Clinical trial NCT03027037: Perinatal Emotion and Relationships Longitudinal Study
Official title: Perinatal Emotion and Relationships Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression, Postpartum
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: John Templeton Foundation
name: Emory University
name: University of Michigan
name: Columbia University
name: Queen's University
First posted: 2017-01-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Occurrence of mood episodes and anxiety disorders
timeFrame: Throughout study (pregnancy to 6 months postpartum)
measure: Mood and anxiety symptoms
timeFrame: Throughout study (pregnancy to 6 months postpartum)
measure: Emotion reactivity and regulation
timeFrame: Throughout study (pregnancy to 6 months postpartum)
measure: Empathic accuracy
timeFrame: Throughout study (pregnancy to 6 months postpartum)
measure: Prosocial behavior
timeFrame: Throughout study (pregnancy to 6 months postpartum)
measure: Well-being and social support
timeFrame: Throughout study (pregnancy to 6 months postpartum)
measure: Parenting sensitivity, efficacy, stress, bond with infant
timeFrame: Throughout study (pregnancy to 6 months postpartum)
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Sona Dimidjian, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Boulder
name: June Gruber, PhD
role: PRINCIPAL_INVESTIGATOR
References: