Accessible Support in Surgical Training During a Pandemic Study (ASSIST)
Primary Purpose
Stress, Burnout, Professional, Depression, Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness Training - Headspace App
Sponsored by
About this trial
This is an interventional prevention trial for Stress
Eligibility Criteria
Inclusion Criteria:
- First and second year surgical residents
- Enrolled in the Surgical Foundations program at the University of Ottawa
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
The control group will receive standard of care, which does not involve routine in-person or free access to mobile mindfulness therapy.
Outcomes
Primary Outcome Measures
Stress
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Stress
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Stress
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Burnout
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Burnout
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Burnout
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Anxiety
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
Anxiety
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
Anxiety
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
Secondary Outcome Measures
Adherence
App usage (minutes / week)
Adherence
App usage (minutes / week)
Satisfaction with App Usage
Likhert Scale (0 to 5, where higher is better)
Satisfaction with App Usage
Likhert Scale (0 to 5, where higher is better)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04914104
Brief Title
Accessible Support in Surgical Training During a Pandemic Study
Acronym
ASSIST
Official Title
Accessible Support in Surgical Training During a Pandemic Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The COVID-19 pandemic has fundamentally changed the surgical trainee experience. The personal risks and uncertainties of this environment have compounded the difficulty of this notoriously stressful training. Burnout in the medical profession is prolific, and health care workers are not immune to the adverse mental health effects of the pandemic. Of all health professionals, surgical trainees frequently report the highest rates of burnout and severe stress. In particular, high burnout is associated with profoundly increased rates of depression and suicidal ideation in these trainees. In addition to the adverse effects of burnout and stress on the mental health wellbeing of trainees, excessive stress in the operating room can threaten patient safety and slow motor skill acquisition.
In response, many organizations have sought out methods to mitigate the negative mental health effects of surgical training. One promising intervention is mindfulness-based stress reduction. The perception of stress in surgical trainees is mediated by both cognitive and behavioural factors, which demonstrates an opportunity for mindfulness-based stress reduction (MBSR) interventions to modulate the perceived stress. In-person MBSR has been investigated in previous randomized trials of first year surgical residents. These pilot reports describe promising feasibility and adherence to mindfulness practice, with improved stress and cognitive control in the interventional arms.
Mindfulness techniques lend themselves to self-guided instruction provided by mobile apps and are a widely available resource. Mobile app-based mindfulness practice demonstrates comparable improvements in self-reported well-being when compared with in-person mindfulness sessions. When time is a scarce commodity, participant adherence is crucial to the effectiveness of any intervention. Mindfulness-based interventions have typically boasted strong adherence exceeding an average of 16 minutes per day after 3 months, particularly when self-directed. Specifically, adherence to optional online mindfulness-based practice is promising in medical trainees, with over half of trainees voluntarily adhering to regularly scheduled online mindfulness meditation after 8 weeks. In Canadian medical students, a pilot study demonstrated improved self-compassion from mindfulness-based interventions with an average adherence of only 20 minutes per week. When compared with a traditional weekly 8-session intensive mindfulness program, an abbreviated 4-session program demonstrated comparable improvements in perceived stress and empathy.
Ironically during a pandemic when stress levels at their highest, traditional wellness programs such as in-person counselling are not available due to the social distancing protocols. The investigators propose mindfulness-based therapy in the form of a mobile app to fill this void in high risk health professionals. This study investigates the effectiveness of mindfulness therapy delivered by a mobile app in surgical residents to reduce burnout and associated repercussions during the COVID-19 pandemic.
The primary objective of this investigation is to determine if access to mindfulness therapy delivered by a mobile app is effective in improving the mental well-being in surgical trainees, when compared with the current standard of care. Mental well-being encompasses a variety of factors including stress, burnout, depression and anxiety. Additional secondary objectives include adherence to mindfulness therapy and subject satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Burnout, Professional, Depression, Anxiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive standard of care, which does not involve routine in-person or free access to mobile mindfulness therapy.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training - Headspace App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stress
Description
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Time Frame
6 weeks
Title
Stress
Description
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Time Frame
12 weeks
Title
Stress
Description
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Time Frame
18 weeks
Title
Burnout
Description
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Time Frame
6 weeks
Title
Burnout
Description
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Time Frame
12 weeks
Title
Burnout
Description
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Time Frame
18 weeks
Title
Anxiety
Description
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
Time Frame
6 weeks
Title
Anxiety
Description
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
Time Frame
12 weeks
Title
Anxiety
Description
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Adherence
Description
App usage (minutes / week)
Time Frame
6 weeks
Title
Adherence
Description
App usage (minutes / week)
Time Frame
12 weeks
Title
Satisfaction with App Usage
Description
Likhert Scale (0 to 5, where higher is better)
Time Frame
6 weeks
Title
Satisfaction with App Usage
Description
Likhert Scale (0 to 5, where higher is better)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
First and second year surgical residents
Enrolled in the Surgical Foundations program at the University of Ottawa
Exclusion Criteria:
None
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Accessible Support in Surgical Training During a Pandemic Study
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