Using a Preparation and Education Intervention to Reduce Postpartum Depression Among New Mothers (The MADE IT 2 Study)
|ClinicalTrials.gov Identifier: NCT00951717|
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : November 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Depression, Postpartum Depression||Behavioral: Behavioral education intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||590 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preparation and Patient Education to Reduce Postpartum Depressive Symptoms|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
No Intervention: Treatment as usual
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
Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail.
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
- Depressive symptoms [ Time Frame: Measured at baseline ]
- Depressive symptoms [ Time Frame: Measured at 3 weeks ]
- Depressive symptoms [ Time Frame: Measured at 3 months ]
- Depressive symptoms [ Time Frame: Measured at 6 months ]
- Breastfeeding continuation rate [ Time Frame: Measured at baseline ]
- Breastfeeding continuation rate [ Time Frame: Measured at 3 weeks ]
- Breastfeeding continuation rate [ Time Frame: Measured at 3 months ]
- Breastfeeding continuation rate [ Time Frame: Measured at 6 months ]
- Physical functioning [ Time Frame: Measured at baseline ]
- Physical functioning [ Time Frame: Measured at 3 weeks ]
- Physical functioning [ Time Frame: Measured at 3 months ]
- Physical functioning [ Time Frame: Measured at 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951717
|United States, New York|
|Mount Sinai Hospital|
|New York, New York, United States, 10029|
|Principal Investigator:||Elizabeth Howell, MD, MPP||Icahn School of Medicine at Mount Sinai|