Mental Health Wellness 1NCT04803812
Supporting the Wellness of Ontario Physicians During COVID-19
A study testing Remote SMS (short message service, also known as "text message") delivery in people with Mental Health Wellness 1 and Anxiety, run by Ontario Medical Association at 1 site in Canada.
Trial summary
In light of the coronavirus pandemic, the challenge of physician burnout has taken on a new urgency. Long-hours and difficult, sometimes unsafe work conditions are creating a severe strain for emergency physicians and others on the frontlines of Ontario's response to COVID-19. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Anxiety, Happiness
- What is being tested?
- Remote SMS (short message service, also known as "text message") delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,124 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jan 2021to 2 Sep 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Active membership to the Ontario Medical Association (OMA). Up-to-date cell phone information registered to the OMA.
Who cannot join
- Participation in the OMA Physician Burnout Task Force. Opt-out from the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
In light of the coronavirus pandemic, the challenge of physician burnout has taken on a new urgency. Long-hours and difficult, sometimes unsafe work conditions are creating a severe strain for emergency physicians and others on the frontlines of Ontario's response to COVID-19. There are a variety of evidence-informed ways that physicians can protect their wellbeing with modest investments of time and energy that will be applied. The evaluation will be a randomized trial comparing the outcomes from each of the three treatment arms. Researchers may also use a pre-post comparison with control parameters to conduct an exploratory analysis to assess efficacy.
- Conditions
- Mental Health Wellness 1, Anxiety, Happiness
- Being tested
- Remote SMS (short message service, also known as "text message") delivery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote SMS (short message service, also known as "text message") deliveryOther
Assessing the comparative effects of SMS types (storytelling; resources/strategies; and a combination of both) on physician wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| Receive weekly SMS containing wellness stories shared by other Ontario physicians | Experimental | Not described Receives: Other: Remote SMS (short message service, also known as "text message") delivery |
| Receive weekly SMS containing aim wellness resources/strategies. | Experimental | Not described Receives: Other: Remote SMS (short message service, also known as "text message") delivery |
| Receive weekly SMS combining wellness stories & resources/strategies | Experimental | Not described Receives: Other: Remote SMS (short message service, also known as "text message") delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wellbeing (Short Warwick-Edinburgh Mental Well-being Scale measure)
Self-reported wellbeing scores, as measured by the short Warwick-Edinburgh Mental Well-being Scale--(S)WEMWBS. The (S)WEMWBS is designed to measure positive mental wellbeing and asks people to what extent they agree with statements such as "I've been feeling optimistic about the future", "I've been feeling relaxed", and "I've been feeling close to people". This scale has a range of 7 to 35; higher scores indicate higher positive mental wellbeing.
Measured: 6 months
Secondary outcomes (2)
Happiness (UK ONS measure)
Self-reported happiness scores, as measured through weekly pulse surveys using a question developed by the UK Office for National Statistics (ONS) - hereby referred to as ONS-happiness ("on a scale where 0 is "not at all" and 10 is "completely", overall, how happy did you feel yesterday?"). This scale has a range from 0 to 10, with higher scores indicating greater happiness.
Measured: 6 months
Anxiety (UK ONS measure)
Self-reported anxiety scores, as measured through pulse surveys using an ONS question, hereby referred to as ONS-anxiety ("on a scale where 0 is "not at all" and 10 is "completely", overall, how anxious did you feel yesterday?"). This scale has a range from 0 to 10, with higher scores indicating greater anxiety.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start26 Jan 2021
- Primary completion2 Sep 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 19,124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Medical Association
- Sponsor type
- University, hospital or other
- Collaborators
- The Behavioural Insights Team
- Responsible party
- Sponsor
- Investigators
- James Wright, Principal investigator, Ontario Medical Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803812
- Sponsor's protocol ID
- 39707
- Status last verified
- Nov 2021
- First submitted
- 8 Feb 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting the Wellness of Ontario Physicians During COVID-19
- ClinicalTrials.gov ID
- NCT04803812
- Acronym / sponsor ID
- 39707
- Conditions
- Mental Health Wellness 1, Anxiety, Happiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19,124 participants (actual)
- Lead sponsor
- Ontario Medical AssociationUniversity, hospital or other
- Collaborators
- The Behavioural Insights Team
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 18 Mar 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.
In light of the coronavirus pandemic, the challenge of physician burnout has taken on a new urgency. Long-hours and difficult, sometimes unsafe work conditions are creating a severe strain for emergency physicians and others on the frontlines of Ontario's response to COVID-19. There are a variety of evidence-informed ways that physicians can protect their wellbeing with modest investments of time and energy that will be applied. The evaluation will be a randomized trial comparing the outcomes from each of the three treatment arms. Researchers may also use a pre-post comparison with control parameters to conduct an exploratory analysis to assess efficacy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Receive weekly SMS containing wellness stories shared by other Ontario physicians | Experimental | Other: Remote SMS (short message service, also known as "text message") delivery |
| Receive weekly SMS containing aim wellness resources/strategies. | Experimental | Other: Remote SMS (short message service, also known as "text message") delivery |
| Receive weekly SMS combining wellness stories & resources/strategies | Experimental | Other: Remote SMS (short message service, also known as "text message") delivery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Active membership to the Ontario Medical Association (OMA). Up-to-date cell phone information registered to the OMA.
Key exclusion criteria (1 listed)
- Participation in the OMA Physician Burnout Task Force. Opt-out from the intervention.
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 |
|---|---|---|
| Remote SMS (short message service, also known as "text message") deliveryAssessing the comparative effects of SMS types (storytelling; resources/strategies; and a combination of both) on physician wellbeing. | Other | Receive weekly SMS combining wellness stories & resources/strategies, Receive weekly SMS containing aim wellness resources/strategies., Receive weekly SMS containing wellness stories shared by other Ontario physicians |
Primary outcome
Wellbeing (Short Warwick-Edinburgh Mental Well-being Scale measure)
Time frame: 6 months
Self-reported wellbeing scores, as measured by the short Warwick-Edinburgh Mental Well-being Scale--(S)WEMWBS. The (S)WEMWBS is designed to measure positive mental wellbeing and asks people to what extent they agree with statements such as "I've been feeling optimistic about the future", "I've been feeling relaxed", and "I've been feeling close to people". This scale has a range of 7 to 35; higher scores indicate higher positive mental wellbeing.
2 secondary outcomes
Happiness (UK ONS measure)
Time frame: 6 months
Anxiety (UK ONS measure)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
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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.
James Wright principal investigator
Ontario Medical Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote SMS (short message service, also known as "text message") delivery in people with Mental Health Wellness 1 and Anxiety, run by Ontario Medical Association at 1 site in Canada.
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 1 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: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wellbeing (Short Warwick-Edinburgh Mental Well-being Scale measure) (time frame: 6 months). 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 30 Nov 2021.