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

Preparation and Patient Education to Reduce Postpartum Depressive Symptoms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00951717
Enrollment
590
Registered
2009-08-04
Start date
2009-07-31
Completion date
2010-10-31
Last updated
2011-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Depression, Postpartum

Keywords

Postpartum Depressive Symptoms, Physical Symptoms, Emotional Symptoms, Infant Colic, Social Support, Breastfeeding

Brief 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.

Detailed 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.

Interventions

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Depressive symptomsMeasured at baseline

Secondary

MeasureTime frame
Breastfeeding continuation rateMeasured at baseline
Physical functioningMeasured at baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026