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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
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 26, 2021
    Last Updated
    August 2, 2021
    Sponsor
    University of Ottawa
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    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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