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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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 |
doi_str_mv | 10.1371/journal.pone.0223095 |
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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<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).
MB-BP has good acceptability and feasibility, and may engage with self-regulation and behavioral determinants of hypertension.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0223095</identifier><identifier>PMID: 31774807</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>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</subject><ispartof>PloS one, 2019-11, Vol.14 (11), p.e0223095-e0223095</ispartof><rights>COPYRIGHT 2019 Public Library of Science</rights><rights>2019 Loucks et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2019 Loucks et al 2019 Loucks et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c593t-849b21b4a10deb66fa0e196f46671483e1010953ad8438f2b672dd583286aeb13</citedby><cites>FETCH-LOGICAL-c593t-849b21b4a10deb66fa0e196f46671483e1010953ad8438f2b672dd583286aeb13</cites><orcidid>0000-0002-9962-0386 ; 0000-0002-6269-9027 ; 0000-0002-3585-8379</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6881004/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6881004/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2095,2914,23846,27903,27904,53770,53772,79347,79348</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31774807$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Shiu, Cheng-Shi</contributor><creatorcontrib>Loucks, Eric B</creatorcontrib><creatorcontrib>Nardi, William R</creatorcontrib><creatorcontrib>Gutman, Roee</creatorcontrib><creatorcontrib>Kronish, Ian M</creatorcontrib><creatorcontrib>Saadeh, Frances B</creatorcontrib><creatorcontrib>Li, Yu</creatorcontrib><creatorcontrib>Wentz, Anna E</creatorcontrib><creatorcontrib>Webb, Julie</creatorcontrib><creatorcontrib>Vago, David R</creatorcontrib><creatorcontrib>Harrison, Abigail</creatorcontrib><creatorcontrib>Britton, Willoughby B</creatorcontrib><title>Mindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 single-arm clinical trial</title><title>PloS one</title><addtitle>PLoS One</addtitle><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<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).
MB-BP has good acceptability and feasibility, and may engage with self-regulation and behavioral determinants of hypertension.</description><subject>Acceptability</subject><subject>Alcohol</subject><subject>Alcohol use</subject><subject>Attention task</subject><subject>Automatic control</subject><subject>Behavior</subject><subject>Behavioral sciences</subject><subject>Biology and Life Sciences</subject><subject>Blood Pressure</subject><subject>Blood Pressure Determination</subject><subject>Cardiovascular disease</subject><subject>Clinical trials</subject><subject>Curricula</subject><subject>Curriculum</subject><subject>Diet</subject><subject>Drinking (Alcoholic beverages)</subject><subject>Epidemiology</subject><subject>Evaluation</subject><subject>Exercise</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Focus Groups</subject><subject>Follow-Up Studies</subject><subject>Health care</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Hypertension - psychology</subject><subject>Hypertension - therapy</subject><subject>Intervention</subject><subject>Interviews as Topic</subject><subject>Laws, regulations and rules</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Meditation</subject><subject>Meta-analysis</subject><subject>Middle Aged</subject><subject>Mindfulness</subject><subject>Patient Acceptance of Health Care</subject><subject>Patient compliance</subject><subject>People and Places</subject><subject>Physical activity</subject><subject>Pressure reduction</subject><subject>Public health</subject><subject>Qualitative Research</subject><subject>Self awareness</subject><subject>Social Sciences</subject><subject>Systematic review</subject><subject>Treatment Outcome</subject><subject>Young 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Blood Pressure Reduction (MB-BP): Stage 1 single-arm clinical trial</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c593t-849b21b4a10deb66fa0e196f46671483e1010953ad8438f2b672dd583286aeb13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Acceptability</topic><topic>Alcohol</topic><topic>Alcohol use</topic><topic>Attention task</topic><topic>Automatic control</topic><topic>Behavior</topic><topic>Behavioral sciences</topic><topic>Biology and Life Sciences</topic><topic>Blood Pressure</topic><topic>Blood Pressure Determination</topic><topic>Cardiovascular disease</topic><topic>Clinical 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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<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).
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> |
fulltext | fulltext |
identifier | ISSN: 1932-6203 |
ispartof | PloS one, 2019-11, Vol.14 (11), p.e0223095-e0223095 |
issn | 1932-6203 1932-6203 |
language | eng |
recordid | cdi_plos_journals_2319185398 |
source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS); EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
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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