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Perinatal Emotion and Relationships Longitudinal Study (PEARLS)

27. marts 2020 opdateret af: Sona Dimidjian, University of Colorado, Boulder
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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80309
        • University of Colorado Boulder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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).

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Colorado, Boulder

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Sona Dimidjian, PhD, University of Colorado, Boulder
  • Ledende efterforsker: June Gruber, PhD, University of Colorado, Boulder

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2015

Primær færdiggørelse (Faktiske)

1. januar 2018

Studieafslutning (Faktiske)

1. januar 2018

Datoer for studieregistrering

Først indsendt

17. januar 2017

Først indsendt, der opfyldte QC-kriterier

17. januar 2017

Først opslået (Skøn)

20. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 49683

Plan for individuelle deltagerdata (IPD)

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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