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Fostering Resilience in Physician Moms

Primary Purpose

Stress, Psychological

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Manualized Therapy

Control Group

About this trial

This is an interventional prevention trial for Stress, Psychological focused on measuring Resilience

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group therapy

Control Group

Arm Description

12 week manualized group therapy (one hour per week)

Participants get one hour of time away from patient care/duties to do as they wish.

Outcomes

Primary Outcome Measures

level of depression

Beck Depression Inventory

Secondary Outcome Measures

biomarker of stress

C-reactive protein

biomarker of stress

nerve-growth factor

Professional functioning

The Maslach Burnout Inventory

perceived social support

Quality of Social Support Scale

Parenting stress

Parenting Stress Inventory

Full Information

NCT ID

NCT02540473

First Posted

August 28, 2015

Last Updated

August 28, 2017

Sponsor

Mayo Clinic

Collaborators

Arizona State University

1. Study Identification

Unique Protocol Identification Number

NCT02540473

Brief Title

Fostering Resilience in Physician Moms

Official Title

Fostering Resilience: An Intervention for Women Physicians at Risk for Burnout

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Arizona State University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress, Psychological

Keywords

Resilience

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group therapy

Arm Type

Experimental

Arm Description

12 week manualized group therapy (one hour per week)

Arm Title

Control Group

Arm Type

Other

Arm Description

Participants get one hour of time away from patient care/duties to do as they wish.

Intervention Type

Behavioral

Intervention Name(s)

Manualized Therapy

Intervention Description

Relational psychotherapy mothers

Intervention Type

Behavioral

Intervention Name(s)

Control Group

Intervention Description

one hour of free time to do with as they wish

Primary Outcome Measure Information:

Title

level of depression

Description

Beck Depression Inventory

Time Frame

Baseline to 3 months

Secondary Outcome Measure Information:

Title

biomarker of stress

Description

C-reactive protein

Time Frame

Baseline to 3 months

Title

biomarker of stress

Description

nerve-growth factor

Time Frame

Baseline to 3 months

Title

Professional functioning

Description

The Maslach Burnout Inventory

Time Frame

Baseline to 3 months

Title

perceived social support

Description

Quality of Social Support Scale

Time Frame

Baseline to 3 months

Title

Parenting stress

Description

Parenting Stress Inventory

Time Frame

Baseline to 3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cynthia Stonnington, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32627860

Citation

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.

Results Reference

derived

PubMed Identifier

28410972

Citation

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.

Results Reference

derived

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Fostering Resilience in Physician Moms

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