Perinatal Emotion and Relationships Longitudinal Study

NCT ID: NCT03027037

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-01-31

Brief Summary

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This study, funded by the John Templeton Foundation, will examine birth and the early postpartum period (BEPP) as a transformative life experience that may shift women's experience of emotion in such ways as to a) support enhanced other-oriented emotions and b) underlie risk or resilience from psychopathology.

Detailed Description

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Specifically, the study will investigate the extent to which women can accurately have knowledge about and predict changes in self- and other-oriented emotion processes associated with BEPP. The investigators will also characterize the extent to which BEPP changes self- and other-oriented emotion processes and self- and other-oriented social behaviors. Further, the investigators will identify distinct trajectories of change in cognitive processes and self- and other-oriented emotion processes related to BEPP, and examine how those trajectories are associated with psychological adjustment (e.g., risk and relapse of psychopathology). Finally, the investigators will identify which particular features of BEPP are related to distinct patterns of change in self- and other-oriented emotion processes.

Conditions

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Depression, Postpartum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Remitted Major Depression Group

Women in this group will have experienced at least one episode of major depression in their lifetime, but no episodes in the two months prior to study enrollment.

No interventions assigned to this group

Control Group

Women in this group will never have experienced any Diagnostic and Statistical Manual of Mental Disorders, 5th Edition Axis I psychological disorder.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Over age 18
* Female
* Currently pregnant - approximately no more than 34 weeks gestational age
* Able to read and write in English fluently
* MDD Group: Meet DSM-IV/DSM-5 criteria for at least 1 past episode of Major Depressive Disorder
* MDD Group: DO NOT meet DSM-IV/DSM-5 criteria for any episodes of Major Depressive Disorder in past 2 months (currently in symptom remission)

Exclusion Criteria

* Previous birth to a living child (i.e., this pregnancy is not their first child)
* Imminently suicidal or homicidal
* History of severe head trauma, stroke, neurological disease
* History of brain tumors or surgery
* Severe medical illness (e.g., autoimmune disorder, blindness, cardiovascular disease, HIV/AIDS)
* Endocrine disorders (e.g., Cushing's disease, thyroid disorder)
* Alcohol/substance abuse or dependence within the past six months
* Current psychotic episode (impairing ability to consent, participate, or keep patient and experimenter safe)
* Inability to follow study procedures
* CTL Group: Current or lifetime Axis I disorder (i.e., anxiety disorders, major depression, mania/hypomania, dysthymia, schizophrenia, schizoaffective disorder, substance abuse/dependence, eating disorders, hypochondriasis, pain disorder, or adjustment disorders)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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John Templeton Foundation

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role collaborator

University of Colorado, Boulder

OTHER

Sponsor Role lead

Responsible Party

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Sona Dimidjian

Professor and Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sona Dimidjian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

June Gruber, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Locations

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University of Colorado Boulder

Boulder, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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49683

Identifier Type: -

Identifier Source: org_study_id

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