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.

Integrative medical group visits for patients with chronic pain: results of a pilot single-site hybrid implementation-effectiveness feasibility study.

Background: Approximately 20% of adults in the United States experience chronic pain. Integrative Medical Group Visit (IMGV) offers an innovative approach to chronic pain management through training in mindfulness, nutrition, and other mind-body techniques combined with peer support. To date, there are no studies on IMGV implementation, despite its promise as a feasible non-pharmacological intervention for chronic pain management. In this study, we assessed the feasibility of implementing IMGV and assessing its effectiveness for chronic pain. Methods: Implementation Mapping was used to develop and evaluate implementation strategies for IMGV. Strategies included disseminating educational materials, conducting ongoing training, and conducting educational meetings. IMGV was delivered by three healthcare providers: an allopathic physician, registered yoga teacher, and naturopathic physician. The effectiveness of IMGV on patient health outcomes was assessed through qualitative interviews and a Patient-Reported Outcomes Scale (PROMIS-29). Provider perspectives of acceptability, appropriateness, and feasibility were assessed through periodic reflections (group interviews reflecting on the process of implementation) and field notes. Paired t-tests were used to assess changes between scores at baseline and post intervention. Qualitative data were coded by three experienced qualitative researchers using thematic content analysis. Results: Of the initial 16 patients enrolled in research, 12 completed at least two sessions of the IMGV. Other than fatigue, there was no statistically significant difference between the pre- and post-scores. Patients reported high satisfaction with IMGV, noting the development of new skills for self-care and the supportive community of peers. Themes from patient interviews and periodic reflections included the feasibility of virtual delivery, patient perspectives on acceptability, provider perspectives of feasibility and acceptability, ease of recruitment, complexity of referral and scheduling process, balancing medical check-in with group engagement, and nursing staff availability. Conclusions: IMGV was feasible, acceptable, and effective from the perspectives of patients and providers. Although statistically significant differences were not observed for most PROMIS measures, qualitative results suggested that participants experienced increased social support and increased pain coping skills. Providers found implementation strategies effective, except for engaging nurses, due to staff being overwhelmed from the pandemic. Lessons learned from this pilot study can inform future research on implementation of IMGV.

A Systematic Review of the Adherence to Home-Practice Meditation Exercises in Patients with Chronic Pain.

Mindfulness-, compassion-, and acceptance-based (i.e., "third wave") psychotherapies are effective for treating chronic pain conditions. Many of these programs require that patients engage in the systematic home practice of meditation experiences so they can develop meditation skills. This systematic review aimed at evaluating the frequency, duration, and effects of home practice in patients with chronic pain undergoing a "third wave" psychotherapy. A comprehensive database search for quantitative studies was conducted in PubMed, Embase, and Web of Sciences Core Collection; 31 studies fulfilled the inclusion criteria. The reviewed studies tended to indicate a pattern of moderately frequent practice (around four days/week), with very high variability in terms of time invested; most studies observed significant associations between the amount of practice and positive health outcomes. Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy were the most common interventions and presented low levels of adherence to home practice (39.6% of the recommended time). Some studies were conducted on samples of adolescents, who practiced very few minutes, and a few tested eHealth interventions with heterogeneous adherence levels. In conclusion, some adaptations may be required so that patients with chronic pain can engage more easily and, thus, effectively in home meditation practices.

Mechanisms of mindfulness in patients with migraine: Results of a qualitative study.

OBJECTIVE: To understand the mechanisms of mindfulness' impact on migraine. BACKGROUND: Promising mindfulness research demonstrates potential benefit in migraine, but no data-driven model exists from the lived experiences of patients that explains the mechanisms of mindfulness in migraine. METHODS: Semi-structured qualitative interviews were conducted with adults with migraine who participated in two mindfulness-based stress reduction (MBSR) clinical trials (n = 43). Interviews were audio-recorded, transcribed, and summarized into a framework matrix with development of a master codebook. Constructivist grounded theory approach was used to identify themes/subthemes. RESULTS: Participants who learned mindfulness techniques through MBSR experienced altered pain perception, altered response to migraine attacks and disease, increased awareness of external and internal experiences, improved overall well-being, and group benefits. Mindfulness resulted in earlier stress-body awareness and increased interoceptive awareness resulting in earlier attack recognition, leading to earlier and more effective management. Interictal factors of self-blame, guilt, and stigma decreased while migraine acceptance, hope, empowerment, self-efficacy, and self-compassion increased. Improved emotion regulation resulted in decreased fear of migraine, pain catastrophizing, anticipatory anxiety, and pain reactivity. Although taught as prevention, mindfulness was used both acutely and prophylactically. We created a conceptual model hypothesizing that MBSR skills led to an infusion of mindfulness in daily life, resulting in altered pain perception and experience, ultimately leading to improvement in overall well-being, which may positively feed back to the infusion of mindfulness in daily life. The therapeutic benefit of learning mindfulness in a group setting may moderate these effects. CONCLUSIONS: This study identified several new potential mechanisms of mindfulness' effect on migraine. After learning MBSR skills, participants reported altered pain and migraine perception and experiences. Increased stress-body and interoceptive awareness resulted in earlier migraine awareness and treatment. Mindfulness may target important interictal factors that affect disease burden such as fear of migraine, pain catastrophizing, and anticipatory anxiety. This is the first data-driven study to help elucidate the mechanisms of mindfulness on migraine from patient voices and can help direct future research endeavors.

Integrative Approaches to Pediatric Chronic Pain in an Urban Safety-Net Hospital: Cost Savings, Clinical Benefits, and Safety.

Purpose: Chronic pain experienced by children and adolescents represents a significant burden in terms of health, quality of life, and economic costs to U.S. families. In 2015, the Boston Medical Center (BMC) Interdisciplinary Pain Clinic initiated an Integrative Medicine (IM) team model to address chronic pain in children. Team members included a pediatrician, child psychologist, physical therapist, acupuncturist, and massage therapist. Children were referred to the pain clinic from primary care and specialty services within BMC, the largest safety-net hospital in the northeastern United States. For this observational assessment, consent and assent were obtained from parents and pediatric patients. Individualized treatment plans were recommended by the IM team. Methods: Self-reported survey and electronic medical record data were collected about socioeconomic demographics, pain, use of medical and IM services, and quality of life. The authors compared health and quality of life indicators and costs of care for each participant from the year before entering the project with these same indicators for the subsequent year. Results: Eighty-three participants were enrolled. Participants ranged in age from 4 to 22 years (mean 14.7 years). Eighty percent of the group were females. Forty-two percent of the sample were white, 30% were Hispanic/Latinx, and 28% were African American. Primary types of pain were abdominal (52%), headache (23%), musculoskeletal (18%), and other (7%). Quality of life indicators improved (p = 0.049) and pain interference decreased (Wilcoxon p = 0.040). Major economic drivers of cost were emergency department (ED) visits, inpatient hospitalizations, and consultations with medical specialists. For the 46 participants who completed the project, the following total cost savings were noted: $27,819 (surgeries), $17,638 (ED visits), $25,033 (hospitalizations), and $42,843 (specialist consults). No adverse events were reported. Conclusion: The authors' experience demonstrated that the use of IM approaches in an interdisciplinary team approach is safe, feasible, and acceptable to families. Considerable cost savings were observed in the area of surgical procedures, hospitalizations, and consultations with specialists.

Depression Predicts Chronic Pain Interference in Racially Diverse, Income-Disadvantaged Patients.

BACKGROUND: Chronic pain is one of the most common reason adults seek medical care in the United States, with prevalence estimates ranging from 11% to 40%. Mindfulness meditation has been associated with significant improvements in pain, depression, physical and mental health, sleep, and overall quality of life. Group medical visits are increasingly common and are effective at treating myriad illnesses, including chronic pain. Integrative Medical Group Visits (IMGV) combine mindfulness techniques, evidence based integrative medicine, and medical group visits and can be used as adjuncts to medications, particularly in diverse underserved populations with limited access to non-pharmacological therapies. OBJECTIVE AND DESIGN: The objective of the present study was to use a blended analytical approach of machine learning and regression analyses to evaluate the potential relationship between depression and chronic pain in data from a randomized clinical trial of IMGV in diverse, income-disadvantaged patients suffering from chronic pain and depression. METHODS: The analytical approach used machine learning to assess the predictive relationship between depression and pain and identify and select key mediators, which were then assessed with regression analyses. It was hypothesized that depression would predict the pain outcomes of average pain, pain severity, and pain interference. RESULTS: Our analyses identified and characterized a predictive relationship between depression and chronic pain interference. This prediction was mediated by high perceived stress, low pain self-efficacy, and poor sleep quality, potential targets for attenuating the adverse effects of depression on functional outcomes. CONCLUSIONS: In the context of the associated clinical trial and similar interventions, these insights may inform future treatment optimization, targeting, and application efforts in racialized, income-disadvantaged populations, demographics often neglected in studies of chronic pain.

Incorporating Acupuncture Into American Healthcare: Initiating a Discussion on Implementation Science, the Status of the Field, and Stakeholder Considerations.

INTRODUCTION: The field of implementation science is the study of methods that promote the uptake of evidence-based interventions into healthcare policy and practice. While acupuncture has gained significant traction in the American healthcare landscape, its journey has been somewhat haphazard and non-linear. METHODS: In June 2019, a group of thirty diverse stakeholders was convened by the Society for Acupuncture Research with the support of a Patient Centered Outcomes Research Institute, Eugene Washington Engagement Award. This group of stakeholders represented a diverse mix of patients, providers, academicians, researchers, funders, allied health professionals, insurers, association leaders, certification experts, and military program developers. The collective engaged in discussion that explored acupuncture's status in healthcare, including reflections on its safety, effectiveness, best practices, and the actual implementation of acupuncture as seen from diverse stakeholder viewpoints. OBJECTIVES: A primary goal was to consider how to utilize knowledge from the field of implementation science more systematically and intentionally to disseminate information about acupuncture and its research base, through application of methods known to implementation science. The group also considered novel challenges that acupuncture may present to known implementation processes. FINDINGS: This article summarizes the initial findings of this in-person meeting of stakeholders and the ongoing discussion among the subject matter experts who authored this report. The goal of this report is to catalyze greater conversation about how the field of implementation science might intersect with practice, access, research, and policymaking pertaining to acupuncture. Core concepts of implementation science and its relationship to acupuncture are introduced, and the case for acupuncture as an Evidence Based Practice (EBP) is established. The status of the field and current environment of acupuncture is examined, and the perspectives of four stakeholder groups--patients, two types of professional practitioners, and researchers--are explored in more detail.

A Teaching Kitchen Medical Groups Visit with an eHealth Platform for Hypertension and Cardiac Risk Factors: A Qualitative Feasibility Study.

Introduction: Our Whole Lives-Hypertension (OWL-H) is an eHealth toolkit for hypertension and cardiac risks factors. It is a hybrid online self-management platform that teaches blood pressure (BP) self-monitoring and evidence-based lifestyle modifications combined with in-person teaching kitchen medical group visit. Qualitative feedback from participants regarding the facilitators and barriers of using OWL-H has been discussed in this article. Methods: The OWL-H platform was pilot tested in a pre-post trial with two cohorts of participants with hypertension (N = 24). The online intervention utilized OWL-H for teaching mindfulness meditation, the Dietary Approaches to Stop Hypertension nutrition plan, and evidence-based strategies for lifestyle modifications. Three in-person teaching kitchen medical group visits were held to demonstrate cooking skills to reinforce the online platform. Semi-structured focus group discussions (FGDs) were held after the intervention. Results: Fourteen of the 24 participants in the trial participated in the FGDs, and 1 participant provided feedback in a solo interview. Major themes that emerged included: (1) participants' request to tailor OWL-H's recipes and meal planning to suit their own dietary needs or preferences, to personalize the Home Practices (e.g., meditation) according to individual preferences (e.g., addition of nature sounds or guided visual imagery); (2) the strengths and weaknesses of OWL-H as a BP self-monitoring tool; (3) the need for community support in managing BP; and (4) participants noted lack of time, work and commute, Internet connectivity, stress, and sickness as obstacles in using OWL-H. Participants described feeling outpaced by the growth of technology and raised concerns of poor Internet connectivity hampering their use of OWL-H. Conclusion: OWL-H and the accompanying teaching kitchen medical group visit are potential tools to help reduce hypertension and cardiac risk factors. The intervention was found to have acceptability among people with lower income. Clinical Trials Registration#: NCT03974334.

The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain.

Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical trial entitled OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness). OPTIMUM is offered online via telehealth and includes medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR for persons with cLBP. In diverse health-care settings in the US, such as a safety net hospital, federally qualified health centers, and a large academic health system, 450 patients will be assigned randomly to the MGV + MBSR or to usual PCP care alone. Participants will complete self-report surveys at baseline, following the 8-week program, and at 6- and 12-month follow-up. Health care utilization data will be obtained through electronic health records and via brief monthly surveys completed by participants. The primary outcome measure is the PEG (Pain, enjoyment, and general activity) at the 6-month follow-up. Additionally, we will assess psychological function, healthcare resource use, and opioid prescriptions. This trial, which is part of the NIH HEAL Initiative, has the potential to enhance primary care treatment of cLBP by combining PCP visits with a non-pharmacological treatment modeled on MBSR. Because it is offered online and integrated into primary care, it is expected to be scalable and accessible to underserved patients. Clinical Trials.gov: NCT04129450.

Feasibility of Implementation Mapping for Integrative Medical Group Visits.

Objectives: Implementation science is key to translating complementary and integrative health intervention research into practice as it can increase accessibility and affordability while maximizing patient health outcomes. The authors describe using implementation mapping to (1) identify barriers and facilitators impacting the implementation of an Integrative Medical Group Visit (IMGV) intervention in an outpatient setting with a high burden of patients with chronic pain and (2) select and develop implementation strategies utilizing theory and stakeholder input to address those barriers and facilitators. Design: The authors selected a packaged, evidence-based, integrative pain management intervention, the IMGV, to implement in an outpatient clinic with a high burden of patients with chronic pain. The authors used implementation mapping to identify implementation strategies for IMGV, considering theory and stakeholder input. Stakeholder interviews with clinic staff, faculty, and administrators (n = 15) were guided by the Consolidated Framework for Implementation Research. Results: Based on interview data, the authors identified administrators, physicians, nursing staff, and scheduling staff as key stakeholders involved in implementation. Barriers and facilitators focused on knowledge, buy-in, and operational procedures needed to successfully implement IMGV. The implementation team identified three cognitive influences on behavior that would impact performance: knowledge, outcome expectations, and self-efficacy; and three theoretical change methods: cue to participate, communication, and mobilization. Implementation strategies identified included identifying and preparing champions, participation in ongoing training, developing and distributing educational materials, and organizing clinician implementation team meetings. Conclusions: This study provides an example of the application of implementation mapping to identify theory-driven implementation strategies for IMGV. Implementation mapping is a feasible method that may be useful in providing a guiding structure for implementation teams as they employ implementation frameworks and select implementation strategies for integrative health interventions.

Group Medical Visits and Clinician Wellbeing.

There is strong evidence for clinical benefits of group medical visits (GMVs) (also known as shared medical appointments) for prenatal care, diabetes, chronic pain, and a wide range of other conditions. GMVs can increase access to integrative care while providing additional benefits including increased clinician-patient contact time, cost savings, and support with prevention and self-management of chronic conditions. During the COVID-19 pandemic, many clinical sites are experimenting with new models of care delivery including virtual GMVs using telehealth. Little research has focused on which clinicians offer this type of care, how the GMV approach affects the ways they practice, and their job satisfaction. Workplace-based interventions have been shown to decrease burnout in individual physicians. We argue that more research is needed to understand if GMVs should be considered among these workplace-based interventions, given their potential benefits to clinician wellbeing. GMVs can benefit clinician wellbeing in multiple ways, including: (1) Extended time with patients; (2) Increased ability to provide team-based care; (3) Understanding patients' social context and addressing social determinants of health. GMVs can be implemented in a variety of settings in many different ways depending on institutional context, patient needs and clinician preferences. We suggest that GMV programs with adequate institutional support may be beneficial for preventing burnout and improving retention among clinicians and health care teams more broadly, including in integrative health care. Just as group support benefits patients struggling with loneliness and social isolation, GMVs can help address these and other concerns in overwhelmed clinicians.

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.

Food Habits, Stressors, and Use of Complementary Medicine Therapies Among Pediatric Patients Who Attend an Integrative Medicine Pediatric Pain Clinic.

Purpose: Chronic pain is a growing problem among children and adolescents, and is more prevalent in low-income families. This observational study was conducted to describe the demographics and various descriptors, complementary medicine therapy (CMT) use, and lifestyle factors (i.e., food habits and supplement use) of pediatric patients with chronic pain. Methods: Boston Medical Center's Interdisciplinary Pediatric Pain Clinic provides patient education and unique treatment plans, tailored with medical and nonpharmacologic interventions for managing complex and chronic pain. Patient data were obtained through electronic medical chart review and self-reported surveys, and were completed by participants and parents at enrollment. Results: Of the 83 participants, the average age was 15.4 ± 4.3, and 80% were female. Referrals to the clinic were due to abdominal pain (52%), headache (23%), and musculoskeletal or other pain (25%). Thirty-one percent were on food assistance programs, with only 24% of patients currently using CMTs and 85% using pain medications. More than half of all participants (63%) missed up to 5 days of school in the past year, while 26% missed more than 6 days. School or academics (77%) were the most frequently self-reported stressor, followed by social/peer issues (39%), bullying (18%), and parental stress (18%). A very small proportion of patients had sufficient intake of dairy (12%), water (23%), vegetables (1%), and fruits (22%). Conclusion: Chronic pain can significantly affect lifestyle factors, stress, and child development. Patients evaluated at the clinic had poor diets and report having stressors regarding school, social/peer issues, parental stress, and bullying.

An Innovative Electronic Health Toolkit (Our Whole Lives for Chronic Pain) to Reduce Chronic Pain in Patients With Health Disparities: Open Clinical Trial.

BACKGROUND: Chronic pain affects millions of Americans. Our Whole Lives, an electronic health (eHealth) toolkit for Chronic Pain (Our Whole Lives for Chronic Pain [OWLCP]), is a mind-body chronic pain management platform that teaches self-management strategies to reduce pain impact and pain medication use. OBJECTIVE: The primary goal of this study was to evaluate the feasibility of OWLCP in reducing pain impact and pain-related outcomes. METHODS: We conducted a pre-post clinical study (2 cohorts) to assess the feasibility of OWLCP usage among low-income patients with chronic pain. Outcome data, collected at baseline and 9 weeks, included Patient-Reported Outcomes Measurement Information System (PROMIS-29), pain self-efficacy, and pain medication use. In the statistical analysis, we used descriptive statistics, logistic regression, linear regression, and qualitative methods. RESULTS: Among the enrolled 43 participants, the average age was 50 years, (39/43) 91% were female, (16/43) 37% were black, and (7/43) 16% were Hispanic. From baseline to follow-up, the PROMIS measures showed a reduction in depression (P=.02), pain interference (P=.003), and average pain impact score (P=.007). Pain self-efficacy increased ((P<.001), whereas opioid use had a 13% reduction (P=.03). CONCLUSIONS: The eHealth chronic pain management platform, OWLCP, is a potential tool to reduce the impact of chronic pain for low-income racially diverse populations.

Natural Health Product-Drug Interaction Causality Assessment in Pediatric Adverse Event Reports Associated with Attention-Deficit/Hyperactivity Disorder Medication.

Background: Some pediatric patients with attention-deficit/hyperactivity disorder (ADHD) use natural health products (NHPs) such as herbal remedies. Although herbal remedies are generally considered to be safe when they are used appropriately, they may contain active components that can interact with medications being used concurrently, with potential for NHP-drug interactions leading to adverse events. Objectives: The objectives of this study were (1) to identify adverse event reports (AERs) involving commonly used herbal remedies and ADHD prescription medicines in children and adolescents; (2) to evaluate the quality of collected AERs; and (3) to assess whether NHP-drug interactions can be causally linked to reported adverse events. Methods: We systematically searched the FDAble database (FDAble.com) for herbal remedies commonly used by patients (4-18 years old) also taking ADHD drugs from 1997 to 2015. We assessed the completeness of the AERs and used three causality assessment tools modified for NHPs (Naranjo Adverse Drug Reaction Probability Scale, HORN Drug Interaction Probability Scale, and World Health Organization Uppsala Monitoring Centre Scale). Results: Of the 23 identified AERs involving both an herbal remedy and an ADHD prescription medication, most involved multiple (>3) substances with inadequate detail to assess multiple potential interactions. Following data extraction and evaluation of completeness, five AERs involving only one herbal remedy and one ADHD medication were evaluated for causality. An NHP-drug interaction was assessed to be probable in one case and to be possible in another. Both these reports involved a methylphenidate formulation and St. John's wort. Conclusions: Eighteen of the 23 identified AERs involving both an herbal remedy and an ADHD drug also involved other multiple ingredient products. The reporting quality was poor for the five AERs examined. Further research is needed to study the interaction between St. John's wort and methylphenidate.

Using Health Information Technology to Engage African American Women on Nutrition and Supplement Use During the Preconception Period.

Importance: Healthy nutrition and appropriate supplementation during preconception have important implications for the health of the mother and newborn. The best way to deliver preconception care to address health risks related to nutrition is unknown. Methods: We conducted a secondary analysis of data from a randomized controlled trial designed to study the impact of conversational agent technology in 13 domains of preconception care among 528 non-pregnant African American and Black women. This analysis is restricted to those 480 women who reported at least one of the ten risks related to nutrition and dietary supplement use. Interventions: An online conversational agent, called "Gabby", assesses health risks and delivers 12 months of tailored dialogue for over 100 preconception health risks, including ten nutrition and supplement risks, using behavioral change techniques like shared decision making and motivational interviewing. The control group received a letter listing their preconception risks and encouraging them to talk to a health care provider. Results: After 6 months, women using Gabby (a) reported progressing forward on the stage of change scale for, on average, 52.9% (SD, 35.1%) of nutrition and supplement risks compared to 42.9% (SD, 35.4) in the control group (IRR 1.22, 95% CI 1.03-1.45, P = 0.019); and (b) reported achieving the action and maintenance stage of change for, on average, 52.8% (SD 37.1) of the nutrition and supplement risks compared to 42.8% (SD, 37.9) in the control group (IRR 1.26, 96% CI 1.08-1.48, P = 0.004). For subjects beginning the study at the contemplation stage of change, intervention subjects reported progressing forward on the stage of change scale for 75.0% (SD, 36.3%) of their health risks compared to 52.1% (SD, 47.1%) in the control group (P = 0.006). Conclusion: The scalability of Gabby has the potential to improve women's nutritional health as an adjunct to clinical care or at the population health level. Further studies are needed to determine if improving nutrition and supplement risks can impact clinical outcomes including optimization of weight. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT01827215.

Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial.

BACKGROUND: Current treatment options for chronic pain and depression are largely medication-based, which may cause adverse side effects. Integrative Medical Group Visits (IMGV) combines mindfulness techniques, evidence based integrative medicine, and medical group visits, and is a promising adjunct to medications, especially for diverse underserved patients who have limited access to non-pharmacological therapies. OBJECTIVE: Determine the effectiveness of IMGV compared to a Primary Care Provider (PCP) visit in patients with chronic pain and depression. DESIGN: 9-week single-blind randomized control trial with a 12-week maintenance phase (intervention-medical groups; control-primary care provider visit). SETTING: Academic tertiary safety-net hospital and 2 affiliated federally-qualified community health centers. PARTICIPANTS: 159 predominantly low income racially diverse adults with nonspecific chronic pain and depressive symptoms. INTERVENTIONS: IMGV intervention- 9 weekly 2.5 hour in person IMGV sessions, 12 weeks on-line platform access followed by a final IMGV at 21 weeks. MEASUREMENTS: Data collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain Inventory). Secondary outcomes included pain medication use and utilization. RESULTS: There were no differences in pain or depression at any time point. At 9 weeks, the IMGV group had fewer emergency department visits (RR 0.32, 95% CI: 0.12, 0.83) compared to controls. At 21 weeks, the IMGV group reported reduction in pain medication use (Odds Ratio: 0.42, CI: 0.18-0.98) compared to controls. LIMITATIONS: Absence of treatment assignment concealment for patients and disproportionate group attendance in IMGV. CONCLUSION: Results demonstrate that low-income racially diverse patients will attend medical group visits that focus on non-pharmacological techniques, however, in the attention to treat analysis there was no difference in average pain levels between the intervention and the control group. TRIAL REGISTRATION: clinicaltrials.gov NCT02262377.

Blood Lead Levels of Children Using Traditional Indian Medicine and Cosmetics: A Feasibility Study.

BACKGROUND: Traditional Indian cosmetics and Ayurvedic medicines may contain lead. Previous studies have shown a relationship between eye cosmetic use (kohl) in children and elevated blood lead levels (BLLs) > 10 µg/dL. However, an association between Ayurvedic use and elevated BLLs in children is unknown and understudied. METHODS: We assessed the feasibility of collecting BLLs in children attending Ayurvedic outpatient settings in India. Our pilot study took place over 3 days in the summer of 2010 at a large public Ayurveda hospital and a small pediatric clinic in southern India. Using a trained interpreter, we administered a standardized questionnaire in Malayalam, assessing sociodemographics, Ayurvedic medicine use, kohl use, and other potential risk factors for lead exposure, to parents of pediatric outpatients. We also analyzed BLLs using a portable lead analyzer. RESULTS: The study enrolled 29 children (mean age, 3.8 years). The mean BLL was 6.7 µg/dL (SD = 3.5; range, 3.5-20.2). Seventy-two percent of the children used Ayurvedic medicine in the past 2 years and 55% reported kohl use. Mean BLL of Ayurvedic users and nonusers was 6.2 µg/dL and 8.5 µg/dL, respectively (P = .08). Kohl users had a statistically significant higher BLL than nonusers (8.0 µg/dL vs 5.3 µg/dL, P = .03). CONCLUSIONS: It is feasible to collect BLLs in pediatric Ayurvedic outpatient clinics in southern India. Collaborative relationships with community members and hospital staff were essential. Further research is needed to investigate Ayurveda and kohl use as risk factors for elevated lead burden among Indian children.

Feasibility and Acceptability of Mindfulness-Based Group Visits for Smoking Cessation in Low-Socioeconomic Status and Minority Smokers with Cancer.

Objective: Smoking cessation studies tailored for low-income and racial/ethnic minority cancer patients are limited. African American and low-socioeconomic status (SES) smokers have higher cancer mortality rates and are less likely to use evidence-based smoking cessation treatments compared with white and higher SES counterparts. Mindfulness training is a promising approach to address racial and SES disparities in smoking cessation. The authors assessed the feasibility and acceptability of a mindfulness-based smoking cessation (MBSC) medical group visit for low-income and racially diverse smokers with cancer. Design and intervention: The authors adapted the integrative medical group visit model used for chronic pain and included the You Can Quit smoking cessation curriculum used at the study site, Tobacco Treatment Center. The program was conducted in eight weekly 2-h visits. The authors then tested the feasibility and acceptability of this intervention for actively smoking cancer patients and cancer survivors in two pilot groups (N = 18) using a pre-post design. Setting/Location: This study took place at Boston Medical Center, a large urban safety net academic teaching hospital. Outcome measures: The authors used a medical group visit intake form to collect data on weekly cigarette intake and home practice. They also gathered additional qualitative data from focus groups and in-depth interviews. Results: Over 50% of participants (n = 10) self-identified as black and 56% reported an annual income of $20,000 or less. Over two-thirds of the participants attended four or more of the eight group visits. There was a significant decrease in weekly cigarette intake from 75.1 cigarettes at baseline to 44.3 at 3 months (p = 0.039). None of the participants quit smoking. Participants were satisfied with the program and reported positive lifestyle changes. Conclusion: MBSC group visits are feasible and acceptable among racially diverse and low-SES smokers with cancer and should be further studied in a larger cohort.