PMHI: Perinatal Mental Health in India: A Cohort and Validation Study

Sponsor

University of Oxford (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05485701

Collaborator

National Institute of Mental Health and Neuro Sciences, India (Other), Dr. Rajendra Prasad Government Medical College (Other)

2,332

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety Suicidal Ideation Somatization PTSD	Diagnostic Test: Screening tools for common mental disorders

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2332 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Perinatal Mental Health in India: A Cohort and Validation Study

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Perinatal women 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 A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.
Non-perinatal women 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 A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.

Arm

Intervention/Treatment

Perinatal women

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

A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.

Non-perinatal women

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

A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.

Outcome Measures

Primary Outcome Measures

Phase 1: Codes and themes relating to acceptability of screening for perinatal mental disorders [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 [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 [September 2023 - August 2024]
During the cohort study, prevalence and incidence of mental disorders (depression, anxiety, PTSD, somatisation and suicidality) will be assessed.
Phase 3: Odds ratios (with 95% confidence intervals) for factors associated with common mental disorders among perinatal and non-perinatal women [September 2023 - August 2024]
During the cohort study, risk factors associated with mental disorders (depression, anxiety, PTSD, somatisation and suicidality) will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.