CClinicalTrials.gg
CompletedNCT03027037PEARLSUpdated Mar 31, 2020

Perinatal Emotion and Relationships Longitudinal Study

An observational study in Depression, Postpartum, sponsored by University of Colorado, Boulder. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-31.

Sponsored by University of Colorado, Boulder · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression, Postpartum
03

In context

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's enrollment of 150 is below the median of 200 across 88 observational studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

University of Colorado, Boulder is the lead sponsor of 86 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
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).

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Occurrence of mood episodes and anxiety disorders

    Assessed via interview

    Time frame: Throughout study (pregnancy to 6 months postpartum)

  2. Mood and anxiety symptoms

    Assessed via questionnaires

    Time frame: Throughout study (pregnancy to 6 months postpartum)

  3. Emotion reactivity and regulation

    Assessed via questionnaires, experimental tasks, and physiological measurement

    Time frame: Throughout study (pregnancy to 6 months postpartum)

  4. Empathic accuracy

    Assessed via experimental tasks

    Time frame: Throughout study (pregnancy to 6 months postpartum)

  5. Prosocial behavior

    Assessed via questionnaires and experimental tasks

    Time frame: Throughout study (pregnancy to 6 months postpartum)

  6. Well-being and social support

    Assessed via questionnaires

    Time frame: Throughout study (pregnancy to 6 months postpartum)

  7. Parenting sensitivity, efficacy, stress, bond with infant

    Assessed via questionnaires and behavioral observation

    Time frame: Throughout study (pregnancy to 6 months postpartum)

07

Study locations

1 site
  • University of Colorado Boulder
    Boulder, Colorado 80309, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03027037
Lead sponsor
University of Colorado, Boulder
Collaborators
John Templeton Foundation, Emory University, University of Michigan, Columbia University, Queen's University
Responsible party
Sona Dimidjian (Professor and Director, University of Colorado, Boulder) — Principal investigator
First posted
Jan 20, 2017
Start date
Nov 2015
Primary completion
Jan 2018
Completion
Jan 2018
Last update
Mar 31, 2020

Study contacts

Sona Dimidjian, PhD
principal investigator · University of Colorado, Boulder
June Gruber, PhD
principal investigator · University of Colorado, Boulder

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion