BurnoutNCT06734767
The Effect of an MBSR Course on Medical Trainee and Medical Academic Faculty Stress and Burnout
A study testing Mindfulness Based Stress Reduction 8-week course in people with Burnout, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The study team is seeking to evaluate the efficacy of the Mindfulness Based Stress Reduction (MBSR) course at reducing stress and burnout. This will be done through the collection of brief anonymous online surveys (the Perceived Stress Scale and the Mini Z) before the MBSR course and at 2 weeks, 6 months, and 12… 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 Based Stress Reduction 8-week course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2024to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- A physician in The Mount Sinai Hospital System
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The study team is seeking to evaluate the efficacy of the Mindfulness Based Stress Reduction (MBSR) course at reducing stress and burnout. This will be done through the collection of brief anonymous online surveys (the Perceived Stress Scale and the Mini Z) before the MBSR course and at 2 weeks, 6 months, and 12 months following the end of the course. Participation is completely voluntary and will not affect anyone's ability to take this course, and the course instructors will have no knowledge of who has or has not participated in the study.
Read the detailed description
The study is a pre- and post- survey design with the 8-week MBSR course as the intervention. MBSR is an evidence-based curriculum with a greater than 40-year history, that has been taught at Mount Sinai since 2018. Study participants will be those who have voluntarily signed up to take the course in response to an email describing the course that was sent by the office of the Mount Sinai Graduate Medical Education (GME). The study participants will be separated into two groups: faculty and trainees, and the study will span approximately two weeks prior to the start of the course (9/13/2023) (the "pre-" period) and six months after the completion of the course 5/31/2024) (the "post-" period). The course will be delivered by Zoom, but the participants will be joining from all Mount Sinai locations. The MBSR course itself involves didactics (i.e., stress physiology, review of mindfulness research, mindful communication practices), group discussions based on individual experiences with the mindful practices taught in the course, and the teaching of meditation practices including sitting and moving meditation practices. Home practices are offered as guidance each week but are not required. There is no planned control group at this time.
- Conditions
- Burnout
- Being tested
- Mindfulness Based Stress Reduction 8-week course
- Keywords
- Burnout, MBSR, mindfulness, physician well-being
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction 8-week courseBehavioural
The Mindfulness Based Stress Reduction (MBSR) 8-week course is an evidence-based curriculum that has been taught for over 40 years and is offered world-wide, teaching mindfulness skills and practices such as meditation.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction course faculty participants | Other | Faculty physicians who have chosen to take the free 8-week course are offered the opportunity to anonymously enroll in the study. Receives: Behavioral: Mindfulness Based Stress Reduction 8-week course |
| Mindfulness Based Stress Reduction course trainee participants | Other | Trainee physicians who have chosen to take the free 8-week course are offered the opportunity to anonymously enroll in the study. Receives: Behavioral: Mindfulness Based Stress Reduction 8-week course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is a validated 10-question survey tool that evaluates an individual's stress level. Each question is scored from 0-4 - Full scale range from 0-40, with higher score indicating higher perceived stress.
Measured: Baseline and at 2 weeks, 6 months, and 12 months following the end of the course (course is 8 weeks)
Secondary outcomes (2)
The "Mini Z" survey
The Mini Z is a validated one-question survey designed to gauge the degree of burnout an individual is experiencing.
Full score from 1-5, with higher score indicating more burnout.
Measured: Baseline and at 2 weeks, 6 months, and 12 months following the end of the course (course is 8 weeks)
Burnout questions
How often do you feel "burned out' by your work? How often do you feel you've become more callous toward people since you took this job? Each question is scored 0-6, with cumulate total score from 0-12. Higher score indicates more burnout.
Measured: Baseline and at 2 weeks, 6 months, and 12 months following the end of the course (course is 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start28 Mar 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
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 Icahn School of Medicine at Mount SinaiThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Medical practitioners who choose to register for a free mindfulness course are evaluated for improvements in their ability to manage stress and mitigate burnout.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Zahn, Icahn School of Medicine at Mount Sinai
- Investigators
- Jeffrey Zahn, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734767
- Sponsor's protocol ID
- STUDY-23-01113
- Status last verified
- Apr 2025
- First submitted
- 10 Dec 2024
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Surveys are filed anonymously, no identifying information of participants
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an MBSR Course on Medical Trainee and Medical Academic Faculty Stress and Burnout
- ClinicalTrials.gov ID
- NCT06734767
- Acronym / sponsor ID
- STUDY-23-01113
- Conditions
- Burnout
- Keywords
- Burnout, MBSR, mindfulness, physician well-being
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Dec 2024 (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 study team is seeking to evaluate the efficacy of the Mindfulness Based Stress Reduction (MBSR) course at reducing stress and burnout. This will be done through the collection of brief anonymous online surveys (the Perceived Stress Scale and the Mini Z) before the MBSR course and at 2 weeks, 6 months, and 12 months following the end of the course. Participation is completely voluntary and will not affect anyone's ability to take this course, and the course instructors will have no knowledge of who has or has not participated in the study.
Detailed description
The study is a pre- and post- survey design with the 8-week MBSR course as the intervention. MBSR is an evidence-based curriculum with a greater than 40-year history, that has been taught at Mount Sinai since 2018. Study participants will be those who have voluntarily signed up to take the course in response to an email describing the course that was sent by the office of the Mount Sinai Graduate Medical Education (GME). The study participants will be separated into two groups: faculty and trainees, and the study will span approximately two weeks prior to the start of the course (9/13/2023) (the "pre-" period) and six months after the completion of the course 5/31/2024) (the "post-" period). The course will be delivered by Zoom, but the participants will be joining from all Mount Sinai locations. The MBSR course itself involves didactics (i.e., stress physiology, review of mindfulness research, mindful communication practices), group discussions based on individual experiences with the mindful practices taught in the course, and the teaching of meditation practices including sitting and moving meditation practices. Home practices are offered as guidance each week but are not required. There is no planned control group at this time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Medical practitioners who choose to register for a free mindfulness course are evaluated for improvements in their ability to manage stress and mitigate burnout.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction course faculty participants | Other | Behavioral: Mindfulness Based Stress Reduction 8-week courseFaculty physicians who have chosen to take the free 8-week course are offered the opportunity to anonymously enroll in the study. |
| Mindfulness Based Stress Reduction course trainee participants | Other | Behavioral: Mindfulness Based Stress Reduction 8-week courseTrainee physicians who have chosen to take the free 8-week course are offered the opportunity to anonymously enroll in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A physician in The Mount Sinai Hospital System
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 Based Stress Reduction 8-week courseThe Mindfulness Based Stress Reduction (MBSR) 8-week course is an evidence-based curriculum that has been taught for over 40 years and is offered world-wide, teaching mindfulness skills and practices such as meditation. | Behavioural | Mindfulness Based Stress Reduction course faculty participants, Mindfulness Based Stress Reduction course trainee participants |
Primary outcome
Perceived Stress Scale (PSS)
Time frame: Baseline and at 2 weeks, 6 months, and 12 months following the end of the course (course is 8 weeks)
The Perceived Stress Scale (PSS) is a validated 10-question survey tool that evaluates an individual's stress level. Each question is scored from 0-4 - Full scale range from 0-40, with higher score indicating higher perceived stress.
2 secondary outcomes
The "Mini Z" survey
Time frame: Baseline and at 2 weeks, 6 months, and 12 months following the end of the course (course is 8 weeks)
Burnout questions
Time frame: Baseline and at 2 weeks, 6 months, and 12 months following the end of the course (course is 8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No. Surveys are filed anonymously, no identifying information of participants
Related trials for Burnout
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Caregiver Burnout
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Active, not recruiting
Online Mindfulness-Based Stress Reduction for the Mental Health of Healthcare Professionals
Occupational Stress or Workplace Stress, Burnout, Professionals
Active, not recruiting
Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
Stress, Psychological, Occupational, Stress, Psychological
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.
Jeffrey Zahn, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Based Stress Reduction 8-week course in people with Burnout, run by Icahn School of Medicine at Mount Sinai 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: enrolling by invitation, as of the sponsor's last update on 20 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Perceived Stress Scale (PSS) (time frame: Baseline and at 2 weeks, 6 months, and 12 months following the end of the course (course is 8 weeks)). 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 20 Apr 2025.