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Identification and Therapy of Postpartum Depression

2013年9月30日 更新者:Katherine Wisner、University of Pittsburgh
This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.

研究概览

详细说明

Depression is a serious illness that can interfere with everyday life. Researchers believe that it is one of the most common complications during and after pregnancy. Depression after pregnancy is called postpartum depression and may be caused by a rapid change in hormone levels during and immediately after pregnancy. Postpartum depression can occur anytime within the first year after childbirth and can negatively affect both mothers and their children. Mothers with postpartum depression may experience low energy, difficulty concentrating, irritability, and inability to meet their children's needs for love and affection. As a result, women with postpartum depression may feel guilty and lose confidence in themselves as parents. Research shows that children of mothers with postpartum depression may have delays in language development, difficulty with emotional bonding to others, behavioral problems, lower activity levels, sleep problems, and distress. This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.

Participants in this single blind study will be randomly assigned to receive either enhanced treatment as usual or telephone-based care management for the first year postpartum. All participants will have a 90-minute in-home interview upon study entry to assess depressive symptoms, functional status, medical history, and post-pregnancy plans. Participants assigned to care management will receive two calls in the first month postpartum, followed by monthly calls for the remainder of the first postpartum year. During each 10- to 20-minute call, participants will be asked to provide information regarding current depressive symptoms, steps they have taken to seek depression-related care, and any barriers they have encountered in the process. In addition, a care manager will act as an advocate for the participants and assist in obtaining specialized services as necessary throughout the year. Participants assigned to receive enhanced treatment as usual will not receive monthly phone calls or tailored care management. All participants will receive follow-up calls at 3, 6, and 12 months postpartum to assess outcome measures; these calls will last about 30 minutes.

研究类型

介入性

注册 (实际的)

628

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • Women's Behavioral HealthCARE Program, Suite 410, 3501 Forbes Ave

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • 4-6 weeks postpartum
  • English-speaking
  • Score of at least 10 on the Edinburgh Postnatal Depression Scale

Exclusion Criteria:

  • DSM-IV diagnosis of bipolar disorder or psychotic episode
  • Active substance abuse within 6 months prior to study entry
  • Has not received obstetrical care
  • History of a suicide attempt within 6 months of study entry

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:塔乌
参与者将照常接受治疗
Participants receive treatment as usual for postpartum depression. Women assigned to this arm receive research assessments at 3, 6, and 12 months postpartum. At the baseline home visit where diagnostic assessments are completed women are given information about community and health plan resources if they choose to seek care for depression symptoms. Women are also given phone contact numbers for the research program.
实验性的:DCM
Participants will receive care management for postpartum depression
Depression Care Manager calls postpartum women and encourages women to seek appropriate depression care. In this context the depression care manager helps the women to identify barriers to appropriate care, her preferred method of care, and resources available. Calls are made initially at 2 calls per month, followed by one call per month and calls every other month for women who are doing well. Women assigned to this group receive research assessments at 3, 6, and 12 months postpartum. They also receive information about community and health plan resources available for women with depression.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Depressive symptoms, social functioning, and health
大体时间:Measured at Months 3, 6, and 12 postpartum
Measured at Months 3, 6, and 12 postpartum
Preferences for depression treatment
大体时间:Measured at baseline and Month 12
Measured at baseline and Month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Katherine L. Wisner, MD, RN、University of Pittsburgh

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年8月1日

初级完成 (实际的)

2012年3月1日

研究完成 (实际的)

2012年3月1日

研究注册日期

首次提交

2006年1月25日

首先提交符合 QC 标准的

2006年1月25日

首次发布 (估计)

2006年1月27日

研究记录更新

最后更新发布 (估计)

2013年10月7日

上次提交的符合 QC 标准的更新

2013年9月30日

最后验证

2013年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • R01MH071825 (美国 NIH 拨款/合同)
  • DSIR 82-SEMS (其他标识符:National Institute of Mental Health)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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