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.

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.

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.

Brief Self-Compassion Training Alters Neural Responses to Evoked Pain for Chronic Low Back Pain: A Pilot Study.

OBJECTIVE: Self-compassion meditation, which involves compassion toward the self in moments of suffering, shows promise for improving pain-related functioning, but its underlying mechanisms are unknown. This longitudinal, exploratory pilot study investigated the effects of a brief (eight contact hours, two weeks of home practice) self-compassion training on pain-related brain processing in chronic low back pain (cLBP). METHODS: We evaluated functional magnetic resonance imaging (fMRI) response to evoked pressure pain and its anticipation during a self-compassionate state and compared altered brain responses following training with changes on self-reported measures of self-compassion (Self-Compassion Scale [SCS]), interoceptive awareness (Multidimensional Assessment of Interoceptive Awareness [MAIA]), and clinical pain intensity. RESULTS: In a sample of participants with cLBP (N = 20 total, N = 14 with complete longitudinal data) who underwent self-compassion training, we observed reduced clinical pain intensity and disability (P < 0.01) and increased trait self-compassion and interoceptive awareness (all P < 0.05) following training. Evoked pressure pain response in the right temporo-parietal junction (TPJ) was reduced following training, and decreases were associated with reduced clinical pain intensity. Further, increased fMRI responses to pain anticipation were observed in the right dorsolateral prefrontal cortex (dlPFC) and ventral posterior cingulate cortex (vPCC), and these increases were associated with mean post-training changes in SCS scores and scores from the body listening subscale of the MAIA. DISCUSSION: These findings, though exploratory and lacking comparison with a control condition, suggest that self-compassion training supports regulation of pain through the involvement of self-referential (vPCC), salience-processing (TPJ), and emotion regulatory (dlPFC) brain areas. The results also suggest that self-compassion could be an important target in the psychotherapeutic treatment of cLBP, although further studies using controlled experimental designs are needed to determine the specificity of these effects.

Implementing group visits for opioid use disorder: A case series.

Background: Group-based models of Office-Based Opioid Treatment with buprenorphine-naloxone (B/N) are increasingly being implemented in clinical practice to increase access to care and provide additional therapeutic benefits. While previous studies reported these Group-Based Opioid Treatment (GBOT) models are feasible for providers and acceptable to patients, there has been no literature to help providers with the more practical aspects of how to create and maintain GBOT in different outpatient settings. Case series: We present 4 cases of GBOT implementation across a large academic health care system, highlighting various potential approaches for providers who seek to implement GBOT and demonstrate "success" based on feasibility and sustainability of these models. For each case, we describe the pros and cons and detail the personnel and resources involved, patient mix and group format, workflow logistics, monitoring and management, and sustainability components. Discussion: The implementation details illustrate that there is no one-size-fits-all approach, although feasibility is commonly supported by a team-based, patient-centered medical home. This approach includes the capacity for referral to higher levels of mental health and addiction support services and is bolstered by ongoing provider communication and shared resources across the health system. Future research identifying the core and malleable components to implementation, their evidence base, and how they might be influenced by site-specific resources, culture, and other contextual factors can help providers better understand how to implement a GBOT model in their unique clinical environment.

Mindfulness Training Enhances Self-Regulation and Facilitates Health Behavior Change for Primary Care Patients: a Randomized Controlled Trial.

BACKGROUND: Self-management of health is important for improving health outcomes among primary care patients with chronic disease. Anxiety and depressive disorders are common and interfere with self-regulation, which is required for disease self-management. An insurance-reimbursable mindfulness intervention integrated within primary care may be effective for enhancing chronic disease self-management behaviors among primary care patients with anxiety, depression, trauma, and stress-related and adjustment disorders compared with the increasingly standard practice of referring patients to outside mindfulness resources. OBJECTIVE: Mindfulness Training for Primary Care (MTPC) is an 8-week, referral-based, insurance-reimbursable program integrated into safety-net health system patient-centered medical homes. We hypothesized that MTPC would be more effective for catalyzing chronic disease self-management action plan initiation within 2 weeks, versus a low-dose comparator (LDC) consisting of a 60-min mindfulness introduction, referral to community and digital resources, and addition to a 6-month waitlist for MTPC. PARTICIPANTS: Primary care providers (PCPs) and mental health clinicians referred 465 patients over 12 months. All participants had a DSM-V diagnosis. DESIGN AND INTERVENTIONS: Participants (N = 136) were randomized in a 2:1 allocation to MTPC (n = 92) or LDC (n = 44) in a randomized controlled comparative effectiveness trial. MTPC incorporates mindfulness, self-compassion, and mindfulness-oriented behavior change skills and is delivered as insurance-reimbursable visits within primary care. Participants took part in a chronic disease self-management action planning protocol at week 7. MAIN MEASURES: Level of self-reported action plan initiation on the action plan initiation survey by week 9. KEY RESULTS: Participants randomized to MTPC, relative to LDC, had significantly higher adjusted odds of self-management action plan initiation in an intention-to-treat analysis (OR = 2.28; 95% CI = 1.02 to 5.06, p = 0.025). CONCLUSIONS: An 8-week dose of mindfulness training is more effective than a low-dose mindfulness comparator in facilitating chronic disease self-management behavior change among primary care patients.

Why use group visits for opioid use disorder treatment in primary care? A patient-centered qualitative study.

BACKGROUND: Primary care providers are well positioned to respond to the opioid crisis by providing buprenorphine/naloxone (B/N) through shared medical appointments (SMAs). Although quantitative research has been previously conducted on SMAs with B/N, the authors conducted a qualitative assessment from the patients' point of view, considering whether and how group visits provide value for patients. METHODS: Twenty-five participants with opioid use disorder (OUD) who were enrolled in a weekly B/N group visit at a family medicine clinic participated in either of two 1-hour-long focus groups, which were conducted as actual group visits. Participants were prompted with the question "How has this group changed you as a person?" Data were audio-recorded and professionally transcribed and analyzed using a qualitative thematic approach, identifying common communication behaviors and resulting attitudes about the value of the group visit model. RESULTS: Participants demonstrated several communication behaviors that support group members in their recovery, including offering direct emotional support to others struggling with difficult experiences, making an intentional effort to probe about others' lives, venting about heavy situations, joking to lighten the mood, and expressing feelings of gratitude to the entire group. These communication behaviors appear to act as mechanisms to foster a sense of accountability, a shared identity, and a supportive community. Other demonstrated group behaviors may detract from the value of the group experience, including side conversations, tangential comments, and individual participants disproportionately dominating group time. CONCLUSION: The group visit format for delivering B/N promotes group-specific communication behaviors that may add unique value in supporting patients in their recovery. Future research should elucidate whether these benefits can be isolated from those achieved solely through medication treatment with B/N and if similar benefits could be achieved in non-primary care sites.

Mindfulness and Cardiovascular Disease Risk: State of the Evidence, Plausible Mechanisms, and Theoretical Framework.

The purpose of this review is to provide (1) a synopsis on relations of mindfulness with cardiovascular disease (CVD) and major CVD risk factors, and (2) an initial consensus-based overview of mechanisms and theoretical framework by which mindfulness might influence CVD. Initial evidence, often of limited methodological quality, suggests possible impacts of mindfulness on CVD risk factors including physical activity, smoking, diet, obesity, blood pressure, and diabetes regulation. Plausible mechanisms include (1) improved attention control (e.g., ability to hold attention on experiences related to CVD risk, such as smoking, diet, physical activity, and medication adherence), (2) emotion regulation (e.g., improved stress response, self-efficacy, and skills to manage craving for cigarettes, palatable foods, and sedentary activities), and (3) self-awareness (e.g., self-referential processing and awareness of physical sensations due to CVD risk factors). Understanding mechanisms and theoretical framework should improve etiologic knowledge, providing customized mindfulness intervention targets that could enable greater mindfulness intervention efficacy.

Finding the right match: mindfulness training may potentiate the therapeutic effect of nonjudgment of inner experience on smoking cessation.

Mindfulness training (MT) is an emerging therapeutic modality for addictive disorders. Nonjudgment of inner experience, a component of mindfulness, may influence addiction treatment response. To test whether this component influences smoking cessation, tobacco smokers (n = 85) in a randomized control trial of MT vs. Freedom from Smoking (FFS), a standard cognitive-behaviorally-oriented treatment, were divided into split-half subgroups based on baseline Five Facet Mindfulness Questionnaire nonjudgment subscale. Smokers who rarely judge inner experience (nonjudgment > 30.5) smoked less during follow-up when randomized to MT (3.9 cigs/d) vs. FFS (11.1 cigs/d), p < .01. Measuring trait nonjudgment may help personalize treatment assignments, improving outcomes.

Online group-based internal family systems treatment for posttraumatic stress disorder: Feasibility and acceptability of the program for alleviating and resolving trauma and stress.

OBJECTIVE: Demand for trauma-focused therapy continues to increase, especially in community mental health care settings where group treatment models can be cost-effective and increase access to care. The Internal Family Systems (IFS) model for posttraumatic stress disorder (PTSD) may offer an effective therapeutic approach. The purpose of this proof-of-concept study was to evaluate the feasibility and acceptability of a novel, trauma-focused, group-based treatment approach and investigate potential mechanisms of action. METHOD: Study participants completed the Program for Alleviating and Resolving Trauma and Stress (PARTS), an online-delivered program including 16 weeks of 90-min IFS-based groups with eight 50-min individual IFS counseling sessions. Participants completed assessments including clinician-administered and self-report measures of PTSD, common comorbid conditions (e.g., complex PTSD [disturbances in self-organization], depression, anxiety, and suicidality), and potential mechanisms (e.g., decentering, self-compassion, and emotion regulation). RESULTS: Most participants (n = 11/15; 73%) attended 12+ group sessions, with 92% (12/13 responders) reporting they would recommend PARTS to a friend. All respondents reported the program was helpful (13/13; 100%). PTSD symptom severity was reduced from baseline to Weeks 16 (d = -0.7, p = .005) and 24 (d = -0.9, p < .001). A clinically meaningful response (i.e., 10+ point reduction on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders [5th ed.]) was demonstrated in 53% of participants (8/15) by Week 24. Decentering, self-compassion, and emotion regulation all improved (p < .05). CONCLUSIONS: PARTS was feasible and acceptable as a group-based, online intervention in an urban, public community health care system. While PARTS showed promise in reducing overall PTSD symptom severity, well-controlled efficacy research is needed. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

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.

Clinician beliefs and attitudes about buprenorphine/naloxone diversion.

BACKGROUND AND OBJECTIVES: Concern about diversion of buprenorphine/naloxone (B/N) in the United States may affect prescribing patterns and policy decisions. This study examines addiction treatment clinician beliefs and attitudes regarding B/N diversion. METHODS: Participants (n = 369) completed a 34-item survey in 2010 during two national symposia on opioid dependence. We conducted multivariable regression, examining the relationship of perceived danger from B/N diversion with clinician characteristics and their beliefs about B/N treatment and diversion. We compared causal beliefs about diversion among clinicians with and without B/N treatment experience. RESULTS: Forty percent of clinicians believed that B/N diversion is a dangerous problem. The belief that B/N diversion increases accidental overdoses in the community was strongly associated with perceived danger from B/N diversion. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Attitudes and beliefs, not education level, were associated with clinician's perceived danger from B/N diversion. Clinicians with greater B/N patient experience were more likely to believe treatment access barriers are the major cause of B/N diversion.

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).

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.

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.

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).

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.

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.

"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.

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.