Perinatal Mental Health Study (PMHS) India
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Screening tools for common mental disorders.
- Who it may be relevant to
- Registry conditions: Depression, Anxiety, Suicidal Ideation, Somatization. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India
Overview
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.
Interventions
- 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.
Primary outcome measures
- Phase 1: Codes and themes relating to acceptability of screening for perinatal mental disorders [Time frame: To be completed by August 2022]
- Phase 2: Psychometric properties of screening tools for common mental disorders [Time frame: 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 [Time frame: 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 [Time frame: September 2023 - August 2024]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
India · 2 centers
- Dr Rajendra Prasad Government Medical College — Kangra
- National Institute of Mental Health and Neuro Sciences — Bengaluru
Publications
- 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. PMID 34622290
- Fellmeth G, Sharma D, Kanwar P, Chawla K, Gupta V, Thakur A, Harrison S, Quigley MA, Bharti O, Chandra PS, Desai G, Thippeswamy H, Singh S, Nair M, Kishore MT, Alderdice F, Verma A; Perinatal Mental Health Study (PMHS) Group. Identifying common mental disorders among perinatal and non-perinatal women in northern India: a cross-sectional validation study of the diagnostic accuracy of six self-repor PMID 41857859
Identifiers
NCT: NCT05485701 · 10-20