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Completed

NCT Number: NCT03027037

Perinatal Emotion and Relationships Longitudinal Study

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.

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Key information

Conditions

Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Colorado Boulder

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Occurrence of mood episodes and anxiety disorders

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

    Assessed via interview

  2. Mood and anxiety symptoms

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

    Assessed via questionnaires

  3. Emotion reactivity and regulation

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

    Assessed via questionnaires, experimental tasks, and physiological measurement

  4. Empathic accuracy

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

    Assessed via experimental tasks

  5. Prosocial behavior

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

    Assessed via questionnaires and experimental tasks

  6. Well-being and social support

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

    Assessed via questionnaires

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

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

    Assessed via questionnaires and behavioral observation

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • Columbia University
  • Emory University
  • John Templeton Foundation
  • Queen's University
  • University of Michigan

Registry information

Acronym: PEARLS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 20, 2017
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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