<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/NCT01693874</url>
  </required_header>
  <id_info>
    <org_study_id>AT007064</org_study_id>
    <nct_id>NCT01693874</nct_id>
  </id_info>
  <brief_title>Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging</brief_title>
  <official_title>Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are developing and then testing whether Mindfulness-Based Stress Reduction,&#xD;
      a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms&#xD;
      and improves cognitive functioning in older adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cognitive functioning</measure>
    <time_frame>approximately 2 months of study intervention</time_frame>
    <description>neuropsychological battery examining memory, executive functioning, and attention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mind-wandering</measure>
    <time_frame>2 months of intervention</time_frame>
    <description>computerized task(s) of mind-wandering</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mindfulness</measure>
    <time_frame>2 months of intervention</time_frame>
    <description>self-report plus ecological momentary assessment measurements of mindfulness (process variable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anxiety and depressive symptoms</measure>
    <time_frame>2 months of intervention</time_frame>
    <description>scales of self-report anxiety and depressive symptoms from NIH PROMIS, and worry severity (Penn State Worry Questionnaire Abbreviated). also we will examine ecological momentary assessment measurements of anxiety and depressive symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Anxiety Disorders</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Mindfulness Based Stress Reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in this arm receive Mindfulness Based Stress Reduction (MBSR).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All participants in this arm receive an attention control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MBSR</intervention_name>
    <description>Mindfulness-Based Stress Reduction</description>
    <arm_group_label>Mindfulness Based Stress Reduction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>control (health education)</intervention_name>
    <description>health education</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 65+&#xD;
&#xD;
          -  current depressive and/or anxiety symptoms&#xD;
&#xD;
          -  current depressive and/or anxiety disorder&#xD;
&#xD;
          -  able to participate in behavioral study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to participate in study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Lenze, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julie Wetherell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>St Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>March 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Eric Lenze</investigator_full_name>
    <investigator_title>Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>anxiety</keyword>
  <keyword>depression</keyword>
  <keyword>cognition</keyword>
  <keyword>MBSR</keyword>
  <keyword>mindfulness</keyword>
  <keyword>stress</keyword>
  <keyword>elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Anxiety Disorders</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/NCT01693874
org study id: AT007064
nct id: NCT01693874
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The investigators are developing and then testing whether Mindfulness-Based Stress Reduction,
      a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms
      and improves cognitive functioning in older adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: cognitive functioning
time frame: approximately 2 months of study intervention
description: neuropsychological battery examining memory, executive functioning, and attention
measure: mind-wandering
time frame: 2 months of intervention
description: computerized task(s) of mind-wandering
measure: mindfulness
time frame: 2 months of intervention
description: self-report plus ecological momentary assessment measurements of mindfulness (process variable).
measure: anxiety and depressive symptoms
time frame: 2 months of intervention
description: scales of self-report anxiety and depressive symptoms from NIH PROMIS, and worry severity (Penn State Worry Questionnaire Abbreviated). also we will examine ecological momentary assessment measurements of anxiety and depressive symptoms.
arm group label: Mindfulness Based Stress Reduction
arm group type: Experimental
description: All participants in this arm receive Mindfulness Based Stress Reduction (MBSR).
arm group label: control
arm group type: Active Comparator
description: All participants in this arm receive an attention control
intervention type: Behavioral
intervention name: MBSR
description: Mindfulness-Based Stress Reduction
arm group label: Mindfulness Based Stress Reduction
intervention type: Behavioral
intervention name: control (health education)
description: health education
arm group label: control
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Lenze, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
last name: Julie Wetherell, PhD
role: Principal Investigator
affiliation: University of California, San Diego
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Eric Lenze
investigator title: Professor of Psychiatry
mesh term: Depression
mesh term: Anxiety Disorders