Clinical trial NCT03283254: PREPP: Preventing Postpartum Depression
Official title: Preventing Postpartum Depression: A Dyadic Approach Adjunctive to Obstetric Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression (PPD)
Keywords: Postpartum Depression Treatment
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-09-14
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: One receives PREPP prevention intervention and the other group receives Enhanced Treatment as Usual (psychoeducation about Postpartum Depression, referral and monitoring)
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Score on the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Through the 4th Month Postpartum
measure: Score on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Through the 4th Month Postpartum
measure: Score on HRSD-24
timeFrame: Through the 4th Month Postpartum
measure: Score on the PHQ-9
timeFrame: Through the 4th Month Postpartum
measure: Hamilton Anxiety Scale (HRSA)
timeFrame: Through the 4th Month Postpartum
measure: Sleep Efficiency (SEact)
timeFrame: Through the 4th Month Postpartum
Secondary outcomes:
measure: Score on Brief Infant Sleep Questionnaire (BISQ) (baby)
timeFrame: Through the 4th Month Postpartum
measure: Cry Behavior (baby)
timeFrame: Through the 4th Month Postpartum
measure: Sleep Behavior (baby)
timeFrame: Through the 4th Month Postpartum
measure: Total Sleep Time (TSTact) (mother)
timeFrame: Through the 4th Month Postpartum
Other outcomes:
measure: Total Number of Sleep Hours reported on the Self-Reported Sleep Log (mother)
timeFrame: Through the 4th Month Postpartum
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University
name: Catherine Monk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Elizabeth Werner, PhD
role: STUDY_DIRECTOR
References: