<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/NCT03811990</url>
  </required_header>
  <id_info>
    <org_study_id>2018-04-0089</org_study_id>
    <nct_id>NCT03811990</nct_id>
  </id_info>
  <brief_title>Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?</brief_title>
  <official_title>Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas at Austin</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>
      Emergency medicine is notorious for its high rate of burnout and mental health issues. The&#xD;
      emergency department (ED) is a high paced work environment dealing with life and death&#xD;
      issues. Employees in the ED work shift times that are not conducive to a natural circadian&#xD;
      rhythm. All of these factors lead to high rates of burnout and overall dissatisfaction with&#xD;
      their career choice. These are known downsides of a career in emergency medicine, but little&#xD;
      effort is put into addressing this issue in everyday EDs.&#xD;
&#xD;
      Cell phones offer an easy and convenient means to participate in meditation. There are&#xD;
      multiple evidence-based meditation apps available to cell phone users free of charge.&#xD;
      Meditation has been shown to decrease burnout, rates of depression, and rates of anxiety. We&#xD;
      hypothesize that weekly use of a meditation-based cell phone application will improve the&#xD;
      mental health of emergency department employees as measured on various wellness inventories.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 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>
    <intervention_model_description>Randomized, non-blinded, control trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in depression score</measure>
    <time_frame>90 and 180 days</time_frame>
    <description>Beck Depression Inventory, numeric score of 0-63 with a score of 63 being the most depressed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in anxiety score</measure>
    <time_frame>90 and 180 days</time_frame>
    <description>Beck Anxiety Inventory, numeric score of 0-63 with a score of 63 being the most anxious</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in stress levels</measure>
    <time_frame>90 and 180 days</time_frame>
    <description>Perceived Stress Scale, numeric score of 0-40 with a score of 40 being the most stressed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in burnout level</measure>
    <time_frame>90 and 180 days, numeric scale between 0 and 6 with 6 being the highest score</time_frame>
    <description>Maslach Burnout Inventory, measures level of stress on a numeric scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Burnout, Professional</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cleveland Clinic Stress Free Now Meditations For Healers</intervention_name>
    <description>Phone-based meditation application</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Employment in the Emergency Department (with at least 8 shifts a month at Dell Seton&#xD;
             Medical Center or Seton Medical Center) as either an attending physician, resident&#xD;
             physician, or nurse&#xD;
&#xD;
          -  Age greater than/equal to 18 years old and younger than 75 years old&#xD;
&#xD;
          -  Must own a mobile phone operating on the iOS system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already use a phone-based meditation app on a weekly basis&#xD;
&#xD;
          -  Currently undergoing psychological treatment in the form of weekly therapy or&#xD;
             psychotropic medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keith Lambert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas at Austin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Keith Lambert, MD</last_name>
    <phone>7206294136</phone>
    <email>KLambert@asecnsion.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Texas Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keith Lambert, MD</last_name>
      <phone>720-629-4136</phone>
      <phone_ext>7206294136</phone_ext>
      <email>KLambert@asecnsion.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Coulon SM, Monroe CM, West DS. A Systematic, Multi-domain Review of Mobile Smartphone Apps for Evidence-Based Stress Management. Am J Prev Med. 2016 Jul;51(1):95-105. doi: 10.1016/j.amepre.2016.01.026. Epub 2016 Mar 15.</citation>
    <PMID>26993534</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Burnout, Professional</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/NCT03811990
org study id: 2018-04-0089
nct id: NCT03811990
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Emergency medicine is notorious for its high rate of burnout and mental health issues. The
      emergency department (ED) is a high paced work environment dealing with life and death
      issues. Employees in the ED work shift times that are not conducive to a natural circadian
      rhythm. All of these factors lead to high rates of burnout and overall dissatisfaction with
      their career choice. These are known downsides of a career in emergency medicine, but little
      effort is put into addressing this issue in everyday EDs.

      Cell phones offer an easy and convenient means to participate in meditation. There are
      multiple evidence-based meditation apps available to cell phone users free of charge.
      Meditation has been shown to decrease burnout, rates of depression, and rates of anxiety. We
      hypothesize that weekly use of a meditation-based cell phone application will improve the
      mental health of emergency department employees as measured on various wellness inventories.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, non-blinded, control trial
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in depression score
time frame: 90 and 180 days
description: Beck Depression Inventory, numeric score of 0-63 with a score of 63 being the most depressed
measure: Change in anxiety score
time frame: 90 and 180 days
description: Beck Anxiety Inventory, numeric score of 0-63 with a score of 63 being the most anxious
measure: Change in stress levels
time frame: 90 and 180 days
description: Perceived Stress Scale, numeric score of 0-40 with a score of 40 being the most stressed
measure: Change in burnout level
time frame: 90 and 180 days, numeric scale between 0 and 6 with 6 being the highest score
description: Maslach Burnout Inventory, measures level of stress on a numeric scale
arm group label: Control
arm group type: No Intervention
arm group label: Intervention
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Cleveland Clinic Stress Free Now Meditations For Healers
description: Phone-based meditation application
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Keith Lambert, MD
role: Principal Investigator
affiliation: University of Texas at Austin
last name: Keith Lambert, MD
phone: 7206294136
email: KLambert@asecnsion.org
facility: 
status: Recruiting
contact: 
country: United States
citation: Coulon SM, Monroe CM, West DS. A Systematic, Multi-domain Review of Mobile Smartphone Apps for Evidence-Based Stress Management. Am J Prev Med. 2016 Jul;51(1):95-105. doi: 10.1016/j.amepre.2016.01.026. Epub 2016 Mar 15.
PMID: 26993534
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Burnout, Professional
sharing ipd: No