NCT05724420

Brief 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., 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 4, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

February 2, 2023

Last Update Submit

February 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Study Arms (2)

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.

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.

Interventions

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..

STRIVE Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Sequence generation: computer-generated randomization in REDCAP program to two groups for each resident year cohort; STRIVE program and control group. Blinding: Post-interventional analysis will be performed by a dedicated team member blinded to the intervention assignment who will not participate in course delivery.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial with a 1:1 allocation ratio between intervention (STRIVE course) and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Consultant Anesthesiologist, Principal Investigator

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 13, 2023

Study Start

April 4, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations