<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03256890</url>
  </required_header>
  <id_info>
    <org_study_id>1412001171-3</org_study_id>
    <secondary_id>1UH2AT009145</secondary_id>
    <nct_id>NCT03256890</nct_id>
  </id_info>
  <brief_title>Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT</brief_title>
  <acronym>MB-BP</acronym>
  <official_title>Mindfulness-Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim is to evaluate impacts of a behavioral intervention called &quot;Mindfulness-Based&#xD;
      Blood Pressure Reduction&quot; (MB-BP) vs. enhanced usual care control on systolic blood pressure&#xD;
      at 6 months, via a randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effects of mindfulness interventions customized for prehypertensive/hypertensive patients are&#xD;
      poorly understood. Until methodologically rigorous studies to evaluate customized&#xD;
      interventions for hypertension are performed, it will be unknown whether the observed&#xD;
      preliminary effects of general mindfulness interventions on blood pressure reduction could be&#xD;
      much more effective with a tailored approach. Consequently, this study proposes to conduct a&#xD;
      behavioral intervention study to evaluate whether Mindfulness-Based Stress Reduction (MBSR)&#xD;
      customized to prehypertensive and hypertensive patients has the potential to provide&#xD;
      clinically relevant reductions in blood pressure. This customized intervention is called&#xD;
      Mindfulness-Based Blood Pressure Reduction (MB-BP). The study follows the NIH Stage Model for&#xD;
      Behavioral Intervention Development, where targets likely proximally affected by the&#xD;
      intervention are identified, that should also have effect on the longer-term outcomes (e.g.&#xD;
      blood pressure, mortality). The selected targets, consistent with theoretical frameworks and&#xD;
      early evidence how mindfulness interventions could influence mental and physical health&#xD;
      outcomes, are measures of self-regulation including (1) attention control (specifically the&#xD;
      Sustained Attention Response Task and Mindful Attention Awareness Scale), (2) emotion&#xD;
      regulation (specifically the Pittsburgh Stress Battery and the Perceived Stress Scale), and&#xD;
      (3) self-awareness (specifically the Heart Beat Detection Task and Multidimensional&#xD;
      Assessment of Interoceptive Awareness). Based on the degree of target engagement, MB-BP can&#xD;
      be further customized to better engage with the targets as needed.&#xD;
&#xD;
      Specific aims are as follows.&#xD;
&#xD;
      The primary aim is to evaluate impacts of MB-BP vs. enhanced usual care control on systolic&#xD;
      blood pressure at 6 months. Follow-up time periods include 10 weeks and 6 months.&#xD;
&#xD;
      Secondary aims include evaluating impacts of MB-BP vs. enhanced usual care control on&#xD;
      self-regulation mechanistic target engagement, including (1) attention control (specifically&#xD;
      the Sustained Attention Response Task and Mindful Attention Awareness Scale), (2) emotion&#xD;
      regulation (specifically the Pittsburgh Stress Battery and the Perceived Stress Scale), and&#xD;
      (3) self-awareness (specifically the Heart Beat Detection Task and Multidimensional&#xD;
      Assessment of Interoceptive Awareness). Further secondary aims include evaluating impacts of&#xD;
      MB-BP vs. active control on medical regimen adherence, including (1) physical activity, (2)&#xD;
      Dietary Approaches to Stop Hypertension (DASH)-consistent diet, (3) alcohol consumption, (4)&#xD;
      body mass index, and (5) antihypertensive medication use and adherence. Secondary blood&#xD;
      pressure outcomes include diastolic blood pressure.&#xD;
&#xD;
      This study is a randomized controlled trial, with blinding of staff performing participant&#xD;
      assessments and data analysts performing statistical analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2017</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 18, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Directly assessed as mean of second and third blood pressure readings</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary Approaches to Stop Hypertension-consistent diet</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Self-report via Willet Food Frequency Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sustained Attention to Response Task (SART)</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Behavioral measure of attention control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful Attention Awareness Scale (MAAS)</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Self-report measure of attention control and mindfulness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Stress Battery</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Behavioral measure of stress reactivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Self-report measure of perceived stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heartbeat Detection Task</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Behavioral measure of self-awareness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Assessment of Interoceptive Awareness (MAIA)</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Self-report measure of self-awareness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity - self report</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Self-report via International Physical Activity Questionnaire (IPAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity - step count</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Directly assessed via FitBit step count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol consumption</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Self-report via Willet Food Frequency Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Directly assessed as weight (kg) per height (m) squared, using a validated stadiometer to assess height, and validated scale to measure weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antihypertensive medication adherence</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antihypertensive medication use</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Directly assessed via medication bottle labels that participants bring to clinic assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Directly assessed as mean of second and third readings</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Hypertension</condition>
  <condition>Prehypertension</condition>
  <arm_group>
    <arm_group_label>MB-BP Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group participants receive an educational brochure from American Heart Association entitled &quot;Understanding and Controlling Your High Blood Pressure Brochure&quot; (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 &quot;enhanced usual care&quot; at this time. All participants who have uncontrolled hypertension (blood pressure &gt;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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MB-BP Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>MB-BP Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Usual Care Control</intervention_name>
    <description>Control group participants receive an educational brochure from American Heart Association entitled &quot;Understanding and Controlling Your High Blood Pressure Brochure&quot; (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 &quot;enhanced usual care&quot; at this time. All participants who have uncontrolled hypertension (blood pressure &gt;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.</description>
    <arm_group_label>Enhanced Usual Care Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic pressure or&#xD;
             taking antihypertensive medication). Preference is given to recruiting uncontrolled&#xD;
             hypertensives (≥140 mmHg systolic or ≥90 mmHg diastolic pressure)&#xD;
&#xD;
          -  Able to speak, read, and write in English.&#xD;
&#xD;
          -  All adults (≥18 years of age), genders and racial/ethnic groups are eligible to be&#xD;
             included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current regular meditation practice (&gt;once/week)&#xD;
&#xD;
          -  Serious medical illness precluding regular class attendance&#xD;
&#xD;
          -  Current substance abuse, suicidal ideation or eating disorder&#xD;
&#xD;
          -  History of bipolar or psychotic disorders or self-injurious behaviors.&#xD;
&#xD;
        These participants are excluded because they may disrupt group participation, require&#xD;
        additional or specialized treatment, or are already participating in practices similar to&#xD;
        the intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric B Loucks, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brown University School of Public Health</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mindfulness</keyword>
  <keyword>blood pressure</keyword>
  <keyword>hypertension</keyword>
  <keyword>prehypertension</keyword>
  <keyword>self regulation</keyword>
  <keyword>Science of Behavior Change</keyword>
  <keyword>attention control</keyword>
  <keyword>self awareness</keyword>
  <keyword>emotion regulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Prehypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03256890
org study id: 1412001171-3
secondary id: 1UH2AT009145
nct id: NCT03256890
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
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.
measure: Systolic blood pressure
time frame: 6 month follow-up
description: Directly assessed as mean of second and third blood pressure readings
measure: Dietary Approaches to Stop Hypertension-consistent diet
time frame: 6 month follow-up
description: Self-report via Willet Food Frequency Questionnaire
measure: Sustained Attention to Response Task (SART)
time frame: 6 month follow-up
description: Behavioral measure of attention control
measure: Mindful Attention Awareness Scale (MAAS)
time frame: 6 month follow-up
description: Self-report measure of attention control and mindfulness
measure: Pittsburgh Stress Battery
time frame: 6 month follow-up
description: Behavioral measure of stress reactivity
measure: Perceived Stress Scale
time frame: 6 month follow-up
description: Self-report measure of perceived stress
measure: Heartbeat Detection Task
time frame: 6 month follow-up
description: Behavioral measure of self-awareness
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
time frame: 6 month follow-up
description: Self-report measure of self-awareness
measure: Physical Activity - self report
time frame: 6 month follow-up
description: Self-report via International Physical Activity Questionnaire (IPAQ)
measure: Physical Activity - step count
time frame: 6 month follow-up
description: Directly assessed via FitBit step count
measure: Alcohol consumption
time frame: 6 month follow-up
description: Self-report via Willet Food Frequency Questionnaire
measure: Body Mass Index
time frame: 6 month follow-up
description: Directly assessed as weight (kg) per height (m) squared, using a validated stadiometer to assess height, and validated scale to measure weight.
measure: Antihypertensive medication adherence
time frame: 6 month follow-up
description: 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.
measure: Antihypertensive medication use
time frame: 6 month follow-up
description: Directly assessed via medication bottle labels that participants bring to clinic assessments
measure: Diastolic blood pressure
time frame: 6 month follow-up
description: Directly assessed as mean of second and third readings
arm group label: MB-BP Intervention
arm group type: Experimental
description: 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.
arm group label: Enhanced Usual Care Control
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: MB-BP Intervention
description: 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.
arm group label: MB-BP Intervention
intervention type: Other
intervention name: Enhanced Usual Care Control
description: 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.
arm group label: Enhanced Usual Care Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric B Loucks, PhD
role: Principal Investigator
affiliation: Brown University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Prehypertension