Burnout, ProfessionalNCT03811990
Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?
A study testing Cleveland Clinic Stress Free Now Meditations For Healers in people with Burnout, Professional and Depression, run by University of Texas at Austin at 1 site in United States.
Trial summary
Emergency medicine is notorious for its high rate of burnout and mental health issues. The emergency department (ED) is a high paced work environment dealing with life and death issues. Employees in the ED work shift times that are not conducive to a natural circadian rhythm. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Depression, Anxiety
- What is being tested?
- Cleveland Clinic Stress Free Now Meditations For Healers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2018to 1 Jun 2020
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employment in the Emergency Department (with at least 8 shifts a month at Dell Seton Medical Center or Seton Medical Center) as either an attending physician, resident physician, or nurse
- Age greater than/equal to 18 years old and younger than 75 years old
- Must own a mobile phone operating on the iOS system
Who cannot join
- Already use a phone-based meditation app on a weekly basis
- Currently undergoing psychological treatment in the form of weekly therapy or psychotropic medications
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas Austin
Austin, Texas, 78701
Keith Lambert, MD, 720-629-4136 ext. 7206294136, KLambert@asecnsion.org
About this study
Emergency medicine is notorious for its high rate of burnout and mental health issues. The emergency department (ED) is a high paced work environment dealing with life and death issues. Employees in the ED work shift times that are not conducive to a natural circadian rhythm. All of these factors lead to high rates of burnout and overall dissatisfaction with their career choice. These are known downsides of a career in emergency medicine, but little effort is put into addressing this issue in everyday EDs.
Cell phones offer an easy and convenient means to participate in meditation. There are multiple evidence-based meditation apps available to cell phone users free of charge. Meditation has been shown to decrease burnout, rates of depression, and rates of anxiety. We hypothesize that weekly use of a meditation-based cell phone application will improve the mental health of emergency department employees as measured on various wellness inventories.
- Conditions
- Burnout, Professional, Depression, Anxiety, Stress
- Being tested
- Cleveland Clinic Stress Free Now Meditations For Healers
- 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.
Cleveland Clinic Stress Free Now Meditations For HealersBehavioural
Phone-based meditation application
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Active comparator | Not described Receives: Behavioral: Cleveland Clinic Stress Free Now Meditations For Healers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression score
Beck Depression Inventory, numeric score of 0-63 with a score of 63 being the most depressed
Measured: 90 and 180 days
Change in anxiety score
Beck Anxiety Inventory, numeric score of 0-63 with a score of 63 being the most anxious
Measured: 90 and 180 days
Change in stress levels
Perceived Stress Scale, numeric score of 0-40 with a score of 40 being the most stressed
Measured: 90 and 180 days
Change in burnout level
Maslach Burnout Inventory, measures level of stress on a numeric scale
Measured: 90 and 180 days, numeric scale between 0 and 6 with 6 being the highest score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start19 Dec 2018
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, non-blinded, control trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Lambert, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811990
- Sponsor's protocol ID
- 2018-04-0089
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coulon SM, Monroe CM, West DS. A Systematic, Multi-domain Review of Mobile Smartphone Apps for Evidence-Based Stress Management. Am J Prev Med. 2016 Jul;51(1):95-105. doi: 10.1016/j.amepre.2016.01.026. Epub 2016 Mar 15.
PubMed 26993534
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?
- ClinicalTrials.gov ID
- NCT03811990
- Acronym / sponsor ID
- 2018-04-0089
- Conditions
- Burnout, Professional, Depression, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 22 Jan 2019 (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.
Emergency medicine is notorious for its high rate of burnout and mental health issues. The emergency department (ED) is a high paced work environment dealing with life and death issues. Employees in the ED work shift times that are not conducive to a natural circadian rhythm. All of these factors lead to high rates of burnout and overall dissatisfaction with their career choice. These are known downsides of a career in emergency medicine, but little effort is put into addressing this issue in everyday EDs.
Cell phones offer an easy and convenient means to participate in meditation. There are multiple evidence-based meditation apps available to cell phone users free of charge. Meditation has been shown to decrease burnout, rates of depression, and rates of anxiety. We hypothesize that weekly use of a meditation-based cell phone application will improve the mental health of emergency department employees as measured on various wellness inventories.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, non-blinded, control trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Active comparator | Behavioral: Cleveland Clinic Stress Free Now Meditations For Healers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employment in the Emergency Department (with at least 8 shifts a month at Dell Seton Medical Center or Seton Medical Center) as either an attending physician, resident physician, or nurse
- Age greater than/equal to 18 years old and younger than 75 years old
- Must own a mobile phone operating on the iOS system
Key exclusion criteria (2 listed)
- Already use a phone-based meditation app on a weekly basis
- Currently undergoing psychological treatment in the form of weekly therapy or psychotropic medications
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 |
|---|---|---|
| Cleveland Clinic Stress Free Now Meditations For HealersPhone-based meditation application | Behavioural | Intervention |
Primary outcome
Change in depression score
Time frame: 90 and 180 days
Beck Depression Inventory, numeric score of 0-63 with a score of 63 being the most depressed
Change in anxiety score
Time frame: 90 and 180 days
Beck Anxiety Inventory, numeric score of 0-63 with a score of 63 being the most anxious
Change in stress levels
Time frame: 90 and 180 days
Perceived Stress Scale, numeric score of 0-40 with a score of 40 being the most stressed
Change in burnout level
Time frame: 90 and 180 days, numeric scale between 0 and 6 with 6 being the highest score
Maslach Burnout Inventory, measures level of stress on a numeric scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Background: PubMed 26993534Coulon SM, Monroe CM, West DS. A Systematic, Multi-domain Review of Mobile Smartphone Apps for Evidence-Based Stress Management. Am J Prev Med. 2016 Jul;51(1):95-105. doi: 10.1016/j.amepre.2016.01.026. Epub 2016 Mar 15.
- 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.
Keith Lambert, MD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleveland Clinic Stress Free Now Meditations For Healers in people with Burnout, Professional and Depression, run by University of Texas at Austin at 1 site in United States.
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 3 inclusion and 2 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 24 Jan 2019. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith Lambert, MD (7206294136, KLambert@asecnsion.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression score (time frame: 90 and 180 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03811990, which also lists 1 linked publication.
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 24 Jan 2019.