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PREPP: Preventing Postpartum Depression (PREPP)

Primary Purpose

Postpartum Depression

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Practical Resources for Effective Postpartum Parenting
Enhanced Treatment As Usual
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression focused on measuring Postpartum Depression Treatment

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.)

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Practical Resources for Effective Postpartum (PREPP)

Enhanced Treatment as Usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postpartum Depression Symptoms
Postpartum Depression Symptoms measured by Edinburgh Postnatal Depression Scale

Secondary Outcome Measures

Improved Sleep
Improved self-report of sleep quality on Pittsburgh Sleep Quality Index and improved sleep shown on actigraphy monitor
Infant Behavior
Cry behavior and sleep behavior measured by The Baby Day Diary
Greater infant left frontal EEG power reflecting sleep spindle activity
More positive perceptions and objective assessments of maternal postpartum sleep efficiency will be mediated by greater infant left frontal EEG power reflecting sleep spindle activity and associated longer average durations of infant nocturnal sleep per maternal report and actigraphy.

Full Information

First Posted
August 14, 2017
Last Updated
September 25, 2023
Sponsor
Columbia University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03283254
Brief Title
PREPP: Preventing Postpartum Depression
Acronym
PREPP
Official Title
Preventing Postpartum Depression: A Dyadic Approach Adjunctive to Obstetric Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
The study is paused.
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Postpartum Depression Treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Outcomes Assessor
Masking Description
The person administering the outcome measures is blind to participant group.
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Practical Resources for Effective Postpartum (PREPP)
Arm Type
Experimental
Arm Description
A psychotherapeutic preventive intervention that involves psychoeducation and cognitive behavioral techniques.
Arm Title
Enhanced Treatment as Usual
Arm Type
Active Comparator
Arm Description
Psychoeducation about Postpartum Depression, referral to treatment in the community and monitoring
Intervention Type
Behavioral
Intervention Name(s)
Practical Resources for Effective Postpartum Parenting
Other Intervention Name(s)
PREPP
Intervention Description
A preventive psychotherapy intervention for Postpartum Depression
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Treatment As Usual
Other Intervention Name(s)
ETAU
Intervention Description
Psychoeducation about Postpartum Depression, referral to treatment in the community, clinical monitoring
Primary Outcome Measure Information:
Title
Postpartum Depression Symptoms
Description
Postpartum Depression Symptoms measured by Edinburgh Postnatal Depression Scale
Time Frame
6-16 weeks postpartum
Secondary Outcome Measure Information:
Title
Improved Sleep
Description
Improved self-report of sleep quality on Pittsburgh Sleep Quality Index and improved sleep shown on actigraphy monitor
Time Frame
3rd trimester of pregnancy - 16 weeks postpartum
Title
Infant Behavior
Description
Cry behavior and sleep behavior measured by The Baby Day Diary
Time Frame
6 & 16 weeks postpartum
Title
Greater infant left frontal EEG power reflecting sleep spindle activity
Description
More positive perceptions and objective assessments of maternal postpartum sleep efficiency will be mediated by greater infant left frontal EEG power reflecting sleep spindle activity and associated longer average durations of infant nocturnal sleep per maternal report and actigraphy.
Time Frame
Newborn-6 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy pregnant women between 18-45 years old (based on self report) A score of ≥21 on the Predictive Index of Postnatal Depression (PIPD), indicating risk for developing postpartum depression A healthy, singleton pregnancy (based on self report) English speaking (based on self report) Receiving standard prenatal care (based on self report) Exclusion Criteria: 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Monk, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Werner, PhD
Organizational Affiliation
Columbia University
Official's Role
Study Director
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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PREPP: Preventing Postpartum Depression

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