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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03027037
Other study ID # 49683
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2015
Est. completion date January 2018

Study information

Verified date March 2020
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Colorado Boulder Boulder Colorado

Sponsors (6)

Lead Sponsor Collaborator
University of Colorado, Boulder Columbia University, Emory University, John Templeton Foundation, Queen's University, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of mood episodes and anxiety disorders Assessed via interview Throughout study (pregnancy to 6 months postpartum)
Primary Mood and anxiety symptoms Assessed via questionnaires Throughout study (pregnancy to 6 months postpartum)
Primary Emotion reactivity and regulation Assessed via questionnaires, experimental tasks, and physiological measurement Throughout study (pregnancy to 6 months postpartum)
Primary Empathic accuracy Assessed via experimental tasks Throughout study (pregnancy to 6 months postpartum)
Primary Prosocial behavior Assessed via questionnaires and experimental tasks Throughout study (pregnancy to 6 months postpartum)
Primary Well-being and social support Assessed via questionnaires Throughout study (pregnancy to 6 months postpartum)
Primary Parenting sensitivity, efficacy, stress, bond with infant Assessed via questionnaires and behavioral observation Throughout study (pregnancy to 6 months postpartum)
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