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NCT Number: NCT05485701

Perinatal Mental Health Study (PMHS) India

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

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Dr Rajendra Prasad Government Medical College, Kangra, Himachal Pradesh, India

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About this study

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.

Who can participate

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:

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Phase 1: Codes and themes relating to acceptability of screening for perinatal mental disorders

    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.

  2. Phase 2: Psychometric properties of screening tools for common mental disorders

    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.

  3. Phase 3: Point prevalence, period prevalence and incidence (with 95% confidence intervals) of common mental disorders among perinatal and non-perinatal women

    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.

  4. Phase 3: Odds ratios (with 95% confidence intervals) for factors associated with common mental disorders among perinatal and non-perinatal women

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gracia Fellmeth, DPhil

CONTACT

[email protected]

00441865289745

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Dr. Rajendra Prasad Government Medical College
  • National Institute of Mental Health and Neuro Sciences, India

Registry information

Official study title

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

Acronym: PMHS

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 3, 2022
Registry last updated
Dec 7, 2023

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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