NCT04977726

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 8, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 14, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2022

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

July 8, 2021

Last Update Submit

February 2, 2023

Conditions

Stress, Emotional

Outcome Measures

Primary Outcomes (3)

  • Participant Recruitment Potential

    9 months

  • STRIVE Course Completion

    Number of participants randomized to the intervention that complete the STRIVE course

    9 months

  • Follow-up Survey Compliance

    9 months

Other Outcomes (1)

  • Self-Reported Resilience at 3 months

    9 months

Study Arms (2)

STRIVE - Simulation Training for Resilience in Various Environments

EXPERIMENTAL
Behavioral: STRIVE curriculum

Control

SHAM COMPARATOR
Behavioral: STRIVE curriculum

Interventions

STRIVE curriculumBEHAVIORAL

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.

ControlSTRIVE - Simulation Training for Resilience in Various Environments

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 \& Emergency Medicine postgraduate residency programs.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Consultant Anesthesiologist, Principal Investigator

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 27, 2021

Study Start

October 14, 2021

Primary Completion

November 14, 2021

Study Completion

May 21, 2022

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)