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Burnout, ProfessionalNCT07221422

The PREGNANT (Pregnant Resident Empowerment, GuidaNce, and Advocacy iN Training) Coaching Project

A study testing Coaching Program in people with Burnout, Professional and Well-Being, Psychological, run by Massachusetts General Hospital at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a mixed-methods study designed to develop and evaluate an innovative coaching program for physician trainee mothers. Approximately 48 participants will be recruited from informational flyers posted in resident work areas and distributed by program directors and GME. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Coaching Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesUnited States
Study dates
4 Nov 2025to 1 Dec 2026
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 or older
  • English fluency and literacy
  • Resident or fellow level MD or DO trainee
  • Pregnant or up to 3 months post-partum

Who cannot join

  • Unable to provide consent.
  • Unable to complete electronic surveys and video calls.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

This is a mixed-methods study designed to develop and evaluate an innovative coaching program for physician trainee mothers. Approximately 48 participants will be recruited from informational flyers posted in resident work areas and distributed by program directors and GME. Interested participants will email study staff. Participants will be randomized to the control or intervention arm. Intervention participants will meet monthly with a novice physician coach of their choice (one-on-one) and a certified physician coach (with an assigned group of 6 peers through video-conferencing).

Participants in both arms of the study will respond to surveys at three points: enrollment (baseline), 4 months, and 7 months. At each point, they will spend approximately 10 minutes filling the survey. The survey will query demographics, burnout, professional fulfillment, imposter phenomenon, self-valuation, self-efficacy, resilience, quality of life, and impact of work on professional relationships. The coaching intervention will last 4 months, and the 7 month survey will be used only to assess long-term effects of the intervention. At the conclusion of the study (7 months after enrollment), participants will be interviewed over video communication (secure Partners or Harvard Zoom) for approximately 30 minutes.

Read the detailed description

To bridge the gaps identified in traditional mentorship programs, the PREGNANT study aims to develop and evaluate a novel, 4-month coaching program tailored to the childbearing trainees. Professional coaching is one of the few interventions shown to be effective in reducing burnout by providing structured and unstructured discussions through active listening and goal setting. It is uniquely positioned to address gaps identified in the previous mentorship program, as it does not rely on shared experiences, offers a focused solution with clear objectives, and provides trainees the tools to sustainably reduce burnout by fostering resilience, self-efficacy, and self-compassion. Despite its efficacy, many coaching programs rely on resource-intensive, in-person interventions, which reduce accessibility for trainees and pose scalability challenges.To overcome these barriers, our pilot study draws on the success of two types of innovative programs: 1) those that increase number of available one-on-one coaches by training practicing physicians in coaching techniques so they can function as "novice coaches" and 2) web-based group coaching programs with asynchronous learning opportunities, led by certified physician coaches, ensuring accessibility for trainees regardless of geographical or scheduling constraints. Unlike traditional life-coaching interventions that use external non-physician consultants, this program will be delivered by physician coaches who understand the challenges, social hierarchy, and culture of medical training. This distinction ensures that coaching is relevant and contextualized to the realities faced by childbearing trainees, thereby enhancing its effectiveness and impact.

This initiative will purposively include lesbian, gay, bisexual, transgender, queer, and other sexual identities (LGBTQ+) and underrepresented in medicine (URiM) trainee parents, who have been underrepresented in previous research on trainee parents and face barriers that make it harder to balance family life and training. LGBTQ+ parents often have fewer benefits and unique challenges, such as limited access to parental leave and more frequent use of assisted reproductive technology, while URiM parents face compounded challenges from the intersectionality of their identities.

The expected outcome of this project is the development of a structured, scalable coaching program that reduces burnout in childbearing trainees by integrating one-on-one coaching with community-building and group support. This program will have a significant positive impact on the clinical learning environment by enhancing its diversity, equity, and belonging while improving the well-being of a vulnerable population.

Being tested
Coaching Program
Medical subject headings
Burnout, Professional, Psychological Well-Being, imposter syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coaching ProgramBehavioural

    Novel, 4-month coaching program tailored to the childbearing trainees. This consists of 4 1:1 coaching sessions with a novice faculty coach and 4 group sessions with a certified coach.

Study groups in NCT07221422
Study groupRoleWhat they receive
InterventionExperimentalIntervention participants will not be given protected time to participate and will have the same clinical workload as controls. They will meet monthly with a novice physician coach of their choice (one-on-one) and a certified physician coach (with an assigned group of 6 peers). To build community, participants are encouraged to attend sessions with their coaching group, but we will accommodate full schedules by allowing (1) participation in sessions with other coaching groups, (2) asynchronous video learning including self-guided exercises. Video conferencing will be used to facilitate attendance and scalability.
Receives: Behavioral: Coaching Program
ControlOtherDelayed intervention. At the conclusion of the study, control participants will be offered a 2-hour workshop (led by a certified coach) covering group session topics, provided access to the videos, and given self-guided exercises used for asynchronous learning.
Receives: Behavioral: Coaching Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Burnout

    8-item Emotional Exhaustion (EE) and Depersonalization (DP) subscales in the Stanford Professional Fulfillment Index (SPFI). Higher scores are associated with more feelings of burnout while lower scores are associated with lower levels of burnout.

    Measured: Measured in survey data at 3 time points: Enrollment, month 4 and month 7 of study.

Secondary outcomes (8)
  1. Burnout

    Six item abbreviated version of the Maslach Burnout Inventory, including the Emotional Exhaustion (EE) and Depersonalization (DP) subscales. Higher scores are associated with higher levels of burnout while lower scores are associated with lower levels of burnout.

    Measured: Measured in survey data at 3 time points: Enrollment, month 4 and month 7 of study.

  2. Professional fulfillment

    Four item Stanford Professional Fulfillment Index subscale. Higher scores are associated with higher measures of professional fulfillment, and lower scores are associated with lower levels of professional fulfillment.

    Measured: Measured in survey data at 3 time points: Enrollment, month 4 and month 7 of study.

  3. Imposter Phenomenon

    20-question Clance Imposter Phenomenon Scale. Imposter phenomenon - associated with work-life integration challenges, burnout, and low professional fulfillment - is more common in high-achieving women during times of life transition and causes self-doubt despite objective evidence of achievement. Higher scores are associated with high feelings of imposter phenomenon and low scores are associated with less imposter phenomenon.

    Measured: Measured in survey data at 3 time points: Enrollment, month 4 and month 7 of study.

  4. Self-valuation

    Four item Clinician Self-Valuation scale. Low self-valuation - associated with burnout - is more common in women. It includes a harsh response to perceived personal shortcomings and deferral of personal needs to meet others' needs to meet others' needs. High scores are associated with low self-valuation while low scores are associated with high self-valuation.

    Measured: Measured in survey data at 3 time points: Enrollment, month 4 and month 7 of study.

  5. Self-efficacy

    Eight item New Generalized Self-Efficacy Scale. Self-efficacy is an individuals' perceived ability to perform across challenges, associated with lower levels of emotional exhaustion. High scores are associated with high levels of self-efficacy, low scores are associated with low levels of self-efficacy.

    Measured: Measured in survey data at 3 time points: Enrollment, month 4 and month 7 of study.

  6. Resilience

    Two item Connor Davidson Resilience Scale. Resilience - negatively correlated with physician burnout - includes adaptability to stress, a growth mindset, and enhanced social support, and improves with professional coaching. High scores are associated with high levels of resilience while low scores are associated with low levels of resilience.

    Measured: Measured in survey data at 3 time points: Enrollment, month 4 and month 7 of study.

  7. Quality of life (QoL)

    single-item validated linear analogue self-assessment

    Measured: Measured in survey data at 3 time points: Enrollment, month 4 and month 7 of study.

  8. Impact of Work on Personal Relationships

    Four-item Stanford Professional Fulfillment Index - Impostor Work Performance Relations (IWPR) Scale. Higher scores are associated with greater feelings of social isolation, burnout, and increased patient complaints.

    Measured: Measured in survey data at 3 time points: Enrollment, month 4 and month 7 of study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2025
  2. Study start4 Nov 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07221422
Sponsor's protocol ID
2025P000907
Status last verified
Sep 2026
First submitted
23 Oct 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schlick CJR, Ellis RJ, Etkin CD, Greenberg CC, Greenberg JA, Turner PL, Buyske J, Hoyt DB, Nasca TJ, Bilimoria KY, Hu YY. Experiences of Gender Discrimination and Sexual Harassment Among Residents in General Surgery Programs Across the US. JAMA Surg. 2021 Oct 1;156(10):942-952. doi: 10.1001/jamasurg.2021.3195.

    PubMed 34319377
  • Rangel EL, Smink DS, Castillo-Angeles M, Kwakye G, Changala M, Haider AH, Doherty GM. Pregnancy and Motherhood During Surgical Training. JAMA Surg. 2018 Jul 1;153(7):644-652. doi: 10.1001/jamasurg.2018.0153.

    PubMed 29562068
  • Li RD, Janczewski LM, Eng JS, Foote DC, Wu C, Johnson JK, Easter SR, Kim E, Buyske J, Turner PL, Nasca TJ, Bilimoria KY, Hu YY, Rangel EL. Pregnancy and Parenthood Among US Surgical Residents. JAMA Surg. 2024 Oct 1;159(10):1127-1137. doi: 10.1001/jamasurg.2024.2399.

    PubMed 39018050
  • Rowe SG, Stewart MT, Van Horne S, Pierre C, Wang H, Manukyan M, Bair-Merritt M, Lee-Parritz A, Rowe MP, Shanafelt T, Trockel M. Mistreatment Experiences, Protective Workplace Systems, and Occupational Distress in Physicians. JAMA Netw Open. 2022 May 2;5(5):e2210768. doi: 10.1001/jamanetworkopen.2022.10768.

    PubMed 35522279
  • National Academies of Sciences, Engineering, and Medicine; National Academy of Medicine; Committee on Systems Approaches to Improve Patient Care by Supporting Clinician Well-Being. Taking Action Against Clinician Burnout: A Systems Approach to Professional Well-Being. Washington (DC): National Academies Press (US); 2019 Oct 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK552618/

    PubMed 31940160
  • Sullivan MC, Bucholz EM, Yeo H, Roman SA, Bell RH, Sosa JA. "Join the club": effect of resident and attending social interactions on overall satisfaction among 4390 general surgery residents. Arch Surg. 2012 May;147(5):408-14. doi: 10.1001/archsurg.2012.27.

    PubMed 22785631
  • Dyrbye LN, Shanafelt TD, Gill PR, Satele DV, West CP. Effect of a Professional Coaching Intervention on the Well-being and Distress of Physicians: A Pilot Randomized Clinical Trial. JAMA Intern Med. 2019 Oct 1;179(10):1406-1414. doi: 10.1001/jamainternmed.2019.2425.

    PubMed 31380892
  • Palamara K, McKinley SK, Chu JT, Merrill AL, Yu L, Parangi S, Makowski MS, Park YS, Donelan K, Stein SL. Impact of a Virtual Professional Development Coaching Program on the Professional Fulfillment and Well-Being of Women Surgery Residents: A Randomized Controlled Trial. Ann Surg. 2023 Feb 1;277(2):188-195. doi: 10.1097/SLA.0000000000005562. Epub 2022 Jun 29.

    PubMed 35766397
  • Fainstad T, Mann A, Suresh K, Shah P, Dieujuste N, Thurmon K, Jones CD. Effect of a Novel Online Group-Coaching Program to Reduce Burnout in Female Resident Physicians: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2210752. doi: 10.1001/jamanetworkopen.2022.10752.

    PubMed 35522281
  • Lyu HG, Davids JS, Scully RE, Melnitchouk N. Association of Domestic Responsibilities With Career Satisfaction for Physician Mothers in Procedural vs Nonprocedural Fields. JAMA Surg. 2019 Aug 1;154(8):689-695. doi: 10.1001/jamasurg.2019.0529.

    PubMed 30969336

Questions about this trial

What is this clinical trial studying?

A study testing Coaching Program in people with Burnout, Professional and Well-Being, Psychological, run by Massachusetts General Hospital at 2 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Burnout (time frame: Measured in survey data at 3 time points: Enrollment, month 4 and month 7 of study.). 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 NCT07221422, which also lists 10 linked publications.

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 10 Sep 2026.

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