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临床试验/NCT03196726
NCT03196726已完成不适用

POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2

Ministry of Health, Malaysia12 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
12
主要终点
changes in depression level

研究概览

简要总结

Randomized-controlled trial on the effectiveness of managing postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer as compared to Medical Officer alone

详细描述

This was a two-group double-blind randomized controlled trial (RCT) conducted in six primary care clinics at Klang Valley, with 27 subjects in each arms. All post-partum women at 4 to 24 weeks, registered at these clinics, were screened using self-administered Edinburgh Postnatal Depression Scale for symptoms of depression. Those who scored 12 or more and/or positive for question on suicidal behaviour, were interviewed by trained Research Assistants using Mini International Neuropsychiatric Interview, a diagnostic interview tool. Those with mild to moderate depression were invited to join this study, while severe depressed cases were referred to the Family Medicine Specialist for appropriate management. Consented eligible women were randomized into either control group; managed by Medical Officers alone, or intervention group; managed by both Medical Officers and trained nurses. Medical officers were given standard refresher course on Postnatal Depression management based on Clinical Practice Guideline while nurses were trained using brief cognitive-behavioural therapy (CBT) module, which consists of 6 modules for 6 weekly sessions. Depression level and its severity were assessed using self-administered Beck's Depression Index (BDI) and Automatic Thought Questionnaire (ATQ), at Baseline, Week 3 and Week 6.

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
Double (Participant, Care Provider)

盲法说明

Participants randomized by offering 2 opaque envelope to group them into either as control or intervention group.

Medical officers were responsible in the management of all participants using standard Clinical Practice Guideline (CPG). Participants from intervention group will see Medical Officer first before being given CBT by nurse

入排标准

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

入选标准

  • postpartum 4-24 weeks
  • registered with selected primary care clinics
  • Edinburgh Postnatal Depression score: 12 or more; and Mini diagnostic interview:
  • positive (mild to moderate depression)
  • consented to participate

排除标准

  • severe depression or psychosis

结局指标

主要结局

changes in depression level

时间窗: at baseline (Week 0), week 3 and Week 6

assess changes in Beck Depression Index (BDI) score

次要结局

未报告次要终点

研究者

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

NOOR ANI AHMAD

Public Health Specialist

Ministry of Health, Malaysia

研究点 (12)

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