NCT00601757

Brief Summary

This study will evaluate the effectiveness of an interpersonal therapy treatment called the Postpartum Prevention Program in preventing the development of postpartum depression in pregnant women who are financially disadvantaged.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

6.9 years

First QC Date

January 22, 2008

Last Update Submit

January 29, 2014

Conditions

Depression, PostpartumDepression

Keywords

Preventive InterventionPostpartum DepressionWomen on Public Assistance

Outcome Measures

Primary Outcomes (1)

  • Longitudinal Interval Follow-up Examination (LIFE)

    Measured at Months 3, 6, and 12 postpartum

Secondary Outcomes (1)

  • Adjustment disorder or depression not otherwise specified (NOS) as measured by the Structured Clinical Interview for DSM Disorders (SCID)

    Measured within Month 6 postpartum

Study Arms (2)

1

OTHER

Participants assigned to the Postpartum Prevention Program

Behavioral: The Postpartum Prevention Program (PPP)

2

OTHER

Participants assigned to enhanced care as usual

Behavioral: Enhanced care as usual (ECU)

Interventions

The Postpartum Prevention Program (PPP)BEHAVIORAL

PPP includes interpersonal therapy sessions as well as distribution of educational material on postpartum depression. The group sessions will take place during the participant's last trimester of pregnancy. There will be four weekly sessions prior to delivery and one booster session within the first 2 weeks of the postpartum period.

1
Enhanced care as usual (ECU)BEHAVIORAL

ECU includes the usual medical care provided for pregnant women at the Women's Primary Care Center at Women and Infants Hospital as well as the provision of educational material and a list of treatment resources for postpartum depression. Participants will also receive more intensive follow-up in terms of their mental health status than is typically provided in usual practice.

2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Speaks and comprehends English sufficiently to complete the study procedures
  • Willing and able to receive public assistance
  • Between 20 and 34 weeks of gestation
  • Score of greater than 27 on the Cooper Risk Survey to identify risk of PPD

You may not qualify if:

  • Currently receiving mental health services from a healthcare provider
  • Meets criteria for a current affective disorder, anxiety disorder (excluding simple phobia), substance use disorder, or psychosis, as determined by the relevant modules of the Structured Clinical Interview for DSM-IV Nonpatient Version (SCID-NP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Womens' Care Inc.

Providence, Rhode Island, 02903, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Thundermist Health Center

Woonsocket, Rhode Island, 02895, United States

Location

Related Publications (1)

  • Zlotnick C, Tzilos G, Miller I, Seifer R, Stout R. Randomized controlled trial to prevent postpartum depression in mothers on public assistance. J Affect Disord. 2016 Jan 1;189:263-8. doi: 10.1016/j.jad.2015.09.059. Epub 2015 Sep 30.

    PMID: 26454186DERIVED

MeSH Terms

Conditions

Depression, PostpartumDepression

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Caron Zlotnick, PhD

    Women and Infants Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Behavioral Medicine Research

Study Record Dates

First Submitted

January 22, 2008

First Posted

January 28, 2008

Study Start

January 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

US(3)