Perinatal Emotion and Relationships Longitudinal Study

Completed

• Conditions: Depression, Postpartum

• Registration Number: NCT03027037
• Lead Sponsor: University of Colorado, Boulder

Brief 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.

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 Timeline

• Study Start: 2015-11
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Boulder; 🇺🇸 Boulder, Colorado, United States