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| Name | Class |
|---|---|
| National Institute of Mental Health and Neuro Sciences, India | OTHER |
| Dr. Rajendra Prasad Government Medical College | OTHER |
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The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening tools for common mental disorders | Diagnostic Test | A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality. |
| 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 |
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Inclusion Criteria:
For Phase 1 (qualitative study) and Phase 2 (validation study):
Pregnant women:
Post-partum women:
Non-perinatal women:
For Phase 3 (prospective cohort study):
Perinatal women:
Non-perinatal women:
Exclusion Criteria:
The participant may not enter the study if:
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.
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gracia Fellmeth, DPhil | Contact | 00441865289745 | gracia.fellmeth@ndph.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Gracia Fellmeth, DPhil | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Rajendra Prasad Government Medical College | Recruiting | Kangra | Himachal Pradesh | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34622290 | Background | 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. | |
| 41857859 | Derived |
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Upon completion of the study, sharing of data with other researchers will be considered by the study team on a case-by-case basis. If data is shared this will not include any patient-identifying information.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D059020 | Suicidal Ideation |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D013405 | Suicide |
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| National Institute of Mental Health and Neuro Sciences | Recruiting | Bengaluru | Karnataka | India |
|
| 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-report measures. BMJ Open. 2026 Mar 18;16(3):e111111. doi: 10.1136/bmjopen-2025-111111. |
| D016728 |
| Self-Injurious Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |