Stress, EmotionalNCT05724420
STRIVE - Resilience Curriculum for Novice Physicians-In-Training
A study testing STRIVE course delivery in people with Stress, Emotional, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The goal of this trial is to compare self-reported resilience scores in junior physicians-in-training after completion of formal resilience training. The main questions this trial aims to answer are: Does formal resilience training improve self-reported resilience scores? Does the timing of resilience training (i.e.… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotional
- What is being tested?
- STRIVE course delivery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 4 Apr 2023to Dec 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All first- and second-year medical residents enrolled in the Schulich School of Medicine \& Dentistry Anesthesia and Emergency Medicine postgraduate residency programs will be eligible to participate, regardless of age, gender, health status, or race. The respective residency program directors have approved study content and procedure.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Sonja Payne, 5196858500 ext. 37014, sonja.payne@lhsc.on.ca
About this study
Official title: Evaluation of a Formal Resilience Curriculum for Novice Physicians-in-training on Self-reported Resilience: a Randomized Controlled Trial
The goal of this trial is to compare self-reported resilience scores in junior physicians-in-training after completion of formal resilience training. The main questions this trial aims to answer are:
- Does formal resilience training improve self-reported resilience scores?
- Does the timing of resilience training (i.e., first vs second year of residency training) impact the effect of training? All participants will be provided with resources on resilience and learner support as per usual institutional practice. The intervention group will also participate in a formal resilience training program.
Researchers will compare self-reported resilience scores 3 months after training to determine the effect of the training program.
Read the detailed description
Physician wellness has gained much attention over recent years due to growing concerns regarding mental illness and burnout. The COVID-19 pandemic further highlighted the importance of physician health.
Resilience, defined as the capacity of an individual to adapt well and even thrive in the setting of adversity and stress, has been identified as an indicator of physician wellness. Resilience is a multidimensional concept that integrates personal factors, such as personality, with previous challenging experiences, leading to positive adaptation.
Simulation Training for Resilience in Various Environments (STRIVE) is an adaptation of a formal resilience curriculum developed by the Department of National Defense in Canada for military personnel. Fundamental skills learned during the course are applied and reinforced through experiential learning with high-fidelity simulation accompanied by effective debriefing.
Physicians-in-training have been identified as a population cohort with a high prevalence of burnout, depersonalization, and fatigue. Research demonstrates that institutional culture on wellbeing has a greater impact on resident satisfaction compared to the area of specialization. Therefore, we propose that institutional curricula and training in physician wellness may improve self-reported resilience in physicians-in-training.
The study will be conducted at London Health Sciences Centre, University Hospital in London, Ontario. A total of 60 participants will be recruited from the PGY-1 and PGY-2 residents from the Anesthesia and Emergency Medicine residency programs at the commencement of the academic year 2023.
The study aims to compare self-reported resilience of participants before and after the training, to determine if there is a statistically significant improvement in resilience scores, based on the CD-RISC-10 scores at 3 months.
- Conditions
- Stress, Emotional
- Being tested
- STRIVE course delivery
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIVE course deliveryBehavioural
STRIVE is adapted from the Road to Mental Readiness curriculum, developed by the Department of National Defence in Canada. It is comprised of a 4-hour formal education session where participants are provided knowledge, skills and resources specific to self-assessment for mental wellness and effective mindfulness strategies. High fidelity simulation sessions are then utilized to reinforce and apply mindfulness techniques learned in the formal session..
| Study group | Role | What they receive |
|---|---|---|
| STRIVE Group | Experimental | STRIVE is comprised of a 4-hour formal education session where participants are provided knowledge, skills, and resources specific to self-assessment for mental wellness and effective mindfulness strategies.
High-fidelity simulation sessions are utilised to reinforce and apply mindfulness techniques learned in the formal session. Clinical scenarios are designed to be challenging and stressful. Receives: Behavioral: STRIVE course delivery |
| Control | No intervention | Residents randomized to the control group will receive information regarding resilience development as per the usual standard of communication. All new residents will receive contact details of physician wellness services available at Schulich School of Medicine \& Dentistry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate of the effect of formal resilience training using the STRIVE course on self-reported resilience at 3 months.
Self-reported resilience will be quantified using the abbreviated Connor-Davidson Resilience Scale (CD RISC-10). Scores range from 0 to 40 with a higher score indicating higher resilience.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start4 Apr 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, EmotionalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial with a 1:1 allocation ratio between intervention (STRIVE course) and control groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonja Payne, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724420
- Sponsor's protocol ID
- 13156
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Formal Resilience Curriculum for Novice Physicians-in-training on Self-reported Resilience: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05724420
- Acronym / sponsor ID
- 13156
- Conditions
- Stress, Emotional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Feb 2023 (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.
The goal of this trial is to compare self-reported resilience scores in junior physicians-in-training after completion of formal resilience training. The main questions this trial aims to answer are:
- Does formal resilience training improve self-reported resilience scores?
- Does the timing of resilience training (i.e., first vs second year of residency training) impact the effect of training? All participants will be provided with resources on resilience and learner support as per usual institutional practice. The intervention group will also participate in a formal resilience training program.
Researchers will compare self-reported resilience scores 3 months after training to determine the effect of the training program.
Detailed description
Physician wellness has gained much attention over recent years due to growing concerns regarding mental illness and burnout. The COVID-19 pandemic further highlighted the importance of physician health.
Resilience, defined as the capacity of an individual to adapt well and even thrive in the setting of adversity and stress, has been identified as an indicator of physician wellness. Resilience is a multidimensional concept that integrates personal factors, such as personality, with previous challenging experiences, leading to positive adaptation.
Simulation Training for Resilience in Various Environments (STRIVE) is an adaptation of a formal resilience curriculum developed by the Department of National Defense in Canada for military personnel. Fundamental skills learned during the course are applied and reinforced through experiential learning with high-fidelity simulation accompanied by effective debriefing.
Physicians-in-training have been identified as a population cohort with a high prevalence of burnout, depersonalization, and fatigue. Research demonstrates that institutional culture on wellbeing has a greater impact on resident satisfaction compared to the area of specialization. Therefore, we propose that institutional curricula and training in physician wellness may improve self-reported resilience in physicians-in-training.
The study will be conducted at London Health Sciences Centre, University Hospital in London, Ontario. A total of 60 participants will be recruited from the PGY-1 and PGY-2 residents from the Anesthesia and Emergency Medicine residency programs at the commencement of the academic year 2023.
The study aims to compare self-reported resilience of participants before and after the training, to determine if there is a statistically significant improvement in resilience scores, based on the CD-RISC-10 scores at 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial with a 1:1 allocation ratio between intervention (STRIVE course) and control groups.
| Arm | Type | Receives |
|---|---|---|
| STRIVE Group | Experimental | Behavioral: STRIVE course deliverySTRIVE is comprised of a 4-hour formal education session where participants are provided knowledge, skills, and resources specific to self-assessment for mental wellness and effective mindfulness strategies. High-fidelity simulation sessions are utilised to reinforce and apply mindfulness techniques learned in the formal session. Clinical scenarios are designed to be challenging and stressful. |
| Control | No intervention | –Residents randomized to the control group will receive information regarding resilience development as per the usual standard of communication. All new residents will receive contact details of physician wellness services available at Schulich School of Medicine \& Dentistry. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All first- and second-year medical residents enrolled in the Schulich School of Medicine \& Dentistry Anesthesia and Emergency Medicine postgraduate residency programs will be eligible to participate, regardless of age, gender, health status, or race. The respective residency program directors have approved study content and procedure.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| STRIVE course deliverySTRIVE is adapted from the Road to Mental Readiness curriculum, developed by the Department of National Defence in Canada. It is comprised of a 4-hour formal education session where participants are provided knowledge, skills and resources specific to self-assessment for mental wellness and effective mindfulness strategies. High fidelity simulation sessions are then utilized to reinforce and apply mindfulness techniques learned in the formal session.. | Behavioural | STRIVE Group |
Primary outcome
To evaluate of the effect of formal resilience training using the STRIVE course on self-reported resilience at 3 months.
Time frame: 3 months
Self-reported resilience will be quantified using the abbreviated Connor-Davidson Resilience Scale (CD RISC-10). Scores range from 0 to 40 with a higher score indicating higher resilience.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRIVE course delivery in people with Stress, Emotional, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonja Payne ((519)685-8500, sonja.payne@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate of the effect of formal resilience training using the STRIVE course on self-reported resilience at 3 months. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.