Effect of Adapted Mindfulness Training in Participants With Elevated Office Blood Pressure: The MB-BP Study: A Randomized Clinical Trial.

Background Hypertension is a leading risk factor for cardiovascular disease. Despite availability of effective lifestyle and medication treatments, blood pressure (BP) is poorly controlled in the United States. Mindfulness training may offer a novel approach to improve BP control. The objective was to evaluate the effects of Mindfulness-Based Blood Pressure Reduction (MB-BP) versus enhanced usual care control on unattended office systolic BP. Methods and Results Methods included a parallel-group phase 2 randomized clinical trial conducted from June 2017 to November 2020. Follow-up time was 6 months. Outcome assessors and data analyst were blinded to group allocation. Participants had elevated unattended office BP (≥120/80 mm Hg). We randomized 201 participants to MB-BP (n=101) or enhanced usual care control (n=100). MB-BP is a mindfulness-based program adapted for elevated BP. Loss-to-follow-up was 17.4%. The primary outcome was change in unattended office systolic BP at 6 months. A total of 201 participants (58.7% women; 81.1% non-Hispanic White race and ethnicity; mean age, 59.5 years) were randomized. Results showed that MB-BP was associated with a 5.9-mm Hg reduction (95% CI, -9.1 to -2.8 mm Hg) in systolic BP from baseline and outperformed the control group by 4.5 mm Hg at 6 months (95% CI, -9.0 to -0.1 mm Hg) in prespecified analyses. Plausible mechanisms with evidence to be impacted by MB-BP versus control were sedentary activity (-350.8 sitting min/wk [95% CI, -636.5 to -65.1] sitting min/wk), Dietary Approaches to Stop Hypertension diet (0.32 score [95% CI, -0.04 to 0.67]), and mindfulness (7.3 score [95% CI, 3.0-11.6]). Conclusions A mindfulness-based program adapted for individuals with elevated BP showed clinically relevant reductions in systolic BP compared with enhanced usual care. Mindfulness training may be a useful approach to improve BP. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03256890 and NCT03859076.

Students experiences of an 8-week mindfulness-based intervention at a college of opportunity: a qualitative investigation of the mindfulness-based college program.

BACKGROUND: Mindfulness-based programs have the potential to improve the well-being of undergraduate students by reducing anxiety, depression, and isolation in the wake of the COVID-19 pandemic. The aim of this qualitative study was to explore lived experiences of undergraduates in a mindfulness-based program at a "college of opportunity" that has high proportions of first-generation college students. Specifically, we sought to: (1) explore the application of mindfulness practices in students' daily lives; (2) explore how participants believe mindfulness training affected their health and well-being; (3) learn participants' recommendations and suggested changes for mindfulness-based interventions in future iterations. METHODS: Students were recruited from XXX and consented to participate in semi-structured digitally conducting interviews after the completion of the 8-week intervention in the Fall/Spring 2020 academic year. Data were analyzed using Applied Thematic Analysis and a codebook was constructed using a consensus-driven process using both a priori and emergent coding. All transcripts were double-coded, and concordance was achieved for all interviews. RESULTS: Qualitative results indicated that the most applied practices were those that could be easily incorporated into a daily routine. Furthermore, students reported an increased ability to cope with a variety of stressors, decreased reactivity, and enhanced resilience specifically concerning mental health challenges. Additionally, engaging in mindfulness training improved students' ability to navigate social distancing measures, other COVID-19-specific stress, and enhanced motivation for self-care practices to sustain well-being. Concerning preferred intervention delivery modality, participants stated that due to multiple, growing responsibilities (e.g., pressures of commuting to class) they preferred in-person delivery, shorter sessions over a longer period, with classes in the morning or early afternoon. CONCLUSIONS: Findings provide pragmatic and psychosocial insights into students' application of mindfulness training across personal, professional, and academic domains enhancing their well-being. This work builds on qualitative work concerning students' perceptions and applications of mindfulness while offering insights into the future of mindfulness programs among undergraduates. TRIAL REGISTRATION: Clinicaltrials.gov NCT03124446.

Mindfulness-based interventions for medication adherence: A systematic review and narrative synthesis.

OBJECTIVE: Inadequate medication adherence is a significant limitation for achieving optimal health outcomes across chronic health conditions. Mindfulness-based interventions (MBIs) have been increasingly applied to promote medical regimen adherence as MBIs have been shown to improve patient-level barriers to adherence (i.e., depressive symptoms, cognitive impairment, stress). The purpose of this review is to investigate the state of research regarding MBIs targeting medication adherence in chronic illnesses and to identify evidence gaps to inform future studies. METHODS: The search reviewed 5 databases (e.g., PubMed, PsycINFO, Embase, CINAHL, Proquest Thesis/Dissertations) to identify trials that quantitatively evaluated the effect of MBIs on medication adherence. Study abstracts and full texts were screened identifying eligible studies, and findings were summarized using a narrative synthesis. RESULTS: A total of 497 studies were reviewed; 41 were eligible for full text review and 9 were included in narrative synthesis: seven were RCTs and two were pre-post designs. Study quality varied, with five rated moderate or high risk for bias. Clinical populations tested included living with HIV (k = 3), cardiovascular disease (k = 3), psychological disorders (k = 2), and men who underwent a radical prostatectomy (k = 1). Four studies found significant improvements in medication adherence, however only two of these studies had low risk of bias. CONCLUSIONS: Research on MBI's for medication adherence is developing, but the effectiveness of MBIs remains unclear due to the nascent stage of evidence and methodological limitations of existing studies. Researchers should prioritize rigorous experimental designs, theory-driven investigations of behavioral mechanisms, and the use of objective measurements of adherence.

Mindfulness-Based College: A Stage 1 Randomized Controlled Trial for University Student Well-Being.

OBJECTIVE: To evaluate effects of a mindfulness-based program, adapted to the young adult life course stage (age, 18-29 years), named Mindfulness-Based College (MB-College). The primary outcome was a young adult health summary score, composed of key health risk factors: body mass index, physical activity, fruit and vegetable intake, alcohol consumption, stress, loneliness, and sleep duration. Secondary outcomes were hypothesized self-regulation mechanisms, including attention control, interoceptive awareness, and emotion regulation. METHODS: This was a stage 1 randomized controlled trial of the 9-week MB-College program (n = 47) versus enhanced usual care control (n = 49) including students from three universities. Assessments were at baseline, during the beginning of the college term when stress is typically lower, and at MB-College completion (3-month follow-up), when term-related stress is typically higher. Intention-to-treat, linear regression analyses estimated the marginal effects of MB-College versus control on the outcomes. RESULTS: MB-College participants (mean age = 20 years, 68% female, 37% racial minorities) demonstrated improved health summary scores at follow-up compared with control participants whose health summary scores worsened (marginal effect for MB-College versus control = 0.23; p = .004). Effects on loneliness were pronounced (marginal effect = -3.11 for the Revised University of Los Angeles Loneliness Scale score; p = .03). Secondary analyses showed significant impacts of MB-College on hypothesized self-regulation mechanisms (e.g., Sustained Attention to Response Task correct no-go percent, p = .0008; Multidimensional Assessment of Interoceptive Awareness, p < .0001; Center for Epidemiologic Studies-Depression scale, p = .03). CONCLUSIONS: Findings of this early stage clinical trial suggest that MB-College may foster well-being in young adults.Trial Registration: NCT03124446.

Mindfulness and cardiovascular health: Qualitative findings on mechanisms from the mindfulness-based blood pressure reduction (MB-BP) study.

BACKGROUND: Mindfulness-based programs hold promise for improving cardiovascular health (e.g. physical activity, diet, blood pressure). However, despite theoretical frameworks proposed, no studies have reported qualitative findings on how study participants themselves believe mindfulness-based programs improved their cardiovascular health. With an emphasis on in-depth, open-ended investigation, qualitative methods are well suited to explore the mechanisms underlying health outcomes. The objective of this qualitative study was to explore the mechanisms through which the mindfulness-based program, Mindfulness-Based Blood Pressure Reduction (MB-BP), may influence cardiovascular health. METHODS: This qualitative study was conducted as part of a Stage 1 single arm trial with one-year follow-up. The MB-BP curriculum was adapted from Mindfulness-Based Stress Reduction to direct participants' mindfulness skills towards modifiable determinants of blood pressure. Four focus group discussions were conducted (N = 19 participants), and seven additional participants were selected for in-depth interviews. Data analysis was conducted using the standard approach of thematic analysis. Following double-coding of audio-recorded transcripts, four members of the study team engaged in an iterative process of data analysis and interpretation. RESULTS: Participants identified self-awareness, attention control, and emotion regulation as key mechanisms that led to improvements in cardiovascular health. Within these broader themes, many participants detailed a process beginning with increased self-awareness to sustain attention and regulate emotions. Many also explained that the specific relationship between self-awareness and emotion regulation enabled them to respond more skillfully to stressors. In a secondary sub-theme, participants suggested that higher self-awareness helped them engage in positive health behaviors (e.g. healthier dietary choices). CONCLUSION: Qualitative analyses suggest that MB-BP mindfulness practices allowed participants to engage more effectively in self-regulation skills and behaviors lowering cardiovascular disease risk, which supports recent theory. Results are consistent with quantitative mechanistic findings showing emotion regulation, perceived stress, interoceptive awareness, and attention control are influenced by MB-BP.

Mindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 single-arm clinical trial.

BACKGROUND AND OBJECTIVES: Impacts of mindfulness-based programs on blood pressure remain equivocal, possibly because the programs are not adapted to engage with determinants of hypertension, or due to floor effects. Primary objectives were to create a customized Mindfulness-Based Blood Pressure Reduction (MB-BP) program, and to evaluate acceptability, feasibility, and effects on hypothesized proximal self-regulation mechanisms. Secondary outcomes included modifiable determinants of blood pressure (BP), and clinic-assessed systolic blood pressure (SBP). METHODS: This was a Stage 1 single-arm trial with one year follow-up. Focus groups and in-depth interviews were performed to evaluate acceptability and feasibility. Self-regulation outcomes, and determinants of BP, were assessed using validated questionnaires or objective assessments. The MB-BP curriculum was adapted from Mindfulness-Based Stress Reduction to direct participants' mindfulness skills towards modifiable determinants of blood pressure. RESULTS: Acceptability and feasibility findings showed that of 53 eligible participants, 48 enrolled (91%). Of these, 43 (90%) attended at least 7 of the 10 MB-BP classes; 43 were followed to one year (90%). Focus groups (n = 19) and semi-structured interviews (n = 10) showed all participants viewed the delivery modality favorably, and identified logistic considerations concerning program access as barriers. A priori selected primary self-regulation outcomes showed improvements at one-year follow-up vs. baseline, including attention control (Sustained Attention to Response Task correct no-go score, p<0.001), emotion regulation (Difficulties in Emotion Regulation Score, p = 0.02), and self-awareness (Multidimensional Assessment of Interoceptive Awareness, p<0.001). Several determinants of hypertension were improved in participants not adhering to American Heart Association guidelines at baseline, including physical activity (p = 0.02), Dietary Approaches to Stop Hypertension-consistent diet (p<0.001), and alcohol consumption (p<0.001). Findings demonstrated mean 6.1 mmHg reduction in SBP (p = 0.008) at one year follow-up; effects were most pronounced in Stage 2 uncontrolled hypertensives (SBP≥140 mmHg), showing 15.1 mmHg reduction (p<0.001). CONCLUSION: MB-BP has good acceptability and feasibility, and may engage with self-regulation and behavioral determinants of hypertension.