NCT05280964

Brief Summary

This is a single-institution randomized controlled trial. 101 female residents were recurited from the University of Colorado School of Medicine. They enrolled beginning in January 2021 and participated in the coaching program for 6 months via a web-based system. Participants were randomized into either the intervention or wait-list control arm. Participants in the intervention arm began the 6-month coaching program in January, 2021. Participants in the wait-list control arm have received no additional resources from the Better Together program between January and June 2021. The wait-list control group was invited to begin the 6-month coaching program in July 2021. In December 2021, participants from both the intervention and wait-list control groups will be invited to complete a 2nd post survey (identical to the post-survey from June 2021). There will be no incentive for completion of the 2nd post survey. Finally, the longitudinal effect of the program will be assessed by offering the same survey measuring wellbeing via various indices to the intervention arm at 6 months (1/2022), 12 months (7/2022) and 18 months (1/2023) after their intervention. Participation in this survey will be completely voluntary and not incentivized/compensated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

February 23, 2022

Last Update Submit

April 7, 2023

Conditions

BurnoutSelf-compassionMoral InjuryImpostor Phenomenon

Keywords

BurnoutMedical Education

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Burnout at 6 months, 12 months and 18 months

    The Maslach's burnout inventory is a 22-item measurement of worker burnout which assesses emotional exhaustion (EE), depersonalization (DP), and personal fulfillment (PF) domains. Possible scores range from 0-6 on a Likert scale for each item. Scores oof EE ≥ 27 points, DP ≥ 10, and PF \<33 would indicate a high degree of burnout. Scores of EE≤18 points, DP≤5 points, and PF≥40 points would indicate a low degree of burnout.

    Baseline measurement, post-intervention measurements at 6 months, 12 months and 18 months

Secondary Outcomes (3)

  • Change from baseline Self Compassion at 6 months, 12 months and 18 months

    Baseline measurement, post-intervention measurements at 6 months, 12 months and 18 months

  • Change from baseline Imposter Syndrome at 6 months, 12 months and 18 months

    Baseline measurement, post-intervention measurements at 6 months, 12 months and 18 months

  • Change from baseline Moral Injury at 6 months, 12 months and 18 months

    Baseline measurement, post-intervention measurements at 6 months, 12 months and 18 months

Study Arms (2)

Intervention

EXPERIMENTAL

Enrolled into a 6 month coaching program from January 1 2021 to June 30 2021

Behavioral: Better Together Physician Coaching

Control/Wait-list

NO INTERVENTION

No intervention from January 1 2021 to July 1 2021 (they were offered the coaching program from July 1 2021-Dec 31 2021)

Interventions

Better Together Physician CoachingBEHAVIORAL

6 month, online group coaching program

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTrainees who identify as female, including transwomen, gender non-conforming, non-binary, and gender queer.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • graduate medical education trainees (residents and fellows) at the University of Colorado
  • Female identifying

You may not qualify if:

  • Non trainees
  • non- female identifying

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado School of Medicine

Aurora, Colorado, 80230, United States

Location

Related Publications (8)

  • Rotenstein LS, Torre M, Ramos MA, Rosales RC, Guille C, Sen S, Mata DA. Prevalence of Burnout Among Physicians: A Systematic Review. JAMA. 2018 Sep 18;320(11):1131-1150. doi: 10.1001/jama.2018.12777.

    PMID: 30326495RESULT

  • Pommier E, Neff KD, Toth-Kiraly I. The Development and Validation of the Compassion Scale. Assessment. 2020 Jan;27(1):21-39. doi: 10.1177/1073191119874108. Epub 2019 Sep 13.

    PMID: 31516024RESULT

  • Mantri S, Lawson JM, Wang Z, Koenig HG. Identifying Moral Injury in Healthcare Professionals: The Moral Injury Symptom Scale-HP. J Relig Health. 2020 Oct;59(5):2323-2340. doi: 10.1007/s10943-020-01065-w.

    PMID: 32681398RESULT

  • Villwock JA, Sobin LB, Koester LA, Harris TM. Impostor syndrome and burnout among American medical students: a pilot study. Int J Med Educ. 2016 Oct 31;7:364-369. doi: 10.5116/ijme.5801.eac4.

    PMID: 27802178RESULT

  • 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.

    PMID: 31380892RESULT

  • Palamara K, Chu JT, Chang Y, Yu L, Cosco D, Higgins S, Tulsky A, Mourad R, Singh S, Steinhauser K, Donelan K. Who Benefits Most? A Multisite Study of Coaching and Resident Well-being. J Gen Intern Med. 2022 Feb;37(3):539-547. doi: 10.1007/s11606-021-06903-5. Epub 2021 Jun 7.

    PMID: 34100238RESULT

  • Mann A, Fainstad T, Shah P, Dieujuste N, Thurmon K, Dunbar K, Jones C. "We're all going through it": impact of an online group coaching program for medical trainees: a qualitative analysis. BMC Med Educ. 2022 Sep 13;22(1):675. doi: 10.1186/s12909-022-03729-5.

    PMID: 36100880DERIVED

  • 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.

    PMID: 35522281DERIVED

MeSH Terms

Conditions

Burnout, PsychologicalStress Disorders, Post-Traumaticimposter syndrome

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 15, 2022

Study Start

December 1, 2020

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

April 10, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)