Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,332
- 试验地点
- 2
- 主要终点
- Phase 3: Odds ratios (with 95% confidence intervals) for factors associated with common mental disorders among perinatal and non-perinatal women
研究概览
简要总结
The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.
详细描述
The purpose of this observational study is to assess the mental health of perinatal women living in two low-income settings in India. The first phase will explore women's awareness of mental illness and acceptability of screening for mental disorders. The second phase will be a validation study, during which the psychometric properties of screening tools will be assessed against a gold standard. The third stage will comprise a cohort study, during which the prevalence of and risk factors for mental disorders among perinatal and non-perinatal women will be established.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For Phase 1 (qualitative study) and Phase 2 (validation study):
- •Pregnant women:
- •Aged 18 to 45 years
- •Currently pregnant (any trimester)
- •Willing and able to give informed consent
- •Post-partum women:
- •Aged 18 to 45 years
- •Currently post-partum (between 1-12 months postpartum)
- •Willing and able to give informed consent
- •Non-perinatal women:
- •Aged 18 to 45 years
- •Not currently pregnant and not given birth in the past 12 months
- •Willing and able to give informed consent
- •For Phase 3 (prospective cohort study):
- •Perinatal women:
- •Aged 18 to 45 years
- •In early pregnancy (estimated gestational age <20 weeks) at recruitment
- •Not planning to relocate for the duration of the study period
- •Willing and able to give informed consent
- •Expressed a willingness to continue to participate for the four planned visits
- •Non-perinatal women:
- •Aged 18 to 45 years
- •Not currently pregnant and not given birth in the last 12 months
- •Not planning to relocate for the duration of the study period
- •Willing and able to give informed consent
- •Expressed a willingness to continue to participate for the four planned visits
排除标准
- •The participant may not enter the study if:
- •They have an acutely severe psychiatric illness which impairs their ability to take part in the study
- •They are not willing or able to provide informed consent
- •Other than for current severe psychiatric illness which affects ability to participate in the study, we will not exclude any participant on the basis of current or prior physical, psychological or psychiatric co-morbidities so long as she is willing to participate, her ability to take part is not compromised and her ability to give informed consent is not impaired by these conditions.
结局指标
主要结局
Phase 3: Odds ratios (with 95% confidence intervals) for factors associated with common mental disorders among perinatal and non-perinatal women
时间窗: September 2023 - August 2024
During the cohort study, risk factors associated with mental disorders (depression, anxiety, PTSD, somatisation and suicidality) will be assessed.
Phase 1: Codes and themes relating to acceptability of screening for perinatal mental disorders
时间窗: To be completed by August 2022
These will be themes emerging from focus groups with women around awareness of perinatal mental disorders and acceptability of screening.
Phase 2: Psychometric properties of screening tools for common mental disorders
时间窗: September 2022 - August 2023
The psychometric properties (sensitivity, specificity, area under the receiver operating curve, optimal cut-off and accuracy) of eight screening tools in Kannada and Hindi will be established among three groups of women: pregnant, post-partum and non-perinatal.
Phase 3: Point prevalence, period prevalence and incidence (with 95% confidence intervals) of common mental disorders among perinatal and non-perinatal women
时间窗: September 2023 - August 2024
During the cohort study, prevalence and incidence of mental disorders (depression, anxiety, PTSD, somatisation and suicidality) will be assessed.
次要结局
未报告次要终点