Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Loucks EB

PROVIDER: S-EPMC6881004 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Loucks Eric B EB Nardi William R WR Gutman Roee R Kronish Ian M IM Saadeh Frances B FB Li Yu Y Wentz Anna E AE Webb Julie J Vago David R DR Harrison Abigail A Britton Willoughby B WB

PloS one 20191127 11

<h4>Background and objectives</h4>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 ...[more]

PMID: 31774807

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Project description:BackgroundMindfulness-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.MethodsThis 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.ResultsParticipants 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).ConclusionQualitative 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.

Project description:ObjectivesPreventing migraine headaches and improving the quality of life for patients with migraine remains a challenge. We hypothesized intensive meditation training would reduce the disease burden of migraine.MethodAn unblinded trial was analyzed as a single cohort exposed to a silent 10-day Vipassana meditation retreat that included 100 hr of sitting meditation. Participants with chronic or episodic migraine were enrolled and followed for 1 year. The primary outcome was a change in mean monthly migraine days at 12 months from baseline. Secondary outcomes included headache frequency and intensity, acute medication use, work days missed, home meditation, sleep quality, general health, quality of life, migraine impact, positive and negative affect, perceived stress, mindfulness, and pain catastrophizing.ResultsThree hundred people were screened and 58 (19%) agreed to participate and enrolled in the intensive meditation training. Forty-six participants with chronic migraine (≥ 15 headaches/month of which ≥ 8 were migraines) and 12 with episodic migraine (< 15 and ≥ 4 migraines/month) attended and 45 (78%) completed the retreat. At 12 months, the average migraine frequency was reduced by 2.7 days (from 16.6 at baseline) per 28 days (95%CI - 4.3, - 1.3) and headaches by 3.4 (20.1 at baseline) per 28 days (- 4.9, - 1.9). Fifty percent responder rate was 29% for migraine. Acute medication use dropped by an average of 2.2 days (- 3.9, - 0.5) per 28 days, and participants reported 2.3 fewer days (- 4.0, - 0.5) on which they reduced their activity due to migraines. The most striking and promising effects were in several secondary outcomes, including migraine-specific quality of life, pain catastrophizing, and perceived stress. The significant improvements observed immediately following the intervention were sustained at 12 months follow-up.ConclusionsTraining in Vipassana meditation via a 10-day retreat may reduce the frequency and burden of migraine.PreregistrationClinicalTrials.gov: NCT00663585.

Project description:BackgroundAcetaminophen is widely used as first-line therapy for chronic pain because of its perceived safety and the assumption that, unlike nonsteroidal anti-inflammatory drugs, it has little or no effect on blood pressure (BP). Although observational studies suggest that acetaminophen may increase BP, clinical trials are lacking. We, therefore, studied the effects of regular acetaminophen dosing on BP in individuals with hypertension.MethodsIn this double-blind, placebo-controlled, crossover study, 110 individuals were randomized to receive 1 g acetaminophen 4× daily or matched placebo for 2 weeks followed by a 2-week washout period before crossing over to the alternate treatment. At the beginning and end of each treatment period, 24-hour ambulatory BPs were measured. The primary outcome was a comparison of the change in mean daytime systolic BP from baseline to end of treatment between the placebo and acetaminophen arms.ResultsOne-hundred three patients completed both arms of the study. Regular acetaminophen, compared with placebo, resulted in a significant increase in mean daytime systolic BP (132.8±10.5 to 136.5±10.1 mm Hg [acetaminophen] vs 133.9±10.3 to 132.5±9.9 mm Hg [placebo]; P<0.0001) with a placebo-corrected increase of 4.7 mm Hg (95% CI, 2.9-6.6) and mean daytime diastolic BP (81.2±8.0 to 82.1±7.8 mm Hg [acetaminophen] vs 81.7±7.9 to 80.9±7.8 mm Hg [placebo]; P=0.005) with a placebo-corrected increase of 1.6 mm Hg (95% CI, 0.5-2.7). Similar findings were seen for 24-hour ambulatory and clinic BPs.ConclusionsRegular daily intake of 4 g acetaminophen increases systolic BP in individuals with hypertension by ≈5 mm Hg when compared with placebo; this increases cardiovascular risk and calls into question the safety of regular acetaminophen use in this situation. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01997112. URL: https://www.clinicaltrialsregister.eu; Unique identifier: 2013-003204-40.

Project description:BackgroundHypertension is a major cause of cardiovascular disease. The Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP). However, adherence is typically low. Mindfulness training adapted to improving health behaviors that lower BP could improve DASH adherence, in part through improved interoceptive awareness relevant to dietary consumption. The primary objective of the MB-BP trial was to evaluate effects of the Mindfulness-Based Blood Pressure Reduction (MB-BP) program on interoceptive awareness. Secondary objectives assessed whether MB-BP impacts DASH adherence, and explored whether interoceptive awareness mediates DASH dietary changes.MethodsParallel-group phase 2 randomized clinical trial conducted from June 2017-November 2020 with 6 months follow-up. Data analyst was blinded to group allocation. Participants had elevated unattended office BP (≥120/80 mmHg). We randomized 201 participants to MB-BP (n=101) or enhanced usual care control (n=100). Loss-to-follow-up was 11.9%. Outcomes were the Multidimensional Assessment of Interoceptive Awareness (MAIA; range 0-5) score, and the DASH adherence score (range 0-11) assessed via a 163-item Food Frequency Questionnaire.ResultsParticipants were 58.7% female, 81.1% non-Hispanic white, with mean age 59.5 years. Regression analyses demonstrated that MB-BP increased the MAIA score by 0.54 (95% CI: 0.35,0.74; p<.0001) at 6 months follow-up vs. control. MB-BP increased the DASH score by 0.62 (95% CI: 0.13,1.11; p=0.01) at 6 months vs. control, in participants with poor DASH adherence at baseline.ConclusionsA mindfulness training program adapted to improving health behaviors that lower BP improved interoceptive awareness and DASH adherence. MB-BP could support DASH dietary adherence in adults with elevated BP.Clinical trial registrationClinicaltrials.gov identifier NCT03859076 (https://clinicaltrials.gov/ct2/show/NCT03859076; MAIA) and NCT03256890 (https://clinicaltrials.gov/ct2/show/NCT03256890; DASH diet adherence).

Project description:BackgroundIn Austria only 41% of patients with treated hypertension (HTN) have their blood pressure (BP) controlled. This study investigated a strategy to improve BP control in primary care.MethodsGeneral practitioners (GPs) were randomized to interventional care vs. standard care and included patients with uncontrolled office BP > 140/90 mm Hg. In interventional care, antihypertensive therapy was up-titrated using a single pill combination (olmesartan, amlodipine and/or hydrochlorothiazde) in 4‑week intervals. In standard care, physicians were encouraged to treat according to the 2013 European Society of Cardiology guidelines for the management of arterial hypertension. The primary endpoint was the proportion of patients with controlled office BP < 140/90 mm Hg at 6 months. The main secondary endpoint was the improvement in 24 h ambulatory BP (ABPM, Clinicaltrials.gov NCT02377661).ResultsBetween 2015-2017, 20 GPs contributed to patient recruitment. The trial was discontinued due to slow recruitment after inclusion of 139 eligible patients, 54 of whom were included in the interventional group. A significantly larger proportion of patients in interventional vs. standard care achieved the office BP target (67% ± 26% vs. 39% ± 29%, respectively, mean difference -27.9%, 95% confidence interval CI -54.0%; -1.7%, p = 0.038). The proportion of patients with controlled 24 h ABPM (<130/80 mm Hg) was similar between groups (49% ± 33% vs. 40% ± 34%, respectively, mean difference -8.8%, 95% CI -40.7%; 23.1%, p = 0.57). At baseline, pretreated patients received an average of 1.5 ± 0.8 vs. 1.7 ± 0.9 antihypertensive prescriptions. At 6 months, the respective BP reductions were achieved with 1.2 ± 0.5 prescriptions in interventional vs. 2.0 ± 1.0 in standard care (p < 0.01).ConclusionIn both groups statistically and clinically significant BP reductions were observed after 6 months. In the interventional care group, a larger proportion of patients achieved the office BP target compared to standard care. The 24 h ambulatory blood pressure levels were controlled in 44% of patients at 6 months, without significant differences between groups. The respective BP reductions were achieved with a significantly lower medication burden in interventional care.

Dataset Information

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

Publications

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

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