Perinatal Mental Health Study (PMHS) India

NCT05485701 | Recruiting

• 1 other identifier: 10-20
• Study Type: observational
• Target: 2,332
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Depression; Anxiety; Suicidal Ideation; Somatization; PTSD

Keywords

Perinatal; Post-partum; Antenatal; Low- and middle-income country; India; Common mental disorders; Screening; Validation; Prevalence; Risk factor

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

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.

Non-perinatal women; Perinatal women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• National Institute of Mental Health and Neuro Sciences, India: collaborator
• Dr. Rajendra Prasad Government Medical College: collaborator

Study Sites (2)

Dr Rajendra Prasad Government Medical College

Kangra, Himachal Pradesh, India

RECRUITING

National Institute of Mental Health and Neuro Sciences

Bengaluru, Karnataka, India

RECRUITING

Related 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.

  PMID: 34622290 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Suicidal Ideation; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Suicide; Self-Injurious Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Gracia Fellmeth, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gracia Fellmeth, DPhil

CONTACT

00441865289745; gracia.fellmeth@ndph.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: September 1, 2022
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 7, 2023

Record last verified: 2023-11

Locations

IN (2)