<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/NCT03240705</url>
  </required_header>
  <id_info>
    <org_study_id>16.413</org_study_id>
    <nct_id>NCT03240705</nct_id>
  </id_info>
  <brief_title>Increasing Medical Student Well-being Through Gratitude Journaling</brief_title>
  <official_title>Randomised Controlled Trial of Gratitude Reporting vs no Intervention on Well-being of Medical Students During Clerkship</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</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>
      Clerkship causes significant stress to medical students. Some interventions to increase&#xD;
      well-being have been described but none have been studied prospectively in this context.&#xD;
&#xD;
      The primary objective of this study is to examine the effects of gratitude journaling on&#xD;
      medical clerks' perceived well-being.&#xD;
&#xD;
      Students will be randomised to one of two groups: gratitude journaling or no intervention.&#xD;
      The participants of the experimental group will be asked to complete an online gratitude&#xD;
      journal 3 times per week and will be compared to the participants in the control group.&#xD;
&#xD;
      The students in both groups will answer a standardised questionnaire evaluating well-being&#xD;
      before and after their surgical rotation.&#xD;
&#xD;
      Those randomised to the intervention group will perform gratitude journaling three times a&#xD;
      week during their surgical rotation. This activity consists of writing something that made&#xD;
      them feel happy during their day.&#xD;
&#xD;
      Those randomised in the control group (no intervention) will proceed with their normal&#xD;
      rotation, without additional gratitude journaling.&#xD;
&#xD;
      The main outcome will be evaluated by comparing the well-being at the end of the surgical&#xD;
      rotation as evaluated by a composite well-being assessment scale between both groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medical education involves 2 years of rotations in different medical and surgical&#xD;
      specialties. These cause significant stress to clerks, in particular during the surgery&#xD;
      rotation. In other professional fields, mindfulness techniques have shown only small to&#xD;
      moderate effect on mental health compared to the control group.&#xD;
&#xD;
      An alternative approach to increasing well-being is gratitude journaling. A study examining&#xD;
      this approach in student populations demonstrated enhanced well-being and life satisfaction.&#xD;
&#xD;
      The primary objective of this study is to examine the effects of gratitude journaling on&#xD;
      medical clerks' perceived well-being.&#xD;
&#xD;
      Students will be randomised to one of two groups: gratitude journaling or no intervention.&#xD;
      The participants of the experimental group will be asked to complete an online gratitude&#xD;
      journal 3 times per week and will be compared to the participants in the control group.&#xD;
&#xD;
      The students in both groups will answer a standardised questionnaire evaluating well-being&#xD;
      before and after their surgical rotation.&#xD;
&#xD;
      Those randomised to the intervention group will perform gratitude journaling three times a&#xD;
      week during their surgical rotation. This activity consists of writing something that made&#xD;
      them feel happy during their day.&#xD;
&#xD;
      Those randomised in the control group (no intervention) will proceed with their normal&#xD;
      rotation, without additional gratitude journaling.&#xD;
&#xD;
      The main outcome will be evaluated by comparing the well-being at the end of the surgical&#xD;
      rotation as evaluated by a composite well-being assessment scale between both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Actual">December 22, 2021</completion_date>
  <primary_completion_date type="Actual">December 22, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The questionnaires will be coded as to not be able to identify study arm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Well-being</measure>
    <time_frame>6 weeks after enrollment</time_frame>
    <description>Medical student well-being at the end of their surgical rotation. Measured by Perceived Stress Scale (Cohen, 1983)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Well-being</measure>
    <time_frame>6 weeks after enrollment</time_frame>
    <description>Medical student well-being at the end of their surgical rotation. Measured by Satisfaction with Life Scale (Diener, 1985)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Well-being before and after comparison</measure>
    <time_frame>6 weeks after enrollment in study</time_frame>
    <description>Before and after comparison of well-being by comparing initial and post-intervention questionnaires (Perceived Stress Scale (Cohen, 1983))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance with gratitude journaling</measure>
    <time_frame>6 weeks after enrollment in study</time_frame>
    <description>Proportion of empty entries in the student's gratitude journal</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Stress, Psychological</condition>
  <arm_group>
    <arm_group_label>Gratitude journaling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students perform gratitude journaling 3 times per week on a form. This activity consists of writing elements of their day that brought happiness to them. Can be in keyword form or in sentences.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Students proceed with their surgical clerkship as is standard in our institution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Gratitude journaling</intervention_name>
    <description>Gratitude journaling 3 times a week during surgical rotation</description>
    <arm_group_label>Gratitude journaling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical students at the University of Montreal about to begin their surgical clerkship&#xD;
             rotation.&#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>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erica Patocskai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculté de Médecine de l'Université de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1J4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>van Dijk I, Lucassen PLBJ, Akkermans RP, van Engelen BGM, van Weel C, Speckens AEM. Effects of Mindfulness-Based Stress Reduction on the Mental Health of Clinical Clerkship Students: A Cluster-Randomized Controlled Trial. Acad Med. 2017 Jul;92(7):1012-1021. doi: 10.1097/ACM.0000000000001546.</citation>
    <PMID>28121650</PMID>
  </reference>
  <reference>
    <citation>Pettitt BJ. Medical student concerns and fears before their third-year surgical clerkship. Am J Surg. 2005 Apr;189(4):492-6. doi: 10.1016/j.amjsurg.2004.09.017.</citation>
    <PMID>15820468</PMID>
  </reference>
  <reference>
    <citation>Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.</citation>
    <PMID>6668417</PMID>
  </reference>
  <reference>
    <citation>Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.</citation>
    <PMID>16367493</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress</keyword>
  <keyword>Medical education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, 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>


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/NCT03240705
org study id: 16.413
nct id: NCT03240705
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Clerkship causes significant stress to medical students. Some interventions to increase
      well-being have been described but none have been studied prospectively in this context.

      The primary objective of this study is to examine the effects of gratitude journaling on
      medical clerks' perceived well-being.

      Students will be randomised to one of two groups: gratitude journaling or no intervention.
      The participants of the experimental group will be asked to complete an online gratitude
      journal 3 times per week and will be compared to the participants in the control group.

      The students in both groups will answer a standardised questionnaire evaluating well-being
      before and after their surgical rotation.

      Those randomised to the intervention group will perform gratitude journaling three times a
      week during their surgical rotation. This activity consists of writing something that made
      them feel happy during their day.

      Those randomised in the control group (no intervention) will proceed with their normal
      rotation, without additional gratitude journaling.

      The main outcome will be evaluated by comparing the well-being at the end of the surgical
      rotation as evaluated by a composite well-being assessment scale between both groups.
Medical education involves 2 years of rotations in different medical and surgical
      specialties. These cause significant stress to clerks, in particular during the surgery
      rotation. In other professional fields, mindfulness techniques have shown only small to
      moderate effect on mental health compared to the control group.

      An alternative approach to increasing well-being is gratitude journaling. A study examining
      this approach in student populations demonstrated enhanced well-being and life satisfaction.

      The primary objective of this study is to examine the effects of gratitude journaling on
      medical clerks' perceived well-being.

      Students will be randomised to one of two groups: gratitude journaling or no intervention.
      The participants of the experimental group will be asked to complete an online gratitude
      journal 3 times per week and will be compared to the participants in the control group.

      The students in both groups will answer a standardised questionnaire evaluating well-being
      before and after their surgical rotation.

      Those randomised to the intervention group will perform gratitude journaling three times a
      week during their surgical rotation. This activity consists of writing something that made
      them feel happy during their day.

      Those randomised in the control group (no intervention) will proceed with their normal
      rotation, without additional gratitude journaling.

      The main outcome will be evaluated by comparing the well-being at the end of the surgical
      rotation as evaluated by a composite well-being assessment scale between both groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: The questionnaires will be coded as to not be able to identify study arm.
measure: Well-being
time frame: 6 weeks after enrollment
description: Medical student well-being at the end of their surgical rotation. Measured by Perceived Stress Scale (Cohen, 1983)
measure: Well-being
time frame: 6 weeks after enrollment
description: Medical student well-being at the end of their surgical rotation. Measured by Satisfaction with Life Scale (Diener, 1985)
measure: Well-being before and after comparison
time frame: 6 weeks after enrollment in study
description: Before and after comparison of well-being by comparing initial and post-intervention questionnaires (Perceived Stress Scale (Cohen, 1983))
measure: Compliance with gratitude journaling
time frame: 6 weeks after enrollment in study
description: Proportion of empty entries in the student's gratitude journal
arm group label: Gratitude journaling
arm group type: Experimental
description: Students perform gratitude journaling 3 times per week on a form. This activity consists of writing elements of their day that brought happiness to them. Can be in keyword form or in sentences.
arm group label: No intervention
arm group type: No Intervention
description: Students proceed with their surgical clerkship as is standard in our institution.
intervention type: Behavioral
intervention name: Gratitude journaling
description: Gratitude journaling 3 times a week during surgical rotation
arm group label: Gratitude journaling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erica Patocskai, MD
role: Principal Investigator
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
facility: 
country: Canada
citation: van Dijk I, Lucassen PLBJ, Akkermans RP, van Engelen BGM, van Weel C, Speckens AEM. Effects of Mindfulness-Based Stress Reduction on the Mental Health of Clinical Clerkship Students: A Cluster-Randomized Controlled Trial. Acad Med. 2017 Jul;92(7):1012-1021. doi: 10.1097/ACM.0000000000001546.
PMID: 28121650
citation: Pettitt BJ. Medical student concerns and fears before their third-year surgical clerkship. Am J Surg. 2005 Apr;189(4):492-6. doi: 10.1016/j.amjsurg.2004.09.017.
PMID: 15820468
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PMID: 6668417
citation: Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
PMID: 16367493
responsible party type: Sponsor
mesh term: Stress, Psychological
sharing ipd: No