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/NCT06003920</url>
    </required_header>
    <id_info>
      <org_study_id>1902099</org_study_id>
      <nct_id>NCT06003920</nct_id>
    </id_info>
    <brief_title>Outcomes of a Small Process Group on Medical Students' Grit, Resilience, and Stress</brief_title>
    <official_title>Outcomes of a Small Process Group on Medical Students' Grit, Resilience, and Stress: A Quasi-experimental Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Western University of Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Western University of Health Sciences</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 incidence of burnout and mental ill-health begins very early in medical school and&#xD;
        continues to be high throughout training. Medical students are under high amounts of stress,&#xD;
        which often becomes chronic, and can lead to both physical and psychological issues as a&#xD;
        student, resident, and physician. Chronic stress and burnout in medical students are not a&#xD;
        new phenomenon, but recent research has highlighted the worsening mental health of medical&#xD;
        students, with as high as three-quarters of students reporting mental ill-health. It is vital&#xD;
        that ways are found to reduce burnout and assist in improving the mental health of medical&#xD;
        students. This quasi-experimental study aimed to assess the effect of a small process group&#xD;
        vs. a control group of preclinical medical students on their stress, resilience, and grit.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators assessed the effects of a year-long small process group intervention, led&#xD;
        by a psychiatrist, which aimed to improve self-awareness, mindfulness, and resilience in&#xD;
        first and second-year medical students. Students self-selected into the process group, and&#xD;
        the same number were randomly recruited as controls from the rest of the preclinical student&#xD;
        body. The psychiatrist who led the groups was blinded to student participation in the study.&#xD;
        Students in the process and control groups were surveyed with the Perceived Stress Scale, the&#xD;
        Connor-Davidson Resilience Scale, and the Grit Scale in September 2022, and again after nine&#xD;
        months and 25 sessions, in May 2023, after the academic year. Statistical analysis was done&#xD;
        with R Studio. Bandura's theory of self-efficacy was used to conceptualize the study.&#xD;
        Recruitment was done by email, as was data collection. The intervention included guided&#xD;
        exploration of the psychodynamic process, group dynamic theory, cognitive behavioral therapy,&#xD;
        dialectical behavioral therapy, boundaries, and empathy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 24, 2022</start_date>
    <completion_date type="Actual">May 30, 2023</completion_date>
    <primary_completion_date type="Actual">May 30, 2023</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Care Provider)</masking>
      <masking_description>Interventionist was blinded to which group participants were also research participants.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Perceived Stress Scale-14</measure>
      <time_frame>34 weeks</time_frame>
      <description>Stress measured on a 0-56 scale; higher number means more stress. Each of the 14 questions is measured on a 0-4 scale of 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Connor-Davidson Resilience Scale-25</measure>
      <time_frame>34 weeks</time_frame>
      <description>Resilience is measured on this 25-item scale, with higher numbers meaning more resilience. The score can range between 0 and 100. Each item has anchors from 0-4.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Grit Scale</measure>
      <time_frame>34 weeks</time_frame>
      <description>The original 12-item grit scale was used to measure grit; each items is rated 1-5, then scores are summed and divided by 12, so the final score is between 1-5. Higher scores mean more grit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Medication or diagnosis change</measure>
      <time_frame>34 weeks</time_frame>
      <description>Change in anti-depression, anti-anxiety, or other mental health medications or diagnoses on a binary yes/no scale.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">16</enrollment>
    <condition>Stress</condition>
    <arm_group>
      <arm_group_label>Process Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Medical students enrolled in the small process group, led by psychiatrist.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Medical students from the same cohorts, not enrolled in the small process group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Process group</intervention_name>
      <description>The medical student process group served as a space for students to gain increased self-awareness through guided exploration of the psychodynamic processes.</description>
      <arm_group_label>Process Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The participant must be an enrolled student at the College of Osteopathic Medicine of&#xD;
               the Pacific-NW&#xD;
  &#xD;
            2. Participant must be in their first or second year of medical school&#xD;
  &#xD;
            3. Participant must be at least 18 years of age&#xD;
  &#xD;
            4. Participant must self-select into either the intervention group or control group&#xD;
  &#xD;
            5. Participant must sign informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Data will be excluded if a student goes on a LOA during the course of the year&#xD;
  &#xD;
            2. Data will be excluded if a student does not attend a minimum of 12 out of 25 small&#xD;
               group sessions&#xD;
  &#xD;
            3. Student does not give informed consent&#xD;
  &#xD;
            4. Student withdraws consent at any time&#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>Edie L Sperling, DPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Western University of Health Sciences</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>College of Osteopathic Medicine of the Pacific - Northwest</name>
        <address>
          <city>Lebanon</city>
          <state>Oregon</state>
          <zip>97355</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>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 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>Western University of Health Sciences</investigator_affiliation>
      <investigator_full_name>Edie Sperling</investigator_full_name>
      <investigator_title>Assistant Professor and Vice-Chair, Medical Anatomical Sciences</investigator_title>
    </responsible_party>
    <keyword>medical students</keyword>
    <keyword>stress</keyword>
    <keyword>grit</keyword>
    <keyword>resilience</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All anonymized demographic and outcome data will be shared in an open-access data repository.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Study protocol and SAP will be shared with results. Informed consent is shared here.</ipd_time_frame>
      <ipd_access_criteria>Open access.</ipd_access_criteria>
      <ipd_url>https://www.kaggle.com/datasets/esperling/stress-grit-and-resilience-in-medical-students</ipd_url>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>June 24, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT06003920/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06003920
  org study id: 1902099
  nct id: NCT06003920
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The incidence of burnout and mental ill-health begins very early in medical school and
        continues to be high throughout training. Medical students are under high amounts of stress,
        which often becomes chronic, and can lead to both physical and psychological issues as a
        student, resident, and physician. Chronic stress and burnout in medical students are not a
        new phenomenon, but recent research has highlighted the worsening mental health of medical
        students, with as high as three-quarters of students reporting mental ill-health. It is vital
        that ways are found to reduce burnout and assist in improving the mental health of medical
        students. This quasi-experimental study aimed to assess the effect of a small process group
        vs. a control group of preclinical medical students on their stress, resilience, and grit.
  The investigators assessed the effects of a year-long small process group intervention, led
        by a psychiatrist, which aimed to improve self-awareness, mindfulness, and resilience in
        first and second-year medical students. Students self-selected into the process group, and
        the same number were randomly recruited as controls from the rest of the preclinical student
        body. The psychiatrist who led the groups was blinded to student participation in the study.
        Students in the process and control groups were surveyed with the Perceived Stress Scale, the
        Connor-Davidson Resilience Scale, and the Grit Scale in September 2022, and again after nine
        months and 25 sessions, in May 2023, after the academic year. Statistical analysis was done
        with R Studio. Bandura's theory of self-efficacy was used to conceptualize the study.
        Recruitment was done by email, as was data collection. The intervention included guided
        exploration of the psychodynamic process, group dynamic theory, cognitive behavioral therapy,
        dialectical behavioral therapy, boundaries, and empathy.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Care Provider)
  masking description: Interventionist was blinded to which group participants were also research participants.
  measure: Perceived Stress Scale-14
  time frame: 34 weeks
  description: Stress measured on a 0-56 scale; higher number means more stress. Each of the 14 questions is measured on a 0-4 scale of 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often.
  measure: Connor-Davidson Resilience Scale-25
  time frame: 34 weeks
  description: Resilience is measured on this 25-item scale, with higher numbers meaning more resilience. The score can range between 0 and 100. Each item has anchors from 0-4.
  measure: The Grit Scale
  time frame: 34 weeks
  description: The original 12-item grit scale was used to measure grit; each items is rated 1-5, then scores are summed and divided by 12, so the final score is between 1-5. Higher scores mean more grit.
  measure: Medication or diagnosis change
  time frame: 34 weeks
  description: Change in anti-depression, anti-anxiety, or other mental health medications or diagnoses on a binary yes/no scale.
  arm group label: Process Group
  arm group type: Experimental
  description: Medical students enrolled in the small process group, led by psychiatrist.
  arm group label: Control Group
  arm group type: No Intervention
  description: Medical students from the same cohorts, not enrolled in the small process group.
  intervention type: Behavioral
  intervention name: Process group
  description: The medical student process group served as a space for students to gain increased self-awareness through guided exploration of the psychodynamic processes.
  arm group label: Process Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Edie L Sperling, DPT
  role: Principal Investigator
  affiliation: Western University of Health Sciences
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Western University of Health Sciences
  investigator full name: Edie Sperling
  investigator title: Assistant Professor and Vice-Chair, Medical Anatomical Sciences
  sharing ipd: Yes
  ipd description: All anonymized demographic and outcome data will be shared in an open-access data repository.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Study protocol and SAP will be shared with results. Informed consent is shared here.
  ipd access criteria: Open access.
  ipd url: https://www.kaggle.com/datasets/esperling/stress-grit-and-resilience-in-medical-students
  provided document: 