Clinical trial NCT00951717: Using a Preparation and Education Intervention to Reduce Postpartum Depression Among New Mothers (The MADE IT 2 Study)
Official title: Preparation and Patient Education to Reduce Postpartum Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Depression
Keywords: Postpartum Depressive Symptoms
Physical Symptoms
Emotional Symptoms
Infant Colic
Social Support
Breastfeeding
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-08-04
Enrollment: 590
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptoms
timeFrame: Measured at baseline
measure: Depressive symptoms
timeFrame: Measured at 3 weeks
measure: Depressive symptoms
timeFrame: Measured at 3 months
measure: Depressive symptoms
timeFrame: Measured at 6 months
Secondary outcomes:
measure: Breastfeeding continuation rate
timeFrame: Measured at baseline
measure: Breastfeeding continuation rate
timeFrame: Measured at 3 weeks
measure: Breastfeeding continuation rate
timeFrame: Measured at 3 months
measure: Breastfeeding continuation rate
timeFrame: Measured at 6 months
measure: Physical functioning
timeFrame: Measured at baseline
measure: Physical functioning
timeFrame: Measured at 3 weeks
measure: Physical functioning
timeFrame: Measured at 3 months
measure: Physical functioning
timeFrame: Measured at 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Elizabeth Howell, MD, MPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bodnar-Deren S, Klipstein K, Fersh M, Shemesh E, Howell EA. Suicidal Ideation During the Postpartum Period. J Womens Health (Larchmt). 2016 Dec;25(12):1219-1224. doi: 10.1089/jwh.2015.5346. Epub 2016 May 26.
citation: Balbierz A, Bodnar-Deren S, Wang JJ, Howell EA. Maternal depressive symptoms and parenting practices 3-months postpartum. Matern Child Health J. 2015 Jun;19(6):1212-9. doi: 10.1007/s10995-014-1625-6.
citation: Howell EA, Bodnar-Deren S, Balbierz A, Loudon H, Mora PA, Zlotnick C, Wang J, Leventhal H. An intervention to reduce postpartum depressive symptoms: a randomized controlled trial. Arch Womens Ment Health. 2014 Feb;17(1):57-63. doi: 10.1007/s00737-013-0381-8. Epub 2013 Sep 10.
citation: Negron R, Martin A, Almog M, Balbierz A, Howell EA. Social support during the postpartum period: mothers' views on needs, expectations, and mobilization of support. Matern Child Health J. 2013 May;17(4):616-23. doi: 10.1007/s10995-012-1037-4.