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临床试验/NCT00816725
NCT00816725已完成不适用

Using the Internet for English/Spanish Randomized Trials for Postpartum Depression

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2009年1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
1,000
试验地点
2
主要终点
Edinburgh Postnatal Depression Scale (EPDS)

研究概览

简要总结

The original trial will evaluate the effectiveness of a Web-based program in preventing postpartum depression. The site has been modified to provide materials from both conditions.

详细描述

Depression is a mental health condition in which symptoms such as sadness, inability to feel pleasure, and loss of energy interfere with a person's normal life. Postpartum depression is a type of depression experienced by women after giving birth to a child. In this study an intervention for preventing postpartum depression that has been adapted for use over the Internet will be tested. Administering a depression-prevention program over the Internet has several advantages: after the initial investment is made to develop the program, costs are lower for treating each patient; online treatment is more accessible to a greater number of people than any given clinic; and participants who may be worried about a stigma associated with mental health problems often feel more comfortable seeking information through the Internet. Previous research has shown that symptoms of depression can be reduced through Internet-based interventions, but no research has examined such interventions specifically for postpartum depression. The program tested in this study is not aimed at replacing in-person mental health care-in fact, people who have signs of serious depression will be directed to in-person mental health care. Instead, the program is aimed at providing an additional mental health service among the range of available options.

The original trial was a two-arm pilot prevention of postpartum depression trial comparing the Internet-based course called "Mothers and Babies/Mamás y Bebés" (M&B) to informational materials on postpartum depression. In the original trial, 1088 pregnant women were recruited and randomized (as anticipated) to either condition. The study Website has therefore been modified such that all participants who consent to participate will now receive materials from both conditions. We have eliminated the randomization procedure.

As in the original study, participants be allowed to enroll at any time during their pregnancies and will be followed for 6 months after the birth of their children, so the length of participation will vary between 6 and 15 months. After undergoing a screening process, participants will now have access to both the Internet-based course called "Mothers and Babies/Mamás y Bebés" (M&B) and the informational materials. The informational materials will include information about postpartum depression and depression that may occur before childbirth. All participants will be invited via email to complete monthly assessments for the duration of the study. These assessments will measure mood, depression, and satisfaction with the assigned intervention.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Fluent in English or Spanish

排除标准

  • 未提供

结局指标

主要结局

Edinburgh Postnatal Depression Scale (EPDS)

时间窗: Measured monthly for 6 months postpartum

次要结局

  • Center for Epidemiologic Studies-Depression (CES-D) Scale(Measured monthly for 6 months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alinne Barrera

Staff Psychologist

University of California, San Francisco

研究点 (2)

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