Change Your Life With Seven Sheets of Paper: A Pilot Randomized Controlled Trial for Postnatal Depression: A Pilot Randomized Controlled Trial for Postnatal Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
The aim of this study is to deliver CBT based intervention called "Change your life with 7 Sheets of paper" to women with mild to moderate postnatal depression (PND) through trained traditional birth attendants (TBAs). Participants will be recruited from low income area in Karachi Pakistan. Edinburg Postnatal Depression scale (EPDS) will be used to screen mothers having children between birth till 12 months. Group intervention will be delivered through trained TBAs.
详细描述
The prevalence rate of PND in Pakistani women and its effect on the growth and development of young children and child mortality is very high. Despite availability of interventions to improve maternal health, the major issue in implementation of those interventions is because of limited availability of trained health professionals . Therefore the aim of this study is to train TBAs in delivering Cognitive Behaviour Therapy (CBT) based intervention called "Changing your life with seven sheets of paper". Participants will be recruited from low income area in Karachi. Total 36 participants will be recruited and randomized into 2 groups; intervention and Treatment As Usual (TAU) group. Total 8 sessions will be delivered by trained TBAs over the period of 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
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
- •Mothers with a child between 0-12 months
- •Women who score 14 or above on Edinburgh Postnatal Depression scale (EPDS)
- •Age range between 18 to 45 years
- •Women able to provide written informed consent.
排除标准
- •Severe depression or any other major psychiatric disorder
- •Severe suicidal ideation
- •Currently receiving any psychiatric or psychological treatment
- •Intellectual disability in mother
- •Chronic medical condition
- •Having children with intellectual or physical disability
结局指标
主要结局
Edinburgh Postnatal Depression Scale (EPDS)
时间窗: Change in scores from baseline to 3rd month
EPDS will be used to assess postnatal depression
次要结局
- Patient health Questionnaire-9(Change in scores from baseline to 3rd month)
- World Health Organization Quality of Life(Change in scoares from baseline to 3rd month)