PREPP: Preventing Postpartum Depression

NCT03283254 | Completed Results DMC

• 3 other identifiers: AAAV4354R01HD0920627428
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression (PPD)

Keywords

Postpartum Depression Treatment

Outcome Measures

Primary Outcomes (6)

• Score on the Edinburgh Postnatal Depression Scale (EPDS)

  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)

  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

  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

  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)

  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

  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 Outcomes (7)

• Total Nocturnal Sleep Duration - Brief Infant Sleep Questionnaire (BISQ)

  6 weeks and 16 weeks postpartum

• Total Daytime Sleep Duration - Brief Infant Sleep Questionnaire (BISQ)

  6 weeks and 16 weeks postpartum

• Total Number of Instances of Waking up at Night - Brief Infant Sleep Questionnaire (BISQ)

  6 weeks and 16 weeks postpartum

• Total Settling Time to Fall Asleep for the Night - Brief Infant Sleep Questionnaire (BISQ)

  6 weeks and 16 weeks postpartum

• Daily Minutes of Infant Crying Over 4 Days

  6 weeks and 16 weeks postpartum

Other Outcomes (1)

• Total Daily Minutes of Sleep Reported on the Self-Reported Sleep Log (Mother)

  28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum

Study Arms (2)

Practical Resources for Effective Postpartum (PREPP)

EXPERIMENTAL

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

Behavioral: Practical Resources for Effective Postpartum Parenting (PREPP)

Enhanced Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Enhanced Treatment As Usual (ETAU)

Interventions

Practical Resources for Effective Postpartum Parenting (PREPP) 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.

Also known as: PREPP

Practical Resources for Effective Postpartum (PREPP)

Enhanced Treatment As Usual (ETAU) 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.

Also known as: ETAU

Enhanced Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women between 18-45 years old (based on self report)
• 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
• A healthy, singleton pregnancy (based on self report)
• English speaking (based on self report)
• Receiving standard prenatal care (based on self report)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Columbia University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Elizabeth Werner, Ph.D.
• Organization: Columbia University

ew150@cumc.columbia.edu

646-774-8945

Study Officials

• Catherine Monk, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Elizabeth Werner, PhD

  Columbia University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person administering the outcome measures is blind to participant group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diana Vagelos Professor of Women's Mental Health (in Obstetrics and Gynecology and Psychiatry)

Model Details: Two groups: One receives PREPP prevention intervention and the other group receives Enhanced Treatment as Usual (psychoeducation about Postpartum Depression, referral and monitoring)

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: September 14, 2017
• Study Start: February 12, 2018
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: September 26, 2025
• Results First Posted: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After the completion of the study
• Access Criteria: Permission of the PI

Locations

US (1)