A Randomized Clinical Trial for Depressed Mothers at Primary Care Level (DMH)
Efectividad de la Farmacoterapia Monitorizada en Pacientes Deprimidas de la atención Primaria de Salud y su repercusión Sobre la Salud Mental de Sus Hijos
A randomized clinical trial was carried out at primary care level in Santiago, Chile to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (TM) and the usual treatment (TH) and its impact on children's mental health.
Hypothesis: pharmacological intervention for depression controlled by phone from a central level will be more effective than usual care in depressed mothers.
研究概览
详细说明
Aim:to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (TM) and the usual treatment (TH) and its impact on children's mental health.
Material and methods: A RCT wasw carried out at primary care clinics in Santiago.Sample:three hundred and forty five depressed women . One children of each mother was randomly selected. Women are randomly assigned to receive the usual therapy or a pharmacological intervention with periodical telephone contacts with medical collaboration personnel, to reinforce compliance with treatment and educate about the disease, for 6 months. Women were blindly evaluated at 3, 6 and 12 months with the Hamilton depression rating score (HDRS) and the SF-36 to assess depressive symptoms and quality of life, respectively; the Dyadic Adjustment Scale to assess marital adjustment.
Child psychopathology was assessed with the Child Behavior Checklist (CBCL), the Brief Psychiatric Rating Scale for Children (BPRS-C), Screen for Child Anxiety Related Emotional Disorders(SCARED)and the Children's Depression Inventory.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Region Metropolitana
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Santiago、Region Metropolitana、智利
- CORESAM Conchali
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- depressed mothers with al least one child aged 6-16
Exclusion Criteria:
- currently treatment for depression,psychosis,bipolar depression,alcohol or drug abuse, gravidity.
学习计划
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：control group
patients can receive pharmacotherapy and psychotherapy and specialized treatment
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Fluoxetine oral,20-60 mg/day for 6 months with telephone monitorization
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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depressive symptoms measured with the HDRS
大体时间：at 3,6 and 12 months after randomization
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at 3,6 and 12 months after randomization
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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quality of life measured with the SF-36
大体时间：at 3,6 and 12 months after randomization
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at 3,6 and 12 months after randomization
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合作者和调查者
调查人员
- 首席研究员：rosemarie fritsch, MD、University of Chile
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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