Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindfulness-Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial

Conditions
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Hypertension, Prehypertension

Intervention / Treatment
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* Behavioral: MB-BP Intervention
* Other: Enhanced Usual Care Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MB-BP Intervention<br>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. | Behavioral: MB-BP Intervention<br>* 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.<br>|
| Active Comparator: Enhanced Usual Care Control<br>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. | Other: Enhanced Usual Care Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Directly assessed as mean of second and third blood pressure readings | 6 month follow-up | 
| Dietary Approaches to Stop Hypertension-consistent diet | Self-report via Willet Food Frequency Questionnaire | 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Attention to Response Task (SART) | Behavioral measure of attention control | 6 month follow-up | 
| Mindful Attention Awareness Scale (MAAS) | Self-report measure of attention control and mindfulness | 6 month follow-up | 
| Pittsburgh Stress Battery | Behavioral measure of stress reactivity | 6 month follow-up | 
| Perceived Stress Scale | Self-report measure of perceived stress | 6 month follow-up | 
| Heartbeat Detection Task | Behavioral measure of self-awareness | 6 month follow-up | 
| Multidimensional Assessment of Interoceptive Awareness (MAIA) | Self-report measure of self-awareness | 6 month follow-up | 
| Physical Activity - self report | Self-report via International Physical Activity Questionnaire (IPAQ) | 6 month follow-up | 
| Physical Activity - step count | Directly assessed via FitBit step count | 6 month follow-up | 
| Alcohol consumption | Self-report via Willet Food Frequency Questionnaire | 6 month follow-up | 
| 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. | 6 month follow-up | 
| 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. | 6 month follow-up | 
| Antihypertensive medication use | Directly assessed via medication bottle labels that participants bring to clinic assessments | 6 month follow-up | 
| Diastolic blood pressure | Directly assessed as mean of second and third readings | 6 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, blood pressure, hypertension, prehypertension, self regulation, Science of Behavior Change, attention control, self awareness, emotion regulation