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

Depression Clinical Trial

Official title:

Preparation and Patient Education to Reduce Postpartum Depressive Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951717
• Other study ID #: 05-1062
• Secondary ID: R01MH077683DSIR
• Status: Completed
• Phase: N/A
• First received: August 3, 2009
• Last updated: November 18, 2011
• Start date: July 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2011
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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
• Depressive Disorder

Intervention

Behavioral:
• Behavioral education intervention
One education session with a social worker while at the hospital, provision of an educational pamphlet and summary sheet for partner, a needs assessment by the social worker 2 weeks after hospital discharge, and additional patient education and reinforcement of self-management skills, as needed

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms		Measured at baseline	Yes
Primary	Depressive symptoms		Measured at 3 weeks	Yes
Primary	Depressive symptoms		Measured at 3 months	Yes
Primary	Depressive symptoms		Measured at 6 months	Yes
Secondary	Breastfeeding continuation rate		Measured at baseline	Yes
Secondary	Breastfeeding continuation rate		Measured at 3 weeks	Yes
Secondary	Breastfeeding continuation rate		Measured at 3 months	Yes
Secondary	Breastfeeding continuation rate		Measured at 6 months	Yes
Secondary	Physical functioning		Measured at baseline	Yes
Secondary	Physical functioning		Measured at 3 weeks	Yes
Secondary	Physical functioning		Measured at 3 months	Yes
Secondary	Physical functioning		Measured at 6 months	Yes