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CTRI Number  CTRI/2024/01/061508 [Registered on: 16/01/2024] Trial Registered Prospectively
Last Modified On: 03/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   A community-based study on women’s perinatal mental health in rural India  
Scientific Title of Study   Early-stage development of a complex, community-based intervention to improve women’s perinatal health in rural communities in India- PRAMH 2  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PRAMH Phase 2_Protocol_v1.0_2023 08 30  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr D Praveen 
Designation  Program Head, Primary Healthcare Research  
Affiliation  George Institute for Global Health 
Address  Research & Development Department, Primary Healthcare Research Division, #401, 4th Floor, Shangrila Plaza, Plot No.14, Road No. 2, Banjara Hills, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  04030994444  
Fax    
Email  dpraveen@georgeinstitute.org.in  
 
Details of Contact Person
Scientific Query  
Name  Dr D Praveen 
Designation  Program Head,  
Affiliation  George Institute for Global Health 
Address  Research & Development Department, Primary Healthcare Research Division, #401, 4th Floor, Shangrila Plaza, Plot No.14, Road No. 2, Banjara Hills, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  4030994443  
Fax    
Email  dpraveen@georgeinstitute.org.in  
 
Details of Contact Person
Public Query  
Name  Thout Sudhir Raj 
Designation  Research Fellow 
Affiliation  George Institute for Global Health 
Address  Research & Development Department, Primary Healthcare Research Division, #401, 4th Floor, Shangrila Plaza, Plot No.14, Road No. 2, Banjara Hills, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  04030994444  
Fax    
Email  traj@georgeinstitute.org.in  
 
Source of Monetary or Material Support  
Primary Health centres in Siddipet, Telangana and Faridabad, Haryana. 
 
Primary Sponsor  
Name  Medical Research Council UK 
Address  2nd Floor David Phillips Building, Polaris House, North Star Avenue, Swindon, SN2 1ET, United Kingdom 
Type of Sponsor  Other [Global public health organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
D Praveen   District Health Medical Officer  DHMO Office, Integrated District Offices Complex, Duddeda(V),Kondapak(M),Siddipet(D),Telangana- 502277 districts in Telangana needs to be updated. Medak
Medak
TELANGANA 		 04030994444

dpraveen@georgeinstitute.org.in 
D Praveen   DMHO  DMHO, Faridabad district,
Faridabad
HARYANA 		 04030994444

dpraveen@georgeinstitute.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The George Institute Ethics Committee, The George Institute for Global Health, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All women who are pregnant and one year after birth who are at risk or experience mental health problems  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  community-based intervention support women with common perinatal mental disorders (CPMDs)  Using the community-initiated care approach, the study will: (1) train community health workers to use digital technology to identify women with CPMDs and link community and health care system; (2) train peer-workers to administer the Thinking Healthy Programme in village support groups; (3) develop a community anti-stigma campaign.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  All women who are pregnant and one year after birth who are at risk or experience mental health problems (PHQ9 >4; or GAD7 >4; or SIDAS ≥9)  
 
ExclusionCriteria 
Details  [4:32 PM] Thout Sudhir Raj
women who decline participation; women who plan to move away and not return to the same village in the next 6 months; women who plan to temporarily move away (e.g., to their mother’s village around the time of birth) within the trial period (6 months); women who do not speak and understand verbal communication in the local study language, or girls aged < 18 years of age. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine community attitudes and beliefs around PMH, context, and health services available in Haryana, using our in Telangana adapted situational analysis tool
To refine our proposed intervention with stakeholders in ToC workshops, clarify pathways to impact, and develop a shared project vision 		 Baseline to 4-6 months of intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
To develop a digital screening tool to identify women at risk of CPMDs (“ASHAs”)
To develop peer groups to support women during pregnancy and after birth (“Peer groups”)
To co-develop a novel strategy and campaign to address stigma and discrimination around PMH (“Community campaign”) 		 Baseline to 4-6 months of intervention. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The Perinatal Mental Health (PRAMH) Phase 2 study aims to develop a complex intervention to address the significant challenge of preventing, detecting and supporting women with common perinatal mental disorders (CPMDs) in rural India, by integrating mental health into maternity care. Building on the findings from the formative Phase 1 (January 2022 - June 2023), the overall aim of the PRAMH study is to develop a clear theory of change and pathway for future development, implementation, and evaluation.

The research question is: Can a complex, community-based intervention support women with CPMDs in rural India? The study will use mixed methods and a learning health systems approach, working in close partnership with women with lived experience of CPMDs, families, local communities, and key stakeholders, such as policy and non-governmental organisations. The study aims to build a systems approach that identifies and targets perinatal mental health (PMH), stigma and critical social determinants of PMH. Iterative, multi-sectoral collaboration will guide the development of the intervention, training, data collection, and evaluation.

The study will develop a community-based, technology-enabled, task-shifting intervention. Using the community-initiated care approach, the study will: (1) train community health workers to use digital technology to identify women with CPMDs and link community and health care system; (2) train peer-workers to administer the Thinking Healthy Programme in village support groups; (3) develop a community anti-stigma campaign. PRAMH is building on the ongoing, large randomised controlled SMARThealth Pregnancy trial (clinicaltrials.gov NCT05752955) and will be using the SMARThealth platform.

If proven feasible and acceptable, PRAMH can be tested and evaluated in a randomised controlled trial. The intervention has the potential to improve promotion, prevention and treatment for CPMDs in rural India and other LMICs.

 
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