Burnout, PsychologicalResiWellNCT06149156
Resident Well-being and Performance
A study testing Healthy Minds Program App and Well-being Resources in people with Burnout, Psychological, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This project aims to investigate the effectiveness of a meditation intervention utilizing a smart phone-based meditation app on resident burnout, well-being, and performance self-efficacy in a randomized clinical trial. 500 participants will be enrolled for a 4 week intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Psychological
- What is being tested?
- Healthy Minds Program App and Well-being Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2024to 1 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resident in a high burnout rate specialty: family medicine, internal medicine, obstetrics and gynecology, emergency medicine, general surgery, or surgical sub-specialty (plastic surgery, urology, neurosurgery, orthopedic surgery, vascular surgery, cardiothoracic surgery, otolaryngology, ophthalmology)
Who cannot join
- Participants who have previously used the HMP (a version of HMP has been freely available to the public since 2020)
- Participants who have been practicing meditation daily or almost daily for the prior six months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Efficacy of a Mobile Health Mindfulness-based Intervention on Resident Well-being and Performance
This project aims to investigate the effectiveness of a meditation intervention utilizing a smart phone-based meditation app on resident burnout, well-being, and performance self-efficacy in a randomized clinical trial. 500 participants will be enrolled for a 4 week intervention.
Read the detailed description
Burnout is an increasingly prevalent challenge in the medical field and especially prominent in residency. Burnout negatively affects learning and decision-making, physician performance, and patient outcomes. Studies have shown that mindfulness-based interventions are effective at reducing burnout and strengthening well-being in physicians. Furthermore, mobile health mindfulness-based interventions have similar benefits to in-person interventions while offering the advantages of increased scalability, lack of physical constraint, and lower costs. This project will use a novel mobile health MBI and measure resident burnout, well-being, and self-efficacy in performance.
- Conditions
- Burnout, Psychological
- Being tested
- Healthy Minds Program App, Well-being Resources
- Keywords
- Residency, Well-being, Physician Health, Physician Burnout, Mindfulness, Mobile health
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Minds Program AppBehavioural
The four-week intervention comprises two introductory lessons and guided meditations followed by one week of content for each pillar of well-being. Each week includes two brief lessons (5-7 minutes) with education on the scientific research behind the practices, as well as examples of how to strengthen the skills of each pillar in daily life, along with three guided meditations for which the participant can select the practice length (5-30 minutes).
Well-being ResourcesBehavioural
List of well-being resources that comprises of online video links and books
| Study group | Role | What they receive |
|---|---|---|
| Healthy Minds Program (HMP) intervention | Experimental | Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice. Receives: Behavioral: Healthy Minds Program App |
| Waitlist Control | Active comparator | Participants will receive a list of well-being resources. They will be given access to HMP at the end of the study. Receives: Behavioral: Well-being Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress Measured by the Perceived Stress Scale
The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., "In the last week, how often have you felt nervous and 'stressed'?"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "very often." Total scores range from 0 to 40 where higher scores indicate greater perceived stress.
Measured: baseline, week 1, week 2, week 3, week 4, 3 months
Secondary outcomes (11)
Change in Burnout Measured by the Abbreviated Maslach Burnout Inventory: Personal Accomplishment Dimension
The Abbreviated Maslach Burnout Inventory (MBI) is a 9-item questionnaire to assesses burnout as a continuum on three different dimensions: Emotional Exhaustion, Depersonalization, and reduced Personal Accomplishment. It is scored on a 6-point Likert scale. Total possible range of scores for each sub-scale is 0-18, lower scores on the Personal Accomplishment dimension indicate higher burnout..
Measured: baseline, 4 weeks, 3 months
Change in Burnout Measured by the Abbreviated Maslach Burnout Inventory: Depersonalization and Emotional Exhaustion Dimensions
The Abbreviated Maslach Burnout Inventory (MBI) is a 9-item questionnaire to assesses burnout as a continuum on three different dimensions: Emotional Exhaustion, Depersonalization, and reduced Personal Accomplishment. It is scored on a 6-point Likert scale. Total possible range of scores for each sub-scale is 0-18, higher scores on the Depersonalization and Emotional Exhaustion dimensions indicate higher burnout.
Measured: baseline, 4 weeks, 3 months
Change in Flourishing Measured by the Flourishing Index Score
The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing.
Measured: baseline, 4 weeks, 3 months
Change in Resilience Measured by the Brief Resilience SCale
The Brief Resilience Scale is a 6-item questionnaire where participants report their resilience in responding to difficult events or setbacks. It is scored on a 0-6 scale, with the total score being the average of scores across all items with higher scores indicating higher resilience.
Measured: baseline, 4 weeks, 3 months
Change in Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
The PROMIS Sleep Disturbance scale is a computer-adaptive measure where participants report how often in the past 7 days they had various sleep-related experiences (e.g., "my sleep was restful"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, standard deviation (SD) = 10) where higher scores indicate more sleep disturbance.
Measured: baseline, 4 weeks, 3 months
Change in Awareness Measured by Five Facet Mindfulness Questionnaire Acting with Awareness Subscale Score
he Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is a 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus.
Measured: baseline, 4 weeks, 3 months
Change in Healthy Minds Index (HM Index)
The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0 to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Scores between 0 and 4 will be reported where higher scores indicate more of each quality.
Measured: baseline, week 1, week 2, week 3, week 4, 3 months
Change in General Self-Efficacy Measured by the General Self-Efficacy Scale
The General Self-Efficacy Scale is a 10-item questionnaire where participants report their general sense of perceived self-efficacy in coping with daily hassles and experiencing stressful life events. It is scored on a 4-point Likert sale and is summed into a total score ranging from 10-40. Higher scores indicate higher general self-efficacy
Measured: baseline, 4 weeks, 3 months
Change in Self-efficacy of Performance Measured by self-report on Accreditation Council for Graduate Medical Education (ACGME) Residency Milestones
The Accreditation Council for Graduate Medical Education Milestones are an assessment of core competencies for residents to track progression. We will assess Milestones in the core competencies of Patient Care, Practice-Based Learning and Improvement, Professionalism, and Interpersonal and Communication Skills. Participants will report their self-assessment of milestones on a 1-5 Likert scale.
Measured: baseline, 4 weeks, 3 months
Change in Connection Measured by NIH Toolbox Loneliness Score
The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness.
Measured: baseline, 4 weeks, 3 months
Change in Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., "I understand my life's meaning"). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life.
Measured: baseline, 4 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start21 Feb 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 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 Burnout, PsychologicalStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Goldberg, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149156
- Sponsor's protocol ID
- 2023-1432
- Other IDs
- A171600, IRB Approval 2/9/2024
- Acronym
- ResiWell
- Status last verified
- Apr 2025
- First submitted
- 20 Nov 2023
- Last updated
- 1 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan SF, Siddiqui H, Paur B, Marada S, Cortright L, Ignatowski N, Elfenbein DM, Minichiello V, Barrett B, Davidson RJ, Goldberg SB. Demographics in distress: a national study of burnout and well-being of resident physicians in high-burnout specialties. BMC Med Educ. 2026 Jan 30;26(1):344. doi: 10.1186/s12909-026-08702-0.
PubMed 41618292
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Mobile Health Mindfulness-based Intervention on Resident Well-being and Performance
- ClinicalTrials.gov ID
- NCT06149156
- Acronym / sponsor ID
- ResiWell / 2023-1432
- Conditions
- Burnout, Psychological
- Keywords
- Residency, Well-being, Physician Health, Physician Burnout, Mindfulness, Mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 28 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.
This project aims to investigate the effectiveness of a meditation intervention utilizing a smart phone-based meditation app on resident burnout, well-being, and performance self-efficacy in a randomized clinical trial. 500 participants will be enrolled for a 4 week intervention.
Detailed description
Burnout is an increasingly prevalent challenge in the medical field and especially prominent in residency. Burnout negatively affects learning and decision-making, physician performance, and patient outcomes. Studies have shown that mindfulness-based interventions are effective at reducing burnout and strengthening well-being in physicians. Furthermore, mobile health mindfulness-based interventions have similar benefits to in-person interventions while offering the advantages of increased scalability, lack of physical constraint, and lower costs. This project will use a novel mobile health MBI and measure resident burnout, well-being, and self-efficacy in performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Minds Program (HMP) intervention | Experimental | Behavioral: Healthy Minds Program AppParticipants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice. |
| Waitlist Control | Active comparator | Behavioral: Well-being ResourcesParticipants will receive a list of well-being resources. They will be given access to HMP at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resident in a high burnout rate specialty: family medicine, internal medicine, obstetrics and gynecology, emergency medicine, general surgery, or surgical sub-specialty (plastic surgery, urology, neurosurgery, orthopedic surgery, vascular surgery, cardiothoracic surgery, otolaryngology, ophthalmology)
Key exclusion criteria (2 listed)
- Participants who have previously used the HMP (a version of HMP has been freely available to the public since 2020)
- Participants who have been practicing meditation daily or almost daily for the prior six months
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 |
|---|---|---|
| Healthy Minds Program AppThe four-week intervention comprises two introductory lessons and guided meditations followed by one week of content for each pillar of well-being. Each week includes two brief lessons (5-7 minutes) with education on the scientific research behind the practices, as well as examples of how to strengthen the skills of each pillar in daily life, along with three guided meditations for which the participant can select the practice length (5-30 minutes). | Behavioural | Healthy Minds Program (HMP) intervention |
| Well-being ResourcesList of well-being resources that comprises of online video links and books | Behavioural | Waitlist Control |
Primary outcome
Change in Stress Measured by the Perceived Stress Scale
Time frame: baseline, week 1, week 2, week 3, week 4, 3 months
The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., "In the last week, how often have you felt nervous and 'stressed'?"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "very often." Total scores range from 0 to 40 where higher scores indicate greater perceived stress.
11 secondary outcomes
Change in Burnout Measured by the Abbreviated Maslach Burnout Inventory: Personal Accomplishment Dimension
Time frame: baseline, 4 weeks, 3 months
Change in Burnout Measured by the Abbreviated Maslach Burnout Inventory: Depersonalization and Emotional Exhaustion Dimensions
Time frame: baseline, 4 weeks, 3 months
Change in Flourishing Measured by the Flourishing Index Score
Time frame: baseline, 4 weeks, 3 months
Change in Resilience Measured by the Brief Resilience SCale
Time frame: baseline, 4 weeks, 3 months
Change in Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
Time frame: baseline, 4 weeks, 3 months
Change in Awareness Measured by Five Facet Mindfulness Questionnaire Acting with Awareness Subscale Score
Time frame: baseline, 4 weeks, 3 months
Change in Healthy Minds Index (HM Index)
Time frame: baseline, week 1, week 2, week 3, week 4, 3 months
Change in General Self-Efficacy Measured by the General Self-Efficacy Scale
Time frame: baseline, 4 weeks, 3 months
Change in Self-efficacy of Performance Measured by self-report on Accreditation Council for Graduate Medical Education (ACGME) Residency Milestones
Time frame: baseline, 4 weeks, 3 months
Change in Connection Measured by NIH Toolbox Loneliness Score
Time frame: baseline, 4 weeks, 3 months
Change in Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
Time frame: baseline, 4 weeks, 3 months
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 1 May 2025.
- Derived from this study: PubMed 41618292Tan SF, Siddiqui H, Paur B, Marada S, Cortright L, Ignatowski N, Elfenbein DM, Minichiello V, Barrett B, Davidson RJ, Goldberg SB. Demographics in distress: a national study of burnout and well-being of resident physicians in high-burnout specialties. BMC Med Educ. 2026 Jan 30;26(1):344. doi: 10.1186/s12909-026-08702-0.
- 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.
Simon Goldberg principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Minds Program App and Well-being Resources in people with Burnout, Psychological, run by University of Wisconsin, Madison 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 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: finished, as of the sponsor's last update on 1 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?
Change in Stress Measured by the Perceived Stress Scale (time frame: baseline, week 1, week 2, week 3, week 4, 3 months). 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 NCT06149156, 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 1 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.