Screening tools for common mental disorders
Diagnostic TestA number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.
NCT Number: NCT05485701
The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.
Interested in participating?
Request Info18 year–45 year
Female
Observational
Dr Rajendra Prasad Government Medical College, Kangra, Himachal Pradesh, 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.
Time frame: 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.
Time frame: 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.
Time frame: September 2023 - August 2024
During the cohort study, prevalence and incidence of mental disorders (depression, anxiety, PTSD, somatisation and suicidality) will be assessed.
Time frame: September 2023 - August 2024
During the cohort study, risk factors associated with mental disorders (depression, anxiety, PTSD, somatisation and suicidality) will be assessed.
Contact information is provided by the study sponsor or research team.
University of Oxford
Other
Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India
Acronym: PMHS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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