PREPP: Preventing Postpartum Depression

  • STATUS
    Recruiting
  • End date
    Aug 10, 2022
  • participants needed
    300
  • sponsor
    New York State Psychiatric Institute
Updated on 23 March 2021
behavior therapy
prenatal
depressed mood
psychotherapy

Summary

The primary aim of this study is to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2) improve the quality of the mother-infant interaction and subsequent child development. Specifically, the study team will investigate: (1) the effectiveness of the intervention compared to usual care; (2) if the effects of the intervention can be detected in the assessments of the quality of mother-infant interaction; (3) if there are prenatal and/or postnatal biomarkers that can help identify infants whose behavior is more likely to play a role in their mothers' depression; (4) if these markers differentiate which infants will be most responsive to the intervention(s); and (5), if assessments of brain function at birth and at 4-6 weeks of age provide biological nodal points for identifying the effects of the intervention on infant brain development. Participants will be recruited during their 2nd trimester, and will be randomly separated into one of two groups: a group that receives coaching in parenting techniques (4 in-person coaching sessions and 1 phone session) or one that receives treatment as usual.

Description

Of the nearly 4 million mothers delivering live births each year in the United States, approximately 560,000 - or 14% - will develop major or minor depression within the first four months postpartum, when the rate peaks. This number dwarfs prevalence rates for gestational diabetes (2-5%) and is comparable to preterm birth (11.4%). Postpartum depression (PPD) has substantial consequences: poorer maternal quality of life, significant emotional suffering, and suicide risk. PPD predicts diminished mother-infant bonding, and poor outcomes in social-emotional and, in some groups, cognitive development. PPD is undertreated in part because women are reluctant to seek treatment due to the stigma associated with mental health care, logistical barriers to at-tending added health care appointments, and disinclination to take medications while breastfeeding. Of preventive interventions, few embed services in obstetrical care or leverage the unique mother-infant dyadic orientation of the childbearing period. The investigators developed a novel intervention based on the conceptualization of maternal depression as a potential disorder of the mother-infant dyad, and one that can be approached through psychological and behavioral changes in the mother - commencing before birth - that affect her and the child. PREPP (Practical Resources for Effective Postpartum Parenting) enrolls distressed pregnant women at risk for PPD, spans late pregnancy to the 6 week postpartum check up, comprises four in-person 'coaching' sessions adjunctive to obstetrical (OB) prenatal and postnatal appointments, one phone session, and imparts (a) mindfulness and self-reflection skills, (b) parenting skills, and (c) psycho-education.

The primary aim of this study is to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2) improve the quality of the mother-infant interaction and subsequent child development.

Details
Condition Postpartum depression, Post-Partum Depression, Post-Partum Depression
Treatment Practical Resources for Effective Postpartum Parenting, Enhanced Treatment As Usual
Clinical Study IdentifierNCT03283254
SponsorNew York State Psychiatric Institute
Last Modified on23 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy pregnant women between 18-45 years old (based on self report)
A score of 21 on the Predictive Index of Postnatal Depression (PIPD), indicating risk for developing postpartum depression
A healthy, singleton pregnancy (based on self report)
English speaking (based on self report)
Receiving standard prenatal care (based on self report)

Exclusion Criteria

Multi-fetal pregnancy (based on self-report)
Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)
Acute medical illness or significant pregnancy complication (based on self-report)
Currently in weekly, individual psychotherapy, including psychopharmacology (based on self report)
Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)
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