Using a Preparation and Education Intervention to Reduce Postpartum Depression Among New Mothers (The MADE IT 2 Study)

Not Applicable

Completed

• Conditions: Depression, Postpartum; Depression
• Interventions: Behavioral: Behavioral education intervention

• Registration Number: NCT00951717
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-18
• Last Update Posted: 2011-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 590

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral education	Behavioral education intervention	Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail.

Primary Outcome Measures

Name	Time	Method
Depressive symptoms	Measured at 6 months

Secondary Outcome Measures

Name	Time	Method
Breastfeeding continuation rate	Measured at 6 months
Physical functioning	Measured at 6 months

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States