Christine Lathren’s research while affiliated with University of North Carolina at Chapel Hill and other places

Background Underrepresentation of diverse populations in clinical trials poses challenges to equity and external validity in health care research. To successfully recruit underrepresented participants in pragmatic clinical trials, researchers must understand the perspectives and needs of individuals from diverse backgrounds who participate in research. Objective The purpose of this qualitative study was to gain an understanding of the needs and perspectives of participants of the OPTIMUM trial -- a pragmatic trial evaluating mindfulness-based stress reduction for chronic low back pain. Methods This qualitative study employed focus groups with participants from 3 clinical sites: Boston Medical Center, the University of North Carolina at Chapel Hill, and the University of Pittsburgh. Focus group discussions centered on participants’ experiences, barriers, and facilitators to engagement in the OPTIMUM trial. Data were analyzed using thematic content analysis and the rapid qualitative analysis method, Lightning Reports, for real-time feedback integration into the trial process. Results Six focus groups were conducted with 46 participants, of whom 39.1% were first-time research participants and 56.5% identified as Black or African American. Qualitative analysis identified five key themes:1) The importance of providers in the recruitment of cLBP patients, (2) Motivators to participate and stay engaged in clinical research, (3) Participant lack of understanding of randomized control trials (RCTs) and general research processes, (4) Desire for social connection and community-building among participants, and (5) the Positive impact of regular study staff interaction. Conclusion Equity in RCTs requires intentional strategies to address barriers to participation and engagement faced by historically underrepresented populations. Engaging health care providers in recruitment, fostering positive interactions with study staff, and creating opportunities for social connection can improve recruitment, retention, and engagement. Incorporating community-engaged research methods and real-time feedback mechanisms can further support inclusivity and equity in pragmatic clinical trials.

Background Mindfulness training has been associated with improved health outcomes among family caregivers of people living with dementia, but access to training is limited, especially in rural areas. Moreover, mindfulness training that addresses the unique perspectives of African American families is needed. Objectives The study aimed to test the feasibility and acceptability of a theory-driven, telephone-delivered mindfulness intervention for caregivers of African Americans with moderate-to-severe dementia living in rural eastern North Carolina. Methods In this single-arm, multiple-methods study, pairs of informal caregivers attended an 8-week mindfulness training program involving weekly one-hour telephone-delivered sessions, and an online retreat. Feasibility outcomes included enrollment, retention, attendance, and acceptability. Exploratory pre-post endpoints related to our theoretical model included perceived caregiver burden (Zarit Burden Interview), uncertainty intolerance (Intolerance of Uncertainty Scale), and positive emotions (Meaning and Purpose Scale). Results Seventy-eight percent of screened individuals enrolled, 86% completed the study, and 88% attended ≥6 sessions. Participants found the program valuable, especially via telephone. Perceived burden decreased from pre-to-post intervention (mean difference [MD] −2.7, (95% CI: −4.5, −1.3; Cohen’s d −0.47) and positive emotions increased (MD 2.7, 95% CI 0.81, 4.5; d = 0.37). Both inhibitory (MD -1.0, 95% CI -1.8, −0.09; d = −0.28) and prospective (MD -1.2, 95% CI -2.7, 0.3; d = −0.20) intolerance of uncertainty were lower post-intervention. Discussion A telephone-delivered mindfulness training intervention was feasible and shows promise for reducing perceived burden among rural-dwelling informal caregivers of African Americans with dementia. Further testing in a randomized parallel-group trial comparing mindfulness training to a credible control intervention is warranted. Trial registration ClinicalTrials.gov NCT04058886.

Background 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. Objective This study explored participant perspectives of a virtual mindfulness-based group medical visit for people with chronic low back pain. Methods 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. Results 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. Conclusion 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 equanimit y, 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. Clinicaltrials.gov ID number 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.

INTRODUCTION The professional caregiver workforce (nursing assistants and personal care aides) is critical to quality of care and quality of life in nursing home (NH) and assisted living (AL) settings. The work is highly stressful, so improving responses to stress in this workforce could contribute to satisfaction and retention. This research developed a coping measure appropriate for the diverse professional caregiver workforce. METHODS A multistage process identified and refined existing and new items. Ten racially and ethnically diverse professional caregivers advised on item selection and refinement. Subsequently, using an online QR code‐accessed questionnaire, data were collected from 391 professional caregivers from 10 NHs and 3 AL communities in three states, yielding a sample that was 87% female, widely distributed in age and experience, and racially/ethnically diverse (42% Black, non‐Hispanic/Latinx; 25% White, non‐Hispanic/Latinx; 20% Hispanic/Latinx; 7% Asian, non‐Hispanic/Latinx; and 21% born outside the United States). Analyses examined psychometric properties and principal components analysis identified factors within which items and scales aggregated. RESULTS The final instrument, named the Long‐Term Care Cope (LTC Cope), includes 26 items aggregated into six factors, which explained 60% of the variance: avoidance (five items, loadings 0.58–0.76); adaptive psychological strategies (six items, loadings 0.33–0.89); active engagement (five items, 0.47–0.89); maladaptive psychological strategies (three items, loadings 0.90–0.93); actions to minimize emotional impact (four items, loadings 0.28–0.74); and substance use (three items, loadings 0.61–0.88). Respondents often reported using multiple items within multiple factors when responding to stressful situations at work. DISCUSSION The coping strategies of professional caregivers are highly individual, with caregivers tending to utilize multiple strategies. The LTC Cope instrument and its component subscales are promising for future research to improve understanding of stress‐related coping in this diverse workforce and inform and evaluate interventions. Highlights A new measure was developed to help us better understand how professional caregivers (nursing assistants and personal care aides) deal with work‐related stress. Professional caregivers in nursing homes and assisted living tend to use multiple approaches to deal with job stress. Ways professional caregivers cope with stress vary widely—some address problems directly, some try to deal with the emotional toll of the work, and others involve avoiding the problems or their emotional consequences.

INTRODUCTION Professional caregivers (nursing assistants and personal care aides) in nursing homes (NH) and assisted living (AL) provide the majority of long‐term residential care for persons with Alzheimer's disease and related dementias. Their work is stressful, but until recently, no measures were available to assess stress in this workforce. Using the new Long‐Term Care Cope (LTC COPE) scale, this study evaluates the relationship of coping with staff demographic characteristics and outcomes; the findings can be used to develop and evaluate interventions to improve staff well‐being. METHODS We used a cross‐sectional online questionnaire completed by professional caregivers working in a purposive selection of 10 NHs and three AL communities in California, New York, and North Carolina. The sample included 391 professional caregivers and had a representative distribution by age; it was 87% female; 42% non‐Hispanic/Latinx (NHL) Black, 25% NHL White, 20% Hispanic/Latinx, and 7% NHL Asian. Worker job satisfaction, mental health, and health‐related quality of life were examined in relation to caregiver demographics and the following approaches to coping as measured by the LTC COPE: avoidance, adaptive psychological strategies, active engagement, maladaptive psychological strategies, minimizing emotional impact, and substance use. Statistical comparisons used non‐parametric Spearman correlation coefficients. RESULTS Little difference in coping strategies was noted by sex and education; older caregivers used adaptive psychological strategies more than younger caregivers; and traditionally minoritized adults (NHL Black, NHL Asian, and Hispanic/Latinx), compared to NHL White adults, more often used adaptive and less often used maladaptive psychological coping strategies. The use of maladaptive and avoidance strategies was strongly associated with depressive symptoms, anxiety, and burnout. DISCUSSION Professional caregivers report using a wide variety of coping strategies, with multiple strategies being the norm, and both adaptive/engaged and maladaptive/disengaged approaches are common. Certain coping approaches are strongly linked to depression, anxiety, and burnout; attention to training and support of adaptive and positive coping may augment other efforts to improve job satisfaction and performance. The LTC COPE scale has the potential to guide and evaluate practices to improve workers’ well‐being. Highlights Professional caregivers in nursing homes and assisted living generally use multiple strategies to cope with work‐related stress. Certain coping approaches are strongly linked to depression, anxiety, and burnout. The Long‐Term Care Cope scale has potential to guide and evaluate practices to improve worker well‐being.

This 4‐year prospective study investigated the dynamic relationship between stress, self‐compassion, and resilience among university students, a population with increasing rates of mental health challenges. Drawing on stress theories, the research explored whether the combination of stress and self‐compassion strengthens resilience over time. A sample of 1137 university students (47.6% White, 38% female) completed measures of stress, resilience, and self‐compassion annually during the Spring semester across their four undergraduate years. A random intercept cross‐lagged panel model with latent interactions was used to test the hypothesized causal relationships. Contrary to the common belief that stress is debilitating, the results revealed a positive association between an increase in stress and a subsequent increase in self‐compassion. Moreover, when stress levels increased alongside self‐compassion, students demonstrated higher resilience. Notably, an increase in either stress or self‐compassion alone did not enhance resilience. These findings highlight the synergetic effect between self‐compassion and stress in enhancing resilience; under the right conditions, stress can lead to positive outcomes and increased capacity for coping with future stressors.

Care in nursing homes and assisted living communities is largely provided by direct caregivers (nursing assistants [NAs] and personal care aides [PCAs]), who are >50% minoritized, 20% immigrant, 90% female, 87% without a college degree, and often in poverty. The well-being of direct caregivers is critical to quality of care, but research aimed at improving well-being is hampered because existing measures of stress and coping translate poorly to their backgrounds and work-related experience. To address this gap, we designed and conducted research aimed at describing the range of coping approaches used to address work-related stress, gathering data on a diverse sample of 391 direct caregivers from 9 nursing homes and 4 assisted living communities in 3 states, of which 75% were racially or ethnically minoritized and 21% were immigrant – mirroring the national workforce. Results indicated that 78% of respondents often felt stressed at work, with 30% screening positive for depression and 28% for anxiety, with some caregivers experiencing both (21%). However, working with residents and their families, while stressful (76%), was considered less stressful than workload (90%) and lack of support (83%); in fact, 89% of caregivers said that caring for residents makes them feel appreciated. Coping strategies were diverse, but the most common includedresilient coping (93%), mindfulness (89%), recognizing common humanity (84%), self-kindness (83%), and planning (69%). This presentation will address differences in coping based on demographic characteristics, as well as the relationship between types of coping strategies and reasons for staying in a direct caregiver position.