UH3 Phase - Mindfulness-Based Blood Pressure Reduction (MB-BP) : Stage 2a RCT

Study Overview
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Brief Summary
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The primary aim is to identify the impacts of a behavioral intervention called Mindfulness-Based Blood Pressure Reduction (MB-BP) vs. enhanced usual care on the primary self-regulation target, specifically an assay of self-related processes (Multidimensional Assessment of Interoceptive Awareness) (MAIA) 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.

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
* Other: Enhanced Usual Care Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elevated blood pressure or hypertension defined as ≥120 mmHg systolic or ≥80 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: Exclusion criteria follow standard guidelines and recommendations: current regular mindfulness meditation practice (>once/week) serious medical illness or cognitive condition (e.g., dementia) precluding regular class attendance and/or participation current substance abuse, suicidal ideation or eating disorder history of bipolar or psychotic disorders or self-injurious behaviors.

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 & a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, & specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, & stress reactivity. Students learn a range of mindfulness skills (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, the investigator works to provide access within health insurance constraints. | Behavioral: MB-BP<br>* MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions & a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, & specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, & stress reactivity. Students learn a range of mindfulness skills (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, the investigator works to provide access within health insurance constraints.<br>|
| Active Comparator: Enhanced Usual Care Control<br>Those in the control group receive an educational brochure from the American Heart Association (product code 50-1731) and a validated home blood pressure monitor (Omron, Model PB786N), that has an evidence-based approach to lower blood pressure. 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 it. For participants with uncontrolled hypertension who do not have a physician, the investigator works to provide access within constraints of their health insurance. Additionally, participants randomized to the control group are asked to refrain from engaging in any type of formal mindfulness practice more than weekly during the first six months of study involvement. | Other: Enhanced Usual Care Control<br>* Those in the control group receive an educational brochure from the American Heart Association (product code 50-1731) and a validated home blood pressure monitor (Omron, Model PB786N), that has an evidence-based approach to lower blood pressure. 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 it. For participants with uncontrolled hypertension who do not have a physician, the investigator works to provide access within constraints of their health insurance. Additionally, participants randomized to the control group are asked to refrain from engaging in any type of formal mindfulness practice more than weekly during the first six months of study involvement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Regulation Primary Outcome: Multidimensional Assessment of Interoceptive Awareness (MAIA) | a validated measure of body awareness - a 32 item self-report measure composed of the following 8 subscales: (i) Noticing, (ii) Not-Distracting, (iii) Not-Worrying, (iv) Attention Regulation, (v) Emotional Awareness, (vi) Self-Regulation, (vii) Body Listening, and (viii) Trusting. Individuals rate items using a 6 point Likert scale from 0 ('Never') to 5 ('Always'). Total scores are obtained through reverse coding items 5, 6, 7, 8, 9 and summing all items. Higher scores indicate higher levels of positive awareness. | 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heartbeat Detection Task | Behavioral measure of self-awareness | Baseline, 10 weeks, 6 months | 
| Interoceptive Awareness fMRI Task | Those who elect to take part in the fMRI study will undergo an fMRI scanning session for approximately 40 minutes. Scans will be acquired with a 3T scanner while the subject is in the resting state. Participants will undergo a separate informed consent and screening process for the fMRI imaging, so that they can be in the MB-BP study without imaging if they prefer. | Baseline, 10-week follow-up | 
| Difficulties in Emotion Regulation Scale (DERS) | Behavioral measure of emotion regulation - The Difficulties in Emotion Regulation Scale is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1-5, with 1 being (almost never [0-10%]); 2 (sometimes [11-35%]); 3 (about half the time [36-65%]); 4 (most of the time [66-90%]); and 5 being (almost always [91-100%]). Higher scores indicate more difficulty in emotion regulation. | Baseline, 10 weeks, 6 months | 
| Pittsburgh Stress Battery | Behavioral measure of stress reactivity | Baseline, 10 weeks, 6 months | 
| Perceived Stress Scale (PSS-14) | 14-item self-report measure of perceived stress - Participants indicate how often they have found their lives unpredictable, uncontrollable, and overloaded in the last month. Items are rated on a 4 point Likert scale with 0 being (Never); 1 (Almost Never); 2 (Sometimes); 3 (Fairly often) and 4 (Very often). PSS-14 scores are obtained by reversing the scores on the seven positive items, e.g., 0=4, 1=3, 2=2, etc., and then summing across all 14 items. Items 4, 5, 6, 7, 9, 10, and 13 are the positively stated items. | Baseline, 10 weeks, 6 months | 
| Anxiety Symptoms - self-report | Assessed via the Beck Anxiety Inventory (BAI) scale. The BAI is a 21-item self-report measure of anxiety. Participants indicate how much they have been bothered by an anxiety symptom during the past month. Items are rated on a 3-point Likert scale with 0 being Never); 2 (Mildly but it didn't bother me much); 2 (Moderately - it wasn't pleasant at times); 3 (Severely- it bothered me a lot). The total score is calculated by finding the sum of the 21 items. A score of 0-21= low anxiety, Score of 22-35 = moderate anxiety, Score of 36 and above = potentially concerning levels of anxiety. | Baseline, 10 weeks, 6 months | 
| Depressive Symptoms - self-report | Assessed via Center for Epidemiologic Studies Depression Scale Revised (CESD-R). The CESD-R is a 20-item self-report measure of depression in nine different groups according to the DSM-5. The symptom groups are Sadness (items 2,4,6), Loss of Interest (items 8, 10), Appetite (1,18), Sleep (5,11,19), Thinking/Concentration (3,20), Guilt (9,17), Tired (7,16), Movement (12,13), and Suicidal Ideation (14,15). Response values for each question are 0 (Not at all or less than one day); 1 (1-2 days); 2 (3-4 days); 3 (5-7 days); 4 (Nearly every day for 2 weeks). The total score is calculated as a sum of responses to all 20 questions. | Baseline, 10 weeks, 6 months | 
| Sustained Attention to Response Task (SART) | Behavioral measure of attention control - The Sustained Attention to Response Task (SART) is a computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target (often the digit 3) presented amongst a background of frequent non-targets (0-2, 4-9). After each block, two probe questions are presented in succession. The first asks, Where was your attention focused during this block of trials? Participants respond on a 6-point Likert scale, where 1 represents, on task,  and 6, off task. A second question asks, How aware were you of where your attention was during this block of trials? Participants respond on a similar scale, where 1 represents, aware,  and 6, unaware. | 6 month follow-up | 
| Self-Compassion | Assessed using the 12-item validated Self-Compassion Scale Short Form (SCS-SF); Participants indicate how they typically act towards themselves in difficult times using a 5-point Likert scale with 1 being Almost Never to 5 being Almost Always. The total self-compassion score is calculated by reverse scoring the negative subscale items -self-judgment, isolation, and over-identification (i.e., 1 = 5, 2 = 4, 3 = 3, 4 = 2, 5 = 1) then computing a total mean. | 6 months | 
| Self-Efficacy | Assessed using the validated Self-Control Scale short form and the SECD-6 Scale. The Self Control Scale measures self-control. The scale consists of 36 items, measured on a scale from 1, not at all like me to 5, very much like me. | Baseline, 10 weeks, 6 months | 
| Dietary Approaches to Stop Hypertension (DASH)-consistent diet | Self-report via Willet Food Frequency Questionnaire. Participants are asked to fill in the circle indicating how often on average they have used the food item during the past year. Response categories include Never, or less than once per month, 1-3 per month; 1 per week; 2-4 per week; 5-6 per week; 1 per day; 2-3 per day; 4-5 per day; 6+ per day. | 6 month follow-up | 
| Alcohol consumption - self report | Self-report via Willet Food Frequency Questionnaire. Participants are asked to fill in the circle indicating how often on average they have used the food item during the past year. Response categories include Never, or less than once per month, 1-3 per month; 1 per week; 2-4 per week; 5-6 per week; 1 per day; 2-3 per day; 4-5 per day; 6+ per day. | 6 month-follow up | 
| Electronically-Measured Antihypertensive Medication Adherence | Measured continuously using electronic medication bottle caps (eCAPS, Ottawa, Canada) | 6 months | 
| Body Mass Index | Height and weight directly assessed using standard epidemiologic methods, with change evaluated in participants considered overweight or obese (BMI≥25kg/m) | Baseline, 10 weeks, 6 months | 
| Physical Activity - self report | Assessed via the International Physical Activity Questionnaire (IPAQ). The IPAQ is a 27-item self-reported measure of physical activity. Duration (minutes) and frequency (days) of physical activity in the last seven days is measured in 5 domains (1: job related; 2: transportation; 3: housework, house maintenance, caring for family; 4: Recreation, sport, and leisure time; 5: Time spent sitting). Overall score is calculated using responses to all questions. Amount of physical activity places participant in 1 of 3 categories: 1) Low/inactive; 2) Moderate; 3) High. | Baseline, 10 weeks, 6 months | 

 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