<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/NCT04496947</url>
  </required_header>
  <id_info>
    <org_study_id>2017P000706</org_study_id>
    <nct_id>NCT04496947</nct_id>
  </id_info>
  <brief_title>Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study</brief_title>
  <official_title>Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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 plot study aims to evaluate the effect of 8 weeks of stress reducing intervention on&#xD;
      atherosclerotic plaque inflammation in adults, as quantified by positron emission tomography&#xD;
      (PET) with fluorine-2-deoxy-D-glucose (FDG) in individuals with increased psychosocial&#xD;
      stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized controlled imaging study will be performed to evaluate the impact of&#xD;
      mindfulness-based stress reduction via a mind body program on arterial inflammation in&#xD;
      individuals with self-identified high levels of stress. Individuals will undergo baseline&#xD;
      Fluorodeoxyglucose-Positron emission tomography / magnetic resonance imaging and will then be&#xD;
      randomized to the stress-reduction intervention group or no intervention groups by blocks of&#xD;
      2:1, with stratification by age and sex. The stress reduction sessions focus on developing an&#xD;
      understanding of stress physiology and the physiology of the relaxation response, on&#xD;
      developing a regular practice of eliciting the relaxation response, and on learning cognitive&#xD;
      behavioral and positive psychology/resilience skills.&#xD;
&#xD;
      During the screening period, patient acceptability for the study will be assessed based on&#xD;
      medical history, concomitant medications, physical examination, and clinical laboratory test&#xD;
      results. Acceptability for study participation will be confirmed for subjects who identify as&#xD;
      having increased levels of stress and/or a Perceived Stress Scale score &gt;5. Once the patient&#xD;
      has passed screening, they will undergo baseline imaging followed by randomization and group&#xD;
      assignment. Approximately 12 weeks after randomization, all individuals will return for&#xD;
      follow-up imaging and evaluation.&#xD;
&#xD;
      Thus, 2 Fluorodeoxyglucose-Positron emission tomography / magnetic resonance imaging scans&#xD;
      will be performed throughout the study for baseline and follow up to assess the&#xD;
      intervention's impact on the brain and arterial inflammation, along with changes in related&#xD;
      positron emission tomography / magnetic resonance imaging imaging parameters. Perceived&#xD;
      Stress Scale will be delivered prior to Fluorodeoxyglucose-Positron emission tomography /&#xD;
      magnetic resonance imaging, during both imaging visits to measure perceived psychological&#xD;
      stress. During both imaging sessions, subjects will be exposed to overt faces to measure&#xD;
      signals during brain imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">August 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</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>
    <intervention_model_description>2 groups:&#xD;
stress reduction intervention&#xD;
no intervention</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in arterial inflammation by PET</measure>
    <time_frame>2 months</time_frame>
    <description>Change in arterial inflammation based on FDG PET - from initial imaging to repeat imaging.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Atherosclerosis</condition>
  <condition>Stress</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Stress Reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 week stress reduction course</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stress Reduction</intervention_name>
    <description>The stress reduction program is a multimodal mind-body resiliency program that incorporates 3 core components into each session:&#xD;
Elicitation of the Relaxation Response (RR) through mind-body techniques;&#xD;
Discussion about stress awareness to learn how to identify personal stressors and experiences of stress; and&#xD;
Coping strategies and adaptive perspective-taking to promote positive well-being.</description>
    <arm_group_label>Stress Reduction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Aged between 30-65 years&#xD;
&#xD;
               -  Identifies as having increased levels of stress and/or has a Perceived Stress&#xD;
                  Scale (PSS) score &gt;5 at baseline, and is interested in participating&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Perceived Stress Scale (PSS) score &lt;6&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Tawakol, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MGH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Tawakol, MD</last_name>
    <phone>6177243699</phone>
    <email>atawakol@mgh.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed Tawakol, MD</last_name>
      <phone>617-724-3699</phone>
      <email>atawakol@mgh.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>April 17, 2022</last_update_submitted>
  <last_update_submitted_qc>April 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Ahmed Tawakol</investigator_full_name>
    <investigator_title>Director, Nuclear Cardiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04496947
org study id: 2017P000706
nct id: NCT04496947
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The plot study aims to evaluate the effect of 8 weeks of stress reducing intervention on
      atherosclerotic plaque inflammation in adults, as quantified by positron emission tomography
      (PET) with fluorine-2-deoxy-D-glucose (FDG) in individuals with increased psychosocial
      stress.
This randomized controlled imaging study will be performed to evaluate the impact of
      mindfulness-based stress reduction via a mind body program on arterial inflammation in
      individuals with self-identified high levels of stress. Individuals will undergo baseline
      Fluorodeoxyglucose-Positron emission tomography / magnetic resonance imaging and will then be
      randomized to the stress-reduction intervention group or no intervention groups by blocks of
      2:1, with stratification by age and sex. The stress reduction sessions focus on developing an
      understanding of stress physiology and the physiology of the relaxation response, on
      developing a regular practice of eliciting the relaxation response, and on learning cognitive
      behavioral and positive psychology/resilience skills.

      During the screening period, patient acceptability for the study will be assessed based on
      medical history, concomitant medications, physical examination, and clinical laboratory test
      results. Acceptability for study participation will be confirmed for subjects who identify as
      having increased levels of stress and/or a Perceived Stress Scale score >5. Once the patient
      has passed screening, they will undergo baseline imaging followed by randomization and group
      assignment. Approximately 12 weeks after randomization, all individuals will return for
      follow-up imaging and evaluation.

      Thus, 2 Fluorodeoxyglucose-Positron emission tomography / magnetic resonance imaging scans
      will be performed throughout the study for baseline and follow up to assess the
      intervention's impact on the brain and arterial inflammation, along with changes in related
      positron emission tomography / magnetic resonance imaging imaging parameters. Perceived
      Stress Scale will be delivered prior to Fluorodeoxyglucose-Positron emission tomography /
      magnetic resonance imaging, during both imaging visits to measure perceived psychological
      stress. During both imaging sessions, subjects will be exposed to overt faces to measure
      signals during brain imaging.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2 groups:
stress reduction intervention
no intervention
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change in arterial inflammation by PET
time frame: 2 months
description: Change in arterial inflammation based on FDG PET - from initial imaging to repeat imaging.
arm group label: Stress Reduction
arm group type: Experimental
description: 8 week stress reduction course
arm group label: Control
arm group type: No Intervention
description: No intervention
intervention type: Behavioral
intervention name: Stress Reduction
description: The stress reduction program is a multimodal mind-body resiliency program that incorporates 3 core components into each session:
Elicitation of the Relaxation Response (RR) through mind-body techniques;
Discussion about stress awareness to learn how to identify personal stressors and experiences of stress; and
Coping strategies and adaptive perspective-taking to promote positive well-being.
arm group label: Stress Reduction
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed Tawakol, MD
role: Principal Investigator
affiliation: MGH
last name: Ahmed Tawakol, MD
phone: 6177243699
email: atawakol@mgh.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Ahmed Tawakol
investigator title: Director, Nuclear Cardiology
mesh term: Atherosclerosis
mesh term: Inflammation
sharing ipd: Undecided