DepressionPMHSNCT05485701
Perinatal Mental Health Study (PMHS) India
An observational study of Depression and Anxiety, run by University of Oxford at 2 sites in India.
Trial summary
The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Suicidal Ideation
- What is being tested?
- Screening tools for common mental disorders
- How many people
- 2,332 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Sep 2022to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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:
Show all 26Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
National Institute of Mental Health and Neuro Sciences
Bengaluru, Karnataka
M. Thomas Kishore
- Recruiting
Dr Rajendra Prasad Government Medical College
Kangra, Himachal Pradesh
Ashok Verma
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Anxiety, Suicidal Ideation, Somatization, PTSD
- Being tested
- Screening tools for common mental disorders
- Keywords
- Perinatal, Post-partum, Antenatal, Low- and middle-income country, India, Common mental disorders, Screening, Validation, Prevalence, Risk factor
- Medical subject headings
- Depression, Anxiety Disorders, Suicidal Ideation, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening tools for common mental disordersDiagnostic test
A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Screening tools for common mental disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: September 2023 - August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health and Neuro Sciences, India, Dr. Rajendra Prasad Government Medical College
- Responsible party
- Sponsor
- Investigators
- Gracia Fellmeth, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485701
- Sponsor's protocol ID
- 10-20
- Acronym
- PMHS
- Status last verified
- Nov 2023
- First submitted
- 1 Aug 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 34622290Fellmeth G, Sharma D, Kanwar P, Chawla K, Gupta V, Thakur A, Harrison S, Quigley MA, Bharti O, Chandra PS, Desai G, Thippeswamy H, Singh S, Nair M, Kishore MT, Alderdice F, Verma A; Perinatal Mental Health Study (PMHS) Group. Identifying common mental disorders among perinatal and non-perinatal women in northern India: a cross-sectional validation study of the diagnostic accuracy of six self-report measures. BMJ Open. 2026 Mar 18;16(3):e111111. doi: 10.1136/bmjopen-2025-111111.
PubMed 41857859
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India
- ClinicalTrials.gov ID
- NCT05485701
- Acronym / sponsor ID
- PMHS / 10-20
- Conditions
- Depression, Anxiety, Suicidal Ideation, Somatization, PTSD
- Keywords
- Perinatal, Post-partum, Antenatal, Low- and middle-income country, India, Common mental disorders, Screening, Validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,332 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute of Mental Health and Neuro Sciences, India, Dr. Rajendra Prasad Government Medical College
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perinatal women | – | Diagnostic Test: Screening tools for common mental disordersWomen will be recruited in their first trimester of pregnancy and followed-up until 6 months post-partum. This is the 'exposed' group. |
| Non-perinatal women | – | Diagnostic Test: Screening tools for common mental disordersNon-perinatal women will be recruited as the 'non-exposed' group and followed-up over the same duration as the perinatal group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (26 listed)
- Aged 18 to 45 years
- Currently pregnant (any trimester)
- Willing and able to give informed consent
- Aged 18 to 45 years
- Currently post-partum (between 1-12 months postpartum)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening tools for common mental disordersA number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality. | Diagnostic test | Non-perinatal women, Perinatal women |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Background: PubMed 34622290Fellmeth 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.
- Derived from this study: PubMed 41857859Fellmeth G, Sharma D, Kanwar P, Chawla K, Gupta V, Thakur A, Harrison S, Quigley MA, Bharti O, Chandra PS, Desai G, Thippeswamy H, Singh S, Nair M, Kishore MT, Alderdice F, Verma A; Perinatal Mental Health Study (PMHS) Group. Identifying common mental disorders among perinatal and non-perinatal women in northern India: a cross-sectional validation study of the diagnostic accuracy of six self-report measures. BMJ Open. 2026 Mar 18;16(3):e111111. doi: 10.1136/bmjopen-2025-111111.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gracia Fellmeth, DPhil principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by University of Oxford at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gracia Fellmeth, DPhil (00441865289745, gracia.fellmeth@ndph.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Codes and themes relating to acceptability of screening for perinatal mental disorders (time frame: To be completed by August 2022). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05485701, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023; AzTrials last refreshed its copy on 1 Nov 2026.