Increasing Medical Student Well-being Through Gratitude Journaling

November 8, 2017 updated by: Érica Patocskai, Centre hospitalier de l'Université de Montréal (CHUM)

Randomised Controlled Trial of Gratitude Reporting vs no Intervention on Well-being of Medical Students During Clerkship

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1J4
        • Recruiting
        • Faculté de Médecine de l'Université de Montréal
        • Contact:
        • Sub-Investigator:
          • Samuel Rodriguez-Qizilbash, MD
        • Sub-Investigator:
          • Kerianne Boulva, MD, BSc
        • Principal Investigator:
          • Erica Patocskai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical students at the University of Montreal about to begin their surgical clerkship rotation.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gratitude journaling
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.
Behavioral: Gratitude journaling
Gratitude journaling 3 times a week during surgical rotation
No Intervention: No intervention
Students proceed with their surgical clerkship as is standard in our institution.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Well-being
Time Frame: 6 weeks after enrollment
Medical student well-being at the end of their surgical rotation. Measured by Perceived Stress Scale (Cohen, 1983)
6 weeks after enrollment
Well-being
Time Frame: 6 weeks after enrollment
Medical student well-being at the end of their surgical rotation. Measured by Satisfaction with Life Scale (Diener, 1985)
6 weeks after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Well-being before and after comparison
Time Frame: 6 weeks after enrollment in study
Before and after comparison of well-being by comparing initial and post-intervention questionnaires (Perceived Stress Scale (Cohen, 1983))
6 weeks after enrollment in study
Compliance with gratitude journaling
Time Frame: 6 weeks after enrollment in study
Proportion of empty entries in the student's gratitude journal
6 weeks after enrollment in study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de l'Université de Montréal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16.413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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