NCT01977326已完成不适用
The Effectiveness and Cost-effectiveness of a Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,205
- 试验地点
- 2
- 主要终点
- Hamilton depression rating Scale (HAM-D)
研究概览
简要总结
The objective of this randomised controlled trial (RCT) is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa(i.e. provided by non-specialist health workers)
详细描述
Specific Objectives:
- To determine the effectiveness and cost-effectiveness of task sharing care to community health workers (CHWs), compared to enhanced usual care in South Africa, on both primary outcome measures (severity of prenatal maternal depression symptoms) and on a series of secondary outcome measures (functional status, health care utilization, social support and postnatal infant growth).
- To examine factors influencing the implementation of the task sharing intervention and future scale up, by assessing feasibility, sustainability, quality, and safety, and by qualitative exploration of the experience of task sharing from the perspectives of both CHWs and patients.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women attending antenatal clinics at the Michael Mapongwana Community Health Centre in Khayelitsha, presenting for their first booking appointment, no later than 28 weeks gestation
- •Living in Khayelitsha
- •18 years or older
- •Screen positive for depression with a cut off of 13 or more on the EPDS
- •Able to give informed consent
排除标准
- •Require urgent medical attention or have severe mental health problems, defined as a diagnosis of schizophrenia, bipolar mood disorder, or currently experiencing an episode of psychosis.
- •Women who do not speak isiXhosa as a first language
研究组 & 干预措施
counseling intervention
Experimental
Each woman recruited into the intervention arm will undergo 6 sessions of basic counselling by lay-health workers
干预措施: basic counselling by lay-health workers (Behavioral)
Enhanced usual care
Active Comparator
usual antenatal care with additional 3 - 4 monthly phone calls.
干预措施: Enhanced usual care (Other)
结局指标
主要结局
Hamilton depression rating Scale (HAM-D)
时间窗: baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally
次要结局
- Mini International Psychiatric Interview 2.0.0 (MINI) Major depression(baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up)
- Edinburgh Postnatal depression scale (EPDS)(baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up)
- Multidimensional Scale of Perceived Social Support (MSPSS)(baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up)
- WHO Disability Assessment Schedule (WHO-DAS) 12 item version 2.0(baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up)
- Health services utilisation questionnaire(baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up)
- Cape Town Functional Assessment Instrument for Maternal Depression(baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up)
- Obstetric and Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisation(follow-up 3 months postnatal follow-up 12 months postnatal follow-up)
研究者
A/Prof Crick Lund
Professor
University of Cape Town
研究点 (2)
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