Clinical trial NCT01312883: Mothers Avoiding Depression Through Empowerment Intervention Trial
Official title: Center for Achieving and Sustaining Improved Health in Harlem: Patient Education to Reduce Postpartum Depressive Symptoms Among Minority Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2011-03-11
Enrollment: 540
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: Postpartum depressive symptoms are a major health problem that affects hundreds of women annually. The investgators propose to test an intervention to reduce postpartum depressive symptoms and prevent elevated levels of depressive symptoms in postpartum mothers by preparing and educating women about specific situational triggers of depressive symptoms, by bolstering personal and social resources, by enhancing self-management skills to buffer postpartum demands, and by increasing access to existing healthcare and community resources available to postpartum mothers.

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 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 Black/African American or Hispanic/Latina; White or minority other than Black/African American or Hispanic/Latina will be referred to a parallel study with the same protocol at Mount Sinai Hospital
* Speaks English or Spanish
* Has a working telephone

Primary outcomes:
measure: The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women.
timeFrame: Measured at baseline
measure: The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women.
timeFrame: Measured at 3 weeks postpartum
measure: The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women.
timeFrame: Measured at 3 months postpartum
measure: The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women.
timeFrame: Measured at 6 months postpartum
Secondary outcomes:
measure: Breastfeeding continuation rate and Physical functioning
timeFrame: Measured at baseline and after 3 weeks, 3 months, and 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 A 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, Parides M, Bickell N. An intervention to extend breastfeeding among black and Latina mothers after delivery. Am J Obstet Gynecol. 2014 Mar;210(3):239.e1-5. doi: 10.1016/j.ajog.2013.11.028. Epub 2013 Nov 18.
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.
citation: Howell EA, Balbierz A, Wang J, Parides M, Zlotnick C, Leventhal H. Reducing postpartum depressive symptoms among black and Latina mothers: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):942-9. doi: 10.1097/AOG.0b013e318250ba48.