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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 22, 2008 | ||||||||
| Last Updated Date | March 12, 2009 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Longitudinal Interval Follow-up Examination (LIFE) [ Time Frame: Measured at Months 3, 6, and 12 postpartum ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00601757 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Depression Prevention for Pregnant Women on Public Assistance | ||||||||
| Official Title ICMJE | Depression Intervention for Financially Disadvantaged 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. |
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| 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. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Parallel Assignment | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 240 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00601757 | ||||||||
| Responsible Party | Caron Zlotnick, PhD, Women and Infants Hospital | ||||||||
| Study ID Numbers ICMJE | R01 MH071766, DSIR 83-ATP | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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