Accessible Support in Surgical Training During a Pandemic Study
ASSIST
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The COVID-19 pandemic has fundamentally changed the surgical trainee experience by exacerbating the difficulty of this notoriously stressful training, while limiting access to traditional avenues of mental health support. The investigators propose the application of a mobile app-based mindfulness program to address stress and burnout in the surgical training. The proposed study is a prospective randomized, observer-blinded study including surgical trainees at the University of Ottawa in their first and second years of training. The intervention group will receive free access to the mobile app Headspace and will be encouraged to access the app three times a week for 15 minutes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
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
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
June 4, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedAugust 4, 2021
August 1, 2021
5 months
May 26, 2021
August 2, 2021
Conditions
Outcome Measures
Primary Outcomes (9)
Stress
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
6 weeks
Stress
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
12 weeks
Stress
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
18 weeks
Burnout
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
6 weeks
Burnout
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
12 weeks
Burnout
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
18 weeks
Anxiety
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
6 weeks
Anxiety
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
12 weeks
Anxiety
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
18 weeks
Secondary Outcomes (4)
Adherence
6 weeks
Adherence
12 weeks
Satisfaction with App Usage
6 weeks
Satisfaction with App Usage
12 weeks
Study Arms (2)
Intervention
EXPERIMENTALThe intervention group will receive free access to the mobile app Headspace and directed to access the app three times a week for at least 15 minutes.
Control
NO INTERVENTIONThe control group will receive standard of care, which does not involve routine in-person or free access to mobile mindfulness therapy.
Interventions
The intervention group will receive free access to the mobile app Headspace and directed to access the app three times a week for at least 15 minutes.
Eligibility Criteria
You may qualify if:
- First and second year surgical residents
- Enrolled in the Surgical Foundations program at the University of Ottawa
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Investigtor
Study Record Dates
First Submitted
May 26, 2021
First Posted
June 4, 2021
Study Start
October 1, 2021
Primary Completion
March 1, 2022
Study Completion
March 1, 2022
Last Updated
August 4, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share