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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02540473
Other study ID # 14-009196
Secondary ID
Status Completed
Phase N/A
First received August 28, 2015
Last updated August 28, 2017
Start date February 2015
Est. completion date December 2016

Study information

Verified date August 2017
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Manualized Therapy
Relational psychotherapy mothers
Control Group
one hour of free time to do with as they wish

Locations

Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary level of depression Beck Depression Inventory Baseline to 3 months
Secondary biomarker of stress C-reactive protein Baseline to 3 months
Secondary biomarker of stress nerve-growth factor Baseline to 3 months
Secondary Professional functioning The Maslach Burnout Inventory Baseline to 3 months
Secondary perceived social support Quality of Social Support Scale Baseline to 3 months
Secondary Parenting stress Parenting Stress Inventory Baseline to 3 months
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