- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02540473
Fostering Resilience in Physician Moms
August 28, 2017 updated by: Cynthia M. Stonnington, M.D., Mayo Clinic
Fostering Resilience: An Intervention for Women Physicians at Risk for Burnout
Physicians in general are at risk for burnout, and this risk is heightened among women, particularly mothers.
In a randomized design, central hypotheses in this study are that mothers who attend our 12-week Relational Psychotherapy Mothers Group (RPMG) intervention will show significantly greater decreases in stress, depression, burnout, and associated risk biomarker indices, as compared to comparison controls (who would meet in unstructured gatherings, for an hour a week for 12 weeks).
Additionally the investigators hypothesize that the gains would be maintained three months after the intervention is completed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion of Women and Minorities:
- This study will be restricted to women physician mothers, who are the target of the manualized RPMG program.
- The study will not use race or ethnicity as a basis for selecting subjects.
Inclusion of Children:
- This study does not include children.
Exclusion criteria
- Participation in this study is open to all Mayo physician mothers with a child under the age of 18 years.
- As in past RPMG trials, the only exclusion criteria are if mothers were to indicate active suicidality, or meet criteria for psychoses, during initial assessments or during participation in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group therapy
12 week manualized group therapy (one hour per week)
|
Relational psychotherapy mothers
|
|
Other: Control Group
Participants get one hour of time away from patient care/duties to do as they wish.
|
one hour of free time to do with as they wish
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
level of depression
Time Frame: Baseline to 3 months
|
Beck Depression Inventory
|
Baseline to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
biomarker of stress
Time Frame: Baseline to 3 months
|
C-reactive protein
|
Baseline to 3 months
|
|
biomarker of stress
Time Frame: Baseline to 3 months
|
nerve-growth factor
|
Baseline to 3 months
|
|
Professional functioning
Time Frame: Baseline to 3 months
|
The Maslach Burnout Inventory
|
Baseline to 3 months
|
|
perceived social support
Time Frame: Baseline to 3 months
|
Quality of Social Support Scale
|
Baseline to 3 months
|
|
Parenting stress
Time Frame: Baseline to 3 months
|
Parenting Stress Inventory
|
Baseline to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
- Luthar SS, Curlee A, Tye SJ, Engelman JC, Stonnington CM. Fostering Resilience among Mothers under Stress: "Authentic Connections Groups" for Medical Professionals. Womens Health Issues. 2017 May-Jun;27(3):382-390. doi: 10.1016/j.whi.2017.02.007. Epub 2017 Apr 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
August 28, 2015
First Submitted That Met QC Criteria
September 3, 2015
First Posted (Estimate)
September 4, 2015
Study Record Updates
Last Update Posted (Actual)
August 30, 2017
Last Update Submitted That Met QC Criteria
August 28, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-009196
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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