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

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...

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Veröffentlicht in:PloS one 2019-11, Vol.14 (11), p.e0223095-e0223095
Hauptverfasser: Loucks, Eric B, Nardi, William R, Gutman, Roee, Kronish, Ian M, Saadeh, Frances B, Li, Yu, Wentz, Anna E, Webb, Julie, Vago, David R, Harrison, Abigail, Britton, Willoughby B
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container_issue 11
container_start_page e0223095
container_title PloS one
container_volume 14
creator Loucks, Eric B
Nardi, William R
Gutman, Roee
Kronish, Ian M
Saadeh, Frances B
Li, Yu
Wentz, Anna E
Webb, Julie
Vago, David R
Harrison, Abigail
Britton, Willoughby B
description 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). 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. 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
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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). 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. 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&lt;0.001), emotion regulation (Difficulties in Emotion Regulation Score, p = 0.02), and self-awareness (Multidimensional Assessment of Interoceptive Awareness, p&lt;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&lt;0.001), and alcohol consumption (p&lt;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&lt;0.001). 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Cheng-Shi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 single-arm clinical trial</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2019-11-27</date><risdate>2019</risdate><volume>14</volume><issue>11</issue><spage>e0223095</spage><epage>e0223095</epage><pages>e0223095-e0223095</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>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). 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. 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&lt;0.001), emotion regulation (Difficulties in Emotion Regulation Score, p = 0.02), and self-awareness (Multidimensional Assessment of Interoceptive Awareness, p&lt;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&lt;0.001), and alcohol consumption (p&lt;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&lt;0.001). MB-BP has good acceptability and feasibility, and may engage with self-regulation and behavioral determinants of hypertension.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>31774807</pmid><doi>10.1371/journal.pone.0223095</doi><orcidid>https://orcid.org/0000-0002-9962-0386</orcidid><orcidid>https://orcid.org/0000-0002-6269-9027</orcidid><orcidid>https://orcid.org/0000-0002-3585-8379</orcidid><oa>free_for_read</oa></addata></record>
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subjects Acceptability
Alcohol
Alcohol use
Attention task
Automatic control
Behavior
Behavioral sciences
Biology and Life Sciences
Blood Pressure
Blood Pressure Determination
Cardiovascular disease
Clinical trials
Curricula
Curriculum
Diet
Drinking (Alcoholic beverages)
Epidemiology
Evaluation
Exercise
Feasibility Studies
Female
Focus Groups
Follow-Up Studies
Health care
Humans
Hypertension
Hypertension - psychology
Hypertension - therapy
Intervention
Interviews as Topic
Laws, regulations and rules
Male
Medicine
Medicine and Health Sciences
Meditation
Meta-analysis
Middle Aged
Mindfulness
Patient Acceptance of Health Care
Patient compliance
People and Places
Physical activity
Pressure reduction
Public health
Qualitative Research
Self awareness
Social Sciences
Systematic review
Treatment Outcome
Young adults
title Mindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 single-arm clinical trial
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