Mothers Avoiding Depression Through Empowerment Intervention Trial

Not Applicable

Completed

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

• Registration Number: NCT01312883
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Postpartum depressive symptoms are a major health problem that affects hundreds of women annually. The investgators propose to test an intervention to reduce postpartum depressive symptoms and prevent elevated levels of depressive symptoms in postpartum mothers by preparing and educating women about specific situational triggers of depressive symptoms, by bolstering personal and social resources, by enhancing self-management skills to buffer postpartum demands, and by increasing access to existing healthcare and community resources available to postpartum mothers.

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 survey with a research assistant about their health, mood, and basic demographic information.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Status Verified: 2011-03
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-09
• Last Update Submitted: 2011-03-09
• Study First Posted: 2011-03-11
• Last Update Posted: 2011-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 540

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 Black/African American or Hispanic/Latina; White or minority other than Black/African American or Hispanic/Latina will be referred to a parallel study with the same protocol at Mount Sinai Hospital
• Speaks English or Spanish
• 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
The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women.	Measured at 6 months postpartum

Secondary Outcome Measures

Name	Time	Method
Breastfeeding continuation rate and Physical functioning	Measured at baseline and after 3 weeks, 3 months, and 6 months

Trial Locations

Locations (1)

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