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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preparation and Patient Education to Reduce Postpartum Depressive Symptoms

Conditions
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Depression, Postpartum, Depression

Intervention / Treatment
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* Behavioral: Behavioral education intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual<br>Participants will receive standard postpartum education and discharge materials provided by the hospital and a list of community and Internet resources by mail. | |
| Experimental: Behavioral education<br>Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail. | Behavioral: Behavioral education intervention<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms |  | Measured at baseline | 
| Depressive symptoms |  | Measured at 3 weeks | 
| Depressive symptoms |  | Measured at 3 months | 
| Depressive symptoms |  | Measured at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding continuation rate |  | Measured at baseline | 
| Breastfeeding continuation rate |  | Measured at 3 weeks | 
| Breastfeeding continuation rate |  | Measured at 3 months | 
| Breastfeeding continuation rate |  | Measured at 6 months | 
| Physical functioning |  | Measured at baseline | 
| Physical functioning |  | Measured at 3 weeks | 
| Physical functioning |  | Measured at 3 months | 
| Physical functioning |  | Measured at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Depressive Symptoms, Physical Symptoms, Emotional Symptoms, Infant Colic, Social Support, Breastfeeding