Efectividad de la Farmacoterapia Monitorizada en Pacientes Deprimidas de la atención Primaria de Salud y su repercusión Sobre la Salud Mental de Sus Hijos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- depressive symptoms measured with the HDRS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •depressed mothers with al least one child aged 6-16
排除标准
- •currently treatment for depression,psychosis,bipolar depression,alcohol or drug abuse, gravidity.
研究组 & 干预措施
control group
patients can receive pharmacotherapy and psychotherapy and specialized treatment
干预措施: monitorized pharmacotherapy with antidepressants drugs (Fluoxetine) (Other)
结局指标
主要结局
depressive symptoms measured with the HDRS
时间窗: at 3,6 and 12 months after randomization
次要结局
- quality of life measured with the SF-36(at 3,6 and 12 months after randomization)