PREPP: Preventing Postpartum Depression (PREPP)

September 8, 2025 updated by: Catherine Monk, Columbia University

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 3 coaching sessions and 2 check-in sessions or one that receives treatment as usual.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Practical Resources for Effective Postpartum (PREPP)
A psychotherapeutic preventive intervention that involves psychoeducation and cognitive behavioral techniques.
Behavioral: 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.
Other Names:
  • PREPP
Active Comparator: Enhanced Treatment as Usual
Psychoeducation about Postpartum Depression, referral to treatment in the community and monitoring
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.
Other Names:
  • ETAU

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Score on the Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum
Maternal mood: Postpartum Depression Symptoms will be measured by Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item questionnaire that was developed to identify women who have postpartum depression. Items of the scale correspond to various clinical depression symptoms, such as guilt feeling, sleep disturbance, low energy, anhedonia, and suicidal ideation. Overall assessment is done by total score, which is determined by adding together the scores for each of the 10 items. Scores range from 0 to 30, with higher scores indicate more depressive symptoms (worse outcome).
Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum
Score on the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum
Maternal perception of sleep quality: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. A total of 19 individual items generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Scores range from 0 to 21, where lower scores indicate a healthier sleep quality (better outcome).
Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum
Score on HRSD-24
Time Frame: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum
The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The patient is rated on 24 items scored either on a 3-point (0-2) or 5-point (0-4) Likert-type scale. Total scores range from 0 to 74 with a lower score indicating a better outcome.
Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum
Score on the PHQ-9
Time Frame: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum
The nine-item Patient Health Questionnaire (PHQ-9) is a depressive symptom scale and diagnostic tool introduced in 2001 to screen adult patients in primary care settings. The instrument assesses for the presence and severity of depressive symptoms and a possible depressive disorder. It is scored by simply adding up the individual items' scores. Scores range from 0 to 27 with a lower score indicating a better outcome.
Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum
Hamilton Anxiety Scale (HRSA)
Time Frame: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum
The scale consists of 14 items designed to assess the severity of a patient's anxiety. The patient is rated by on 14 items scored on a 5-point (0-4) Likert-type scale. Total scores range from 0 to 56 with a lower score indicating a better outcome.
Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum
Sleep Efficiency (SEact) of the Mothers
Time Frame: 28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum
Sleep Efficiency (SEact) was measured by an activity monitor worn by the participants continuously over 7 days. SEact is reported as a percent of time spent asleep during the total time spent in bed.
28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Nocturnal Sleep Duration - Brief Infant Sleep Questionnaire (BISQ)
Time Frame: 6 weeks and 16 weeks postpartum
The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days
6 weeks and 16 weeks postpartum
Total Daytime Sleep Duration - Brief Infant Sleep Questionnaire (BISQ)
Time Frame: 6 weeks and 16 weeks postpartum
The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days.
6 weeks and 16 weeks postpartum
Total Number of Instances of Waking up at Night - Brief Infant Sleep Questionnaire (BISQ)
Time Frame: 6 weeks and 16 weeks postpartum
The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days.
6 weeks and 16 weeks postpartum
Total Settling Time to Fall Asleep for the Night - Brief Infant Sleep Questionnaire (BISQ)
Time Frame: 6 weeks and 16 weeks postpartum
The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days.
6 weeks and 16 weeks postpartum
Daily Minutes of Infant Crying Over 4 Days
Time Frame: 6 weeks and 16 weeks postpartum
Cry behavior will be measured by The Baby Day Diary, which is a 24-hour diary of infant and parental behavior for days. The number of minutes for the crying behavior is averaged over a span of 4 days, with a higher number indicating a worse outcome.
6 weeks and 16 weeks postpartum
Length of Longest Sleep at Night for Infants Over 4 Days
Time Frame: 6 weeks and 16 weeks postpartum
Sleep behavior will be measured by The Baby Day Diary, which is a 24-hour diary of infant and parental behavior for days. The number of minutes of sleep is averaged over a span of 4 days. A higher number indicates a better outcome.
6 weeks and 16 weeks postpartum
Total Sleep Time (TSTact) in the Mothers
Time Frame: 28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum
TSTact was measured by an activity monitor worn by the participants continuously over 7 days.
28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Daily Minutes of Sleep Reported on the Self-Reported Sleep Log (Mother)
Time Frame: 28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum
Self-reported sleep time was recorded by participants each night over a span of 7 days.
28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Elizabeth Werner, PhD, Columbia University
  • Principal Investigator: Catherine Monk, PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAV4354
  • 7428 (Other Identifier: New York State Psychiatric Institute Institutional Review Board)
  • R01HD092062 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data may be made available to other researchers.

IPD Sharing Time Frame

After the completion of the study

IPD Sharing Access Criteria

Permission of the PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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