PREPP: Preventing Postpartum Depression



Status:Recruiting
Conditions:Depression, Depression, Women's Studies
Therapuetic Areas:Psychiatry / Psychology, Reproductive
Healthy:No
Age Range:18 - 45
Updated:1/31/2018
Start Date:October 17, 2017
End Date:August 10, 2022
Contact:Elizabeth Werner, Ph.D.
Email:ew150@cumc.columbia.edu
Phone:6463191008

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Preventing Postpartum Depression: A Dyadic Approach Adjunctive to Obstetric Care

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.

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.

Inclusion Criteria:

1. Healthy pregnant women between 18-45 years old (based on self report)

2. A score of ≥21 on the Predictive Index of Postnatal Depression (PIPD), indicating risk
for developing postpartum depression

3. A healthy, singleton pregnancy (based on self report)

4. English speaking (based on self report)

5. Receiving standard prenatal care (based on self report)

Exclusion Criteria:

1. Multi-fetal pregnancy (based on self-report)

2. Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)

3. Acute medical illness or significant pregnancy complication (based on self-report)

4. Currently in weekly, individual psychotherapy, including psychopharmacology (based on
self report)

5. Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)
We found this trial at
1
site
1150 Saint Nicholas Avenue
New York, New York 10032
Principal Investigator: Catherine Monk, PhD
Phone: 646-774-8945
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from
New York, NY
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