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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00951717 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Depression, Postpartum Depression |
Behavioral: Behavioral education intervention |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Preparation and Patient Education to Reduce Postpartum Depressive Symptoms |
| Estimated Enrollment: | 530 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment as usual: No Intervention
Participants will receive standard postpartum education and discharge materials provided by the hospital and a list of community and Internet resources by mail.
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Behavioral education: Experimental
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
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| United States, New York | |
| Mount Sinai Hospital | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Amy N. Balbierz, MPH 212-659-9187 amy.balbierz@mountsinai.org | |
| Principal Investigator: Elizabeth A. Howell, MD, MPP | |
| Principal Investigator: | Elizabeth Howell, MD, MPP | Mount Sinai School of Medicine |
More Information
| Responsible Party: | Mount Sinai School of Medicine ( Elizabeth A. Howell, MD, MPP ) |
| Study ID Numbers: | R01 MH077683, DSIR 83-ATP |
| Study First Received: | August 3, 2009 |
| Last Updated: | August 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00951717 History of Changes |
| Health Authority: | United States: Federal Government |
|
Postpartum Depressive Symptoms Physical Symptoms Emotional Symptoms |
Infant Colic Social Support Breastfeeding |
|
Pregnancy Complications Depression Puerperal Disorders Depression, Postpartum |
Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |