StressASSISTNCT04914104
Accessible Support in Surgical Training During a Pandemic Study
A study testing Mindfulness Training - Headspace App in people with Stress and Burnout, Professional, run by University of Ottawa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Burnout, Professional, Depression, Anxiety
- What is being tested?
- Mindfulness Training - Headspace App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First and second year surgical residents
- Enrolled in the Surgical Foundations program at the University of Ottawa
Who cannot join
- None
About this study
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.
Read the 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.
- Conditions
- Stress, Burnout, Professional, Depression, Anxiety
- Being tested
- Mindfulness Training - Headspace App
- Medical subject headings
- Burnout, Professional, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Training - Headspace AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Mindfulness Training - Headspace App |
| Control | No intervention | The control group will receive standard of care, which does not involve routine in-person or free access to mobile mindfulness therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Measured: 6 weeks
Stress
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Measured: 12 weeks
Stress
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Measured: 18 weeks
Burnout
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Measured: 6 weeks
Burnout
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Measured: 12 weeks
Burnout
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Measured: 18 weeks
Anxiety
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
Measured: 6 weeks
Anxiety
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
Measured: 12 weeks
Anxiety
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
Measured: 18 weeks
Secondary outcomes (4)
Adherence
App usage (minutes / week)
Measured: 6 weeks
Adherence
App usage (minutes / week)
Measured: 12 weeks
Satisfaction with App Usage
Likhert Scale (0 to 5, where higher is better)
Measured: 6 weeks
Satisfaction with App Usage
Likhert Scale (0 to 5, where higher is better)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Rockley, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914104
- Sponsor's protocol ID
- 20210097-01H
- Acronym
- ASSIST
- Status last verified
- Aug 2021
- First submitted
- 26 May 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accessible Support in Surgical Training During a Pandemic Study
- ClinicalTrials.gov ID
- NCT04914104
- Acronym / sponsor ID
- ASSIST / 20210097-01H
- Conditions
- Stress, Burnout, Professional, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindfulness Training - Headspace AppThe 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 intervention | –The control group will receive standard of care, which does not involve routine in-person or free access to mobile mindfulness therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First and second year surgical residents
- Enrolled in the Surgical Foundations program at the University of Ottawa
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Training - Headspace AppThe 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. | Behavioural | Intervention |
Primary outcome
Stress
Time frame: 6 weeks
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Stress
Time frame: 12 weeks
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Stress
Time frame: 18 weeks
Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)
Burnout
Time frame: 6 weeks
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Burnout
Time frame: 12 weeks
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Burnout
Time frame: 18 weeks
Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)
Anxiety
Time frame: 6 weeks
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
Anxiety
Time frame: 12 weeks
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
Anxiety
Time frame: 18 weeks
DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)
4 secondary outcomes
Adherence
Time frame: 6 weeks
Adherence
Time frame: 12 weeks
Satisfaction with App Usage
Time frame: 6 weeks
Satisfaction with App Usage
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training - Headspace App in people with Stress and Burnout, Professional, run by University of Ottawa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: 6 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.