Mothers Avoiding Depression Through Empowerment Intervention Trial — MADE IT  

Postpartum Depression Clinical Trial

Official title: Center for Achieving and Sustaining Improved Health in Harlem: Patient Education to Reduce Postpartum Depressive Symptoms Among Minority Women

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Postpartum Depression

• NCT number: NCT01312883
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Completion date: October 2010