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

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ClinicalTrials.gov Identifier: NCT03256890
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : October 31, 2017
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 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.

Condition or disease Intervention/treatment Phase
Hypertension Prehypertension Behavioral: MB-BP Intervention 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.

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.


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 : June 13, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

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 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
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.

Active Comparator: Enhanced Usual Care Control
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
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 Measures :
  1. Systolic blood pressure [ Time Frame: 6 month follow-up ]
    Directly assessed as mean of second and third blood pressure readings


Secondary Outcome Measures :
  1. Sustained Attention to Response Task (SART) [ Time Frame: 6 month follow-up ]
    Behavioral measure of attention control

  2. Mindful Attention Awareness Scale (MAAS) [ Time Frame: 6 month follow-up ]
    Self-report measure of attention control and mindfulness

  3. Pittsburgh Stress Battery [ Time Frame: 6 month follow-up ]
    Behavioral measure of stress reactivity

  4. Perceived Stress Scale [ Time Frame: 6 month follow-up ]
    Self-report measure of perceived stress

  5. Heartbeat Detection Task [ Time Frame: 6 month follow-up ]
    Behavioral measure of self-awareness

  6. Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: 6 month follow-up ]
    Self-report measure of self-awareness

  7. Physical Activity - self report [ Time Frame: 6 month follow-up ]
    Self-report via International Physical Activity Questionnaire (IPAQ)

  8. Physical Activity - step count [ Time Frame: 6 month follow-up ]
    Directly assessed via FitBit step count

  9. Dietary Approaches to Stop Hypertension-consistent diet [ Time Frame: 6 month follow-up ]
    Self-report via Willet Food Frequency Questionnaire

  10. Alcohol consumption [ Time Frame: 6 month follow-up ]
    Self-report via Willet Food Frequency Questionnaire

  11. Body Mass Index [ Time Frame: 6 month follow-up ]
    Directly assessed as weight (kg) per height (m) squared, using a validated stadiometer to assess height, and validated scale to measure weight.

  12. Antihypertensive medication adherence [ Time Frame: 6 month follow-up ]
    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.

  13. Antihypertensive medication use [ Time Frame: 6 month follow-up ]
    Directly assessed via medication bottle labels that participants bring to clinic assessments

  14. Diastolic blood pressure [ Time Frame: 6 month follow-up ]
    Directly assessed as mean of second and third readings



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:

  • 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.


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): NCT03256890


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

Locations
United States, Rhode Island
Brown University School of Public Health Recruiting
Providence, Rhode Island, United States, 02912
Contact: Frances Saadeh, MPH    401-863-6361    frances_saadeh@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
Principal Investigator: Eric B Loucks, PhD Brown University

Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03256890     History of Changes
Other Study ID Numbers: 1412001171
1UH2AT009145 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

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:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases