POSTNATAL DEPRESSION: Malaysia ASPIRE* Project PHASE 2
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
- 是
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
NOOR ANI AHMAD
Public Health Specialist
Ministry of Health, Malaysia
