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

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ClinicalTrials.gov Identifier: NCT03859076
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Brown University

Brief 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, via a randomized controlled trial.

Condition or disease Intervention/treatment Phase
Hypertension Prehypertension Behavioral: MB-BP Other: Enhanced Usual Care Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Mindfulness Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MB-BP Intervention
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
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.

Active Comparator: Enhanced Usual Care Control
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
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.




Primary Outcome Measures :
  1. Self-Regulation Primary Outcome: Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: 6 month follow-up ]
    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.


Secondary Outcome Measures :
  1. Heartbeat Detection Task [ Time Frame: Baseline, 10 weeks, 6 months ]
    Behavioral measure of self-awareness

  2. Interoceptive Awareness fMRI Task [ Time Frame: Baseline, 10-week follow-up ]
    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.

  3. Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Baseline, 10 weeks, 6 months ]
    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.

  4. Pittsburgh Stress Battery [ Time Frame: Baseline, 10 weeks, 6 months ]
    Behavioral measure of stress reactivity

  5. Perceived Stress Scale (PSS-14) [ Time Frame: Baseline, 10 weeks, 6 months ]
    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.

  6. Anxiety Symptoms - self-report [ Time Frame: Baseline, 10 weeks, 6 months ]
    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.

  7. Depressive Symptoms - self-report [ Time Frame: Baseline, 10 weeks, 6 months ]
    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.

  8. Sustained Attention to Response Task (SART) [ Time Frame: 6 month follow-up ]
    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."

  9. Self-Compassion [ Time Frame: 6 months ]
    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.

  10. Self-Efficacy [ Time Frame: Baseline, 10 weeks, 6 months ]
    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."

  11. Dietary Approaches to Stop Hypertension (DASH)-consistent diet [ Time Frame: 6 month follow-up ]
    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."

  12. Alcohol consumption - self report [ Time Frame: 6 month-follow up ]
    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."

  13. Electronically-Measured Antihypertensive Medication Adherence [ Time Frame: 6 months ]
    Measured continuously using electronic medication bottle caps (eCAPS, Ottawa, Canada)

  14. Body Mass Index [ Time Frame: Baseline, 10 weeks, 6 months ]
    Height and weight directly assessed using standard epidemiologic methods, with change evaluated in participants considered overweight or obese (BMI≥25kg/m)

  15. Physical Activity - self report [ Time Frame: Baseline, 10 weeks, 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859076


Contacts
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Contact: Frances Sadeeh, MPH 401-863-6361 frances_saadeh@brown.edu
Contact: Eric B Loucks, PhD 401-863-6283 eric.loucks@brown.edu

Locations
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United States, Rhode Island
Brown Mindfulness Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Frances Sadeeh, MPH    401-863-6361    frances_sadeeh@brown.edu   
Principal Investigator: Eric B Loucks, PhD         
Sponsors and Collaborators
Brown University
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Eric B Loucks, PhD Brown University

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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03859076     History of Changes
Other Study ID Numbers: 1412001171-2
5UH3AT009145-04 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brown University:
mindfulness
blood pressure
hypertension
prehypertension
self regulation
Science of Behavior Change
attention control
self awareness
emotion regulation
Additional relevant MeSH terms:
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Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases