<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/NCT03296514</url>
  </required_header>
  <id_info>
    <org_study_id>2000020175</org_study_id>
    <nct_id>NCT03296514</nct_id>
  </id_info>
  <brief_title>Mindfulness Based Stress Reduction for Metabolic Syndrome</brief_title>
  <acronym>MBSR</acronym>
  <official_title>Mindfulness-Based Stress Reduction Study for Couples</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</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>
      Mindfulness based stress reduction offered to couples where one has metabolic syndrome to see&#xD;
      if their stress is reduced as measured by bio markers and surveys&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study being designed to pilot a MBSR program for the purposes of future&#xD;
      research.The investigators will be using two cohorts. One who will get the intervention and&#xD;
      the other who will be wait listed and receive the intervention at a later date. Eight week&#xD;
      mindfulness class offered to couples, who also attend an orientation session and a half day&#xD;
      retreat with other couples to learn how to control stress through mindfulness meditation&#xD;
      practices. Participants will come for lab work before intervention, eight weeks after initial&#xD;
      class and at the end of entire program. Bio- markers to be measured are waist circumference,&#xD;
      FBS and cholesterol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">October 5, 2018</completion_date>
  <primary_completion_date type="Actual">October 5, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self- reported physical health status</measure>
    <time_frame>Up to three weeks after intervention ends</time_frame>
    <description>SF 12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived stress</measure>
    <time_frame>Up to three weeks after intervention ends</time_frame>
    <description>Perceived stress scale,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mindfulness Skills</measure>
    <time_frame>Up to three weeks after intervention ends</time_frame>
    <description>Kentucky Inventory of Mindfulness Skills</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Wait List Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Will receive voucher for MBSR after study is concluded</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>These people will receive the MBSR</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MBSR</intervention_name>
    <description>Eight week class on MBSR in addition to an orientation class and a half day retreat</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant has 3 of the following: a Abdominal Obesity; b. Hypertriglyceridemia; c.&#xD;
             Low High Density Lipoproteins (HDL); d. High Blood Pressure; e. High Fasting Blood&#xD;
             Sugar (FBS)&#xD;
&#xD;
          -  Participant must be married or co- habituating&#xD;
&#xD;
          -  Both partners are over sixty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Either partner is non- English speaking&#xD;
&#xD;
          -  Either partner practices mind- body therapies more than once a week/&#xD;
&#xD;
          -  Either partner taking psychiatric medicine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joan Monin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gu J, Strauss C, Bond R, Cavanagh K. How do mindfulness-based cognitive therapy and mindfulness-based stress reduction improve mental health and wellbeing? A systematic review and meta-analysis of mediation studies. Clin Psychol Rev. 2015 Apr;37:1-12. doi: 10.1016/j.cpr.2015.01.006. Epub 2015 Jan 31. Erratum In: Clin Psychol Rev. 2016 Nov;49:119.</citation>
    <PMID>25689576</PMID>
  </reference>
  <reference>
    <citation>Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.</citation>
    <PMID>15256293</PMID>
  </reference>
  <reference>
    <citation>Creswell JD, Myers HF, Cole SW, Irwin MR. Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: a small randomized controlled trial. Brain Behav Immun. 2009 Feb;23(2):184-8. doi: 10.1016/j.bbi.2008.07.004. Epub 2008 Jul 19.</citation>
    <PMID>18678242</PMID>
  </reference>
  <reference>
    <citation>Creswell JD, Irwin MR, Burklund LJ, Lieberman MD, Arevalo JM, Ma J, Breen EC, Cole SW. Mindfulness-Based Stress Reduction training reduces loneliness and pro-inflammatory gene expression in older adults: a small randomized controlled trial. Brain Behav Immun. 2012 Oct;26(7):1095-101. doi: 10.1016/j.bbi.2012.07.006. Epub 2012 Jul 20.</citation>
    <PMID>22820409</PMID>
  </reference>
  <reference>
    <citation>Cramer H, Haller H, Lauche R, Dobos G. Mindfulness-based stress reduction for low back pain. A systematic review. BMC Complement Altern Med. 2012 Sep 25;12:162. doi: 10.1186/1472-6882-12-162.</citation>
    <PMID>23009599</PMID>
  </reference>
  <reference>
    <citation>Biegel GM, Brown KW, Shapiro SL, Schubert CM. Mindfulness-based stress reduction for the treatment of adolescent psychiatric outpatients: A randomized clinical trial. J Consult Clin Psychol. 2009 Oct;77(5):855-66. doi: 10.1037/a0016241.</citation>
    <PMID>19803566</PMID>
  </reference>
  <reference>
    <citation>Birnie K, Garland SN, Carlson LE. Psychological benefits for cancer patients and their partners participating in mindfulness-based stress reduction (MBSR). Psychooncology. 2010 Sep;19(9):1004-9. doi: 10.1002/pon.1651.</citation>
    <PMID>19918956</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Joan Monin</investigator_full_name>
    <investigator_title>Associate professor with term</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03296514/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03296514/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03296514
org study id: 2000020175
nct id: NCT03296514
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mindfulness based stress reduction offered to couples where one has metabolic syndrome to see
      if their stress is reduced as measured by bio markers and surveys
This is a pilot study being designed to pilot a MBSR program for the purposes of future
      research.The investigators will be using two cohorts. One who will get the intervention and
      the other who will be wait listed and receive the intervention at a later date. Eight week
      mindfulness class offered to couples, who also attend an orientation session and a half day
      retreat with other couples to learn how to control stress through mindfulness meditation
      practices. Participants will come for lab work before intervention, eight weeks after initial
      class and at the end of entire program. Bio- markers to be measured are waist circumference,
      FBS and cholesterol.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Self- reported physical health status
time frame: Up to three weeks after intervention ends
description: SF 12
measure: Perceived stress
time frame: Up to three weeks after intervention ends
description: Perceived stress scale,
measure: Mindfulness Skills
time frame: Up to three weeks after intervention ends
description: Kentucky Inventory of Mindfulness Skills
arm group label: Wait List Control
arm group type: No Intervention
description: Will receive voucher for MBSR after study is concluded
arm group label: Intervention
arm group type: Other
description: These people will receive the MBSR
intervention type: Behavioral
intervention name: MBSR
description: Eight week class on MBSR in addition to an orientation class and a half day retreat
arm group label: Intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joan Monin, PhD
role: Principal Investigator
affiliation: Professor
facility: 
country: United States
citation: Gu J, Strauss C, Bond R, Cavanagh K. How do mindfulness-based cognitive therapy and mindfulness-based stress reduction improve mental health and wellbeing? A systematic review and meta-analysis of mediation studies. Clin Psychol Rev. 2015 Apr;37:1-12. doi: 10.1016/j.cpr.2015.01.006. Epub 2015 Jan 31. Erratum In: Clin Psychol Rev. 2016 Nov;49:119.
PMID: 25689576
citation: Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.
PMID: 15256293
citation: Creswell JD, Myers HF, Cole SW, Irwin MR. Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: a small randomized controlled trial. Brain Behav Immun. 2009 Feb;23(2):184-8. doi: 10.1016/j.bbi.2008.07.004. Epub 2008 Jul 19.
PMID: 18678242
citation: Creswell JD, Irwin MR, Burklund LJ, Lieberman MD, Arevalo JM, Ma J, Breen EC, Cole SW. Mindfulness-Based Stress Reduction training reduces loneliness and pro-inflammatory gene expression in older adults: a small randomized controlled trial. Brain Behav Immun. 2012 Oct;26(7):1095-101. doi: 10.1016/j.bbi.2012.07.006. Epub 2012 Jul 20.
PMID: 22820409
citation: Cramer H, Haller H, Lauche R, Dobos G. Mindfulness-based stress reduction for low back pain. A systematic review. BMC Complement Altern Med. 2012 Sep 25;12:162. doi: 10.1186/1472-6882-12-162.
PMID: 23009599
citation: Biegel GM, Brown KW, Shapiro SL, Schubert CM. Mindfulness-based stress reduction for the treatment of adolescent psychiatric outpatients: A randomized clinical trial. J Consult Clin Psychol. 2009 Oct;77(5):855-66. doi: 10.1037/a0016241.
PMID: 19803566
citation: Birnie K, Garland SN, Carlson LE. Psychological benefits for cancer patients and their partners participating in mindfulness-based stress reduction (MBSR). Psychooncology. 2010 Sep;19(9):1004-9. doi: 10.1002/pon.1651.
PMID: 19918956
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Joan Monin
investigator title: Associate professor with term
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No
provided document: 
provided document: 