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Interpersonal Therapy Program for Preventing Postpartum Depression

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Interpersonal Therapy Program for Preventing Postpartum Depression
Official Title  Depression Intervention for Pregnant Women
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.

Study Phase Phase II
Study Type  Interventional
Study Design  Prevention, Randomized, Open Label, Parallel Assignment
Primary Outcome Measure  Longitudinal Interval Follow-up Examination (LIFE) [ Time Frame: Measured at Months 3, 6, and 12 postpartum ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  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 ] [ Designated as safety issue: No ]
Condition  Depression, Postpartum
Depression
Intervention  Behavioral: The Postpartum Prevention Program (PPP)
Behavioral: Enhanced care as usual (ECU)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  240
Start Date  January 2006
Completion Date December 2010
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:

  • Has a high risk pregnancy (e.g., preeclampsia, gestational diabetes, positive HIV serology, multiple gestation)
  • 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)
Gender Female
Ages 18 Years to 40 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Caron Zlotnick, PhD     401-455-6529     caron_zlotnick@brown.edu    
Contact: Toni Amaral     401-865-0687     tamaral@wihri.org    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00601757
Organization ID R01 MH071766
Secondary IDs †† DSIR 83-ATP
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Caron Zlotnick, PhD     Women and Infants Hospital    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  January 22, 2008
Last Updated Date February 8, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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