NCT02540473

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

August 28, 2015

Last Update Submit

August 28, 2017

Conditions

Stress, Psychological

Keywords

Resilience

Outcome Measures

Primary Outcomes (1)

  • level of depression

    Beck Depression Inventory

    Baseline to 3 months

Secondary Outcomes (5)

  • biomarker of stress

    Baseline to 3 months

  • biomarker of stress

    Baseline to 3 months

  • Professional functioning

    Baseline to 3 months

  • perceived social support

    Baseline to 3 months

  • Parenting stress

    Baseline to 3 months

Study Arms (2)

Group therapy

EXPERIMENTAL

12 week manualized group therapy (one hour per week)

Behavioral: Manualized Therapy

Control Group

OTHER

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

Behavioral: Control Group

Interventions

Manualized TherapyBEHAVIORAL

Relational psychotherapy mothers

Group therapy
Control GroupBEHAVIORAL

one hour of free time to do with as they wish

Control Group

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Participation in this study is open to all Mayo physician mothers with a child under the age of 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (2)

  • 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.

    PMID: 32627860DERIVED

  • 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.

    PMID: 28410972DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Cynthia Stonnington, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 4, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

August 30, 2017

Record last verified: 2017-08

Locations

US(1)