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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

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 groups in NCT04914104
Study groupRoleWhat they receive
InterventionExperimentalThe 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
ControlNo interventionThe 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.

  1. Stress

    Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)

    Measured: 6 weeks

  2. Stress

    Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)

    Measured: 12 weeks

  3. Stress

    Perceived Stress Questionnaire (PSQ) (0 - 40, where low is better)

    Measured: 18 weeks

  4. Burnout

    Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)

    Measured: 6 weeks

  5. Burnout

    Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)

    Measured: 12 weeks

  6. Burnout

    Maslach Burnout Inventory - HSS-For Medical Personnel (MBI) (0 to 6)

    Measured: 18 weeks

  7. Anxiety

    DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)

    Measured: 6 weeks

  8. Anxiety

    DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)

    Measured: 12 weeks

  9. Anxiety

    DASS-21 (Depression, Anxiety and Stress Scale) (0 to 63, where low is better)

    Measured: 18 weeks

Secondary outcomes (4)
  1. Adherence

    App usage (minutes / week)

    Measured: 6 weeks

  2. Adherence

    App usage (minutes / week)

    Measured: 12 weeks

  3. Satisfaction with App Usage

    Likhert Scale (0 to 5, where higher is better)

    Measured: 6 weeks

  4. 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.

  1. First posted4 Jun 2021
  2. Study start1 Oct 2021 (estimated)
  3. Primary completion1 Mar 2022 (estimated)
  4. Study completion1 Mar 2022 (estimated)

Resources

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)
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

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.

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