We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Depression Prevention for Pregnant Women on Public Assistance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00601757
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : January 31, 2014
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Caron Zlotnick, Women and Infants Hospital of Rhode Island

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.

Condition or disease Intervention/treatment Phase
Depression, Postpartum Depression Behavioral: The Postpartum Prevention Program (PPP) Behavioral: Enhanced care as usual (ECU) Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Depression Intervention for Financially Disadvantaged Pregnant Women.
Study Start Date : January 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Participants assigned to the Postpartum Prevention Program
Behavioral: The Postpartum Prevention Program (PPP)
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.

Participants assigned to enhanced care as usual
Behavioral: Enhanced care as usual (ECU)
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 Measures :
  1. Longitudinal Interval Follow-up Examination (LIFE) [ Time Frame: Measured at Months 3, 6, and 12 postpartum ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601757

Layout table for location information
United States, Rhode Island
Womens' Care Inc.
Providence, Rhode Island, United States, 02903
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Thundermist Health Center
Woonsocket, Rhode Island, United States, 02895
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
National Institute of Mental Health (NIMH)
Layout table for investigator information
Principal Investigator: Caron Zlotnick, PhD Women and Infants Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Caron Zlotnick, Director of Behavioral Medicine Research, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00601757    
Other Study ID Numbers: R01MH071766 ( U.S. NIH Grant/Contract )
R01MH071766 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014
Keywords provided by Caron Zlotnick, Women and Infants Hospital of Rhode Island:
Preventive Intervention
Postpartum Depression
Women on Public Assistance
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression, Postpartum
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications