Perinatal Mental Health Study (PMHS) India
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Oxford
About this trial
The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 to 45 years
Currently pregnant (any trimester)
Willing and able to give informed consent
Aged 18 to 45 years
Disqualifiers
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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.
Treatment groups
2,332 Participants
are divided into 2 treatment groupsGroup A: Perinatal women1 intervention
Group B: Non-perinatal women1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
To be completed by August 20222
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.
Time frame
September 2022 - August 20233
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.
Time frame
September 2023 - August 20244
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.
Time frame
September 2023 - August 2024Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oxford
Lead sponsor
National Institute of Mental Health and Neuro Sciences, India
Collaborator
Dr. Rajendra Prasad Government Medical College
Collaborator
Source ClinicalTrials.gov