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Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT (MB-BP)

Primary Purpose

Hypertension, Prehypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MB-BP Intervention
Enhanced Usual Care Control
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring mindfulness, blood pressure, hypertension, prehypertension, self regulation, Science of Behavior Change, attention control, self awareness, emotion regulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic pressure or taking antihypertensive medication). Preference is given to recruiting uncontrolled hypertensives (≥140 mmHg systolic or ≥90 mmHg diastolic pressure)
  • Able to speak, read, and write in English.
  • All adults (≥18 years of age), genders and racial/ethnic groups are eligible to be included.

Exclusion Criteria:

  • Current regular meditation practice (>once/week)
  • Serious medical illness precluding regular class attendance
  • Current substance abuse, suicidal ideation or eating disorder
  • History of bipolar or psychotic disorders or self-injurious behaviors.

These participants are excluded because they may disrupt group participation, require additional or specialized treatment, or are already participating in practices similar to the intervention.

Sites / Locations

  • Brown University School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MB-BP Intervention

Enhanced Usual Care Control

Arm Description

MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions and a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, and stress reactivity. Students learn a range of mindfulness skills including body scan exercises, meditation and yoga. Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified; for those without a physician, we work to provide access within health insurance constraints.

Control group participants receive an educational brochure from American Heart Association entitled "Understanding and Controlling Your High Blood Pressure Brochure" (product code 50-1639). Every participant is provided with a validated home blood pressure monitor (Omron, Model PB786N), that as an evidence-based approach to lower blood pressure, would be considered "enhanced usual care" at this time. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for uncontrolled hypertension. For participants with uncontrolled hypertension who do not have a physician, we work participants to provide access within constraints of their health insurance.

Outcomes

Primary Outcome Measures

Systolic blood pressure
Directly assessed as mean of second and third blood pressure readings
Dietary Approaches to Stop Hypertension-consistent diet
Self-report via Willet Food Frequency Questionnaire

Secondary Outcome Measures

Sustained Attention to Response Task (SART)
Behavioral measure of attention control
Mindful Attention Awareness Scale (MAAS)
Self-report measure of attention control and mindfulness
Pittsburgh Stress Battery
Behavioral measure of stress reactivity
Perceived Stress Scale
Self-report measure of perceived stress
Heartbeat Detection Task
Behavioral measure of self-awareness
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Self-report measure of self-awareness
Physical Activity - self report
Self-report via International Physical Activity Questionnaire (IPAQ)
Physical Activity - step count
Directly assessed via FitBit step count
Alcohol consumption
Self-report via Willet Food Frequency Questionnaire
Body Mass Index
Directly assessed as weight (kg) per height (m) squared, using a validated stadiometer to assess height, and validated scale to measure weight.
Antihypertensive medication adherence
Directly assessed via eCAP medication adherence devices (Information Mediary Corp., Ottawa, ON, Canada). Please note that eCAP is the device name, and not an acronym.
Antihypertensive medication use
Directly assessed via medication bottle labels that participants bring to clinic assessments
Diastolic blood pressure
Directly assessed as mean of second and third readings

Full Information

First Posted
August 3, 2017
Last Updated
January 25, 2021
Sponsor
Brown University
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03256890
Brief Title
Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT
Acronym
MB-BP
Official Title
Mindfulness-Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
December 18, 2018 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary aim is to evaluate impacts of a behavioral intervention called "Mindfulness-Based Blood Pressure Reduction" (MB-BP) vs. enhanced usual care control on systolic blood pressure at 6 months, via a randomized controlled trial.
Detailed Description
Effects of mindfulness interventions customized for prehypertensive/hypertensive patients are poorly understood. Until methodologically rigorous studies to evaluate customized interventions for hypertension are performed, it will be unknown whether the observed preliminary effects of general mindfulness interventions on blood pressure reduction could be much more effective with a tailored approach. Consequently, this study proposes to conduct a behavioral intervention study to evaluate whether Mindfulness-Based Stress Reduction (MBSR) customized to prehypertensive and hypertensive patients has the potential to provide clinically relevant reductions in blood pressure. This customized intervention is called Mindfulness-Based Blood Pressure Reduction (MB-BP). The study follows the NIH Stage Model for Behavioral Intervention Development, where targets likely proximally affected by the intervention are identified, that should also have effect on the longer-term outcomes (e.g. blood pressure, mortality). The selected targets, consistent with theoretical frameworks and early evidence how mindfulness interventions could influence mental and physical health outcomes, are measures of self-regulation including (1) attention control (specifically the Sustained Attention Response Task and Mindful Attention Awareness Scale), (2) emotion regulation (specifically the Pittsburgh Stress Battery and the Perceived Stress Scale), and (3) self-awareness (specifically the Heart Beat Detection Task and Multidimensional Assessment of Interoceptive Awareness). Based on the degree of target engagement, MB-BP can be further customized to better engage with the targets as needed. Specific aims are as follows. The primary aim is to evaluate impacts of MB-BP vs. enhanced usual care control on systolic blood pressure at 6 months. Follow-up time periods include 10 weeks and 6 months. Secondary aims include evaluating impacts of MB-BP vs. enhanced usual care control on self-regulation mechanistic target engagement, including (1) attention control (specifically the Sustained Attention Response Task and Mindful Attention Awareness Scale), (2) emotion regulation (specifically the Pittsburgh Stress Battery and the Perceived Stress Scale), and (3) self-awareness (specifically the Heart Beat Detection Task and Multidimensional Assessment of Interoceptive Awareness). Further secondary aims include evaluating impacts of MB-BP vs. active control on medical regimen adherence, including (1) physical activity, (2) Dietary Approaches to Stop Hypertension (DASH)-consistent diet, (3) alcohol consumption, (4) body mass index, and (5) antihypertensive medication use and adherence. Secondary blood pressure outcomes include diastolic blood pressure. This study is a randomized controlled trial, with blinding of staff performing participant assessments and data analysts performing statistical analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Prehypertension
Keywords
mindfulness, blood pressure, hypertension, prehypertension, self regulation, Science of Behavior Change, attention control, self awareness, emotion regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The study will implement blinding of staff performing participant assessments and data analysts performing statistical analyses. The principal investigator will be blinded to group allocation, except for participants that he is involved with instructing in the MB-BP intervention (there are multiple instructors). The prinicipal investigator has no access to the master data file. Equipoise is emphasized for all staff who interact with participants.
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MB-BP Intervention
Arm Type
Experimental
Arm Description
MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions and a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, and stress reactivity. Students learn a range of mindfulness skills including body scan exercises, meditation and yoga. Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified; for those without a physician, we work to provide access within health insurance constraints.
Arm Title
Enhanced Usual Care Control
Arm Type
Active Comparator
Arm Description
Control group participants receive an educational brochure from American Heart Association entitled "Understanding and Controlling Your High Blood Pressure Brochure" (product code 50-1639). Every participant is provided with a validated home blood pressure monitor (Omron, Model PB786N), that as an evidence-based approach to lower blood pressure, would be considered "enhanced usual care" at this time. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for uncontrolled hypertension. For participants with uncontrolled hypertension who do not have a physician, we work participants to provide access within constraints of their health insurance.
Intervention Type
Behavioral
Intervention Name(s)
MB-BP Intervention
Intervention Description
MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions and a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, and stress reactivity. Students learn a range of mindfulness skills including body scan exercises, meditation and yoga. Homework consists of practicing skills for ≥45 min/day, 6 days/week. Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified, if not already overseen for uncontrolled hypertension; those without a physician are worked with to provide access within health insurance constraints.
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care Control
Intervention Description
Control group participants receive an educational brochure from American Heart Association entitled "Understanding and Controlling Your High Blood Pressure Brochure" (product code 50-1639). Every participant is provided with a validated home blood pressure monitor (Omron, Model PB786N), that as an evidence-based approach to lower blood pressure, would be considered "enhanced usual care" at this time. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for uncontrolled hypertension. For participants with uncontrolled hypertension who do not have a physician, we work participants to provide access within constraints of their health insurance.
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Directly assessed as mean of second and third blood pressure readings
Time Frame
6 month follow-up
Title
Dietary Approaches to Stop Hypertension-consistent diet
Description
Self-report via Willet Food Frequency Questionnaire
Time Frame
6 month follow-up
Secondary Outcome Measure Information:
Title
Sustained Attention to Response Task (SART)
Description
Behavioral measure of attention control
Time Frame
6 month follow-up
Title
Mindful Attention Awareness Scale (MAAS)
Description
Self-report measure of attention control and mindfulness
Time Frame
6 month follow-up
Title
Pittsburgh Stress Battery
Description
Behavioral measure of stress reactivity
Time Frame
6 month follow-up
Title
Perceived Stress Scale
Description
Self-report measure of perceived stress
Time Frame
6 month follow-up
Title
Heartbeat Detection Task
Description
Behavioral measure of self-awareness
Time Frame
6 month follow-up
Title
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Description
Self-report measure of self-awareness
Time Frame
6 month follow-up
Title
Physical Activity - self report
Description
Self-report via International Physical Activity Questionnaire (IPAQ)
Time Frame
6 month follow-up
Title
Physical Activity - step count
Description
Directly assessed via FitBit step count
Time Frame
6 month follow-up
Title
Alcohol consumption
Description
Self-report via Willet Food Frequency Questionnaire
Time Frame
6 month follow-up
Title
Body Mass Index
Description
Directly assessed as weight (kg) per height (m) squared, using a validated stadiometer to assess height, and validated scale to measure weight.
Time Frame
6 month follow-up
Title
Antihypertensive medication adherence
Description
Directly assessed via eCAP medication adherence devices (Information Mediary Corp., Ottawa, ON, Canada). Please note that eCAP is the device name, and not an acronym.
Time Frame
6 month follow-up
Title
Antihypertensive medication use
Description
Directly assessed via medication bottle labels that participants bring to clinic assessments
Time Frame
6 month follow-up
Title
Diastolic blood pressure
Description
Directly assessed as mean of second and third readings
Time Frame
6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic pressure or taking antihypertensive medication). Preference is given to recruiting uncontrolled hypertensives (≥140 mmHg systolic or ≥90 mmHg diastolic pressure) Able to speak, read, and write in English. All adults (≥18 years of age), genders and racial/ethnic groups are eligible to be included. Exclusion Criteria: Current regular meditation practice (>once/week) Serious medical illness precluding regular class attendance Current substance abuse, suicidal ideation or eating disorder History of bipolar or psychotic disorders or self-injurious behaviors. These participants are excluded because they may disrupt group participation, require additional or specialized treatment, or are already participating in practices similar to the intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric B Loucks, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University School of Public Health
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35594968
Citation
Polcari JJ, Cali RJ, Nephew BC, Lu S, Rashkovskii M, Wu J, Saadeh F, Loucks E, King JA. Effects of the Mindfulness-Based Blood Pressure Reduction (MB-BP) program on depression and neural structural connectivity. J Affect Disord. 2022 Aug 15;311:31-39. doi: 10.1016/j.jad.2022.05.059. Epub 2022 May 17.
Results Reference
derived

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Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT

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