<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/NCT03296007</url>
  </required_header>
  <id_info>
    <org_study_id>#e2017 - 303</org_study_id>
    <nct_id>NCT03296007</nct_id>
  </id_info>
  <brief_title>Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task</brief_title>
  <official_title>Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task on Individuals With Clinically Significant Symptoms of Chronic Pain, Depression and Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>York University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>York 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>
      The aim of the present study is to evaluate the psychophysiological effects of a smart phone&#xD;
      based mindfulness meditation app (MMA) for individuals with clinically significant symptoms&#xD;
      of major depression and/or anxiety, or symptoms of chronic pain. Specifically, the study aims&#xD;
      to examine parasympathetic tone using HRV (primary outcome), mind-wandering and present&#xD;
      awareness, mood symptoms, and breath focus in groups of participants who self-report&#xD;
      clinically significant symptoms of depression and/or anxiety (DA), chronic pain symptoms&#xD;
      (CP), as well as control participants who do not meet our criteria for either (Controls (C).&#xD;
      All study groups will be randomized to a mindfulness meditation app (MMA+) condition or a&#xD;
      mindfulness meditation condition without the app (MMA-) after a brief stress-induction&#xD;
      procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 10, 2017</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart Rate Variability</measure>
    <time_frame>22 minutes</time_frame>
    <description>A stress biomarker derived from heart rate recordings that reflects parasympathetic control of cardiac output</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2016</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Depression, Anxiety</condition>
  <arm_group>
    <arm_group_label>Mindfulness Meditation App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will use a smartphone app to practice mindfulness meditation for 12 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness Meditation No App</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this arm will not use a smartphone app, but will receive instructions to practice mindfulness meditation for 12 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Meditation</intervention_name>
    <description>A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.</description>
    <arm_group_label>Mindfulness Meditation App</arm_group_label>
    <arm_group_label>Mindfulness Meditation No App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  York University students&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with diagnosed cardiac conditions (e.g. coronary artery disease,&#xD;
             arrhythmias etc) will be excluded due to confounds with heart rate variability&#xD;
             assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Katz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>York University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>York University</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3J 1P3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>June 7, 2022</last_update_submitted>
  <last_update_submitted_qc>June 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>York University</investigator_affiliation>
    <investigator_full_name>Joel Katz</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03296007
org study id: #e2017 - 303
nct id: NCT03296007
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to evaluate the psychophysiological effects of a smart phone
      based mindfulness meditation app (MMA) for individuals with clinically significant symptoms
      of major depression and/or anxiety, or symptoms of chronic pain. Specifically, the study aims
      to examine parasympathetic tone using HRV (primary outcome), mind-wandering and present
      awareness, mood symptoms, and breath focus in groups of participants who self-report
      clinically significant symptoms of depression and/or anxiety (DA), chronic pain symptoms
      (CP), as well as control participants who do not meet our criteria for either (Controls (C).
      All study groups will be randomized to a mindfulness meditation app (MMA+) condition or a
      mindfulness meditation condition without the app (MMA-) after a brief stress-induction
      procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Heart Rate Variability
time frame: 22 minutes
description: A stress biomarker derived from heart rate recordings that reflects parasympathetic control of cardiac output
arm group label: Mindfulness Meditation App
arm group type: Experimental
description: Participants randomized to this arm will use a smartphone app to practice mindfulness meditation for 12 minutes.
arm group label: Mindfulness Meditation No App
arm group type: Active Comparator
description: Participants randomized to this arm will not use a smartphone app, but will receive instructions to practice mindfulness meditation for 12 minutes.
intervention type: Behavioral
intervention name: Mindfulness Meditation
description: A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.
arm group label: Mindfulness Meditation App
arm group label: Mindfulness Meditation No App
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joel Katz, PhD
role: Principal Investigator
affiliation: York University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: York University
investigator full name: Joel Katz
investigator title: Professor
mesh term: Chronic Pain
mesh term: Depression
sharing ipd: No