PREPP: Preventing Postpartum Depression

NCT ID: NCT03283254

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-12
• Study Completion Date: 2024-02-28

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 3 coaching sessions and 2 check-in sessions 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.

Conditions

Postpartum Depression (PPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Practical Resources for Effective Postpartum (PREPP)

A psychotherapeutic preventive intervention that involves psychoeducation and cognitive behavioral techniques.

Group Type: EXPERIMENTAL

Practical Resources for Effective Postpartum Parenting (PREPP)

Intervention Type: BEHAVIORAL

A preventive psychotherapy intervention for PPD: Participants in this arm of the study receive PREPP (Practical Resources for Effective Postpartum Parenting). PREPP is a brief preventive intervention for Postpartum Depression that focuses on the birthing parent-infant dyad and consists of 5 sessions that take place during pregnancy through 6 weeks postpartum carried out by study clinicians referred to as 'coaches.' The sessions of this preventive psychotherapy are comprised of three components: (a) mindfulness and self-reflection skills, (b) parenting skills and (c) psycho-education.

Enhanced Treatment as Usual

Psychoeducation about Postpartum Depression, referral to treatment in the community and monitoring

Group Type: ACTIVE_COMPARATOR

Enhanced Treatment As Usual (ETAU)

Intervention Type: BEHAVIORAL

Psychoeducation, Clinical Assessment, Potential Referral: Participants receive "usual care" along with Postpartum Depression psychoeducation and enhanced support for finding perinatal mental healthcare treatment when appropriate by meeting with a study clinician specifically assigned to provide ETAU in this study at three times that are aligned with PREPP sessions that span from pregnancy to 6 weeks postpartum. At the first contact, participants meet with their assigned ETAU clinician and are given information about PPD, a brief clinical mental health assessment, and a referral for treatment if warranted or requested; the second session is a follow-up mental health clinical assessment with the study clinician and a referral for treatment if warranted or requested; at the third session, participants meet again with their study clinician and receive a mental health assessment, review relevant psychoeducation on PPD and are referred to treatment when appropriate.

Interventions

Practical Resources for Effective Postpartum Parenting (PREPP)

A preventive psychotherapy intervention for PPD: Participants in this arm of the study receive PREPP (Practical Resources for Effective Postpartum Parenting). PREPP is a brief preventive intervention for Postpartum Depression that focuses on the birthing parent-infant dyad and consists of 5 sessions that take place during pregnancy through 6 weeks postpartum carried out by study clinicians referred to as 'coaches.' The sessions of this preventive psychotherapy are comprised of three components: (a) mindfulness and self-reflection skills, (b) parenting skills and (c) psycho-education.

Intervention Type: BEHAVIORAL

Enhanced Treatment As Usual (ETAU)

Psychoeducation, Clinical Assessment, Potential Referral: Participants receive "usual care" along with Postpartum Depression psychoeducation and enhanced support for finding perinatal mental healthcare treatment when appropriate by meeting with a study clinician specifically assigned to provide ETAU in this study at three times that are aligned with PREPP sessions that span from pregnancy to 6 weeks postpartum. At the first contact, participants meet with their assigned ETAU clinician and are given information about PPD, a brief clinical mental health assessment, and a referral for treatment if warranted or requested; the second session is a follow-up mental health clinical assessment with the study clinician and a referral for treatment if warranted or requested; at the third session, participants meet again with their study clinician and receive a mental health assessment, review relevant psychoeducation on PPD and are referred to treatment when appropriate.

Intervention Type: BEHAVIORAL

Other Intervention Names

PREPP; ETAU

Eligibility Criteria

Inclusion Criteria

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

2. A score of ≥19 on the Predictive Index of Postnatal Depression (PIPD), indicating risk for developing postpartum depression or score of ≥7 on the Edinburgh Postnatal Depression Scale

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Catherine Monk

Diana Vagelos Professor of Women's Mental Health (in Obstetrics and Gynecology and Psychiatry)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine Monk, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Elizabeth Werner, PhD

Role: STUDY_DIRECTOR

Columbia University

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HD092062

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7428

Identifier Type: OTHER

Identifier Source: secondary_id

AAAV4354

Identifier Type: -

Identifier Source: org_study_id