Randomized Clinical Trial for the Treatment of Postnatal Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 主要终点
- EPDS
研究概览
简要总结
A randomized clinical trial was carried out at primary care level in Santiago, Chile to investigate a combined treatment for women suffering post-natal depression and preventing the adverse consequences of this illness on infant's growth and development.
详细描述
Background: We compared the effectiveness of a multi-component intervention with usual care to treat postnatal depression among low-income mothers in primary care clinics in Santiago, Chile.
Methods: Randomised controlled trial. Two hundred and thirty mothers with major depression attending postnatal clinics were randomly allocated to either a multi-component intervention or usual care. The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed. Data were analysed on an intention-to-treat basis. The main outcome measure was the Edinburgh Postnatal Depression Scale (EPDS) at 3 and 6 months after randomisation.
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
- •Mothers meeting criteria for current DSM-IV major depression were eligible.
排除标准
- •who had received any form of treatment for their depression during their current postnatal period,
- •those who were pregnant,
- •with psychotic symptoms,
- •serious suicidal risk,
- •history of mania,
- •alcohol or drug abuse
研究组 & 干预措施
PND-MCI
The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed
干预措施: multi-component intervention (Other)
usual care
'Usual care' included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment
干预措施: Usual care (Other)
结局指标
主要结局
EPDS
时间窗: 3 and 6 months
次要结局
- four dimensions of the Short Form-36 (SF-36) Questionnaire: mental health; emotional role; social functioning; and vitality(34) and significant clinical improvement.(3 and 6 months)