Perinatal Emotion and Relationships Longitudinal Study (PEARLS)

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.

Study Overview

• Status: Completed
• Conditions: Depression, Postpartum

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • University of Colorado Boulder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This study will include up to 200 pregnant adult women over the age of 18 across the United States. Two roughly equal groups of participants will be recruited: women with a history of major depressive disorder, currently in remission (MDD) and healthy controls with no current or lifetime history of mental illness (CTL).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder
• Collaborators: Columbia University; University of Michigan; Emory University; Queen's University; John Templeton Foundation
• Investigators: Principal Investigator: Sona Dimidjian, PhD, University of Colorado, Boulder; Principal Investigator: June Gruber, PhD, University of Colorado, Boulder

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 49683

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No