[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07221422":3,"trial-entities:NCT07221422":148,"trial-summary:NCT07221422":154},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":39,"secondary_outcomes":44,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":75,"locations":78,"central_contacts":110,"overall_officials":114,"references":115,"see_also_links":147},"NCT07221422","2025P000907","The PREGNANT (Pregnant Resident Empowerment, GuidaNce, and Advocacy iN Training) Coaching Project","RECRUITING","2026-12-01","2026-02","2026-02-10","2025-11-04","Massachusetts General Hospital","OTHER",false,"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).\n\nParticipants 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.","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.\n\nThis 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.\n\nThe 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.",[18,19,20,21,22],"Burnout, Professional","Well-Being, Psychological","Imposter Phenomenon","Self Efficacy","Quality of Life",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},48,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Coaching Program","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.",[37,38],"Control","Intervention",[40],{"measure":41,"description":42,"timeFrame":43},"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 in survey data at 3 time points: Enrollment, month 4 and month 7 of study.",[45,47,50,52,55,58,61,64],{"measure":41,"description":46,"timeFrame":43},"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.",{"measure":48,"description":49,"timeFrame":43},"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.",{"measure":20,"description":51,"timeFrame":43},"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.",{"measure":53,"description":54,"timeFrame":43},"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.",{"measure":56,"description":57,"timeFrame":43},"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.",{"measure":59,"description":60,"timeFrame":43},"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.",{"measure":62,"description":63,"timeFrame":43},"Quality of life (QoL)","single-item validated linear analogue self-assessment",{"measure":65,"description":66,"timeFrame":43},"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.","FEMALE","18 Years",null,true,{"inclusion":72,"exclusion":73,"raw_text":74},[],[],"Inclusion Criteria:\n\n1. Age 18 or older\n2. English fluency and literacy\n3. Resident or fellow level MD or DO trainee\n4. Pregnant or up to 3 months post-partum\n\nExclusion Criteria:\n\n1. Unable to provide consent.\n2. Unable to complete electronic surveys and video calls.",[76,77],"ADULT","OLDER_ADULT",[79,101],{"facility":12,"status":7,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":98},"Boston","Massachusetts","02114","United States",[85,90,95],{"name":86,"role":87,"phone":88,"email":89},"Erika L Rangel, MD, MS.","CONTACT","617-650-6952","erangel@mgh.harvard.edu",{"name":91,"role":87,"phone":92,"phoneExt":93,"email":94},"Emma AR Askew, B.S.","6177943770","Rangel","easkew@mgh.harvard.edu",{"name":96,"role":97},"Erika L Rangel, MD, MS","PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},42.35843,-71.05977,{"facility":102,"status":7,"city":80,"state":81,"zip":103,"country":83,"contacts":104,"geoPoint":109},"Brigham Women's Hospital","02115",[105,106,107],{"name":96,"role":87,"phone":88,"email":89},{"name":91,"role":87,"phone":92,"email":94},{"name":108,"role":97},"Erika L Rangel, Md, MS",{"lat":99,"lon":100},[111,113],{"name":96,"role":87,"phone":112,"email":89},"6176506952",{"name":91,"role":87,"phone":92,"email":94},[],[116,120,123,126,129,132,135,138,141,144],{"pmid":117,"type":118,"citation":119},"34319377","BACKGROUND","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\u002Fjamasurg.2021.3195.",{"pmid":121,"type":118,"citation":122},"29562068","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\u002Fjamasurg.2018.0153.",{"pmid":124,"type":118,"citation":125},"39018050","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\u002Fjamasurg.2024.2399.",{"pmid":127,"type":118,"citation":128},"35522279","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\u002Fjamanetworkopen.2022.10768.",{"pmid":130,"type":118,"citation":131},"31940160","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:\u002F\u002Fwww.ncbi.nlm.nih.gov\u002Fbooks\u002FNBK552618\u002F",{"pmid":133,"type":118,"citation":134},"22785631","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\u002Farchsurg.2012.27.",{"pmid":136,"type":118,"citation":137},"31380892","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\u002Fjamainternmed.2019.2425.",{"pmid":139,"type":118,"citation":140},"35766397","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\u002FSLA.0000000000005562. Epub 2022 Jun 29.",{"pmid":142,"type":118,"citation":143},"35522281","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\u002Fjamanetworkopen.2022.10752.",{"pmid":145,"type":118,"citation":146},"30969336","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\u002Fjamasurg.2019.0529.",[],{"nct_id":4,"conditions":149,"biomarkers":153},[150,151,22,152],"imposter syndrome","Physical AND emotional exhaustion state","Self efficacy",[],{"nct_id":4,"found":70,"summary":155,"prompt_version":165},{"design":156,"status":157,"heading":158,"summary":159,"follow_up":160,"word_count":161,"commitments":162,"compensation":163,"drugs_mentioned":164},"This is an interventional study designed to enroll about 48 participants. Participants will be randomly assigned to either receive the coaching program or be in a control group.","completed","The PREGNANT Coaching Project for Physician Trainees","This study is testing a new 4-month coaching program called the PREGNANT Coaching Program for pregnant or new physician trainees (residents or fellows). This program aims to help reduce burnout, improve well-being, and boost self-confidence. You would either receive this coaching program or be in a control group. The coaching involves one-on-one sessions with a faculty coach and group sessions with a certified coach. Researchers will measure how well the program works by looking at changes in burnout levels through surveys at the start, 4 months, and 7 months into the study. They are looking for about 48 women who are at least 18 years old, fluent in English, and are pregnant or up to 3 months postpartum. The current recruitment status is unclear.","Participants will be followed for 7 months, with the last survey completed at that time.",124,"You would complete surveys at the start of the study, at 4 months, and at 7 months. Each survey takes about 10 minutes. If in the intervention group, you would have 4 one-on-one coaching sessions and 4 group sessions over 4 months.","Not stated in the trial record.",[34],"v2"]