Stress, PsychologicalNCT02540473
Fostering Resilience in Physician Moms
A study testing Manualized Therapy in people with Stress, Psychological, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Manualized Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- This study does not include children.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stress, Psychological
- Being tested
- Manualized Therapy, Control Group
- Keywords
- Resilience
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manualized TherapyBehavioural
Relational psychotherapy mothers
Control GroupBehavioural
one hour of free time to do with as they wish
| Study group | Role | What they receive |
|---|---|---|
| Group therapy | Experimental | 12 week manualized group therapy (one hour per week) Receives: Behavioral: Manualized Therapy |
| Control Group | Other | Participants get one hour of time away from patient care/duties to do as they wish. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of depression
Beck Depression Inventory
Measured: Baseline to 3 months
Secondary outcomes (5)
biomarker of stress
C-reactive protein
Measured: Baseline to 3 months
biomarker of stress
nerve-growth factor
Measured: Baseline to 3 months
Professional functioning
The Maslach Burnout Inventory
Measured: Baseline to 3 months
perceived social support
Quality of Social Support Scale
Measured: Baseline to 3 months
Parenting stress
Parenting Stress Inventory
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Cynthia M. Stonnington, M.D., Mayo Clinic
- Investigators
- Cynthia Stonnington, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540473
- Sponsor's protocol ID
- 14-009196
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2015
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32627860Luthar 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.
PubMed 28410972
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Resilience: An Intervention for Women Physicians at Risk for Burnout
- ClinicalTrials.gov ID
- NCT02540473
- Acronym / sponsor ID
- 14-009196
- Conditions
- Stress, Psychological
- Keywords
- Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- Feb 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group therapy | Experimental | Behavioral: Manualized Therapy12 week manualized group therapy (one hour per week) |
| Control Group | Other | Behavioral: Control GroupParticipants get one hour of time away from patient care/duties to do as they wish. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- This study does not include children.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manualized TherapyRelational psychotherapy mothers | Behavioural | Group therapy |
| Control Groupone hour of free time to do with as they wish | Behavioural | Control Group |
Primary outcome
level of depression
Time frame: Baseline to 3 months
Beck Depression Inventory
5 secondary outcomes
biomarker of stress
Time frame: Baseline to 3 months
biomarker of stress
Time frame: Baseline to 3 months
Professional functioning
Time frame: Baseline to 3 months
perceived social support
Time frame: Baseline to 3 months
Parenting stress
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Derived from this study: PubMed 32627860Kunzler 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.
- Derived from this study: PubMed 28410972Luthar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Stonnington, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manualized Therapy in people with Stress, Psychological, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of depression (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02540473, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.