<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/NCT04497909</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00103222</org_study_id>
    <nct_id>NCT04497909</nct_id>
  </id_info>
  <brief_title>Online Mindfulness for Medical Trainees</brief_title>
  <official_title>The Impact of Online Mindfulness on Depression, Anxiety, Stress and Burnout in Medical Students and Residents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</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>
      Medical students and medical residents are subject to increased stressors throughout their&#xD;
      education. There is increased depression, anxiety, burnout, and distress in medical trainees&#xD;
      compared to the general population. Globally, roughly 3 out of 10 medical students experience&#xD;
      anxiety. A recent study also found that almost 3 out of 10 medical trainees experience&#xD;
      depression or depressive symptoms and approximately 1 out of 10 have suicidal thoughts. All&#xD;
      of this leads to poorer academics, increased dropout rates as well as reduced empathy and&#xD;
      quality of care in affected trainees.&#xD;
&#xD;
      Mindfulness programs are increasingly being used in medical schools to help deal with&#xD;
      increased levels of depression, anxiety, stress, and burnout. Several studies have looked at&#xD;
      medical students, medical residents, and various other healthcare professionals. These&#xD;
      programs have been found to reduce depression, anxiety and stress while significantly&#xD;
      improving mood, well being and mindfulness.&#xD;
&#xD;
      Although in-person mindfulness programs have shown several benefits, there are limitations to&#xD;
      its use in medical programs. A lack of time, flexibility, accessibility as well as the issue&#xD;
      of cost, impact the uptake of in-person mindfulness programs. A potential alternative to this&#xD;
      is online mindfulness programs. To date, there is limited research regarding medical students&#xD;
      and online mindfulness programs. With that being said, studies focussed on other populations&#xD;
      and online mindfulness have shown reductions in depression, anxiety and stress with&#xD;
      improvements in mindfulness and mood.&#xD;
&#xD;
      The study being proposed involves providing online mindfulness to medical students and&#xD;
      residents in an 8-week program that consists of 8, 1-hour sessions with a mindfulness coach.&#xD;
      Participants will be enrolled through informed consent. All participants will be given pre&#xD;
      and post participation questionnaires to examine the impact of online mindfulness on anxiety,&#xD;
      depression, stress and burnout. The results of this research may lead to future studies&#xD;
      looking at the impact of online mindfulness practice for medical trainees and might also help&#xD;
      open up the possibility of offering such programs in medical schools.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND&#xD;
&#xD;
      The transition to medical school and the subsequent years that follow are a period of&#xD;
      increased stress on trainees. Research shows that there is a higher prevalence of depression,&#xD;
      anxiety and burnout amongst U.S. and Canadian medical students compared to the general&#xD;
      population. In addition, distress is consistently higher in medical trainees compared to the&#xD;
      general population and in age matched non-medical students. A recent systematic review found&#xD;
      the prevalence of depression or depressive symptoms in medical trainees to be 27.2% and&#xD;
      suicidal ideation to be 11.1%. A separate systematic review found that the prevalence of&#xD;
      anxiety in medical students was 33.8% globally. Increased levels of distress and anxiety lead&#xD;
      to poorer academics and increased dropout rates, as well as a reduced empathy, enthusiasm,&#xD;
      and quality of care.&#xD;
&#xD;
      An intervention that has been gaining traction in recent years to manage the psychological&#xD;
      strain placed on medical trainees is mindfulness training. A study of 140 second year medical&#xD;
      students participating in a 10-week mindfulness-based stress reduction program reported&#xD;
      significant improvement in mood and reduced psychological distress. Similar results have been&#xD;
      found in randomised controlled trials with health care professionals as well as surgical and&#xD;
      psychiatric residents. Furthermore, a 2017 systematic review of 19 papers looking at the&#xD;
      effectiveness of mindfulness interventions in healthcare professionals found them to decrease&#xD;
      stress, anxiety and depression while improving mindfulness, empathy and mood. These benefits&#xD;
      may potentially continue over the long term based on results from a 2018 longitudinal study&#xD;
      of mindfulness training in medical and psychology students. At the six year follow up with&#xD;
      the intervention group, they reported increased well being, mindfulness, and problem-focused&#xD;
      coping.&#xD;
&#xD;
      Although in-person mindfulness training has shown several benefits, there are limitations to&#xD;
      implementing these programs in the demanding schedules of medical trainees. In addition to a&#xD;
      lack of time, flexibility, costs, anonymity, and accessibility may limit its effectiveness as&#xD;
      well. A modality that may reduce these limitations is online mindfulness. This format allows&#xD;
      flexibility with regards to when trainees would be able to access the material, it would be&#xD;
      more cost effective and could be accessed from rural and remote areas as suggested in a 2020&#xD;
      pilot study completed with Australian rural medical students. Results indicated significant&#xD;
      reduction in perceived stress and increases in self compassion 4 months after the 8-week&#xD;
      online mindfulness program. Online mindfulness interventions have been studied in several&#xD;
      other populations and a 2016 meta analysis of 15 randomised controlled trials, found online&#xD;
      mindfulness interventions to reduce depression, anxiety, and stress with an associated&#xD;
      increase in well being and mindfulness.&#xD;
&#xD;
      To date, there is limited research looking at online mindfulness as a tool for medical&#xD;
      students and residents. The study being proposed here, would assess the impact of an online&#xD;
      mindfulness intervention on medical trainees with regards to depression, anxiety, stress,&#xD;
      burnout, and mindfulness.&#xD;
&#xD;
      OBJECTIVE&#xD;
&#xD;
      To explore the potential benefits of online mindfulness on depression, anxiety, stress, and&#xD;
      burnout in medical trainees.&#xD;
&#xD;
      To explore the changes in mindfulness level over the course of an online mindfulness program&#xD;
      offered to medical trainees.&#xD;
&#xD;
      HYPOTHESIS&#xD;
&#xD;
      The investigators hypothesize that medical students and residents that participate in the&#xD;
      online mindfulness program will report reduced depression, stress, anxiety, and burnout as&#xD;
      well as improved mindfulness.&#xD;
&#xD;
      MATERIALS AND METHODS&#xD;
&#xD;
      This study is a prospective observational study.&#xD;
&#xD;
      Procedure&#xD;
&#xD;
      Following recruitment, all participants will complete a general demographic form as well as&#xD;
      four scales that measure depression, anxiety, stress, burnout, and mindfulness. The same four&#xD;
      scales will be completed by all participants at the end of the mindfulness training and 3&#xD;
      months after the training.&#xD;
&#xD;
      Online Mindfulness Intervention (OMI)&#xD;
&#xD;
      All participants will be instructed by a mindfulness practitioner/coach online through 8,&#xD;
      1-hour sessions over the course of eight weeks. Trainees will have the ability to retrieve&#xD;
      the online sessions at their convenience. Weekly journals will be provided to measure&#xD;
      attendance and frequency and duration of mindfulness practice.&#xD;
&#xD;
      Instruments&#xD;
&#xD;
      General Demographic Form: A researcher created demographic data form (age, educational level,&#xD;
      prior experience with mindfulness, history of depression and anxiety) to be completed by the&#xD;
      medical trainees at enrolment.&#xD;
&#xD;
      Depression, Anxiety and Stress Scale: 21 item Depression, Anxiety, Stress Scale to be&#xD;
      completed by the medical trainees at three time points.&#xD;
&#xD;
      Oldenburg Burnout Inventory for Students: 16 item scale to measure burnout in students&#xD;
      completed at three time points.&#xD;
&#xD;
      Mindfulness Scales: 15 item Mindfulness Attention Awareness Scale and the 13 item Toronto&#xD;
      Mindfulness Scale will be completed by the medical trainees at three time points.&#xD;
&#xD;
      Mindfulness Weekly Journal: Document recording the duration and frequency of mindfulness&#xD;
      practice during the study to assess attendance to the online class.&#xD;
&#xD;
      DATA ANALYSIS&#xD;
&#xD;
      Study data will be managed using Research Electronic Data Capture, a secure, web-based&#xD;
      software platform, hosted at the University of Alberta. Group demographics will be compared&#xD;
      with t-test, chi-square and Mann-Whitney U as appropriate. The scores of the four&#xD;
      questionnaires will be analyzed with the Wilcoxon Signed-Rank test for within group&#xD;
      comparison. The Spearman correlation test will be used for correlation between the&#xD;
      mindfulness scores and the stress, anxiety, depression, and burnout scores. 2-tailed p-values&#xD;
      will be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The online mindfulness is no longer being offered and recruitment can no longer happen.&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2021</start_date>
  <completion_date type="Actual">June 22, 2023</completion_date>
  <primary_completion_date type="Actual">June 22, 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>
    <intervention_model_description>The three groups of participants are a pre-clerkship cohort consisting of first- and second-year medical students, a clerkship cohort consisting of third- and fourth-year medical students and the third cohort consisting of medical residents.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in stress symptoms time 1</measure>
    <time_frame>Change from recruitment to immediately after the online mindfulness course</time_frame>
    <description>using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in stress symptoms time 2</measure>
    <time_frame>Change from recruitment to 3 months after the online mindfulness course</time_frame>
    <description>using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in anxiety symptoms time 1</measure>
    <time_frame>Change from recruitment to immediately after the online mindfulness course</time_frame>
    <description>using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of anxiety symptoms. Minimum score is 0. Maximum score is 21.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in anxiety symptoms time 2</measure>
    <time_frame>Change from recruitment to 3 months after the online mindfulness course</time_frame>
    <description>using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of anxiety symptoms. Minimum score is 0. Maximum score is 21.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in depression symptoms time 1</measure>
    <time_frame>Change from recruitment to immediately after the online mindfulness course</time_frame>
    <description>using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in depression symptoms time 2</measure>
    <time_frame>Change from recruitment to 3 months after the online mindfulness course</time_frame>
    <description>using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in burnout symptoms time 1</measure>
    <time_frame>Change from recruitment to immediately after the online mindfulness course</time_frame>
    <description>using the Oldenburg Burnout Inventory for Students; a 16 item scale to measure burnout. Scores for individual question range from 1 (strongly disagree) to 4 (strongly agree). A high score means a higher level of burnout symptoms. This scale has 2 subscales. Minimum score is 8. Maximum score is 32 for both subscales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in burnout symptoms time 2</measure>
    <time_frame>Change from recruitment to 3 months after the online mindfulness course</time_frame>
    <description>using the Oldenburg Burnout Inventory for Students; a 16 item scale to measure burnout. Scores for individual question range from 1 (strongly disagree) to 4 (strongly agree). A high score means a higher level of burnout symptoms. This scale has 2 subscales. Minimum score is 8. Maximum score is 32 for both subscales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mindful awareness time 1</measure>
    <time_frame>Change from recruitment to immediately after the online mindfulness course</time_frame>
    <description>using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90.&#xD;
And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale.&#xD;
A high score in both scales (and subscales)means a high mindful awareness level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mindful awareness time 2</measure>
    <time_frame>Change from recruitment to 3 months after the online mindfulness course</time_frame>
    <description>using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90.&#xD;
And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale.&#xD;
A high score in both scales (and subscales)means a high mindful awareness level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of Mindfulness practice 1</measure>
    <time_frame>From recruitment to the end of the online mindfulness elective (8 weeks in total)</time_frame>
    <description>Frequency of mindfulness practice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Mindfulness practice 1</measure>
    <time_frame>From recruitment to the end of the online mindfulness elective (8 weeks in total)</time_frame>
    <description>Duration of mindfulness practice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Mindfulness practice 2</measure>
    <time_frame>From the end of the online mindfulness elective until three months after</time_frame>
    <description>Frequency of mindfulness practice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Mindfulness practice 2</measure>
    <time_frame>From the end of the online mindfulness elective until three months after</time_frame>
    <description>Duration of mindfulness practice</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Stress</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Mindfulness</condition>
  <arm_group>
    <arm_group_label>Pre-clerkship cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First- and second-year medical students</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clerkship cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Third- and fourth-year medical students</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resident cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medical residents</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>Mindfulness online training</description>
    <arm_group_label>Clerkship cohort</arm_group_label>
    <arm_group_label>Pre-clerkship cohort</arm_group_label>
    <arm_group_label>Resident cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - A medical trainee who registered for the online mindfulness elective&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc-Antoine Landry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mindfulness</keyword>
  <keyword>Medical Students</keyword>
  <keyword>Medical Residents</keyword>
  <keyword>Medical Trainees</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT04497909
org study id: Pro00103222
nct id: NCT04497909
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Medical students and medical residents are subject to increased stressors throughout their
      education. There is increased depression, anxiety, burnout, and distress in medical trainees
      compared to the general population. Globally, roughly 3 out of 10 medical students experience
      anxiety. A recent study also found that almost 3 out of 10 medical trainees experience
      depression or depressive symptoms and approximately 1 out of 10 have suicidal thoughts. All
      of this leads to poorer academics, increased dropout rates as well as reduced empathy and
      quality of care in affected trainees.

      Mindfulness programs are increasingly being used in medical schools to help deal with
      increased levels of depression, anxiety, stress, and burnout. Several studies have looked at
      medical students, medical residents, and various other healthcare professionals. These
      programs have been found to reduce depression, anxiety and stress while significantly
      improving mood, well being and mindfulness.

      Although in-person mindfulness programs have shown several benefits, there are limitations to
      its use in medical programs. A lack of time, flexibility, accessibility as well as the issue
      of cost, impact the uptake of in-person mindfulness programs. A potential alternative to this
      is online mindfulness programs. To date, there is limited research regarding medical students
      and online mindfulness programs. With that being said, studies focussed on other populations
      and online mindfulness have shown reductions in depression, anxiety and stress with
      improvements in mindfulness and mood.

      The study being proposed involves providing online mindfulness to medical students and
      residents in an 8-week program that consists of 8, 1-hour sessions with a mindfulness coach.
      Participants will be enrolled through informed consent. All participants will be given pre
      and post participation questionnaires to examine the impact of online mindfulness on anxiety,
      depression, stress and burnout. The results of this research may lead to future studies
      looking at the impact of online mindfulness practice for medical trainees and might also help
      open up the possibility of offering such programs in medical schools.
BACKGROUND

      The transition to medical school and the subsequent years that follow are a period of
      increased stress on trainees. Research shows that there is a higher prevalence of depression,
      anxiety and burnout amongst U.S. and Canadian medical students compared to the general
      population. In addition, distress is consistently higher in medical trainees compared to the
      general population and in age matched non-medical students. A recent systematic review found
      the prevalence of depression or depressive symptoms in medical trainees to be 27.2% and
      suicidal ideation to be 11.1%. A separate systematic review found that the prevalence of
      anxiety in medical students was 33.8% globally. Increased levels of distress and anxiety lead
      to poorer academics and increased dropout rates, as well as a reduced empathy, enthusiasm,
      and quality of care.

      An intervention that has been gaining traction in recent years to manage the psychological
      strain placed on medical trainees is mindfulness training. A study of 140 second year medical
      students participating in a 10-week mindfulness-based stress reduction program reported
      significant improvement in mood and reduced psychological distress. Similar results have been
      found in randomised controlled trials with health care professionals as well as surgical and
      psychiatric residents. Furthermore, a 2017 systematic review of 19 papers looking at the
      effectiveness of mindfulness interventions in healthcare professionals found them to decrease
      stress, anxiety and depression while improving mindfulness, empathy and mood. These benefits
      may potentially continue over the long term based on results from a 2018 longitudinal study
      of mindfulness training in medical and psychology students. At the six year follow up with
      the intervention group, they reported increased well being, mindfulness, and problem-focused
      coping.

      Although in-person mindfulness training has shown several benefits, there are limitations to
      implementing these programs in the demanding schedules of medical trainees. In addition to a
      lack of time, flexibility, costs, anonymity, and accessibility may limit its effectiveness as
      well. A modality that may reduce these limitations is online mindfulness. This format allows
      flexibility with regards to when trainees would be able to access the material, it would be
      more cost effective and could be accessed from rural and remote areas as suggested in a 2020
      pilot study completed with Australian rural medical students. Results indicated significant
      reduction in perceived stress and increases in self compassion 4 months after the 8-week
      online mindfulness program. Online mindfulness interventions have been studied in several
      other populations and a 2016 meta analysis of 15 randomised controlled trials, found online
      mindfulness interventions to reduce depression, anxiety, and stress with an associated
      increase in well being and mindfulness.

      To date, there is limited research looking at online mindfulness as a tool for medical
      students and residents. The study being proposed here, would assess the impact of an online
      mindfulness intervention on medical trainees with regards to depression, anxiety, stress,
      burnout, and mindfulness.

      OBJECTIVE

      To explore the potential benefits of online mindfulness on depression, anxiety, stress, and
      burnout in medical trainees.

      To explore the changes in mindfulness level over the course of an online mindfulness program
      offered to medical trainees.

      HYPOTHESIS

      The investigators hypothesize that medical students and residents that participate in the
      online mindfulness program will report reduced depression, stress, anxiety, and burnout as
      well as improved mindfulness.

      MATERIALS AND METHODS

      This study is a prospective observational study.

      Procedure

      Following recruitment, all participants will complete a general demographic form as well as
      four scales that measure depression, anxiety, stress, burnout, and mindfulness. The same four
      scales will be completed by all participants at the end of the mindfulness training and 3
      months after the training.

      Online Mindfulness Intervention (OMI)

      All participants will be instructed by a mindfulness practitioner/coach online through 8,
      1-hour sessions over the course of eight weeks. Trainees will have the ability to retrieve
      the online sessions at their convenience. Weekly journals will be provided to measure
      attendance and frequency and duration of mindfulness practice.

      Instruments

      General Demographic Form: A researcher created demographic data form (age, educational level,
      prior experience with mindfulness, history of depression and anxiety) to be completed by the
      medical trainees at enrolment.

      Depression, Anxiety and Stress Scale: 21 item Depression, Anxiety, Stress Scale to be
      completed by the medical trainees at three time points.

      Oldenburg Burnout Inventory for Students: 16 item scale to measure burnout in students
      completed at three time points.

      Mindfulness Scales: 15 item Mindfulness Attention Awareness Scale and the 13 item Toronto
      Mindfulness Scale will be completed by the medical trainees at three time points.

      Mindfulness Weekly Journal: Document recording the duration and frequency of mindfulness
      practice during the study to assess attendance to the online class.

      DATA ANALYSIS

      Study data will be managed using Research Electronic Data Capture, a secure, web-based
      software platform, hosted at the University of Alberta. Group demographics will be compared
      with t-test, chi-square and Mann-Whitney U as appropriate. The scores of the four
      questionnaires will be analyzed with the Wilcoxon Signed-Rank test for within group
      comparison. The Spearman correlation test will be used for correlation between the
      mindfulness scores and the stress, anxiety, depression, and burnout scores. 2-tailed p-values
      will be used.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The three groups of participants are a pre-clerkship cohort consisting of first- and second-year medical students, a clerkship cohort consisting of third- and fourth-year medical students and the third cohort consisting of medical residents.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in stress symptoms time 1
time frame: Change from recruitment to immediately after the online mindfulness course
description: using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.
measure: Change in stress symptoms time 2
time frame: Change from recruitment to 3 months after the online mindfulness course
description: using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.
measure: Change in anxiety symptoms time 1
time frame: Change from recruitment to immediately after the online mindfulness course
description: using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of anxiety symptoms. Minimum score is 0. Maximum score is 21.
measure: Change in anxiety symptoms time 2
time frame: Change from recruitment to 3 months after the online mindfulness course
description: using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of anxiety symptoms. Minimum score is 0. Maximum score is 21.
measure: Change in depression symptoms time 1
time frame: Change from recruitment to immediately after the online mindfulness course
description: using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.
measure: Change in depression symptoms time 2
time frame: Change from recruitment to 3 months after the online mindfulness course
description: using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.
measure: Change in burnout symptoms time 1
time frame: Change from recruitment to immediately after the online mindfulness course
description: using the Oldenburg Burnout Inventory for Students; a 16 item scale to measure burnout. Scores for individual question range from 1 (strongly disagree) to 4 (strongly agree). A high score means a higher level of burnout symptoms. This scale has 2 subscales. Minimum score is 8. Maximum score is 32 for both subscales.
measure: Change in burnout symptoms time 2
time frame: Change from recruitment to 3 months after the online mindfulness course
description: using the Oldenburg Burnout Inventory for Students; a 16 item scale to measure burnout. Scores for individual question range from 1 (strongly disagree) to 4 (strongly agree). A high score means a higher level of burnout symptoms. This scale has 2 subscales. Minimum score is 8. Maximum score is 32 for both subscales.
measure: Change in mindful awareness time 1
time frame: Change from recruitment to immediately after the online mindfulness course
description: using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90.
And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale.
A high score in both scales (and subscales)means a high mindful awareness level.
measure: Change in mindful awareness time 2
time frame: Change from recruitment to 3 months after the online mindfulness course
description: using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90.
And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale.
A high score in both scales (and subscales)means a high mindful awareness level.
measure: Frequency of Mindfulness practice 1
time frame: From recruitment to the end of the online mindfulness elective (8 weeks in total)
description: Frequency of mindfulness practice
measure: Duration of Mindfulness practice 1
time frame: From recruitment to the end of the online mindfulness elective (8 weeks in total)
description: Duration of mindfulness practice
measure: Frequency of Mindfulness practice 2
time frame: From the end of the online mindfulness elective until three months after
description: Frequency of mindfulness practice
measure: Duration of Mindfulness practice 2
time frame: From the end of the online mindfulness elective until three months after
description: Duration of mindfulness practice
arm group label: Pre-clerkship cohort
arm group type: Experimental
description: First- and second-year medical students
arm group label: Clerkship cohort
arm group type: Experimental
description: Third- and fourth-year medical students
arm group label: Resident cohort
arm group type: Experimental
description: Medical residents
intervention type: Behavioral
intervention name: Mindfulness
description: Mindfulness online training
arm group label: Clerkship cohort
arm group label: Pre-clerkship cohort
arm group label: Resident cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Marc-Antoine Landry, MD
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No