Purpose The well-being of healthcare teams is an important consideration when seeking to improve patient experience and quality of care. Prior studies have found that changes to working conditions are most effective to improve provider well-being. Integrative Medical Group Visits (IMGVs) modify working conditions in ways that may impact provider well-being. However, little is known about healthcare teams' experience with the implementation and maintenance of IMGVs in clinical settings. Method Interviews were conducted via Zoom and telephone with 21 clinicians, administrators, and staff from safety-net healthcare settings throughout the country who have implemented IMGVs for patients with chronic pain. To be considered an IMGV, patients received care concurrently by a licensed clinician who documented the visit, patients interacted, and clinicians provided integrative healthcare in the form of mind-body practice. Interviews included questions about provider experience, well-being, and satisfaction with the IMGV model. Interviews were recorded, transcribed, and coded using thematic content analysis by a team of trained qualitative researchers. Results The authors identified four themes describing how IMGV positively affected provider well-being: horizontal power dynamic, collaboration with an interprofessional team, guideline-concordant care, and enhanced meaning and purpose. An additional fifth theme identified organizational supports that directly impact provider well-being during IMGV delivery. Conclusion The current study was the first to use interviews from healthcare teams who have implemented IMGV to assess their experience and understand the effect on well-being. The themes identified warrant further investigation into IMGVs as a strategy to promote provider well-being and mitigate aspects of burnout.

OBJECTIVE:Our objective was to develop and assess the effectiveness of a national network of clinicians referring adults with migraine for a remotely delivered clinical trial. BACKGROUND:A national practice-based research network in Headache Medicine would facilitate referrals into clinical trials. Given our unique, entirely virtual study, we established a national network of health care professionals to identify potential participants. METHODS:The BE WELL with Migraine Champion Providers Network™ began to support clinician referrals across the United States into a remotely conducted clinical trial evaluating the efficacy of a nondrug virtual group intervention. Participant trial recruitment includes community outreach and clinician referrals, then potential participants complete a multi-step eligibility process. The primary study team obtains informed consent and collects all study outcomes. Clinicians interested in referring patients register for the Network via a Research Electronic Data Capture survey. The ongoing clinical trial allows for recruitment of trial participants and network members through 2026. We analyzed Network survey results through February 25, 2025, with descriptive statistics and qualitative analyses. We compared participant progression through eligibility assessment between clinician referral and community outreach. RESULTS:The BE WELL with Migraine Champion Providers Network™ includes 46 clinicians across the United States through February 2025, and most (89%) of them are headache specialists. Although many have previously served as trial principal investigator (PI) (54%) or recruited (72%) for a trial in the past, 28% are recruiting for a clinical trial for the first time. Top motivating factors for Network participation included nonpharmacological option (n = 12), research contribution (n = 11), potential for patient improvement (n = 11), and working with PI (n = 9). To date, 905 participants completed the initial online screener, with 5% (n = 41) from clinician referrals and 95% (n = 864) from community recruitment. Of those, 12.3% (n = 107) were eligible to continue and consented and completed the virtual interview. After the interview, 65 participants progressed to the headache log run-in period and then were randomized/eligible for randomization (six from referrals, 59 from community). Of the original participants from clinician referrals who completed the online screener, 14.6% (six of 41) were randomized/eligible for randomization, compared to 6.8% (59 of 864) recruited via community. Once consented, 100% (six of six) of Network-referred patients progressed to randomization/eligibility for randomization versus only 58% (59 of 101) from community recruitment. CONCLUSION:The BE WELL with Migraine Champion Providers Network™ models the development and implementation of a national clinician referring network that can help accomplish the field's research priorities. Although growth and implementation of a national network takes time, our results demonstrate the yield of appropriate referrals eligible for randomization was more than double community recruitment.

Chronic low back pain is globally prevalent and associated with significant impairment in quality of life. Furthermore, people from historically marginalized communities are less likely to receive treatment, contributing to health inequities. Group mindfulness-based interventions improve pain and function, and virtual delivery has been demonstrated to be feasible. Little is known about how participants experience the virtual delivery of mindfulness-based interventions, especially participants from historically marginalized communities. This study explored participant perspectives of a virtual mindfulness-based group medical visit for people with chronic low back pain. Participants were recruited from the intervention arm of OPTIMUM, a study of virtual medical group visits using an adapted Mindfulness-Based Stress Reduction program for chronic low back pain. Semi-structured exit interviews were examined, and reflexive thematic analysis was used to compose key themes. Interviews from 59 participants (mean 56 years, 69.5% women; 45.8% Black or African American) were examined. Two major themes were derived from analysis. The first theme was 'effects of the external environment,' ie, the physical location from which the participant engaged with the session. The subthemes were comfort, social demands in the home setting, and sharing personal spaces. The second theme was 'navigating the virtual platform.' Subthemes were ease, struggle, and levels of support. Patient experiences varied substantially during the virtual mindfulness-based group medical visit intervention and this variation was influenced by social determinants of health. The key themes bring attention to the effects of the external environment and the technology itself on participation for people from historically marginalized communities. Basic tenets of mindfulness, such as present state awareness and equanimity, can provide a structure within which to navigate virtual participation amid home environments. Future studies are needed to explore differences in virtual and in-person mindfulness programs and to adapt virtual mindfulness programs. NCT04129450.

ImportanceDuring buprenorphine treatment for opioid use disorder (OUD), risk factors for opioid relapse or treatment dropout include comorbid substance use disorder, anxiety, or residual opioid craving. There is a need for a well-powered trial to evaluate virtually delivered groups, including both mindfulness and evidence-based approaches, to address these comorbidities during buprenorphine treatment.ObjectiveTo compare the effects of the Mindful Recovery Opioid Use Disorder Care Continuum (M-ROCC) vs active control among adults receiving buprenorphine for OUD.Design, Setting, and ParticipantsThis randomized clinical trial was conducted from January 21, 2021, to September 19, 2023. All study procedures were conducted virtually. Participants were randomized 1:1 and blinded to intervention assignments throughout participation. This trial recruited online from 16 US states and was conducted via online platforms. Patients prescribed buprenorphine for OUD were recruited via social media advertisements, flyers, and health care professional referrals.InterventionsThe M-ROCC program was a 24-week, motivationally adaptive, trauma-informed, mindfulness-based group curriculum. Participants attended a 30-minute informal check-in and 60-minute intervention group each week. The recovery support group control curriculum used 4 evidence-based substance use disorder–focused nonmindfulness approaches and was time and attention matched.Main Outcomes and MeasuresThe primary outcome was the number of 2-week periods with both self-reported and biochemically confirmed abstinence from illicit opioid use during study weeks 13 to 24, which was analyzed with an intention-to-treat approach using generalized estimating equations comparing between-group differences.ResultsThis sample included 196 participants, predominantly female (119 [60.7%]). Mean (SD) age was 41.0 (10.3) years. Opioid use was 13.4% (95% CI, 6.2%-20.5%) in the M-ROCC group and 12.7% (95% CI, 7.5%-18.0%) in the recovery support group, a 0.6% difference (95% CI, −8.2% to 9.5%; P = .89). Cocaine and benzodiazepine use were also not significantly different. Anxiety T scores were reduced across both the M-ROCC and recovery support groups but were not significantly different between groups from baseline to week 24 (1.0; 95% CI, −2.4 to 4.3; P = .57). The M-ROCC participants demonstrated a larger reduction in opioid craving compared with the recovery support group participants: −1.0 (95% CI, −1.7 to −0.2; P = .01; Cohen d = −0.5).Conclusions and RelevanceIn this study, during buprenorphine treatment comparing mindfulness vs active control, both groups significantly reduced anxiety without significant differences in substance use outcomes. Mindfulness led to significantly greater reductions in residual opioid craving than control. The findings of this study suggest that mindfulness training groups may be recommended for people receiving buprenorphine maintenance therapy who have residual opioid craving.Trial RegistrationClinicalTrials.gov Identifier: NCT04278586

IntroductionAdverse childhood experiences (ACE) are transdiagnostic developmental risk factors for various mental and physical health issues, including Opioid Use Disorder (OUD). Existing research demonstrated ACE not only affects the onset, severity, and comorbidity of disorders, but also affects treatment responses. To investigate whether and how ACE modulates treatment effects of Mindfulness Based Intervention (MBI), we conducted secondary analysis on the longitudinal data from a recent clinical trial on the effects of a MBI during outpatient buprenorphine treatment.MethodsUsing data from a RCT that randomized (1:1) a total of 196 patients with OUD into a live online group intervention with either a 24-week MBI or a matched recovery support control group, we conducted temporal path analysis with the following outcome measures: self-critical rumination, pain catastrophizing, pain interference, severity of depression and anxiety.ResultsBoth treatment arms had significant reduction of all symptom measures, but the MBI arm had a significant mechanistic path of ACE (baseline) ➔Self-Critical Rumination (week 8)➔Pain Catastrophizing (week 16) ➔ Pain Interference (week 24), which was not significant in the control arm. Only in the MBI arm, ACE severity was significantly correlated with score reductions of Self-Critical Rumination (week 8), which was not significant in the control arm.ConclusionACE modulated treatment responses to MBI, through a mechanistic path in which symptom changes of Self-Critical Rumination was a mediator between ACE and psychological symptom changes of pain catastrophizing and pain interference, suggesting Self-Critical Rumination can be considered as a therapeutic target in future intervention development.

BACKGROUND:Chronic low back pain (cLBP) is extremely common and is one of the Chronic Overlapping Pain Conditions (COPCs), 10 conditions thought to have similar underlying pathophysiology. Little is known about the prevalence and co-occurrence of cLBP with other commonly accepted conditions referred to as COPCs. METHODS:We assessed participants enrolled in a pragmatic trial of mindfulness-based stress reduction for cLBP to determine the prevalence of co-occurring COPCs using a validated COPC screener. We compared psychosocial and physical functioning among participants with only cLBP and participants with cLBP and additional COPCs using Student's t-tests, chi-squared tests and multivariable linear regression. RESULTS:Among 285 enrollees (age range: 18-88 years, mean age: 52.2 years, SD = 15.3), 272 (95%) reported pain outside the upper and lower back region. One hundred and twenty-nine people (45%) had one COPC, and 68 (24%) had two or more COPCs not including cLBP. The most common COPCs were irritable bowel syndrome (n = 56, 20%); myalgia encephalomyelitis/chronic fatigue syndrome (n = 54, 19%); and fibromyalgia (n = 42, 15%). CONCLUSION:We found strong differences when comparing people with cLBP alone to those with cLBP and COPCs. People with COPCs reported more pain symptoms, higher levels of anxiety, depression, fatigue and scored worse across measures of physical functioning and pain symptoms. An additional COPC was associated with a 7.6-point increase in fatigue scores (95% CI: 5.6, 9.7) on a T-score metric (mean = 50, SD = 10). SIGNIFICANCE STATEMENT:Compared to people with low back pain alone, individuals with additional chronic pain experienced more severe pain symptoms, more anxiety, depression and fatigue. In this sample of people with cLBP, overlapping pain conditions were common, affecting 45% of people. REGISTRATION NUMBER AND REGISTRY NAME:Clinicaltrials.gov identifier NCT04129450.

The OPTIMUM trial is a multisite pragmatic randomized clinical trial of an adapted Mindfulness Based Stress Reduction (MBSR) program for people with chronic low back pain in primary care settings provided via telehealth group medical visits. Researchers conducted fifty-nine exit interviews at the end of the intervention to inform the ongoing conduct of the trial and to better understand patients’ experiences. This manuscript describes a pragmatic approach to the qualitative analysis of exit interviews within a pragmatic clinical trial. The analysis included three important pivots. First, researchers conducted a process evaluation using a rapid approach called the Lightning Report method. Second, team-based approaches to qualitative analysis were utilized to pair experienced and inexperienced qualitative researchers. Third, based upon principles from Big Qual methodology, a codebook was developed and applied to provide an aerial overview of the data in preparation for more in-depth exploration. Based upon these pivots, the process evaluation provided actionable results in a timely fashion, team members increased analytical skills, and multiple analyses are being applied to the data set. By describing the pragmatic decisions to pivot approaches to qualitative analysis, this manuscript contributes to existing literature regarding rapid qualitative analysis methods for process evaluation in pragmatic clinical trials, team-based mentorship in large trials, and applications from Big Qual for large data sets.

Background: Group-based diabetes care, both technology-enabled and in-person, can improve diabetes outcomes in lowincome minority women, but the mechanism remains unclear. Objective: We tested whether diabetes group medical visits (GMVs) reduced hemoglobin A1c(HbA1c) by mitigating diabetes distress (DD), an emotional response affecting nearly half of adults with type 2 diabetes in community settings. Methods: We conducted a mediation and moderation analysis of data from the Women in Control 2.0 comparative effectiveness study, which showed that both technology-enabled and in-person diabetes GMVs improve HbA1c. We tested whether DD mediated the relationship between diabetes GMV engagement and reductions in HbA1c. We also tested whether this relationship was moderated by depressive symptoms and social support. Participants were 309 low-income and minority women. Diabetes GMV engagement was measured using the Group Climate Questionnaire. The mediator, DD, was measured using the Diabetes Distress Screening Scale. The outcome was the 6-month change in HbA1c. Social support was measured using the Medical Outcomes Study Social Support Survey. Results: DD mediated the relationship between engagement and 6-month HbA1c. Specifically, group engagement affected HbA1c by reducing distress associated with the regimen of diabetes self-management (P=.04), and possibly the emotional burden of diabetes (P=.09). The relationship between engagement and 6-month HbA1c was moderated by depressive symptoms (P=.02), and possibly social support (P=.08). Conclusions: Engagement in diabetes GMVs improved HbA1c because it helped reduce diabetes-related distress, especially related to the regimen of diabetes management and possibly related to its emotional burden, and especially for women without depressive symptoms and possibly for women who lacked social support. Trial Registration: ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/study/NCT02726425

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.

Background The well-being of healthcare teams is an important consideration when seeking to improve patient experience and quality of care. Prior studies have found that changes to working conditions are most effective in improving clinician well-being. Integrative Group Medical Visits (IGMVs) modify working conditions in ways that have potential to improve clinician experience. Objective The objective of this study was to understand healthcare teams’ experiences with IGMVs. Methods In this qualitative study, interviews were conducted via Zoom and telephone with 21 clinicians, administrators, and staff from safety-net healthcare settings throughout the United States (U.S.) who have implemented IGMVs for patients with chronic pain. Interviews included questions about clinician experience, well-being, and satisfaction with the IGMV model. Interviews were recorded, transcribed, and coded using thematic content analysis by a team of trained qualitative researchers. Results The authors identified five themes describing how IGMV positively affected clinician well-being: organizational supports, human-centered engagement, collaboration with an interprofessional team, provision of guideline-concordant care, and enhanced meaning and purpose for the clinicians. Conclusion The current study was the first to use interviews from healthcare teams who have implemented IGMV to assess their experience. The themes identified warrant further investigation into IGMVs as a strategy to promote clinician well-being and mitigate aspects of burnout.

Background:Individuals with a uterus experience menopause, the cessation of menses, on average at age 51 years in the United States. While menopause is a natural occurrence for most, over 85% of women experience multiple interfering symptoms. Menopausal women face health disparities, including a lack of access to high-quality healthcare and greater disparities are experienced by women who are black, indigenous, and people of color. Some women are turning away from hormone therapy, and some seek integrative health interventions. Objective:Some menopausal women who seek healthcare do not receive it as they lack access to medical and integrative healthcare providers. A potential solution to this problem is a medical group visit (MGV), during which a provider sees multiple patients at once. The aims of this study were to gather women's opinions about the menopause, provider access, and conventional and integrative health interventions for later use to develop a menopause MGV. Methods:We conducted a Community Engagement Session and a Return of Results (RoR) with midlife women to learn about their menopause experiences, barriers and facilitators to accessing health providers, and their interest in and suggestions for designing a future integrative MGV (IMGV). Thematic qualitative research methods were used to summarize session results. Results:Nine women participated in the Session and six attended the RoR. Participants were well-educated and diverse in race and ethnicity. Themes included: an interest in this topic; unfamiliar medical terms; relevant social factors; desired whole person care; interest in integrative health; barriers and facilitators to accessing healthcare. The group expressed interest in ongoing participation in the future process of adapting an IMGV, naming it MENOGAP. Conclusion:These findings highlight the importance of stakeholder engagement before designing and implementing MENOGAP and the great need among midlife women for education about the menopausal transition, integrative self-care, and healthcare.

Background Chronic pain is one of the most common drivers of healthcare utilization and a marked domain for health disparities, as African American/Black populations experience high rates of chronic pain. Integrative Medical Group Visits (IMGV) combine mindfulness techniques, evidence-based integrative medicine, and medical group visits. In a parent randomized controlled trial, this approach was tested as an adjunct treatment in a diverse, medically underserved population with chronic pain and depression. Objective To determine race-based heterogeneity in the effects of a mindfulness based treatment for chronic pain. Methods This secondary analysis of the parent trial assessed heterogeneity of treatment effects along racialized identity in terms of primary patient-reported pain outcomes in a racially diverse sample suffering from chronic pain and depression. The analytic approach examined comorbidities and sociodemographics between racialized groups. RMANOVAs examined trajectories in pain outcomes (average pain, pain severity, and pain interference) over three timepoints (baseline, 9, and 21 weeks) between participants identifying as African American/Black (n = 90) vs White (n = 29) across both intervention and control conditions. Results At baseline, African American/Black participants had higher pain severity and had significantly different age, work status, and comorbidity profiles. RMANOVA models also identified significant race-based differences in the response to the parent IMGV intervention. There was reduced pain severity in African American/Black subjects in the IMGV condition from baseline to 9 weeks. This change was not observed in White participants over this time period. However, there was a reduction in pain severity in White participants over the subsequent interval from 9 to 21 week where IMGV had no significant effect in African American/Black subjects during this latter time period. Conclusion Interactions between pain and racialization require further investigation to understand how race-based heterogeneity in the response to integrative medicine treatments for chronic pain contribute to the broader landscape of health inequity.

Background Despite the critical need for comprehensive and effective chronic pain care, delivery of such care remains challenging. Group medical visits (GMVs) offer an innovative and efficient model for providing comprehensive care for patients with chronic pain. The purpose of this systematic review was to identify barriers and facilitators (determinants) to implementing GMVs for adult patients with chronic pain.Methods The review included peer-reviewed studies reporting findings on implementation of GMVs for chronic pain, inclusive of all study designs. Pubmed, EMBASE, Web of Science, and Cochrane Library were searched. Studies of individual appointments or group therapy were excluded. The Mixed Methods Appraisal Tool was used to determine risk of bias. Data related to implementation determinants were extracted independently by two reviewers. Data synthesis was guided by the updated Consolidated Framework for Implementation Research.Results Thirty-three articles reporting on 25 studies met criteria for inclusion and included qualitative observational (n = 8), randomized controlled trial (n = 6), quantitative non-randomized (n = 9), quantitative descriptive (n = 3), and mixed methods designs (n = 7). The studies included in this review included a total of 2364 participants. Quality ratings were mixed, with qualitative articles receiving the highest quality ratings. Common multi-level determinants included the relative advantage of GMVs for chronic pain over other available models, the capability and motivation of clinicians, the cost of GMVs to patients and the health system, the need and opportunity of patients, the availability of resources and relational connections supporting recruitment and referral to GMVs within the clinic setting, and financing and policies within the outer setting.Conclusions Multi-level factors determine the implementation of GMVs for chronic pain. Future research is needed to investigate these determinants more thoroughly and to develop and test implementation strategies addressing these determinants to promote the scale-up of GMVs for patients with chronic pain.Trial registration This systematic review was registered with PROSPERO 2021 CRD42021231310.

Researchers administered the Chronic Overlapping Pain Conditions Screener (COPCS) in OPTIMUM, a trial of mindfulness for chronic low back pain (clbp), to assess COPC prevalence and associated conditions. Researchers remove an image and clarified instructions based on Community Advisory Board feedback. Participants received the COPC electronically after eight-weeks enrollment. Associations between baseline demographics and COPC prevalence were evaluated using chi-square tests (categorical variables) and t-tests (continuous variables). Among 299 participants, 77.5% completed the screener. Age ranged from 18-88; 70.7% were female; 40.9% Black, 55.2% White; 6.7% Hispanic/Latino. Seventy-six percent screened positive for cLBP. Prevalence of any chronic pain condition (including cLBP) was 83.6%. Thirty-five percent met criteria for cLBP and additional COPCs. They were more often female (82.7% vs. 66.2%). Mean age among those with only cLBP was 54.3 (95% CI 51.2, 57.3), compared to 48.1 among people with additional conditions (95% CI 45.1, 51.2). Negligible differences existed between groups in education, race, ethnicity, or employment. The most common condition after cLBP was irritable bowel syndrome (19.4%), followed by myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) (18.1%); fibromyalgia (12.1%), headache (10.3%), chronic endometriosis (8.6%), bladder pain syndrome (5.6%), vulvodynia (4.3%), temporomandibular disorder (3.9%) and prostatitis (1.7%). Notably, prevalence of fibromyalgia and ME/CFS was higher than general population estimates, suggesting widespread pain, fatigue, and sleep disruption are common among study participants. That 75.9% of the sample met criteria for cLBP suggests temporal changes in pain reporting, difficulty using the screener, or improvement of back pain since enrollment. Ongoing analysis will inform these results. Funding: National Institute of Health 3 UH3AT01062103S2.

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.

COPYRIGHT © 2023 Falck, Liu-Ambrose, Van U elen, Macpherson, Marquez, Gardiner and Savelberg. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Editorial: The 24-hour activity cycle and cognitive health: how are physical activity, sedentary behavior, and sleep interactively associated with cognitive health across the lifespan?

Medically underserved people with type 2 diabetes mellitus face limited access to group-based diabetes care, placing them at risk for poor disease control and complications. Immersive technology and telemedicine solutions could bridge this gap. The purpose of this study was to compare the effectiveness of diabetes medical group visits (DMGVs) delivered in an immersive telemedicine platform versus an in-person (IP) setting and establish the noninferiority of the technology-enabled approach for changes in hemoglobin A1c (HbA1c) and physical activity (measured in metabolic equivalent of task [MET]) at 6 months. This study is a noninferiority randomized controlled trial conducted from February 2017 to December 2019 at an urban safety net health system and community health center. We enrolled adult women (aged ≥18 years) who self-reported African American or Black race or Hispanic or Latina ethnicity and had type 2 diabetes mellitus and HbA1c ≥8%. Participants attended 8 weekly DMGVs, which included diabetes self-management education, peer support, and clinician counseling using a culturally adapted curriculum in English or Spanish. In-person participants convened in clinical settings, while virtual world (VW) participants met remotely via an avatar-driven, 3D VW linked to video teleconferencing. Follow-up occurred 6 months post enrollment. Primary outcomes were mean changes in HbA1c and physical activity at 6 months, with noninferiority margins of 0.7% and 12 MET-hours, respectively. Secondary outcomes included changes in diabetes distress and depressive symptoms. Of 309 female participants (mean age 55, SD 10.6 years; n=195, 63% African American or Black; n=105, 34% Hispanic or Latina; n=151 IP; and n=158 in VW), 207 (67%) met per-protocol criteria. In the intention-to-treat analysis, we confirmed noninferiority for primary outcomes. We found similar improvements in mean HbA1c by group at 6 months (IP: –0.8%, SD 1.9%; VW: –0.5%, SD 1.8%; mean difference 0.3, 97.5% CI –∞ to 0.3; P<.001). However, there were no detectable improvements in physical activity (IP: –6.5, SD 43.6; VW: –9.6, SD 44.8 MET-hours; mean difference –3.1, 97.5% CI –6.9 to ∞; P=.02). The proportion of participants with significant diabetes distress and depressive symptoms at 6 months decreased in both groups. In this noninferiority randomized controlled trial, immersive telemedicine was a noninferior platform for delivering diabetes care, eliciting comparable glycemic control improvement, and enhancing patient engagement, compared to IP DMGVs. ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425

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.

Chronic pain is one of the most common reasons adults seek medical care in the US, with estimates of prevalence ranging from 11% to 40% and relatively higher rates in diverse populations. 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. The objective of the present study was to assess the effects of race on the primary pain outcomes and evaluate potential relationships between race and additional patient characteristics in data from a randomized clinical trial of IMGV in socially diverse, marginalized patients suffering from chronic pain and depression. It was hypothesized that there would be racial differences in the effects of IMGV on pain outcomes. Our analyses identified significant racial differences in the response to IMGV. Black subjects had increased pain severity throughout the duration of the 21-week study but were less likely to respond to the pain intervention compared to White subjects. These results may be related to differential comorbidity rates, catastrophizing, and digital health literacy among these participant groups. To improve patient outcomes in similar studies, interactions between pain outcomes and these factors require further investigation to affect levels and trajectory of pain severity and enhance the response to complimentary interventions. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT02262377 ### Funding Statement NCT from clinicaltrials.gov: 02262377 This research was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award AD- 1304-6218. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Boston University Medical Campus Institutional Review Board (IRB) and the community health centers (CHC) research committees (IRB Approval Number: H33096). We registered this randomized controlled trial (RCT) in the international trial register [ClinicalTrials.gov: Identifier [NCT02262377][1]]. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Correspondence concerning this article should be directed to Paula Gardiner. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02262377&atom=%2Fmedrxiv%2Fearly%2F2023%2F03%2F22%2F2023.03.03.23286767.atom