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Clinical Trials/NCT00951717
NCT00951717
Completed
Not Applicable

Preparation and Patient Education to Reduce Postpartum Depressive Symptoms

Icahn School of Medicine at Mount Sinai1 site in 1 country590 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression, Postpartum
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
590
Locations
1
Primary Endpoint
Depressive symptoms
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

This study will test an intervention that aims to prevent postpartum depression by providing new mothers with information on and resources for dealing with the disorder.

Detailed Description

Postpartum depression (PPD) is a disorder affecting many women after delivery of a child. Up to 50% of mothers may experience some depressive symptoms after giving birth, and up to 25% of them will develop major depressive disorder. Some situational factors that place mothers at risk of PPD may be changed or minimized, including social support, the mother's efficiency in handling situational stress, and distress from physical symptoms. Preparing mothers to identify potential situational triggers of depressive symptoms, enhancing their postpartum self-management skills, and providing them access to the proper social and healthcare resources may prevent them from developing major depression. This study will test the efficacy of a brief intervention that aims to prevent PPD by preparing mothers to deal with stressful triggers and depressive symptoms. This study will last 6 months. Participants will be randomly assigned to receive either treatment as usual or the behavioral education intervention. The intervention will involve two parts. First, after giving birth and while still in the hospital, participants will complete an education session with a social worker and receive written materials about PPD. Then, 2 weeks after discharge from the hospital, participants will receive a call from the social worker, who will conduct a needs assessment that addresses participants' physical and emotional health. If a participant is experiencing distress, the social worker will refer her to appropriate resources and will reinforce self-management skills. All participants will receive a list of community and hospital resources by mail. Study assessments will take place at 3 weeks, 3 months, and 6 months after study entry. At these points, participants will complete a 20-minute phone survey with a research assistant about their health, mood, and basic demographic information.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
October 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient in the Maternity Unit at Mount Sinai Hospital
  • Infant has a birth weight greater than or equal to 2,500 grams
  • Infant has a 5-minute Apgar score greater than or equal to 7
  • Self-identifies as White or minority other than Black or Hispanic; Black and Hispanic women will be referred to a parallel study with the same protocol at Mount Sinai Hospital
  • Speaks English
  • Has a working telephone

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Depressive symptoms

Time Frame: Measured at 6 months

Secondary Outcomes

  • Breastfeeding continuation rate(Measured at 6 months)
  • Physical functioning(Measured at 6 months)

Study Sites (1)

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