跳至主要内容
临床试验/NCT01312883
NCT01312883已完成不适用

Center for Achieving and Sustaining Improved Health in Harlem: Patient Education to Reduce Postpartum Depressive Symptoms Among Minority Women

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
540
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

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.

时间窗: Measured at 6 months postpartum

次要结局

  • Breastfeeding continuation rate and Physical functioning(Measured at baseline and after 3 weeks, 3 months, and 6 months)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Mothers Avoiding Depression Through Empowerment... | 临床试验