Stress, PsychologicalNCT03240705
Increasing Medical Student Well-being Through Gratitude Journaling
A study testing Gratitude journaling in people with Stress, Psychological, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Gratitude journaling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2017to 22 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical students at the University of Montreal about to begin their surgical clerkship rotation.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site
Faculté de Médecine de l'Université de Montréal
Montreal, Quebec, H3T 1J4
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Stress, Psychological
- Being tested
- Gratitude journaling
- Keywords
- Stress, Medical education
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gratitude journalingBehavioural
Gratitude journaling 3 times a week during surgical rotation
| Study group | Role | What they receive |
|---|---|---|
| Gratitude journaling | Experimental | 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. Receives: Behavioral: Gratitude journaling |
| No intervention | No intervention | Students proceed with their surgical clerkship as is standard in our institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being
Medical student well-being at the end of their surgical rotation. Measured by Perceived Stress Scale (Cohen, 1983)
Measured: 6 weeks after enrollment
Well-being
Medical student well-being at the end of their surgical rotation. Measured by Satisfaction with Life Scale (Diener, 1985)
Measured: 6 weeks after enrollment
Secondary outcomes (2)
Well-being before and after comparison
Before and after comparison of well-being by comparing initial and post-intervention questionnaires (Perceived Stress Scale (Cohen, 1983))
Measured: 6 weeks after enrollment in study
Compliance with gratitude journaling
Proportion of empty entries in the student's gratitude journal
Measured: 6 weeks after enrollment in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start31 Aug 2017
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica Patocskai, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240705
- Sponsor's protocol ID
- 16.413
- Status last verified
- Jan 2023
- First submitted
- 29 May 2017
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28121650Pettitt 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.
PubMed 15820468Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Diener 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.
PubMed 16367493
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Gratitude Reporting vs no Intervention on Well-being of Medical Students During Clerkship
- ClinicalTrials.gov ID
- NCT03240705
- Acronym / sponsor ID
- 16.413
- Conditions
- Stress, Psychological
- Keywords
- Stress, Medical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gratitude journaling | Experimental | Behavioral: Gratitude journalingStudents 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. |
| No intervention | No intervention | –Students proceed with their surgical clerkship as is standard in our institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical students at the University of Montreal about to begin their surgical clerkship rotation.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gratitude journalingGratitude journaling 3 times a week during surgical rotation | Behavioural | Gratitude journaling |
Primary outcome
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)
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)
2 secondary outcomes
Well-being before and after comparison
Time frame: 6 weeks after enrollment in study
Compliance with gratitude journaling
Time frame: 6 weeks after enrollment in study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 28121650van 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.
- Background: PubMed 15820468Pettitt 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 16367493Diener 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Patocskai, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gratitude journaling in people with Stress, Psychological, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being (time frame: 6 weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03240705, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.