Stress, EmotionalNCT04977726
Resilience Curriculum for Novice Physicians-in-training
A study testing STRIVE curriculum 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
To determine the feasibility of delivering a structured resilience curriculum to novice physicians-in-training, we propose a pilot study to evaluate recruitment rates, course attendance and compliance with follow-up surveys. 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 curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 14 Oct 2021to 21 May 2022
- 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 \& Emergency Medicine postgraduate residency programs.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resilience Curriculum for Novice Physicians-in-training: a Randomized Controlled, Feasibility Trial.
To determine the feasibility of delivering a structured resilience curriculum to novice physicians-in-training, we propose a pilot study to evaluate recruitment rates, course attendance and compliance with follow-up surveys. If our study can demonstrate feasibility in course delivery, further engagement of postgraduate specialty programs will facilitate conduct of an appropriately powered randomised controlled trial.
- Conditions
- Stress, Emotional
- Being tested
- STRIVE curriculum
- 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 curriculumBehavioural
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 - Simulation Training for Resilience in Various Environments | Experimental | Not described Receives: Behavioral: STRIVE curriculum |
| Control | Sham comparator | Not described Receives: Behavioral: STRIVE curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment Potential
Measured: 9 months
STRIVE Course Completion
Number of participants randomized to the intervention that complete the STRIVE course
Measured: 9 months
Follow-up Survey Compliance
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start14 Oct 2021
- Primary completion14 Nov 2021
- Study completion21 May 2022
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
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
- Collaborators
- Western University
- 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
- NCT04977726
- Sponsor's protocol ID
- 11098
- Status last verified
- Feb 2023
- First submitted
- 8 Jul 2021
- Last updated
- 6 Feb 2023
- 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 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience Curriculum for Novice Physicians-in-training: a Randomized Controlled, Feasibility Trial.
- ClinicalTrials.gov ID
- NCT04977726
- Acronym / sponsor ID
- 11098
- Conditions
- Stress, Emotional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Western University
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 14 Nov 2021 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 27 Jul 2021 (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.
To determine the feasibility of delivering a structured resilience curriculum to novice physicians-in-training, we propose a pilot study to evaluate recruitment rates, course attendance and compliance with follow-up surveys. If our study can demonstrate feasibility in course delivery, further engagement of postgraduate specialty programs will facilitate conduct of an appropriately powered randomised controlled trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STRIVE - Simulation Training for Resilience in Various Environments | Experimental | Behavioral: STRIVE curriculum |
| Control | Sham comparator | Behavioral: STRIVE curriculum |
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 \& Emergency Medicine postgraduate residency programs.
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 curriculumSTRIVE 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 | Control, STRIVE - Simulation Training for Resilience in Various Environments |
Primary outcome
Participant Recruitment Potential
Time frame: 9 months
STRIVE Course Completion
Time frame: 9 months
Number of participants randomized to the intervention that complete the STRIVE course
Follow-up Survey Compliance
Time frame: 9 months
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 6 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Stress, Emotional
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Recruiting
DBT-P Treatment Study
Emotion Dysregulation
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Not yet recruitingObservational study
Caregiver and Child Anxiety, Relationships, and Daily Emotions ("CARE Study")
Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
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 curriculum 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: finished, as of the sponsor's last update on 6 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. Some participants in this study may receive a placebo. 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?
Participant Recruitment Potential (time frame: 9 months). The study lists 3 primary outcomes in all. 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 6 Feb 2023.