Clinical trial NCT05485701: Perinatal Mental Health Study (PMHS) India
Official title: Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Anxiety
Suicidal Ideation
Somatization
PTSD
Keywords: Perinatal
Post-partum
Antenatal
Low- and middle-income country
India
Common mental disorders
Screening
Validation
Prevalence
Risk factor
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health and Neuro Sciences, India
name: Dr. Rajendra Prasad Government Medical College
First posted: 2022-08-03
Enrollment: 2332
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants are women aged 18-45 years living in two low-income settings who fall into one of the following groups:

(i) pregnant women: women who are pregnant (any trimester of pregnancy) (ii) post-partum women: women who are within 12 months post-partum (iii) non-perinatal women: women who are not currently pregnant and have not given birth within the past 12 months

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Phase 1: Codes and themes relating to acceptability of screening for perinatal mental disorders
timeFrame: To be completed by August 2022
measure: Phase 2: Psychometric properties of screening tools for common mental disorders
timeFrame: September 2022 - August 2023
measure: Phase 3: Point prevalence, period prevalence and incidence (with 95% confidence intervals) of common mental disorders among perinatal and non-perinatal women
timeFrame: September 2023 - August 2024
measure: Phase 3: Odds ratios (with 95% confidence intervals) for factors associated with common mental disorders among perinatal and non-perinatal women
timeFrame: September 2023 - August 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Kangra
country: India
facility: Dr Rajendra Prasad Government Medical College
state: Himachal Pradesh
city: Bengaluru
country: India
facility: National Institute of Mental Health and Neuro Sciences
state: Karnataka
Study officials:
affiliation: University of Oxford
name: Gracia Fellmeth, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fellmeth G, Kishore MT, Verma A, Desai G, Bharti O, Kanwar P, Singh S, Thippeswamy H, Chandra PS, Kurinczuk JJ, Nair M, Alderdice F. Perinatal mental health in India: protocol for a validation and cohort study. J Public Health (Oxf). 2021 Oct 8;43(Suppl 2):ii35-ii42. doi: 10.1093/pubmed/fdab162.