BurnoutNCT04584268
Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents
A study testing mindfulness and standard medical education in people with Burnout, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This was a single-site RCT to assess the effect of a longitudinal mindfulness intervention on burnout for first-year (PGY-1) internal medicine (IM) and pediatrics residents. The primary outcome was Maslach Burnout Inventory MBI) scores at baseline and 12 month follow-up. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout
- What is being tested?
- mindfulness and standard medical education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 20 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Washington University (WUSM) first year residents in internal medicine and pediatrics
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Randomized Controlled Trial of a Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents
This was a single-site RCT to assess the effect of a longitudinal mindfulness intervention on burnout for first-year (PGY-1) internal medicine (IM) and pediatrics residents. The primary outcome was Maslach Burnout Inventory MBI) scores at baseline and 12 month follow-up. Secondary outcomes were feasibility and perceived benefit of the intervention.
- Conditions
- Burnout
- Being tested
- mindfulness, standard medical education
- Keywords
- burnout, medical residents
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulnessBehavioural
in person and smart phone application mindfulness practice
standard medical educationOther
standard medical education / control
| Study group | Role | What they receive |
|---|---|---|
| mindfulness | Experimental | 3 30 minute in person interventions as well as promotion and involvement of self-guided meditations on the Insight Timer smart phone application Receives: Behavioral: mindfulness |
| control | Active comparator | standard medical resident education Receives: Other: standard medical education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maslach Burnout Inventory (MBI)
burnout score on MBI (score range 0-132); based on three components: emotional exhaustion, depersonalization, and personal accomplishment)
Measured: 1 year
feasibility of intervention in graduate medical education
ability to insert into the curriculum without barriers or disruption of other education activities, assessed by interviews from residency leadership
Measured: 1 year
Secondary outcomes (2)
evaluation of intervention
survey to assess opinion of intervention (Likert scale)
Measured: 1 year
effect on mindfulness practice
survey question to assess pre and post-intervention frequency of practicing mindfulness
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Jun 2019
- Primary completion1 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Prater, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584268
- Sponsor's protocol ID
- 201904014
- Status last verified
- Oct 2020
- First submitted
- 23 Jul 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents
- ClinicalTrials.gov ID
- NCT04584268
- Acronym / sponsor ID
- 201904014
- Conditions
- Burnout
- Keywords
- burnout, medical residents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 12 Oct 2020 (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.
This was a single-site RCT to assess the effect of a longitudinal mindfulness intervention on burnout for first-year (PGY-1) internal medicine (IM) and pediatrics residents. The primary outcome was Maslach Burnout Inventory MBI) scores at baseline and 12 month follow-up. Secondary outcomes were feasibility and perceived benefit of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| mindfulness | Experimental | Behavioral: mindfulness3 30 minute in person interventions as well as promotion and involvement of self-guided meditations on the Insight Timer smart phone application |
| control | Active comparator | Other: standard medical educationstandard medical resident education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Washington University (WUSM) first year residents in internal medicine and pediatrics
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 |
|---|---|---|
| mindfulnessin person and smart phone application mindfulness practice | Behavioural | mindfulness |
| standard medical educationstandard medical education / control | Other | control |
Primary outcome
Maslach Burnout Inventory (MBI)
Time frame: 1 year
burnout score on MBI (score range 0-132); based on three components: emotional exhaustion, depersonalization, and personal accomplishment)
feasibility of intervention in graduate medical education
Time frame: 1 year
ability to insert into the curriculum without barriers or disruption of other education activities, assessed by interviews from residency leadership
2 secondary outcomes
evaluation of intervention
Time frame: 1 year
effect on mindfulness practice
Time frame: 1 year
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 12 Oct 2020.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness and standard medical education in people with Burnout, run by Washington University School of Medicine 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 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 12 Oct 2020. 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?
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?
Maslach Burnout Inventory (MBI) (time frame: 1 year). The study lists 2 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 12 Oct 2020.