The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Change in Mental health symptoms. SRQ-20
研究概览
简要总结
CMHD are particularly prevalent among women, posing a major threat to their own and their children's wellbeing.
Despite the high prevalence of CMHD and the existence of effective treatments, interventions supporting women living in low-resourced settings remain limited.
This study builds on a parent study (Zamcharts NCT03991182), which identified a high prevalence of women with anxiety and/or depression. We propose to design, test, and validate a community-based intervention nested within the public primary health system in Zambia, to identify and treat women with mild-to-severe CMHDs.
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 (Investigator, 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
- •Women participating in ZamCharts parent study
- •SRQ-20 >7 (clinically significant symptoms of depression or/anxiety),
- •not planning to move within the next 6 months,
- •with capacity to consent
- •not receiving current mental health care.
排除标准
- •Women with active suicidal ideation (determined by Paykel=4 OR 5),
- •severe substance use (ACOK-SUD >4),
- •mania or psychotic symptoms
结局指标
主要结局
Change in Mental health symptoms. SRQ-20
时间窗: Change between Baseline (at enrollment) and 6 months after enrollment
20 items measuring risk of common mental health problem.
Feasibility of the study
时间窗: Assessed 4 months after enrollment
% of 1 or more sessions completed. Qualitative feedback from participants and providers.
Acceptability
时间窗: Assessed 4 months after enrollment
% of participants completing more than 6 sessions. Qualitative feedback from participants and providers.
次要结局
- Functionality(Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment)
- Change in Anxiety and Depression symptoms.(Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment)
- World Bank's Toolkit and Inventory(Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment)
- Change in Mental health symptoms. PSYCHLOPS(Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment)
研究者
Irene Falgas Bague
Post-Doctoral Research Collaborator
Swiss Tropical & Public Health Institute