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/NCT06000488</url>
    </required_header>
    <id_info>
      <org_study_id>2000035615</org_study_id>
      <nct_id>NCT06000488</nct_id>
    </id_info>
    <brief_title>Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase Physician Assistant (PA) Students.</brief_title>
    <official_title>Open-label Controlled Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase PA Students.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yale University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The following will be an open label controlled efficacy trial of the effects of longitudinal&#xD;
        participation in an existing reflective writing program for medical students on burnout in&#xD;
        physician assistant students.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The pilot of the reflective writing workshop for PA students will follow the existing&#xD;
        curriculum used for the MD program. The workshops will run for 75 minutes with additional&#xD;
        time at the end of the session to complete a post-intervention assessment survey. Planning&#xD;
        and adaptation of the program materials will be conducted by a group of PA students and the&#xD;
        current MD-student leaders of the reflective writing program under the guidance of Dr. Anna&#xD;
        Reisman.&#xD;
  &#xD;
        All PA student participants will be split up into 1-2 groups of 6-10 students based on the&#xD;
        number of participants. Sessions are expected to be held in-person pending COVID-19 guidance&#xD;
        and will be held in reserved classroom space in the PA program building (100 Church Street&#xD;
        South) or in reserved conference rooms at the Cushing-Whitney Medical Library. Trained PA&#xD;
        and/or MD student facilitators will then use prepared materials to guide each group through a&#xD;
        series of prompts, each eliciting written reflections of varying lengths. While all&#xD;
        participants are encouraged to reflect, write, and share their responses, participation at&#xD;
        all levels remains optional. Facilitators will not solicit any participants for a response.&#xD;
        All program participants will be asked to complete a brief post-assessment survey consisting&#xD;
        of short-answer and Likert scale questions about their attitudes towards program&#xD;
        participation. Responses collected will be used to assess the feasibility and acceptability&#xD;
        of the program for PA students and as feedback to guide potential future implementation of&#xD;
        the program.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The study sample will consist of clinical-phase PA students enrolled in the Yale Physician Associate Program Class of 2024.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in total burnout score over time as measured by the Copenhagen Burnout Inventory (CBI)</measure>
      <time_frame>baseline (week 0), and weeks 4,12, and 26</time_frame>
      <description>The Copenhagen Burnout Inventory (CBI) is a well-validated 19-item questionnaire used to measure burnout in different groups (e.g. employees, medical trainees, students) across three domains (personal, work, and client/customer). Total scores range from 0 to 100. Higher scores are associated with greater levels of burnout.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Attitudes and mediators of behavioral change assessed by self report</measure>
      <time_frame>week 26</time_frame>
      <description>Attitudes and potential mediators of behavioral change will be assessed using a post-assessment survey consisting of short-answer and Likert-scale questions to be answered only by individuals who complete the active intervention. The survey will be distributed and completed at the end of each reflective writing workshop session. Analysis of the short response questions will use a rapid qualitative analysis method to identify patterns and themes. Likert-scale data will be analyzed by calculating the percentage of responses selecting each of the 5 dichotomous answer choices. A mean total score will be calculated through summation of all Likert scale categories as a numeric variable from 1-5, with higher scores indicating more positive responses for each question (e.g. Completely agree = 5 pts).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Burn Out</condition>
    <condition>Student Burnout</condition>
    <condition>Physician Assistant Student Burnout</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Reflective Writing Workshop Sessions (RWW)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will participate in three 75-minute RWW sessions scheduled to take place after students finish their 1st, 3rd, and 5th clinical rotations during the study period. reflective writing workshops</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Reflective Writing Workshop Sessions</intervention_name>
      <description>Three workshops of 75 minutes. Trained PA and/or MD student facilitators will then use prepared materials to guide each group through a series of prompts, each eliciting written reflections of varying lengths. While all participants are encouraged to reflect, write, and share their responses, participation at all levels remains optional.</description>
      <arm_group_label>Reflective Writing Workshop Sessions (RWW)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  able to offer consent&#xD;
  &#xD;
            -  able to speak and read English.&#xD;
  &#xD;
            -  must be a student in Yale Physician Associate Program Class of 2024&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mathew Chiang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mathew Chiang</last_name>
      <phone>203-785-3974</phone>
      <email>mathew.chiang@yale.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Yale University</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06520</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</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>Burnout, Psychological</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/NCT06000488
  org study id: 2000035615
  nct id: NCT06000488
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The following will be an open label controlled efficacy trial of the effects of longitudinal
        participation in an existing reflective writing program for medical students on burnout in
        physician assistant students.
  The pilot of the reflective writing workshop for PA students will follow the existing
        curriculum used for the MD program. The workshops will run for 75 minutes with additional
        time at the end of the session to complete a post-intervention assessment survey. Planning
        and adaptation of the program materials will be conducted by a group of PA students and the
        current MD-student leaders of the reflective writing program under the guidance of Dr. Anna
        Reisman.
  
        All PA student participants will be split up into 1-2 groups of 6-10 students based on the
        number of participants. Sessions are expected to be held in-person pending COVID-19 guidance
        and will be held in reserved classroom space in the PA program building (100 Church Street
        South) or in reserved conference rooms at the Cushing-Whitney Medical Library. Trained PA
        and/or MD student facilitators will then use prepared materials to guide each group through a
        series of prompts, each eliciting written reflections of varying lengths. While all
        participants are encouraged to reflect, write, and share their responses, participation at
        all levels remains optional. Facilitators will not solicit any participants for a response.
        All program participants will be asked to complete a brief post-assessment survey consisting
        of short-answer and Likert scale questions about their attitudes towards program
        participation. Responses collected will be used to assess the feasibility and acceptability
        of the program for PA students and as feedback to guide potential future implementation of
        the program.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: The study sample will consist of clinical-phase PA students enrolled in the Yale Physician Associate Program Class of 2024.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in total burnout score over time as measured by the Copenhagen Burnout Inventory (CBI)
  time frame: baseline (week 0), and weeks 4,12, and 26
  description: The Copenhagen Burnout Inventory (CBI) is a well-validated 19-item questionnaire used to measure burnout in different groups (e.g. employees, medical trainees, students) across three domains (personal, work, and client/customer). Total scores range from 0 to 100. Higher scores are associated with greater levels of burnout.
  measure: Attitudes and mediators of behavioral change assessed by self report
  time frame: week 26
  description: Attitudes and potential mediators of behavioral change will be assessed using a post-assessment survey consisting of short-answer and Likert-scale questions to be answered only by individuals who complete the active intervention. The survey will be distributed and completed at the end of each reflective writing workshop session. Analysis of the short response questions will use a rapid qualitative analysis method to identify patterns and themes. Likert-scale data will be analyzed by calculating the percentage of responses selecting each of the 5 dichotomous answer choices. A mean total score will be calculated through summation of all Likert scale categories as a numeric variable from 1-5, with higher scores indicating more positive responses for each question (e.g. Completely agree = 5 pts).
  arm group label: Control
  arm group type: No Intervention
  description: No intervention
  arm group label: Reflective Writing Workshop Sessions (RWW)
  arm group type: Experimental
  description: Participants will participate in three 75-minute RWW sessions scheduled to take place after students finish their 1st, 3rd, and 5th clinical rotations during the study period. reflective writing workshops
  intervention type: Behavioral
  intervention name: Reflective Writing Workshop Sessions
  description: Three workshops of 75 minutes. Trained PA and/or MD student facilitators will then use prepared materials to guide each group through a series of prompts, each eliciting written reflections of varying lengths. While all participants are encouraged to reflect, write, and share their responses, participation at all levels remains optional.
  arm group label: Reflective Writing Workshop Sessions (RWW)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mathew Chiang
  role: Principal Investigator
  affiliation: Yale University
  last name: Mathew Chiang
  phone: 203-785-3974
  email: mathew.chiang@yale.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Burnout, Psychological
  sharing ipd: No