Perinatal Emotion and Relationships Longitudinal Study (PEARLS)
27. mars 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
150
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Colorado
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Boulder, Colorado, Forente stater, 80309
- University of Colorado Boulder
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.
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Control Group
Women in this group will never have experienced any Diagnostic and Statistical Manual of Mental Disorders, 5th Edition Axis I psychological disorder.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Occurrence of mood episodes and anxiety disorders
Tidsramme: Throughout study (pregnancy to 6 months postpartum)
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Assessed via interview
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Throughout study (pregnancy to 6 months postpartum)
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Mood and anxiety symptoms
Tidsramme: Throughout study (pregnancy to 6 months postpartum)
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Assessed via questionnaires
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Throughout study (pregnancy to 6 months postpartum)
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Emotion reactivity and regulation
Tidsramme: Throughout study (pregnancy to 6 months postpartum)
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Assessed via questionnaires, experimental tasks, and physiological measurement
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Throughout study (pregnancy to 6 months postpartum)
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Empathic accuracy
Tidsramme: Throughout study (pregnancy to 6 months postpartum)
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Assessed via experimental tasks
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Throughout study (pregnancy to 6 months postpartum)
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Prosocial behavior
Tidsramme: Throughout study (pregnancy to 6 months postpartum)
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Assessed via questionnaires and experimental tasks
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Throughout study (pregnancy to 6 months postpartum)
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Well-being and social support
Tidsramme: Throughout study (pregnancy to 6 months postpartum)
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Assessed via questionnaires
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Throughout study (pregnancy to 6 months postpartum)
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Parenting sensitivity, efficacy, stress, bond with infant
Tidsramme: Throughout study (pregnancy to 6 months postpartum)
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Assessed via questionnaires and behavioral observation
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Throughout study (pregnancy to 6 months postpartum)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sona Dimidjian, PhD, University of Colorado, Boulder
- Hovedetterforsker: June Gruber, PhD, University of Colorado, Boulder
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2015
Primær fullføring (Faktiske)
1. januar 2018
Studiet fullført (Faktiske)
1. januar 2018
Datoer for studieregistrering
Først innsendt
17. januar 2017
Først innsendt som oppfylte QC-kriteriene
17. januar 2017
Først lagt ut (Anslag)
20. januar 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. mars 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 49683
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