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Depression Prevention for Pregnant Women on Public Assistance

Primary Purpose

Depression, Postpartum, Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
The Postpartum Prevention Program (PPP)
Enhanced care as usual (ECU)
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression, Postpartum focused on measuring Preventive Intervention, Postpartum Depression, Women on Public Assistance

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Womens' Care Inc.
  • Women and Infants Hospital
  • Thundermist Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Participants assigned to the Postpartum Prevention Program

Participants assigned to enhanced care as usual

Outcomes

Primary Outcome Measures

Longitudinal Interval Follow-up Examination (LIFE)

Secondary Outcome Measures

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

Full Information

First Posted
January 22, 2008
Last Updated
January 29, 2014
Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00601757
Brief Title
Depression Prevention for Pregnant Women on Public Assistance
Official Title
Depression Intervention for Financially Disadvantaged Pregnant Women.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Postpartum depression (PPD) occurs in approximately 10% to 16% of mothers who have recently delivered babies. The impact of PPD is profound, causing considerable emotional pain for the mother as well as possible disturbances in infant development and later child adjustment. If left untreated, the mother's depression may cause strain on family life and her relationship with her child. Further research is needed to discover treatments to effectively reduce the risk of experiencing PPD. Despite preliminary findings that suggest that psychosocial treatments may prevent postpartum mood disturbances, few studies have examined the effects of preventive therapy to reduce PPD in women at risk for PPD. An area of even greater neglect is the testing of such a treatment for financially disadvantaged women, who represent a group at high risk for PPD and a group less likely to access treatment for depression than middle-class women. The Postpartum Prevention Program (PPP), an interpersonal therapy program targeting factors that may play a significant role in the development of PPD, may be helpful in reducing the occurrence of PPD. This study will compare the effectiveness of PPP to enhanced care as usual (ECU) in preventing PPD in financially disadvantaged women who are pregnant. Participation in this single-blind study will last until 1 year after delivery. All potential participants will answer an initial questionnaire concerning stresses that may increase the risk of depression, including relationship and emotional difficulties. Selected participants will then undergo an interview about symptoms of depression, emotional difficulties, and alcohol and drug use. Participants identified as having depression will be provided appropriate referrals for treatment and their study participation will end. Participants invited to continue with the study will be randomly assigned to receive PPP or ECU. Participants assigned to receive PPP will attend four weekly 90-minute group sessions prior to delivery and one individual 50-minute booster session within 2 weeks of delivery. During these sessions, participants will learn ways to manage stress and negative feelings and how to access social support resources. Participants assigned to ECU will receive the usual medical care provided for pregnant women, educational material on PPD, and a list of referrals and resources. All participants will complete questionnaires and interviews about their emotional difficulties, relationships with others, and use of services for these difficulties prior to treatment assignment; 4 weeks after treatment assignment; 3 weeks after delivery; and 3, 6, and 12 months after delivery. Participants will also be seen briefly at the hospital at the time of delivery and 3, 6, and 12 months after delivery to assess mother-infant relationships. All questionnaires and assessments will take between 60 and 90 minutes to complete.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum, Depression
Keywords
Preventive Intervention, Postpartum Depression, Women on Public Assistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Participants assigned to the Postpartum Prevention Program
Arm Title
2
Arm Type
Other
Arm Description
Participants assigned to enhanced care as usual
Intervention Type
Behavioral
Intervention Name(s)
The Postpartum Prevention Program (PPP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced care as usual (ECU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Longitudinal Interval Follow-up Examination (LIFE)
Time Frame
Measured at Months 3, 6, and 12 postpartum
Secondary Outcome Measure Information:
Title
Adjustment disorder or depression not otherwise specified (NOS) as measured by the Structured Clinical Interview for DSM Disorders (SCID)
Time Frame
Measured within Month 6 postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caron Zlotnick, PhD
Organizational Affiliation
Women and Infants Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Womens' Care Inc.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Thundermist Health Center
City
Woonsocket
State/Province
Rhode Island
ZIP/Postal Code
02895
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26454186
Citation
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.
Results Reference
derived

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Depression Prevention for Pregnant Women on Public Assistance

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