Perinatal Mental Health Study (PMHS) India

Depression Clinical Trial

— PMHS  

Official title:

Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485701
• Other study ID #: 10-20
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: November 2023
• Source: University of Oxford
• Contact: Gracia Fellmeth, DPhil
• Phone: 00441865289745
• Email: gracia.fellmeth[@]ndph.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2332
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• PTSD
• Somatization
• Suicidal Ideation

Intervention

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.

Locations

Country	Name	City	State
India	National Institute of Mental Health and Neuro Sciences	Bengaluru	Karnataka
India	Dr Rajendra Prasad Government Medical College	Kangra	Himachal Pradesh

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Dr. Rajendra Prasad Government Medical College, National Institute of Mental Health and Neuro Sciences, India

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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