. RESULTS: Participants reported increased difficulty filling buprenorphine prescriptions during the pandemic than before, p = .011, partial η2 = 0.092, and this was correlated with past month opioid use, r = .236, p = .042. DISCUSSION, CONCLUSIONS, AND SCIENTIFIC SIGNIFICANCE: This is the first investigation to report unfilled prescriptions during the pandemic and an association with opioid use. Unfilled prescriptions may contribute to relapse and partially explain increased overdose deaths during COVID-19.

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).

Effects of Adapted Mindfulness Training on Interoception and Adherence to the Dietary Approaches to Stop Hypertension (DASH) Diet: The MB-BP Randomized Clinical Trial.

Background: Hypertension is a major cause of cardiovascular disease. The Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP). However, adherence is typically low. Mindfulness training adapted to improving health behaviors that lower BP could improve DASH adherence, in part through improved interoceptive awareness relevant to dietary consumption. The primary objective of the MB-BP trial was to evaluate effects of the Mindfulness-Based Blood Pressure Reduction (MB-BP) program on interoceptive awareness. Secondary objectives assessed whether MB-BP impacts DASH adherence, and explored whether interoceptive awareness mediates DASH dietary changes. Methods: Parallel-group phase 2 randomized clinical trial conducted from June 2017-November 2020 with 6 months follow-up. Data analyst was blinded to group allocation. Participants had elevated unattended office BP (≥120/80 mmHg). We randomized 201 participants to MB-BP (n=101) or enhanced usual care control (n=100). Loss-to-follow-up was 11.9%. Outcomes were the Multidimensional Assessment of Interoceptive Awareness (MAIA; range 0-5) score, and the DASH adherence score (range 0-11) assessed via a 163-item Food Frequency Questionnaire. Results: Participants were 58.7% female, 81.1% non-Hispanic white, with mean age 59.5 years. Regression analyses demonstrated that MB-BP increased the MAIA score by 0.54 (95% CI: 0.35,0.74; p<.0001) at 6 months follow-up vs. control. MB-BP increased the DASH score by 0.62 (95% CI: 0.13,1.11; p=0.01) at 6 months vs. control, in participants with poor DASH adherence at baseline. Conclusions: A mindfulness training program adapted to improving health behaviors that lower BP improved interoceptive awareness and DASH adherence. MB-BP could support DASH dietary adherence in adults with elevated BP. Clinical Trial Registration: Clinicaltrials.gov identifier NCT03859076 (https://clinicaltrials.gov/ct2/show/NCT03859076; MAIA) and NCT03256890 (https://clinicaltrials.gov/ct2/show/NCT03256890; DASH diet adherence).

Effect of Adapted Mindfulness Training in Participants With Elevated Office Blood Pressure: The MB-BP Study: A Randomized Clinical Trial.

Background Hypertension is a leading risk factor for cardiovascular disease. Despite availability of effective lifestyle and medication treatments, blood pressure (BP) is poorly controlled in the United States. Mindfulness training may offer a novel approach to improve BP control. The objective was to evaluate the effects of Mindfulness-Based Blood Pressure Reduction (MB-BP) versus enhanced usual care control on unattended office systolic BP. Methods and Results Methods included a parallel-group phase 2 randomized clinical trial conducted from June 2017 to November 2020. Follow-up time was 6 months. Outcome assessors and data analyst were blinded to group allocation. Participants had elevated unattended office BP (≥120/80 mm Hg). We randomized 201 participants to MB-BP (n=101) or enhanced usual care control (n=100). MB-BP is a mindfulness-based program adapted for elevated BP. Loss-to-follow-up was 17.4%. The primary outcome was change in unattended office systolic BP at 6 months. A total of 201 participants (58.7% women; 81.1% non-Hispanic White race and ethnicity; mean age, 59.5 years) were randomized. Results showed that MB-BP was associated with a 5.9-mm Hg reduction (95% CI, -9.1 to -2.8 mm Hg) in systolic BP from baseline and outperformed the control group by 4.5 mm Hg at 6 months (95% CI, -9.0 to -0.1 mm Hg) in prespecified analyses. Plausible mechanisms with evidence to be impacted by MB-BP versus control were sedentary activity (-350.8 sitting min/wk [95% CI, -636.5 to -65.1] sitting min/wk), Dietary Approaches to Stop Hypertension diet (0.32 score [95% CI, -0.04 to 0.67]), and mindfulness (7.3 score [95% CI, 3.0-11.6]). Conclusions A mindfulness-based program adapted for individuals with elevated BP showed clinically relevant reductions in systolic BP compared with enhanced usual care. Mindfulness training may be a useful approach to improve BP. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03256890 and NCT03859076.

Trends in Buprenorphine Prescribing for Opioid Use Disorder by Psychiatrists in the US From 2003 to 2021.

This cross-sectional study uses data from a database to compare national trends in patients treated with buprenorphine by psychiatrists and nonpsychiatrists from 2003 to 2021.

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study.

BACKGROUND: A mindfulness-based intervention that reduces comorbid pain, anxiety, and substance use during office-based opioid treatment (OBOT) could enhance retention and prevent overdose. We conducted a pilot study of the Mindful Recovery OUD Care Continuum (M-ROCC), a 24-week trauma-informed program with a motivationally-sensitive curriculum. METHODS: Patients prescribed buprenorphine (N = 18) enrolled in M-ROCC. We collected urine toxicology biweekly. At 0, 4, and 24 weeks, participants completed PROMIS-Pain, PROMIS-Anxiety, Mindfulness (FFMQ), Experiential Avoidance (BEAQ), Interoceptive Awareness (MAIA), and Self-Compassion (SCS-SF) scales. We estimated changes over time using mixed models. Participants completed qualitative interviews at 4 and 24 weeks. RESULTS: Positive urine toxicology decreased over time for cocaine (ß = -.266, p = .008) and benzodiazepines (ß = -.208, p = .028). M-ROCC reduced PROMIS-Pain (Z = -2.29; p = .022), BEAQ (Z = -2.83; p = .0005), and increased FFMQ (Z = 3.51; p < .001), MAIA (Z = 3.40; p = .001), and SCS-SF (Z = 2.29; p = .022). Participants with co-morbid anxiety had decreased PROMIS-Anxiety (Z = -2.53; p = .012). Interviewed participants commonly used mindfulness practices for stress and anxiety (12/12, 100%), and to reduce pain catastrophizing and rumination (7/12, 58%). CONCLUSION AND SCIENTIFIC SIGNIFICANCE: This is the first study to report the effects of a 24-week mindfulness program during buprenorphine treatment on common comorbidities, including pain interference, anxiety, cocaine, and benzodiazepine use. The findings that M-ROCC is associated with reduced experiential avoidance, as well as increased interoceptive awareness and self-compassion, align with proposed mechanisms that are now extended to OUD treatment. Future larger randomized controlled trials are needed before effectiveness can be established and the role of these mechanisms can be confirmed.

Increased insula response to interoceptive attention following mindfulness training is associated with increased body trusting among patients with depression.

Interoceptive dysfunction is often present in anxiety and depression. We investigated the effects of an 8-week intervention, Mindfulness Training for Primary Care (MTPC), on brain mechanisms of interoceptive attention among patients with anxiety and/or depression. We hypothesized that fMRI brain response to interoception in the insula, a region known for interoceptive processing, would increase following the MTPC intervention, and that such increases would be associated with post-intervention changes in self-reported measures of interoceptive awareness. Adults (n = 28) with anxiety and/or depression completed baseline and post-intervention fMRI visits, including a task in which they alternated between focusing on their heartbeat (interoception (INT)) and a control visual attention task (exteroception (EXT)). Following MTPC, we observed increased evoked fMRI response (relative to baseline) in left anterior insula during the INT-EXT task contrast (z > 3.1, p < 0.001 corrected). In patients with moderate-to-severe depression as defined by the Patient Reported Outcomes Measurement Information System (PROMIS), increased post-intervention insula response was associated with increased Body Trusting, a subscale of the Multidimensional Assessment of Interoceptive Awareness (z > 3.1, p = 0.007 corrected). This study demonstrates that patients with mood disorders may respond differentially to mindfulness-based treatment depending on depression severity, and that among those who are more depressed, increased trusting in one's own body sensations and experiencing the body as a safe place to attend to may be necessary components of positive responses to mindfulness-based interventions.

"Today I Can Look in the Mirror and Like Myself": Effects of a Trauma-Informed Mindful Recovery Program on Self-Compassion.

Background: Opioid-related deaths continue to rise. Psychological trauma is commonly comorbid with Opioid Use Disorder (OUD). Adverse childhood experiences can disrupt the development of emotion regulation, increasing risk of substance use. Self-compassion may reduce OUD risk and outcomes by facilitating emotion regulation, decreasing the toxicity of shame, and reducing internalized stigma that can hinder recovery. Mindfulness practice enhances self-compassion. Methods: This study is part of a pilot (N = 18) of the Mindful Recovery OUD Care Continuum (M-ROCC) during buprenorphine office-based opioid treatment (OBOT). The present study was conducted to gain a deeper understanding of the intervention's effects on self-compassion development, and to explore differential changes in self-compassion during the intervention among participants with varying intensity of trauma exposure measured by high levels of childhood adversity (defined by 4+ adverse childhood experiences (ACEs) at baseline). We conducted secondary analyses of a subset of qualitative interview data (N = 11 unique participants) collected for the pilot study (weeks 4 and 24, 14 total interviews) to elaborate upon changes in Self-Compassion Scale (SCS-SF) scores. Results: In the primary pilot study, participants' mean SCS-SF scores shifted significantly from baseline to week 24, ß = 0.22, p = 0.028. This change is elaborated upon through interviews. Despite pervasive challenges to becoming more self-compassionate (e.g., trauma histories and substance use), participants reported increased compassionate self-responding and decreased uncompassionate self-responding. Mindfulness training was identified as the primary mechanism underlying the shift. Kindness to self and others and-to a lesser extent an increased sense of common humanity-were also identified as key to overall self-compassion. Compared to those in the lower ACEs group, participants in the higher ACEs group tended to have lower baseline self-compassion scores (d = 1.09, p = 0.055). Conclusion: M-ROCC may increase self-compassion among patients with OUD during OBOT by increasing compassionate, and decreasing uncompassionate, self-responding. Patients with OUD with greater childhood adversity tended to have lower levels of self-compassion, which improved with M-ROCC. Future trials with larger samples are needed to confirm these potential outcomes, mechanisms, and differential impacts between ACEs subgroups.

The Effects of Combined Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation and Mindfulness Meditation for Chronic Low Back Pain: A Pilot Study.

OBJECTIVE: Respiratory-gated Auricular Vagal Afferent Nerve stimulation (RAVANS) is a safe nonpharmacological approach to managing chronic pain. The purpose of the current study was to examine (1) the feasibility and acceptability of RAVANS, combined with mindful meditation (MM) for chronic low back pain (CLBP), (2) the potential synergy of MM+RAVANS on improving pain, and (3) possible moderators of the influence of MM+RAVANS on pain. DESIGN: Pilot feasibility and acceptability study. SETTING: Pain management center at large academic medical center. SUBJECTS: Nineteen adults with CLBP and previous MM training. METHODS: Participants attended two sessions during which they completed quantitative sensory testing (QST), rated pain severity, and completed a MM+stimulation session. Participants received RAVANS during one visit and sham stimulation during the other, randomized in order. Following intervention, participants repeated QST. RESULTS: MM+RAVANS was well tolerated, acceptable, and feasible to provide relief for CLBP. Both MM+stimulation sessions resulted in improved back pain severity, punctate pain ratings, and pressure pain threshold. Individuals with greater negative affect showed greater back pain improvement from MM+RAVANS while those with greater mindfulness showed greater back pain improvement from MM+sham. CONCLUSIONS: Results suggest that for CLBP patients with prior MM training, the analgesic effects of MM may have overshadowed effects of RAVANS given the brief single session MM+RAVANS intervention. However, those with greater negative affect may benefit from combined MM+RAVANS.

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial.

Background: Increasing buprenorphine/naloxone (B/N) access for opioid use disorder (OUD) is essential yet ensuring adherence and preventing diversion remains challenging. This study examines the feasibility, usability, and acceptability of MySafeRx, a mobile platform integrating motivational coaching, adherence monitoring, and electronic dispensing during office-based B/N treatment. Methods: In this multi-site randomized controlled trial, MySafeRx provided coaching and supervised self-administration of B/N by mobile recovery coaches (MRCs) via videoconference. Referred adults (ages 18-65) with OUD were randomized to 1) 42-days of adjunctive MySafeRx treatment (n = 13) or 2) a standard care control group (n = 14). Results: The randomized sample was 63% female and 100% White. Twelve of 13 MySafeRx participants completed at least one MRC session. The mean system usability score reported by MySafeRx participants was 78.4 (n = 12). Participants indicated they would recommend MySafeRx to a friend (mean= 4.1 of 5), and that the dispenser (4.1 of 5) and videoconferencing (4.2 of 5) were easy to use. The MRC component had the highest acceptability (4.4 of 5). MRCs observed B/N self-administration for an average of 64.3% of the required study days (men: 68.9%; women: 57.9%). On average, men (n = 4) met with MRCs on 32±14 days versus 47±6 days for women (n = 8). Exploratory analyses did not show significant differences between intervention and control groups. Conclusions: Despite the small sample, this study supports usability and acceptability of MySafeRx. Increased adherence monitoring, even with remote coaching had limited appeal, which impacted feasibility due to slow recruitment, especially as community prescribing with relaxed monitoring requirements became more widespread.

From Self-Esteem to Selflessness: An Evidence (Gap) Map of Self-Related Processes as Mechanisms of Mindfulness-Based Interventions.

Self-related processes (SRPs) have been theorized as key mechanisms of mindfulness-based interventions (MBIs), but the evidence supporting these theories is currently unclear. This evidence map introduces a comprehensive framework for different types of SRPs, and how they are theorized to function as mechanisms of MBIs (target identification). The evidence map then assesses SRP target engagement by mindfulness training and the relationship between target engagement and outcomes (target validation). Discussion of the measurement of SRPs is also included. The most common SRPs measured and engaged by standard MBIs represented valenced evaluations of self-concept, including rumination, self-compassion, self-efficacy, and self-esteem. Rumination showed the strongest evidence as a mechanism for depression, with other physical and mental health outcomes also supported. Self-compassion showed consistent target engagement but was inconsistently related to improved outcomes. Decentering and interoception are emerging potential mechanisms, but their construct validity and different subcomponents are still in development. While some embodied self-specifying processes are being measured in cross-sectional and meditation induction studies, very few have been assessed in MBIs. The SRPs with the strongest mechanistic support represent positive and negative evaluations of self-concept. In sum, few SRPs have been measured in MBIs, and additional research using well-validated measures is needed to clarify their role as mechanisms.

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.

Emotion-related constructs engaged by mindfulness-based interventions: A systematic review and meta-analysis.

OBJECTIVES: Mindfulness-based interventions (MBIs) have been widely implemented to improve self-regulation behaviors, often by targeting emotion-related constructs to facilitate change. Yet the degree to which MBIs engage specific measures of emotion-related constructs has not been systematically examined. METHODS: Using advanced meta-analytic techniques, this review examines construct and measurement engagement in trials of adults that used standardized applications of the two most established MBIs: Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), or modified variations of these interventions that met defined criteria. RESULTS: Seventy-two studies (N=7,378) were included (MBSR k=47, MBCT k = 21, Modified k=4). MBIs led to significant improvement in emotion-related processing overall, compared to inactive controls (d=0.58; k =36), and in all constructs assessed: depression (d=0.66; k=26), anxiety (d =0.63; k=19), combined mental health (d =0.75; k=7 ) and stress (d =0.44; k=11). Reactions to pain, mood states, emotion regulation, and biological measures lacked sufficient data for analysis. MBIs did not outperform active controls in any analyses. Measurement tool and population-type did not moderate results, but MBI-type did, in that MBCT showed stronger effects than MBSR, although these effects were driven by a small number of studies. CONCLUSIONS: This review is the first to examine the full scope of emotion-related measures relevant to self-regulation, to determine which measures are most influenced by MBCT/MBSR. Compared to extant reviews, which typically focused on MBI outcomes, this work examined mechanistic processes based on measurement domains and tools. While effect sizes were similar among measurement tools, this review also includes a descriptive evaluation of measures and points of caution, providing guidance to MBI researchers and clinicians for selection of emotion-related measurement tools.

Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study.

As opioid overdose deaths increase, buprenorphine/naloxone (B/N) treatment is expanding, yet almost half of patients are not retained in B/N treatment. Mindfulness-based interventions (MBIs) designed to promote non-judgmental awareness of present moment experience may be complementary to B/N treatment and offer the potential to enhance retention by reducing substance use and addressing comorbid symptoms. In this pilot study, we examined the feasibility and acceptability of the Mindful Recovery OUD Care Continuum (M-ROCC), a trauma-informed, motivationally sensitive, 24-week MBI. Participants (N = 18) were adults with Opioid Use Disorder prescribed B/N. The study team conducted assessments of satisfaction, mindfulness levels, and home practice, as well as qualitative interviews at 4 and 24-weeks. M-ROCC was feasible in a sample with high rates of childhood trauma and comorbid psychiatric diagnoses with 89% of participants retained at 4-weeks and 72% at 24-weeks. Positive qualitative interview responses and a high rate of participants willing to refer a friend (100%) demonstrates program acceptability. Participant mindfulness increased from baseline to 24-weeks (ß = 0.24, p = 0.001, d = 0.51), and increases were correlated with informal mindfulness practice frequency (r = 0.7, p < 0.01). Although limited by small sample size, this pilot study highlights the feasibility and acceptability of integrating MBIs into standard primary care Office-Based Opioid Treatment (OBOT) among a population with substantial trauma history.

Promoting Population Behavioral Health in a Safety-Net Health System During the COVID-19 Pandemic.

The COVID-19 pandemic has been expected to lead to substantial increases in need for behavioral health care. A population health framework can facilitate the development of interventions and policies to promote the equitable distribution of care across the population. This column describes the application of population behavioral health principles in a safety-net health system during the pandemic. The approach includes stepped models of care, interventions to target individuals at high behavioral health risk, and measurement-based care. Early data suggest that these strategies have resulted in expanded behavioral health care capacity.