Perinatal Emotion and Relationships Longitudinal Study

Depression, Postpartum Clinical Trial

— PEARLS  

Official title:

Perinatal Emotion and Relationships Longitudinal Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027037
• Other study ID #: 49683
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Depression, Postpartum

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)