Perinatal Mental Health Study (PMHS) India (PMHS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Depression; PTSD; Anxiety; Suicidal Ideation; Somatization
• Intervention / Treatment: Diagnostic test: Screening tools for common mental disorders

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.

• Study Type: Observational
• Enrollment (Estimated): 2332

Contacts and Locations

• Study Contact: Name: Gracia Fellmeth, DPhil; Phone Number: 00441865289745; Email: gracia.fellmeth@ndph.ox.ac.uk

Study Locations

• India
  • Himachal Pradesh
    • Kangra, Himachal Pradesh, India
      • Recruiting
      • Dr Rajendra Prasad Government Medical College
      • Contact: Ashok Verma
  • Karnataka
    • Bengaluru, Karnataka, India
      • Recruiting
      • National Institute of Mental Health and Neuro Sciences
      • Contact: M. Thomas Kishore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: National Institute of Mental Health and Neuro Sciences, India; Dr. Rajendra Prasad Government Medical College
• Investigators: Principal Investigator: Gracia Fellmeth, DPhil, University of Oxford

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Validation; Prevalence; Screening; India; Perinatal; Antenatal; Risk factor; Low- and middle-income country; Common mental disorders; Post-partum
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: 10-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No