Perinatal Emotion and Relationships Longitudinal Study

NCT03027037 | Completed

• 1 other identifier: 49683
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• John Templeton Foundation: collaborator
• Emory University: collaborator
• University of Michigan: collaborator
• Columbia University: collaborator
• Queen's University: collaborator

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sona Dimidjian, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

• June Gruber, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 20, 2017
• Study Start: November 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)