Accessible Support in Surgical Training During a Pandemic Study (ASSIST)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Burnout, Professional; Depression, Anxiety
• Intervention / Treatment: Behavioral: Mindfulness Training - Headspace App

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First and second year surgical residents
• Enrolled in the Surgical Foundations program at the University of Ottawa

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Behavioral: Mindfulness Training - Headspace App; 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.
No Intervention: Control; The control group will receive standard of care, which does not involve routine in-person or free access to mobile mindfulness therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	App usage (minutes / week)	6 weeks
Adherence	App usage (minutes / week)	12 weeks
Satisfaction with App Usage	Likhert Scale (0 to 5, where higher is better)	6 weeks
Satisfaction with App Usage	Likhert Scale (0 to 5, where higher is better)	12 weeks

Collaborators and Investigators

• Sponsor: University of Ottawa

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 30, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Stress; Occupational Diseases; Burnout, Psychological; Burnout, Professional
• Other Study ID Numbers: 20210097-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No