<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/NCT03239132</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-SN-17-0583</org_study_id>
    <nct_id>NCT03239132</nct_id>
  </id_info>
  <brief_title>MEditation for Post Stroke Depression</brief_title>
  <acronym>MEND</acronym>
  <official_title>MEditation for Post Stroke Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</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>
      The purpose of this study is to establish the feasibility and acceptability of a breath-based&#xD;
      meditation in stroke survivors with post-stroke depression (PSD) and their informal&#xD;
      caregivers, as well as to examine the effects of the breath-based meditation. The hypothesis&#xD;
      is that the breath-based meditation will lead to decreases in the severity of symptoms of&#xD;
      PSD, post-stroke anxiety (PSA), and post-traumatic stress disorder (PTSD), and decreases in&#xD;
      plasma IL-1 pro-inflammatory cytokines post-intervention in stroke survivors with PSD and&#xD;
      their informal caregivers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Actual">February 19, 2019</completion_date>
  <primary_completion_date type="Actual">February 19, 2019</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility as assessed by number screened per week</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility as assessed by proportion of those eligible who enroll to the study</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility as assessed by number of participants who completed the study</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility as assessed by number of participants who adhered to the protocol</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility as assessed by number of participants who completed all study assessments</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-Stroke Depression as assessed by the Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10)</measure>
    <time_frame>baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Stroke Anxiety as assessed by the State-Trait Anxiety Inventory for Adults (STAI-AD)</measure>
    <time_frame>baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of plasma IL-1 family pro-inflammatory cytokines</measure>
    <time_frame>baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Stroke</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Breath-based meditation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control will receive meditation educational materials.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breath-based meditation</intervention_name>
    <description>The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.</description>
    <arm_group_label>Breath-based meditation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Meditation educational materials</intervention_name>
    <description>Meditation educational materials</description>
    <arm_group_label>Breath-based meditation</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stroke survivors will be included if they speak English, can provide written informed&#xD;
             consent, have a history of ischemic stroke, hemorrhagic, or transient ischemic attack&#xD;
             within the past 8 weeks, have a Center for Epidemiologic Studies-Depression (CES-D)&#xD;
             total score of 16 or greater suggestive of clinically significant depressive symptoms,&#xD;
             and currently live at home.&#xD;
&#xD;
          -  Informal caregivers will be included if they are speak English, can provide written&#xD;
             informed consent, and self-identify as a first-time informal caregiver of a stroke&#xD;
             survivor. -&#xD;
&#xD;
          -  To reflect standard practice, stroke survivors and their informal caregivers will be&#xD;
             eligible to participate in the study regardless of whether they are currently&#xD;
             receiving anti-depressant medications; however, the dose must have been stable for at&#xD;
             least one month prior to recruitment into the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stroke survivors will be excluded if they currently reside outside of the home (e.g.,&#xD;
             rehabilitation center).&#xD;
&#xD;
          -  Stroke survivors and their informal caregivers will be excluded if they have severe&#xD;
             cognitive impairment (Montreal Cognitive Assessment (MoCA) cutoff score of 20), active&#xD;
             psychosis, or bipolar disorder; if they currently abuse substances; or if they are&#xD;
             acutely suicidal. Those currently receiving formal psychotherapy or currently engaging&#xD;
             in self-identified meditation practices will also be excluded.&#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>Jennifer E Sanner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>May 31, 2023</last_update_submitted>
  <last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Jennifer Beauchamp</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT03239132
org study id: HSC-SN-17-0583
nct id: NCT03239132
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to establish the feasibility and acceptability of a breath-based
      meditation in stroke survivors with post-stroke depression (PSD) and their informal
      caregivers, as well as to examine the effects of the breath-based meditation. The hypothesis
      is that the breath-based meditation will lead to decreases in the severity of symptoms of
      PSD, post-stroke anxiety (PSA), and post-traumatic stress disorder (PTSD), and decreases in
      plasma IL-1 pro-inflammatory cytokines post-intervention in stroke survivors with PSD and
      their informal caregivers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Feasibility as assessed by number screened per week
time frame: 2 years
measure: Feasibility as assessed by proportion of those eligible who enroll to the study
time frame: 2 years
measure: Feasibility as assessed by number of participants who completed the study
time frame: 2 years
measure: Feasibility as assessed by number of participants who adhered to the protocol
time frame: 2 years
measure: Feasibility as assessed by number of participants who completed all study assessments
time frame: 2 years
measure: Post-Stroke Depression as assessed by the Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10)
time frame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
measure: Post-Stroke Anxiety as assessed by the State-Trait Anxiety Inventory for Adults (STAI-AD)
time frame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
measure: Levels of plasma IL-1 family pro-inflammatory cytokines
time frame: baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends
arm group label: Breath-based meditation
arm group type: Experimental
description: The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials.
arm group label: Control
arm group type: Active Comparator
description: The control will receive meditation educational materials.
intervention type: Behavioral
intervention name: Breath-based meditation
description: The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.
arm group label: Breath-based meditation
intervention type: Behavioral
intervention name: Meditation educational materials
description: Meditation educational materials
arm group label: Breath-based meditation
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer E Sanner, PhD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Jennifer Beauchamp
investigator title: Assistant Professor
mesh term: Stroke
mesh term: Depression
mesh term: Depressive Disorder