xml: <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/NCT06003699</url>
    </required_header>
    <id_info>
      <org_study_id>20230690</org_study_id>
      <nct_id>NCT06003699</nct_id>
    </id_info>
    <brief_title>Mindfulness Training in the Medical Health Care System</brief_title>
    <official_title>Mindfulness Training in the Medical Health Care System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Miami</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 look at how mindfulness-informed emotional intelligence&#xD;
        training may influence how participants think, feel, and act.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">March 4, 2024</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</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>Sequential Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Positive Affect</measure>
      <time_frame>Baseline, up to 11 weeks</time_frame>
      <description>Positive Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Positive has a range of scores from 5 to 25, with a higher score indicating a higher positive mood.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Negative Affect</measure>
      <time_frame>Baseline, up to 11 weeks</time_frame>
      <description>Negative Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Negative has a range of scores from 5 to 25, with a higher score indicating a higher negative mood.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Perceived Stress</measure>
      <time_frame>Baseline, up to 11 weeks</time_frame>
      <description>Perceived stress is assessed with the 4-item Perceived Stress Scale (PSS-4). PSS-4 has a range of scores from 0 to 16, with a higher score indicating a higher level of perceived stress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Decentering</measure>
      <time_frame>Baseline, up to 11 weeks</time_frame>
      <description>Decentering is assessed via the 11-item decentering sub-scale of the experience questionnaire (EQ-D). The decentering score ranges from 1 to 55, with a higher score indicating a higher level of decentering.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Acting with Awareness</measure>
      <time_frame>Baseline, up to 11 weeks</time_frame>
      <description>Mindfulness attitude related to awareness is assessed with the 3-item acting with awareness sub-scale from the Five Factor Mindfulness Questionnaire (FFMQ). Each item is rated on a 5-point scale and higher scores indicate greater awareness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Leadership Self-Awareness</measure>
      <time_frame>Baseline, up to 11 weeks</time_frame>
      <description>Leadership Self-Awareness is assessed with the 4-item self-awareness sub-scale from the Authentic Leadership Questionnaire (ALQ). Each item is rated on a 5-point Likert Scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;frequently&quot;), and higher scores indicate greater self-awareness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Workplace Emotional Intelligence</measure>
      <time_frame>Baseline, up to 11 weeks</time_frame>
      <description>Workplace Emotional Intelligence is assessed with the 16-item Workplace Emotional Intelligence Profile Scale (WEIPS). Each item is rated on a scale from 1(&quot;strongly disagree&quot;) to 7 (&quot;strongly&quot;), and higher scores indicate greater emotional intelligence.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Attentional Performance</measure>
      <time_frame>Baseline, up to 11 weeks</time_frame>
      <description>The Sustained Attention Response Task (SART) is used to assess attentional performance and mind wandering (i.e., off-task thinking which is typically self-generated and compromises the performance of the task at hand). SART has a range of scores from 0 to 1 with a higher score indicating better accuracy when completing the task.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Depression and Anxiety</measure>
      <time_frame>Baseline, up to 11 weeks</time_frame>
      <description>Depression and anxiety is assessed with the 4-item Patient Health Questionnaire (PHQ-4) Each item is rated from 0 (&quot;not at all&quot;) to 3 (&quot;nearly every day&quot;), and ratings are summed together. PHQ-4 has a range of scores from 0 to 12, with higher scores indicating higher levels of depression and anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Burnout</measure>
      <time_frame>Baseline, up to 11 weeks</time_frame>
      <description>Burnout will be assessed with the 12-item Burnout Assessment Tool (BAT-12). Each item is rated on a 5-point Likert scale from 0 (&quot;never&quot;) to 5 (&quot;always&quot;). Ratings are then averaged on a scale of 0 to 5, where a higher score indicates greater burnout.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Sleep</measure>
      <time_frame>Baseline, up to 11 weeks</time_frame>
      <description>Sleep problems will be assessed with the 4-items of the Insomnia Sensitivity Index (ISI-4). Each item is rated on a 5-point Likert scale and ratings are summed together. ISI-4 has a range of scores from 5 to 20, with higher score indicating more severe sleep problems.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Burnout, Professional</condition>
    <condition>Stress</condition>
    <condition>Emotion Regulation</condition>
    <arm_group>
      <arm_group_label>Mindfulness training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 4 weeks of mindfulness-based training and then continue to have access to the mindfulness training exercise throughout the second training interval.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wait-list Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will not receive 4 weeks of mindfulness-based training during the first training interval; they will receive 4 weeks of mindfulness training during the second training interval.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Search Inside Yourself (SIY) program</intervention_name>
      <description>The present project involves the delivery of the Search Inside Yourself (SIY) program. The SIY Program is organized into 6 thematic modules. The first module introduces mindfulness and emotional intelligence and provides scientific evidence for the benefits of practicing mindfulness. The second module introduces Self-Awareness. The remaining four modules cover other domains based on Daniel Goleman's original framework of Emotional Intelligence: self-management, motivation, empathy, and leadership. Each module is associated with a set of practices, such as focused attention, body scan, journaling, empathic listening, and a Leadership Commitment exercise. The program will be delivered over 4 weeks, with one 3-hour session per week for a total of 12 hours that will take to complete all the modules.</description>
      <arm_group_label>Mindfulness training group</arm_group_label>
      <arm_group_label>Wait-list Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Individuals who are between 18 and 80 years of age&#xD;
  &#xD;
            2. Individuals who are fluent English speakers&#xD;
  &#xD;
            3. Individuals who are able to adequately and independently use electronic devices, such&#xD;
               as a laptop, computer, or tablet, and have Internet connection&#xD;
  &#xD;
            4. Individuals who are willing and able to consent to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. Individuals with an active and untreated mental health issue and/or hospitalization for&#xD;
          psychological/mental health issues within the past month&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amishi Jha, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Miami</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ekaterina Denkova, PhD</last_name>
      <phone>305-284-8148</phone>
      <email>exn67@miami.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>McLaren Health Care Corporation</name>
        <address>
          <city>Grand Blanc</city>
          <state>Michigan</state>
          <zip>48439</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Chandan Gupte</last_name>
        <phone>810-342-1148</phone>
      </contact>
      <investigator>
        <last_name>Amishi Jha, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ekaterina Denkova, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Amishi Jha</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>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>
  
  
text: 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/NCT06003699
  org study id: 20230690
  nct id: NCT06003699
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to look at how mindfulness-informed emotional intelligence
        training may influence how participants think, feel, and act.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in Positive Affect
  time frame: Baseline, up to 11 weeks
  description: Positive Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Positive has a range of scores from 5 to 25, with a higher score indicating a higher positive mood.
  measure: Change in Negative Affect
  time frame: Baseline, up to 11 weeks
  description: Negative Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Negative has a range of scores from 5 to 25, with a higher score indicating a higher negative mood.
  measure: Change in Perceived Stress
  time frame: Baseline, up to 11 weeks
  description: Perceived stress is assessed with the 4-item Perceived Stress Scale (PSS-4). PSS-4 has a range of scores from 0 to 16, with a higher score indicating a higher level of perceived stress.
  measure: Change in Decentering
  time frame: Baseline, up to 11 weeks
  description: Decentering is assessed via the 11-item decentering sub-scale of the experience questionnaire (EQ-D). The decentering score ranges from 1 to 55, with a higher score indicating a higher level of decentering.
  measure: Change in Acting with Awareness
  time frame: Baseline, up to 11 weeks
  description: Mindfulness attitude related to awareness is assessed with the 3-item acting with awareness sub-scale from the Five Factor Mindfulness Questionnaire (FFMQ). Each item is rated on a 5-point scale and higher scores indicate greater awareness.
  measure: Change in Leadership Self-Awareness
  time frame: Baseline, up to 11 weeks
  description: Leadership Self-Awareness is assessed with the 4-item self-awareness sub-scale from the Authentic Leadership Questionnaire (ALQ). Each item is rated on a 5-point Likert Scale ranging from 0 ("not at all") to 4 ("frequently"), and higher scores indicate greater self-awareness.
  measure: Change in Workplace Emotional Intelligence
  time frame: Baseline, up to 11 weeks
  description: Workplace Emotional Intelligence is assessed with the 16-item Workplace Emotional Intelligence Profile Scale (WEIPS). Each item is rated on a scale from 1("strongly disagree") to 7 ("strongly"), and higher scores indicate greater emotional intelligence.
  measure: Change in Attentional Performance
  time frame: Baseline, up to 11 weeks
  description: The Sustained Attention Response Task (SART) is used to assess attentional performance and mind wandering (i.e., off-task thinking which is typically self-generated and compromises the performance of the task at hand). SART has a range of scores from 0 to 1 with a higher score indicating better accuracy when completing the task.
  measure: Change in Depression and Anxiety
  time frame: Baseline, up to 11 weeks
  description: Depression and anxiety is assessed with the 4-item Patient Health Questionnaire (PHQ-4) Each item is rated from 0 ("not at all") to 3 ("nearly every day"), and ratings are summed together. PHQ-4 has a range of scores from 0 to 12, with higher scores indicating higher levels of depression and anxiety.
  measure: Change in Burnout
  time frame: Baseline, up to 11 weeks
  description: Burnout will be assessed with the 12-item Burnout Assessment Tool (BAT-12). Each item is rated on a 5-point Likert scale from 0 ("never") to 5 ("always"). Ratings are then averaged on a scale of 0 to 5, where a higher score indicates greater burnout.
  measure: Change in Sleep
  time frame: Baseline, up to 11 weeks
  description: Sleep problems will be assessed with the 4-items of the Insomnia Sensitivity Index (ISI-4). Each item is rated on a 5-point Likert scale and ratings are summed together. ISI-4 has a range of scores from 5 to 20, with higher score indicating more severe sleep problems.
  arm group label: Mindfulness training group
  arm group type: Experimental
  description: Participants will receive 4 weeks of mindfulness-based training and then continue to have access to the mindfulness training exercise throughout the second training interval.
  arm group label: Wait-list Control Group
  arm group type: Active Comparator
  description: Participants will not receive 4 weeks of mindfulness-based training during the first training interval; they will receive 4 weeks of mindfulness training during the second training interval.
  intervention type: Behavioral
  intervention name: Search Inside Yourself (SIY) program
  description: The present project involves the delivery of the Search Inside Yourself (SIY) program. The SIY Program is organized into 6 thematic modules. The first module introduces mindfulness and emotional intelligence and provides scientific evidence for the benefits of practicing mindfulness. The second module introduces Self-Awareness. The remaining four modules cover other domains based on Daniel Goleman's original framework of Emotional Intelligence: self-management, motivation, empathy, and leadership. Each module is associated with a set of practices, such as focused attention, body scan, journaling, empathic listening, and a Leadership Commitment exercise. The program will be delivered over 4 weeks, with one 3-hour session per week for a total of 12 hours that will take to complete all the modules.
  arm group label: Mindfulness training group
  arm group label: Wait-list Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Amishi Jha, PhD
  role: Principal Investigator
  affiliation: University of Miami
  last name: Ekaterina Denkova, PhD
  phone: 305-284-8148
  email: exn67@miami.edu
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Amishi Jha
  investigator title: Professor
  mesh term: Burnout, Professional
  sharing ipd: No