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/NCT05997082</url>
    </required_header>
    <id_info>
      <org_study_id>5492</org_study_id>
      <nct_id>NCT05997082</nct_id>
    </id_info>
    <brief_title>A Mindful Self-compassion Based Intervention for Specialist Rehabilitation Providers</brief_title>
    <official_title>Mindful Self-compassion, Compassion Fatigue, Secondary Traumatic Stress, and Burnout Among Specialist Rehabilitation Providers - a Mixed Methods Study Protocol</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sunnybrook Health Sciences Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sunnybrook Health Sciences Centre</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 goal of this clinical trial is to explore the impact of an online compassion-based&#xD;
        intervention on burnout among specialist rehabilitation providers. Post-intervention&#xD;
        interviews aim to gather information on: burnout and compassion, experiences with the&#xD;
        intervention, barriers and facilitators to taking part, and suggestions for improving online&#xD;
        course delivery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Burnout threatens the sustainability of compassionate care in rehabilitation. This project&#xD;
        explores the impact of an online compassion-based intervention on burnout among specialist&#xD;
        inpatient rehabilitation healthcare providers. Thirty specialist rehabilitation healthcare&#xD;
        providers will be recruited to take part. The online intervention will include six weekly&#xD;
        live one-hour sessions, plus daily pre-recorded meditations. Healthcare provider&#xD;
        socio-demographic, practice, and wellness measures will be collected at baseline,&#xD;
        post-course, and three months later. Qualitative interviews will be used to explore&#xD;
        participant views on burnout and compassion, experiences with the intervention, barriers and&#xD;
        facilitators to taking part, and suggestions for improving online course delivery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>No masking since there is only 1 group.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Professional Quality of Life Scale (ProQOL) Version 5</measure>
      <time_frame>Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention</time_frame>
      <description>Measures the positive and negative effects of one's compassion for those that they help rehabilitate.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Relational Compassion Scale</measure>
      <time_frame>Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention</time_frame>
      <description>Measure's ones tendencies for receiving and providing relational compassion.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Compassion Scale - Short Form</measure>
      <time_frame>Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention</time_frame>
      <description>Measures how one typically acts towards themselves in difficult times.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Brief Interpersonal Reactivity Index</measure>
      <time_frame>Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention.</time_frame>
      <description>Measures the different ways that people may think about their lives.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5 Facet Mindfulness Questionnaire: Short Form</measure>
      <time_frame>Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention</time_frame>
      <description>Measures one's tendencies to engage in mindfulness practices.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress Scale</measure>
      <time_frame>Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention</time_frame>
      <description>Measures one's thoughts and feelings pertaining to stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficulties in Emotion Regulation Scale - Short Form</measure>
      <time_frame>Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention</time_frame>
      <description>Measures emotion regulation.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Burnout, Professional</condition>
    <condition>Compassion Fatigue</condition>
    <condition>Secondary Traumatic Stress</condition>
    <arm_group>
      <arm_group_label>Participants in the intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the intervention will participate in the 6-week mindfulness self-compassion course delivered online.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mindfulness Self-Compassion Course</intervention_name>
      <description>This course is designed to reduce burnout and compassion fatigue among specialist rehabilitation providers. Course materials are adapted from the Center for Mindful Self-Compassion (CMSC).</description>
      <arm_group_label>Participants in the intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Employed substantively as a regulated health professional (e.g., physiatrist, nurse,&#xD;
               allied health professional) by a specialist rehabilitation institute (e.g.,&#xD;
               Sunnybrook/St. John's Rehab, University Hospital Network, Providence Healthcare,&#xD;
               Westpark Healthcare)&#xD;
  &#xD;
            -  Over 18 years of age&#xD;
  &#xD;
            -  Able to speak, read, and write in English&#xD;
  &#xD;
            -  Willing to take part in the MSC course for up to the full 6-week duration&#xD;
  &#xD;
            -  Willing to complete all study related questionnaires&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those already having completed a MSC (mindfulness-based stress reduction) course or&#xD;
               mindfulness-based cognitive therapy within the past 12 months&#xD;
  &#xD;
            -  Those employed as agency staff&#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>Robert Simpson, Md, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sunnybrook Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eva Cohen, BSc</last_name>
      <phone>4162266780</phone>
      <phone_ext>57897</phone_ext>
      <email>eva.cohen@sri.utoronto.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Robert Simpson, MD, PhD</last_name>
      <phone>4162266780</phone>
      <phone_ext>57450</phone_ext>
      <email>robert.simpson@uhn.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>St. John's Rehab (Sunnybrook Health Sciences Centre)</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M3H2L4</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eva Cohen, BSc</last_name>
        <phone>4162266780</phone>
        <phone_ext>57897</phone_ext>
        <email>eva.cohen@sri.utoronto.ca</email>
      </contact>
      <contact_backup>
        <last_name>Robert Simpson, MD, PhD</last_name>
        <phone>4162266780</phone>
        <phone_ext>57450</phone_ext>
        <email>robert.simpson@uhn.ca</email>
      </contact_backup>
      <investigator>
        <last_name>Robert Simpson, MD. PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
      <investigator_full_name>Dr. Robert Simpson</investigator_full_name>
      <investigator_title>Physiatrist and Associate Scientist</investigator_title>
    </responsible_party>
    <keyword>Mindful Self-Compassion</keyword>
    <keyword>Compassion-Based Intervention</keyword>
    <keyword>Meditation</keyword>
    <keyword>Online Intervention</keyword>
    <keyword>Rehabilitation Providers</keyword>
    <keyword>Physiatrists</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasm Metastasis</mesh_term>
      <mesh_term>Fatigue</mesh_term>
      <mesh_term>Compassion Fatigue</mesh_term>
      <mesh_term>Burnout, Professional</mesh_term>
      <mesh_term>Burnout, Psychological</mesh_term>
    </condition_browse>
    <!-- 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/NCT05997082
  org study id: 5492
  nct id: NCT05997082
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to explore the impact of an online compassion-based
        intervention on burnout among specialist rehabilitation providers. Post-intervention
        interviews aim to gather information on: burnout and compassion, experiences with the
        intervention, barriers and facilitators to taking part, and suggestions for improving online
        course delivery.
  Burnout threatens the sustainability of compassionate care in rehabilitation. This project
        explores the impact of an online compassion-based intervention on burnout among specialist
        inpatient rehabilitation healthcare providers. Thirty specialist rehabilitation healthcare
        providers will be recruited to take part. The online intervention will include six weekly
        live one-hour sessions, plus daily pre-recorded meditations. Healthcare provider
        socio-demographic, practice, and wellness measures will be collected at baseline,
        post-course, and three months later. Qualitative interviews will be used to explore
        participant views on burnout and compassion, experiences with the intervention, barriers and
        facilitators to taking part, and suggestions for improving online course delivery.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: No masking since there is only 1 group.
  measure: Professional Quality of Life Scale (ProQOL) Version 5
  time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
  description: Measures the positive and negative effects of one's compassion for those that they help rehabilitate.
  measure: Relational Compassion Scale
  time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
  description: Measure's ones tendencies for receiving and providing relational compassion.
  measure: Self-Compassion Scale - Short Form
  time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
  description: Measures how one typically acts towards themselves in difficult times.
  measure: The Brief Interpersonal Reactivity Index
  time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention.
  description: Measures the different ways that people may think about their lives.
  measure: 5 Facet Mindfulness Questionnaire: Short Form
  time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
  description: Measures one's tendencies to engage in mindfulness practices.
  measure: Perceived Stress Scale
  time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
  description: Measures one's thoughts and feelings pertaining to stress.
  measure: Difficulties in Emotion Regulation Scale - Short Form
  time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
  description: Measures emotion regulation.
  arm group label: Participants in the intervention
  arm group type: Experimental
  description: Participants in the intervention will participate in the 6-week mindfulness self-compassion course delivered online.
  intervention type: Other
  intervention name: Mindfulness Self-Compassion Course
  description: This course is designed to reduce burnout and compassion fatigue among specialist rehabilitation providers. Course materials are adapted from the Center for Mindful Self-Compassion (CMSC).
  arm group label: Participants in the intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Robert Simpson, Md, PhD
  role: Principal Investigator
  affiliation: Sunnybrook Research Institute
  last name: Eva Cohen, BSc
  phone: 4162266780
  phone ext: 57897
  email: eva.cohen@sri.utoronto.ca
  last name: Robert Simpson, MD, PhD
  phone: 4162266780
  phone ext: 57450
  email: robert.simpson@uhn.ca
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Sunnybrook Health Sciences Centre
  investigator full name: Dr. Robert Simpson
  investigator title: Physiatrist and Associate Scientist
  mesh term: Neoplasm Metastasis
  mesh term: Fatigue
  mesh term: Compassion Fatigue
  mesh term: Burnout, Professional
  mesh term: Burnout, Psychological