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HypertensionMB-BPNCT03859076

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

A study testing MB-BP in people with Hypertension and Prehypertension, run by Brown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Prehypertension
What is being tested?
MB-BP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
1 siteUnited States
Study dates
13 Dec 2018to 12 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brown Mindfulness Center

    Providence, Rhode Island, 02903

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
MB-BP, Enhanced Usual Care Control
Keywords
mindfulness, blood pressure, hypertension, prehypertension, self regulation, Science of Behavior Change, attention control, self awareness, emotion regulation
Medical subject headings
Hypertension, Prehypertension, Self-Control, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MB-BPBehavioural

    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.

  • Enhanced Usual Care ControlOther

    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.

Study groups in NCT03859076
Study groupRoleWhat they receive
MB-BP InterventionExperimentalMB-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.
Receives: Behavioral: MB-BP
Enhanced Usual Care ControlActive comparatorThose 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.
Receives: Other: Enhanced Usual Care Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 month follow-up

Secondary outcomes (15)
  1. Heartbeat Detection Task

    Behavioral measure of self-awareness

    Measured: Baseline, 10 weeks, 6 months

  2. 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.

    Measured: Baseline, 10-week follow-up

  3. 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.

    Measured: Baseline, 10 weeks, 6 months

  4. Pittsburgh Stress Battery

    Behavioral measure of stress reactivity

    Measured: Baseline, 10 weeks, 6 months

  5. 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.

    Measured: Baseline, 10 weeks, 6 months

  6. 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.

    Measured: Baseline, 10 weeks, 6 months

  7. 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.

    Measured: Baseline, 10 weeks, 6 months

  8. 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."

    Measured: 6 month follow-up

  9. 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.

    Measured: 6 months

  10. 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."

    Measured: Baseline, 10 weeks, 6 months

  11. 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."

    Measured: 6 month follow-up

  12. 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."

    Measured: 6 month-follow up

  13. Electronically-Measured Antihypertensive Medication Adherence

    Measured continuously using electronic medication bottle caps (eCAPS, Ottawa, Canada)

    Measured: 6 months

  14. Body Mass Index

    Height and weight directly assessed using standard epidemiologic methods, with change evaluated in participants considered overweight or obese (BMI≥25kg/m)

    Measured: Baseline, 10 weeks, 6 months

  15. 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.

    Measured: Baseline, 10 weeks, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2019
  2. Study start13 Dec 2018
  3. Primary completion31 Aug 2020
  4. Study completion12 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03859076
Sponsor's protocol ID
1412001171-2
Other IDs
5UH3AT009145-04
Acronym
MB-BP
Status last verified
Jan 2021
First submitted
20 Feb 2019
Last updated
13 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wu F, Brewer LC, Neves VV, Scarpaci MM, Saadeh FB, Proulx JA, Loucks EB. Impact of the mindfulness-based blood pressure reduction (MB-BP) program on cardiovascular health: A randomized clinical trial. Am J Prev Cardiol. 2026 Mar 28;27:101584. doi: 10.1016/j.ajpc.2026.101584. eCollection 2026 Jun.

    PubMed 42291030
  • Sukhbaatar S, Sun S, Scarpaci MM, Neves VV, Sheridan MA, Loucks EB. Mindfulness for heart and mind: Mindfulness-based blood pressure reduction randomized clinical trial for depression symptoms. Health Psychol. 2026 May;45(5):566-577. doi: 10.1037/hea0001568. Epub 2026 Feb 12.

    PubMed 41678222
  • Loucks EB, Kronish IM, Saadeh FB, Scarpaci MM, Proulx JA, Gutman R, Britton WB, Schuman-Olivier Z. Adapted Mindfulness Training for Interoception and Adherence to the DASH Diet: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2339243. doi: 10.1001/jamanetworkopen.2023.39243.

    PubMed 37917063
  • Loucks EB, Kronish IM, Saadeh FB, Scarpaci MM, Proulx JA, Gutman R, Britton WB, Schuman-Olivier Z. Effects of Adapted Mindfulness Training on Interoception and Adherence to the Dietary Approaches to Stop Hypertension (DASH) Diet: The MB-BP Randomized Clinical Trial. medRxiv [Preprint]. 2023 May 15:2023.05.10.23289818. doi: 10.1101/2023.05.10.23289818.

    PubMed 37292774
  • Loucks EB, Schuman-Olivier Z, Saadeh FB, Scarpaci MM, Nardi WR, Proulx JA, Gutman R, King J, Britton WB, Kronish IM. Effect of Adapted Mindfulness Training in Participants With Elevated Office Blood Pressure: The MB-BP Study: A Randomized Clinical Trial. J Am Heart Assoc. 2023 Jun 6;12(11):e028712. doi: 10.1161/JAHA.122.028712. Epub 2023 May 23.

    PubMed 37218591

Questions about this trial

What is this clinical trial studying?

A study testing MB-BP in people with Hypertension and Prehypertension, run by Brown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Regulation Primary Outcome: Multidimensional Assessment of Interoceptive Awareness (MAIA) (time frame: 6 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03859076, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.

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