Physician BurnoutPhase 2NCT06969950
Evaluating an Intervention for Physician Burnout
A Phase 2 study testing App-Delivered Mindfulness Training (MT). and Online Virtual Training in people with Physician Burnout, run by Brown University at 1 site in United States.
Trial summary
The goals of this randomized controlled trial are 1) to test the efficacy of an app-based program in reducing physician burnout vs. no app (control) in 100 physicians; 2) to explore the role of an online live training to augment outcomes and develop an ongoing and sustainable support community with a subsample of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physician Burnout
- What is being tested?
- App-Delivered Mindfulness Training (MT). and Online Virtual Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2025to 27 Feb 2026
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a physician
- Able to speak English because all study activities will be conducted in English.
- 18+ years
- Direct patient care
Who cannot join
- 1. If using psychotropic medication - not on a stable dosage at least 6 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Judson Brewer, PhD, MD contact
United States1 site, 1 recruiting
- Recruiting
Brown University
Providence, Rhode Island, 02903
Lia Antico, PhD, 4013280763, lia_antico@brown.edu
Lia Antico, PhD
About this study
Official title: Evaluating an Evidence-Based Intervention for Physician Burnout
The goals of this randomized controlled trial are 1) to test the efficacy of an app-based program in reducing physician burnout vs. no app (control) in 100 physicians; 2) to explore the role of an online live training to augment outcomes and develop an ongoing and sustainable support community with a subsample of physicians.
- Conditions
- Physician Burnout
- Being tested
- App-Delivered Mindfulness Training (MT)., Online Virtual Training
- Keywords
- burnout, physicians, app-based, smarthphone, mindfulness
- 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 for two weeks
Online Virtual TrainingOther
A sub-group of 25 participants, either from the both intervention or control group, the will receive a virtual online training delivered via zoom calls. It is a group session program which includes 4 mindfulness-based sessions of about 60 minutes of brief didactic and experience-based for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Early App-Delivered Mindfulness Training (MT). | Experimental | Participants will be asked to utilize the app designed to reduce burnout for 2 weeks Receives: Other: App-Delivered Mindfulness Training (MT). |
| Later App-Delivered Mindfulness Training (MT). | Other | Participants will receive the intervention after the three-month follow-up, not before. Receives: Other: App-Delivered Mindfulness Training (MT). |
| Experimental: Online Virtual Training | Experimental | A sub-group of participants will receive the virtual online training after three-month follow-up or directly after the app-based intervention. Receives: Other: App-Delivered Mindfulness Training (MT).; Other: Online Virtual Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of cynicism
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)-based on the research of West et al., 2009.
Measured: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
Secondary outcomes (5)
Level of emotional exhaustion
1.Maslach Burnout Inventory (MBI) emotional exhaustion. 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).
Measured: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
Level of anxiety
2.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: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
Level of depression
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: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
Level of intolerance of uncertainty
4.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 t all).
Measured: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
Level of self-compassion
5.Self-Compassion Scale. The SCS is a validated 12-item self-report measure of self-compassion on a 5-point Likert scale ranging from 1 (almost never) to 5 (always).
Measured: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start12 Feb 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physician 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will receive the intervention (audio-course) to listen during the study and the other group will have access to the audio-course at the end of the study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lia Antico, PhD, Principal investigator, Brown UniversityJoseph Casamassima, MSc, Study chair, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969950
- Sponsor's protocol ID
- STUDY00000677
- Status last verified
- May 2025
- First submitted
- 28 Mar 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Evaluating an Evidence-Based Intervention for Physician Burnout
- ClinicalTrials.gov ID
- NCT06969950
- Acronym / sponsor ID
- STUDY00000677
- Conditions
- Physician Burnout
- Keywords
- burnout, physicians, app-based, smarthphone, mindfulness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 14 May 2025 (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 goals of this randomized controlled trial are 1) to test the efficacy of an app-based program in reducing physician burnout vs. no app (control) in 100 physicians; 2) to explore the role of an online live training to augment outcomes and develop an ongoing and sustainable support community with a subsample of physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- One group will receive the intervention (audio-course) to listen during the study and the other group will have access to the audio-course at the end of the study
| Arm | Type | Receives |
|---|---|---|
| Experimental: Early App-Delivered Mindfulness Training (MT). | Experimental | Other: App-Delivered Mindfulness Training (MT).Participants will be asked to utilize the app designed to reduce burnout for 2 weeks |
| Later App-Delivered Mindfulness Training (MT). | Other | Other: App-Delivered Mindfulness Training (MT).Participants will receive the intervention after the three-month follow-up, not before. |
| Experimental: Online Virtual Training | Experimental | Other: App-Delivered Mindfulness Training (MT)., Other: Online Virtual TrainingA sub-group of participants will receive the virtual online training after three-month follow-up or directly after the app-based intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being a physician
- Able to speak English because all study activities will be conducted in English.
- 18+ years
- Direct patient care
Key exclusion criteria (1 listed)
- 1. 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 for two weeks | Other | Experimental: Early App-Delivered Mindfulness Training (MT)., Experimental: Online Virtual Training, Later App-Delivered Mindfulness Training (MT). |
| Online Virtual TrainingA sub-group of 25 participants, either from the both intervention or control group, the will receive a virtual online training delivered via zoom calls. It is a group session program which includes 4 mindfulness-based sessions of about 60 minutes of brief didactic and experience-based for four weeks. | Other | Experimental: Online Virtual Training |
Primary outcome
Level of cynicism
Time frame: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
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)-based on the research of West et al., 2009.
5 secondary outcomes
Level of emotional exhaustion
Time frame: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
Level of anxiety
Time frame: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
Level of depression
Time frame: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
Level of intolerance of uncertainty
Time frame: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
Level of self-compassion
Time frame: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).
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 14 May 2025.
- 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.
Judson Brewer, PhD, MD contact
Lia Antico, PhD principal investigator
Brown University
Joseph Casamassima, MSc study chair
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing App-Delivered Mindfulness Training (MT). and Online Virtual Training in people with Physician 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: looking for participants now, 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Lia Antico, PhD In Neuroscience (+1-401-328-0763, lia_antico@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of cynicism (time frame: It will be collected 3 times, at baseline, 2 weeks after (post-app), three months later (follow-up). For the sub-group that will attend the online virtual training intervention, it will be collected after 4 months (post online training intervention).). 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 14 May 2025.