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.

Pilot Observational Study of Patient Reported Outcome Measures for Long COVID Patients in Virtual Integrative Medical Group Visits.

Background: Long COVID is a common, debilitating post-infectious illness for which effective management is unknown. Integrative Medical Group Visits (IMGV) are effective interventions for chronic conditions and could benefit Long COVID patients. More information is needed regarding existing patient reported outcome measures (PROMs) to evaluate efficacy of IMGV for Long COVID. Objective: This study assessed the feasibility of specific PROMS to evaluate IMGVs for Long COVID. Findings will inform future efficacy trials. Methods: The Perceived Stress Scale (PSS-10), General Anxiety Disorder two-question tool (GAD-2), Fibromyalgia Symptom Severity scale (SSS), and Measure Yourself Medical Outcome Profile (MYMOP®) were collected pre- and post-group by teleconferencing platform or telephone and compared using paired t-tests. Patients were recruited from a Long COVID specialty clinic where they participated in 2-hour - 8 weekly IMGV sessions online. Results: Twenty-seven participants enrolled and completed pre-group surveys. Fourteen participants were reachable by phone post-group and completed all pre and post PROMs (78.6% female, 71.4% non-Hispanic White, mean age 49). MYMOP® primary symptomatology was fatigue, shortness of breath and "brain fog". Symptoms decreased in interference when compared to pre-group levels (mean difference -1.3 [95% CI-2.2, -.5]). PSS scores decreased (-3.4 [95% CI -5.8, -1.1]), and GAD-2 mean difference was -1.43 (95% CI -3.12, .26). There were no changes in SSS scores of fatigue (-.21 [95% CI -.68,0.25]), waking unrefreshed (.00 [95%CI -.32, -.32]), or trouble thinking (-.21 [95% CI -.78,0.35]). Conclusion: All PROMs were feasible to administer via teleconferencing platform or telephone. The PSS, GAD-2 and MYMOP® are promising PROMs to track Long COVID symptomatology among IMGV participants. The SSS, while feasible to administer, did not change compared to baseline. Larger, controlled studies are needed to determine the efficacy of virtual IMGVs to address the needs of this large and growing population.

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.

Characteristics and Components of Medical Group Visits for Chronic Health Conditions: A Systematic Scoping Review.

Objectives: Chronic health conditions are a major challenge to the health care system. Medical Group Visits (MGVs) are a valuable health care delivery model used in a variety of medical settings and patient populations. We conducted a systematic scoping review of MGV research literature for chronic health conditions to summarize the characteristics and individual components of MGVs in the United States of America and Canada. Design: We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses scoping review methodology and searched five databases using nine widely used MGV-related terms. Subjects: We included studies conducted in the United States and Canada, whose participants were >18 years old and attended an MGV conducted in a medical setting by a billable health care provider. We excluded groups related to diabetes, pregnancy, and cancer. Results: Of 3777 studies identified, we found 55 eligible studies of which 9 are randomized controlled trials and 46 are observational studies. The majority of studies were conducted in academic medical centers, were observational in design, and recruited patients using physician referrals. The three most frequently studied groups include a combination of several chronic conditions (n = 12), chronic pain conditions (n = 10), and cardiovascular disease (n = 9). Curriculum components included didactics (n = 55), experiential activities (n = 27), and socializing components (n = 12). Didactic areas include (1) medical topics such as symptoms management (n = 27) of which 14 included pain management, and (2) lifestyle/educational component (n = 33) that comprised of talks on nutrition (n = 29), exercise (n = 20), stress (n = 16), and sleep (n = 10). The top integrative medicine (IM) modalities (n = 13) included: mindfulness techniques (n = 8), meditation (n = 6), and yoga (n = 5). Substantial heterogeneity was observed in the recruitment, implementation, curriculum components, and outcomes reported. Conclusion: The MGV is a model of patient-centered care that has captured the attention of researchers. IM modalities are well represented in the curriculum components of MGVs. Further investigation into the components identified by this study, may help in better targeting of group interventions to patients and contexts, where it is most likely to be effective.

Engaging women with an embodied conversational agent to deliver mindfulness and lifestyle recommendations: A feasibility randomized control trial.

OBJECTIVE: This randomized controlled trial evaluates the feasibility of using an Embodied Conversational Agent (ECA) to teach lifestyle modifications to urban women. METHODS: Women were randomized to either 1) an ECA (content included: mindfulness, stress management, physical activity, and healthy eating) or 2) patient education sheets mirroring same content plus a meditation CD/MP3 once a day for one month. General outcome measures included: number of stress management techniques used, physical activity levels, and eating patterns. RESULTS: Sixty-one women ages 18 to 50 were enrolled. On average, 51% identified as white, 26% as black, 23% as other races; and 20% as Hispanic. The major stress management techniques reported at baseline were: exercise (69%), listening to music (70%), and social support (66%). After one month, women randomized to the ECA significantly decreased alcohol consumption to reduce stress (p=0.03) and increased daily fruit consumption by an average of 2 servings compared to the control (p=0.04). CONCLUSION: It is feasible to use an ECA to promote health behaviors on stress management and healthy eating among diverse urban women. PRACTICE IMPLICATIONS: Compared to patient information sheets, ECAs provide promise as a way to teach healthy lifestyle behaviors to diverse urban women.

Online Education for Improving Communication and Documentation of Dietary Supplements Among Health Professionals Practicing in a Hospital Setting.

BACKGROUND: Little is known about the feasibility of online education in improving communication and documentation of dietary supplements (DS) among clinicians. METHODS: This prospective educational study included clinicians at an urban teaching hospital. The curriculum included video streams, didactics, and interactive case presentations to discuss (1) DS safety and effectiveness, (2) cultural competency, (3) managing DS in a hospital setting, and (4) DS adverse events. Participants were surveyed, at baseline and after training, about DS knowledge, confidence, communication, and documentation practices. RESULTS: Thirty-nine of 61 (64%) recruited clinicians completed all four patient cases and post-tests. Most (82%) were women and 59% were physicians. The mean DS knowledge test score increased after the curriculum (p < 0.0001), and the clinician confidence score also increased (p < 0.0001). Most (82%) participants reported that curriculum changed their use of evidence-based resources (p = 0.01). There was a change in the indications for symptom management (p = 0.05) and gastrointestinal/digestive health issues (p = 0.03). There were statistically significant increases in the frequency of asking patients about DS use during discharge (p = 0.01), and 82% responded that the curriculum changed their DS documentation. CONCLUSION: An online curriculum is an effective tool for presenting DS education to clinicians with the goal of improving clinicians' knowledge, confidence, and documentation practices about DS.

Complementary and Alternative Medicine Use Among Women During Pregnancy and Childbearing Years.

OBJECTIVES: Little is known regarding complementary and alternative medicine (CAM) use during pregnancy and the preconception period. Since half of all pregnancies in the United States are unintended, understanding the patterns of CAM use among women of childbearing age has implications for fetal and maternal health. METHODS: Descriptive statistics were generated from the 2012 National Health Interview Study (NHIS) to estimate weighted prevalence and patterns of CAM use by women of childbearing age. Comparisons were made between pregnant and nonpregnant respondents. RESULTS: In this sample of 10,002 women, 7 percent (n = 727) were recently pregnant. Over one-third of all the women used CAM during the previous year (34/38%, pregnant/nonpregnant, respectively) and only half disclosed CAM use to conventional providers (50/49%). In the adjusted model, taking multivitamins (OR 2.52 [CI 2.22-2.86]) and moderate to heavy alcohol use (OR 1.92 [CI 1.53-2.41]) were more likely associated with CAM use. The two most commonly used modalities were herbs (14/17%) and yoga (13/16%). The top reasons for CAM use were to improve general wellness or to prevent disease (33/35%) and to treat back pain (16/18%). When examining all pregnancy-related symptoms treated with CAM, no difference was found in the rates of CAM use between pregnant and nonpregnant users. CONCLUSIONS: CAM use by women of childbearing age in the United States is common, with over a third of the population using one or more therapies. However, only half disclosed their use to conventional providers despite limited evidence on safety and effectiveness. This study highlights the important need for further research in this area.

Kelp use in patients with thyroid cancer.

To report on the incidence and use of kelp among patients with thyroid cancer. Data were collected using a web-based online anonymous survey under Institutional Review Board approval from Boston University. This report is based on 27 responses from subjects with thyroid cancer who use kelp. Demographic factors and complementary and alternative use were included. Respondents were primarily over age 40, white, female and have at least a high school education. The top five modalities were multivitamins, special diets, herbal supplements, prayer for health reasons and herbal tea. Only one patient reported perceiving a particular modality had a negative effect on treatment. Complementary and alternative medicine (CAM) was more often perceived as being used to aid their thyroid cancer treatment than to help with symptoms. On average, respondents who use kelp also use at least 11 additional CAM modalities. Only 1/2 of respondents who use kelp reported telling their physicians about their CAM use, and nearly 1/3 of respondents reported their CAM use was neither known, prescribed nor asked about by their physicians. In comparison to both national surveys of the general US population and patients with thyroid cancer, kelp users with thyroid cancer use at least twice the number of additional CAM therapies and report their use far less often. Physicians who treat patients with thyroid cancer should be aware of these data to further assist in their assessment and care.

Complementary and alternative medicine use among patients with thyroid cancer.

BACKGROUND: To report on the incidence and predictors of use of complementary and alternative medicine (CAM) among patients with thyroid cancer. METHODS: Data were collected using a web-based online anonymous survey under Institutional Review Board approval from Boston University. This report is based on 1327 responses from subjects with thyroid cancer. Patient factors were compared by univariate and multivariate analyses. RESULTS: After excluding multivitamin and prayer use, 74% (n=941) used CAM. Respondents were primarily over age 40, white, and female and held a college degree. The top five modalities were massage therapy, chiropraxy, special diets, herbal tea, and yoga. Few patients reported perceiving a particular modality had a negative effect on treatment. CAM was more often used for treatment of symptoms (73%) than as part of thyroid cancer treatment (27%). Multivariable logistic regression demonstrated that patients reporting a poor health status, higher education, cardiovascular disease, pulmonary symptoms, or persistent, recurrent, or metastatic disease were more likely to use CAM for treatment of thyroid cancer symptoms. Nearly one third of respondents reported their CAM use was not known, prescribed, or asked about by their physicians. CONCLUSIONS: In comparison to national surveys of the general U.S. population, patients with thyroid cancer use CAM therapies twice as often and report their use far less often. Physicians who treat patients with thyroid cancer should be aware of these data to further assist in their assessment and care.

Massage for perioperative pain and anxiety in placement of vascular access devices.

CONTEXT: Despite major advances in cancer treatment, many patients undergo painful procedures during treatment and suffer debilitating side effects as well as report a decrease in quality of life (QOL). This problem is exacerbated for low-income, racial, and ethnic minorities with cancer. Minority cancer patients often enter care with larger tumors and with a more aggressive disease, increasing the risk of debilitating symptoms, such as pain and anxiety. Researchers have never assessed the feasibility and effectiveness of offering massage therapy for low-income, underserved cancer patients who are undergoing port insertion. OBJECTIVE: This study examined the feasibility of conducting a randomized, controlled trial (RCT) that would assess the use of massage therapy to reduce pain and anxiety in urban patients with cancer who undergo surgical placement of a vascular access device (port). The study also assessed the effectiveness of the intervention in reducing perioperative pain and anxiety. DESIGN: The research team conducted a 9-month RC T of 60 cancer patients undergoing port placement. The research team randomly assigned patients in a 2:1 ratio to usual care with massage therapy (intervention group) versus usual care with structured attention (control group). SETTING: The study took place at Boston Medical Center (BMC), which is an urban, tertiary-referral, safety-net hospital. PARTICIPANTS: Participants were cancer patients undergoing port placement. Sixty-seven percent were racial or ethnic minorities, and the majority were female and unemployed, with annual household incomes <$30 000 and publicly funded health insurance coverage. INTERVENTION: For the intervention, an expert panel developed a reproducible, standardized massage therapy intended for individuals undergoing surgical port insertion. Both groups received 20-minute interventions immediately pre- and postsurgery. The research team collected data on pain and anxiety before and after the preoperative and postoperative interventions as well as 1 day after the surgery. OUTCOME MEASURES: With respect to feasibility, the study examined (1) data about recruitment--time to complete enrollment and proportion of racial and ethnic minorities enrolled; (2) participants' retention; and (3) adherence to treatment allocation. The efficacy outcomes included measuring (1) participants' average pain level using an 11-point numerical rating scale (0 = no pain to 10 = worst possible pain) and (2) participants' situational anxiety using the State-Trait Anxiety Inventory (STAI). RESULTS: The research team assigned the 60 patients to the groups over 53 weeks. Sixty-seven percent of the participants were racial or ethnic minorities. A majority were female and unemployed, with annual household incomes <$30 000 and publicly funded health insurance coverage. Of the 40 patients allocated to massage therapy, the majority (n = 33) received both the pre- and postoperative interventions. Massage therapy participants had a statistically significant, greater reduction in anxiety after the first intervention compared with individuals receiving structured attention (-10.27 vs -5.21, P = .0037). CONCLUSIONS: Recruitment of low-income, minority patients into an RCT of massage therapy for perioperative pain and anxiety is feasible. Both massage therapy and structured attention proved beneficial for alleviating preoperative anxiety in cancer patients undergoing port placement.

Concomitant use of prescription medications and dietary supplements in menopausal women: an approach to provider preparedness.

Dietary supplements are becoming increasingly popular as therapies for symptom relief among menopause-age women in the United States. However, a large gap exists between research in the concomitant use of prescription medications and dietary supplements and provider preparedness to guide patient decision making. Many menopausal women take prescription medications, over the counter medications, and herbs and dietary supplements for climactic symptoms or other health conditions. With any drug, there is the potential for interactions. Women taking medications with a narrow therapeutic index, such as anticoagulants, anticonvulsants, and drugs for the treatment of chronic diseases, are at particular risk. Patients should be queried regarding their use of dietary supplements when starting or stopping a prescription drug, or if unexpected reactions occur. When counseling patients, one must carefully consider the risks and benefits of each supplement and medication being taken by each individual.

The clinical content of preconception care: environmental exposures.

Environmental origins of disease risk and harm to health have been increasingly acknowledged for numerous outcomes, in both adult and pediatric populations. Adverse reproductive and developmental effects have also been linked to environmental exposures. In addition to the current queries about a patient's alcohol and smoking history, key determinants of a future pregnancy outcome should also be elicited during the preconception visit. These determinants include: (1) mercury intake via fish consumption; (2) nitrate exposure from well water sources; (3) exposure to chemical, physical, or biologic hazards on the job; and (4) lead and other toxic exposures--possibly from hobbies or the use of lead-glazed dinnerware in the home. Eliciting a detailed environmental history permits tailored recommendations to optimize the woman's health and that of her future pregnancy.

Factors associated with herb and dietary supplement use by young adults in the United States.

BACKGROUND: Little is known about the association between use of herbs and dietary supplements (HDS) and lifestyle/behavior factors in young adults in the US. METHODS: Analyzing the 2002 National Health Interview Survey (NHIS), we examined the patterns of HDS (excluding vitamins/minerals) use among young adults in the United States using descriptive statistics and logistic regression. RESULTS: In our sample of 18 to 30 year olds (n = 6666), 26% were current smokers, 24% were moderate/heavy drinkers, 43% had high physical activity, and 54% and 76% use prescription and over the counter (OTC) medications respectively. Non-vitamin, non-mineral HDS was used by 17% of the overall sample in the last 12 months. In the multivariable analysis, the lifestyle and behavioral factors associated with HDS use include: current smoking (odds ratio 1.41 95% CI [1.16-1.72]); being a former smoker (1.50 [1.15-1.95]); moderate/heavy alcohol use (2.02 [1.53-2.65]); high physical activity levels (2.45 [1.98-3.03]); and prescription medication use (1.51 [1.26-1.81]). Among HDS users, only 24% discussed their use with a health care professional. CONCLUSION: Nearly one in five young adults report using non-vitamin/non-mineral HDS.

Factors associated with herbal therapy use by adults in the United States.

OBJECTIVE: To examine the patterns of herbal therapy use among adults in the United States and to describe factors associated with herb use. DESIGN: We examined the use of natural herbs from the 2002 National Health Interview Survey (NHIS). We analyzed factors associated with herb use and reasons for herb use with logistic regression. RESULTS: Factors associated with herb use include the following: age (45-64 years old), being uninsured, being female, having a higher education, living in the West, using prescription medications or over-the-counter (OTC) medications, and self-identified as "non-Hispanic other." Factors associated with no herb use include being non-Hispanic black and living in the South or Midwest. Seventy-two percent of those who used herbs used prescription medications, and 84% of those who used herbs also used an OTC medication in the prior 12 months. Among adults who used herbs, the most commonly mentioned were echinacea (41%), ginseng (25%), gingko (22%), and garlic (20%). The most frequent conditions for herb use were head or chest cold (30%), musculoskeletal conditions (16%), and stomach or intestinal illness (11%). Among those who used herbs in the prior year, factors associated with using herbs because conventional medical treatments were too expensive included being uninsured, having poor health, and being 25-44 years old. CONCLUSIONS: Nearly 1 in 5 people in the US population report using an herb for treatment of health conditions and/or health promotion. More than half did not disclose this information to a conventional medical professional.

Factors associated with dietary supplement use among prescription medication users.

BACKGROUND: We examined the patterns of nonvitamin dietary supplement (NVDS) use among adult prescription medication users in the United States. METHODS: Using the 2002 National Health Interview Survey, we analyzed factors associated with NVDS use and prescription medication use in the prior 12 months with descriptive, chi(2), and logistic regression analysis. RESULTS: In the United States, 21% of adult prescription medication users reported using NVDSs in the prior 12 months. Of the respondents who used both prescription medications and NVDSs in the prior 12 months, 69% did not discuss this use with a conventional medical practitioner. Among adults who used prescription medications in the prior 12 months, the most commonly used supplements included echinacea, ginseng, ginkgo, garlic, and glucosamine chondroitin. Prescription medication users with menopause and chronic gastrointestinal disorders had the highest rates of NVDS use (33% and 28%, respectively), and prescription medication users with coronary heart disease and history of myocardial infarction had the lowest rates of use (12% each). In the adjusted analysis, factors associated with increased use of NVDSs by prescription medication users included being female, being Hispanic, having more years of education, living in the West, lacking medical insurance, and having chronic conditions. Elderly respondents were less likely to use NVDSs. CONCLUSION: One in 4 prescription medication users took an NVDS in the prior 12 months, yet the majority did not share this with a conventional medical professional.