BurnoutNCT06145425
Testing an Evidence-Based Program for Clinician Burnout
A study testing App-Delivered Mindfulness Training (MT) in people with Burnout, run by Brown University at 1 site in United States.
Trial summary
The goal of this clinical trial is to pilot test an app-based mindfulness training program in reducing burnout in physicians and nurses. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout
- What is being tested?
- App-Delivered Mindfulness Training (MT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 14 Oct 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a physician, resident physician or nurse
- Able to speak English because all study activities will be conducted in English.
- 18+ years
- direct patient care
Who cannot join
- If using psychotropic medication - not on a stable dosage at least 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing an Evidence-Based Program for Physician and Nurse Burnout
The goal of this clinical trial is to pilot test an app-based mindfulness training program in reducing burnout in physicians and nurses.
Read the detailed description
The main question[s] it aims to answer are:
PRIMARY AIM: Determine if the app-based training reduces the level of cynicism (i.e., one of the two main dimensions of burnout).
SECONDARY AIM: Determine if the app-based training reduces the level of emotional exhaustion (i.e. one of the two main dimensions of burnout), anxiety, worry, depression and intolerance of uncertainty. Determine if the app-based training increases self-compassion, non-reactivity and non-judging about inner experiences.
Participants will be asked to:
- Use an app-based mindfulness training program
- Complete online surveys at baseline, immediately post-intervention and 1 month after the post-intervention as follow up
- Conditions
- Burnout
- Being tested
- App-Delivered Mindfulness Training (MT)
- Keywords
- Burnout, Mindfulness, Physicians, Nurses, Resident Physicians
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-Delivered Mindfulness Training (MT)Other
The program is delivered via a smartphone-based platform, which includes 7 mindfulness-based modules of about 15 minutes of brief didactic and experience-based mindfulness training (audio files).
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Participants will be asked to utilize the app. Receives: Other: App-Delivered Mindfulness Training (MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cynicism
The dimension of cynicism in the Maslach Burnout Inventory (MBI) cynicism. The MBI is a validated 22-item self-report measure of risk of burnout. Items are rated on a 7-point Likert scale ranging from 0 (never) to 6 (every day). The investigators will use only one single-item measure of cynicism that was included from the Maslach Burnout Inventory (MBI).
Measured: collected at baseline, immediately post-intervention and one month later as follow up
Secondary outcomes (8)
The dimension of emotional exhaustion in the Maslach Burnout Inventory (MBI).
The MBI is a validated 22-item self-report measure of risk of burnout. Items are rated on a 7-point Likert scale ranging from 0 (never) to 6 (every day). The investigators will use only one single-item measure of emotional exhaustion that was included from the Maslach Burnout Inventory (MBI).
Measured: collected at baseline, immediately post-intervention and one month later as follow up
Generalized Anxiety Disorder 7-items (GAD-7).
The GAD-7 is a validated 7-item measure of anxiety rated on a 4-point Likert scale ranging from 0 (Not at all sure) to 3 (Nearly every day).
Measured: collected at baseline, immediately post-intervention and one month later as follow up
Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale.
The non-reactivity scale is a validated subscale of the 39-item FFMQ which is a self-report psychological measure of mindfulness skills. This subscale contains 7 items which are presented on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never).
Measured: collected at baseline, immediately post-intervention and one month later as follow up
Five Facet Mindfulness Questionnaire (FFMQ) non-judging scale.
The non-judging scale is a validated subscale of the 39-item FFMQ which is a self-report psychological measure of mindfulness skills. This subscale contains 8 items which are presented on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never).
Measured: collected at baseline, immediately post-intervention and one month later as follow up
Patient Health Questionnaire 2-item scale (PHQ-2).
The PHQ-2 is a validated 2-item self-report measure of depression. Items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
Measured: collected at baseline, immediately post-intervention and one month later as follow up
Penn State Worry Questionnaire (PSWQ).
The PSWQ is a validated 16-item self-report measure of worry with items presented on a 5-point Likert scale ranging from 1 (not at all typical of me) to 5 (very typical of me).
Measured: collected at baseline, immediately post-intervention and one month later as follow up
Intolerance of Uncertainty 12-item scale (IUS-12).
The IUS-12 is a validated 12-item self-report measure of intolerance of uncertainty. Items are rated on a 5-point Likert scale ranging from 1 (not at all characteristic of me) to 5 (entirely characteristic of me).
Measured: collected at baseline, immediately post-intervention and one month later as follow up
Self-Compassion Scale - Short Form (SCS-SF).
The SCS-SF is a validated 12-item self-report measure of self-compassion. Items are rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always).
Measured: collected at baseline, immediately post-intervention and one month later as follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start15 Mar 2023
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
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 BurnoutStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3 single groups: physicians, resident physicians and nurses
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Peter G. Peterson Foundation
- Responsible party
- Sponsor
- Investigators
- Judson Brewer, MD, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145425
- Sponsor's protocol ID
- "IRB #2022003296"
- Status last verified
- May 2025
- First submitted
- 17 Nov 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antico L, Brewer J. Digital Mindfulness Training for Burnout Reduction in Physicians: Clinician-Driven Approach. JMIR Form Res. 2025 Jan 24;9:e63197. doi: 10.2196/63197.
PubMed 39854701
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Evidence-Based Program for Physician and Nurse Burnout
- ClinicalTrials.gov ID
- NCT06145425
- Acronym / sponsor ID
- "IRB #2022003296"
- Conditions
- Burnout
- Keywords
- Burnout, Mindfulness, Physicians, Nurses, Resident Physicians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Peter G. Peterson Foundation
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 24 Nov 2023 (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 goal of this clinical trial is to pilot test an app-based mindfulness training program in reducing burnout in physicians and nurses.
Detailed description
The main question[s] it aims to answer are:
PRIMARY AIM: Determine if the app-based training reduces the level of cynicism (i.e., one of the two main dimensions of burnout).
SECONDARY AIM: Determine if the app-based training reduces the level of emotional exhaustion (i.e. one of the two main dimensions of burnout), anxiety, worry, depression and intolerance of uncertainty. Determine if the app-based training increases self-compassion, non-reactivity and non-judging about inner experiences.
Participants will be asked to:
- Use an app-based mindfulness training program
- Complete online surveys at baseline, immediately post-intervention and 1 month after the post-intervention as follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 single groups: physicians, resident physicians and nurses
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Other: App-Delivered Mindfulness Training (MT)Participants will be asked to utilize the app. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being a physician, resident physician or nurse
- Able to speak English because all study activities will be conducted in English.
- 18+ years
- direct patient care
Key exclusion criteria (1 listed)
- If using psychotropic medication - not on a stable dosage at least 6 weeks
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 |
|---|---|---|
| App-Delivered Mindfulness Training (MT)The program is delivered via a smartphone-based platform, which includes 7 mindfulness-based modules of about 15 minutes of brief didactic and experience-based mindfulness training (audio files). | Other | Single arm |
Primary outcome
Changes in cynicism
Time frame: collected at baseline, immediately post-intervention and one month later as follow up
The dimension of cynicism in the Maslach Burnout Inventory (MBI) cynicism. The MBI is a validated 22-item self-report measure of risk of burnout. Items are rated on a 7-point Likert scale ranging from 0 (never) to 6 (every day). The investigators will use only one single-item measure of cynicism that was included from the Maslach Burnout Inventory (MBI).
8 secondary outcomes
The dimension of emotional exhaustion in the Maslach Burnout Inventory (MBI).
Time frame: collected at baseline, immediately post-intervention and one month later as follow up
Generalized Anxiety Disorder 7-items (GAD-7).
Time frame: collected at baseline, immediately post-intervention and one month later as follow up
Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale.
Time frame: collected at baseline, immediately post-intervention and one month later as follow up
Five Facet Mindfulness Questionnaire (FFMQ) non-judging scale.
Time frame: collected at baseline, immediately post-intervention and one month later as follow up
Patient Health Questionnaire 2-item scale (PHQ-2).
Time frame: collected at baseline, immediately post-intervention and one month later as follow up
Penn State Worry Questionnaire (PSWQ).
Time frame: collected at baseline, immediately post-intervention and one month later as follow up
Intolerance of Uncertainty 12-item scale (IUS-12).
Time frame: collected at baseline, immediately post-intervention and one month later as follow up
Self-Compassion Scale - Short Form (SCS-SF).
Time frame: collected at baseline, immediately post-intervention and one month later as follow up
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 14 May 2025.
- Derived from this study: PubMed 39854701Antico L, Brewer J. Digital Mindfulness Training for Burnout Reduction in Physicians: Clinician-Driven Approach. JMIR Form Res. 2025 Jan 24;9:e63197. doi: 10.2196/63197.
- 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.
Judson Brewer, MD, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-Delivered Mindfulness Training (MT) in people with Burnout, run by Brown University 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 4 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 14 May 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?
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?
Changes in cynicism (time frame: collected at baseline, immediately post-intervention and one month later as follow up). 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 NCT06145425, 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 14 May 2025.