Perinatal Mental Health Study (PMHS) India

Study Overview
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Brief Summary
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The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.

Detailed Description
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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.

Official Title
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Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India

Conditions
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Depression, Anxiety, Suicidal Ideation, Somatization, PTSD

Intervention / Treatment
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* Diagnostic Test: Screening tools for common mental disorders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perinatal women<br>Women will be recruited in their first trimester of pregnancy and followed-up until 6 months post-partum. This is the 'exposed' group. | Diagnostic Test: Screening tools for common mental disorders<br>* A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.<br>|
| Non-perinatal women<br>Non-perinatal women will be recruited as the 'non-exposed' group and followed-up over the same duration as the perinatal group. | Diagnostic Test: Screening tools for common mental disorders<br>* A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Codes and themes relating to acceptability of screening for perinatal mental disorders | These will be themes emerging from focus groups with women around awareness of perinatal mental disorders and acceptability of screening. | To be completed by August 2022 | 
| Phase 2: Psychometric properties of screening tools for common mental disorders | 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. | September 2022 - August 2023 | 
| Phase 3: Point prevalence, period prevalence and incidence (with 95% confidence intervals) of common mental disorders among perinatal and non-perinatal women | During the cohort study, prevalence and incidence of mental disorders (depression, anxiety, PTSD, somatisation and suicidality) will be assessed. | September 2023 - August 2024 | 
| Phase 3: Odds ratios (with 95% confidence intervals) for factors associated with common mental disorders among perinatal and non-perinatal women | During the cohort study, risk factors associated with mental disorders (depression, anxiety, PTSD, somatisation and suicidality) will be assessed. | September 2023 - August 2024 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perinatal, Post-partum, Antenatal, Low- and middle-income country, India, Common mental disorders, Screening, Validation, Prevalence, Risk factor