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CTRI Number  CTRI/2025/10/096364 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 20/08/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   The SAHARA Study: Understanding and Supporting Mothers’ Mental Health During and After Pregnancy Through Community Counselling in Rural India 
Scientific Title of Study   Determinants and Course of Perinatal Depression and the Effectiveness of A Lay Counsellor Delivered Psychosocial Intervention in Rural India: A 24-Month Prospective Cohort and Nested Case–Control Study. 
Trial Acronym  SAHARA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAVINDRA AGRAWAL 
Designation  Principal Investigator 
Affiliation  Sangath 
Address  401/B, Sunteck Kanaka Towers, Patto Plaza, Panaji - Goa
House no. 451 (168), Bhatkar Waddo, Socorro, Porvorim, Bardez, Goa – 403501
North Goa
GOA
403001
India 
Phone  09623453635  
Fax    
Email  ravindra.agrawal@sangath.in  
 
Details of Contact Person
Scientific Query
 
Name  RAVINDRA AGRAWAL 
Designation  Principal Investigator 
Affiliation  Sangath 
Address  401/B, Sunteck Kanaka Towers, Patto Plaza, Panaji - Goa
House no. 451 (168), Bhatkar Waddo, Socorro, Porvorim, Bardez, Goa – 403501

GOA
403001
India 
Phone  09623453635  
Fax    
Email  ravindra.agrawal@sangath.in  
 
Details of Contact Person
Public Query
 
Name  RAVINDRA AGRAWAL 
Designation  Principal Investigator 
Affiliation  Sangath 
Address  401/B, Sunteck Kanaka Towers, Patto Plaza, Panaji - Goa
House no. 451 (168), Bhatkar Waddo, Socorro, Porvorim, Bardez, Goa – 403501

GOA
403001
India 
Phone  09623453635  
Fax    
Email  ravindra.agrawal@sangath.in  
 
Source of Monetary or Material Support  
This study is nested within a larger implementation project being conducted through a CSR donation to Sangath by Infosys Foundation Infosys Foundation Neralu, #1/2 (1878), 11th Main, 39th Cross, 4th T Block, Jayanagar, Bangalore 560011, Karnataka, India  
 
Primary Sponsor  
Name  SANGATH 
Address  House no. 451 (168), Bhatkar Waddo, Socorro, Porvorim, Bardez, Goa – 403501 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deeksha Gurjar  Sangath Datia District Office  Sangath, Khare Building, Rajghat Colony, Datia, MP, 475661
Datia
MADHYA PRADESH 
8707266526

deeksha.gurjar@sangath.in 
Balkrishna Tripathi  Sangath Gwalior District Office  Project SAHARA - Gwalior Flat No. 307, Sakshi Green, Sachin Tendulkar Road, Sirol Rd, Prithvi Nagar, Hurawali, Gwalior, Madhya Pradesh Pin -474006
Gwalior
MADHYA PRADESH 
9630191903

balkrishna.tripathi@sangath.in 
VInita Pawar  Sangath Jhabua District Office   Sangath C/O Govind Singh Ranawat 44 MIG Sukhdev Vihar Colony New Housing Board Jhabua, Madhya Pradesh PIN: 457661
Jhabua
MADHYA PRADESH 
8770791855

vinita.pawar@sangath.in 
Dr Rohit Shah  Sangath Morena Site District Office  Project SAHARA - Flat No. 406, Sakshi Green, Sachin Tendulkar Road, Sirol Rd, Prithvi Nagar, Hurawali, Gwalior, Madhya Pradesh Pin -474006 [Note: Morena Site Office is situated at Gwalior]
Morena
MADHYA PRADESH 
7987010315

rohit.shah@sangath.in 
Dr Vandana Shukla  Sangath Narmadapuram (Hoshangabad) Site District Office  Project SAHARA - House Number 77 Mangalmay parisar Chhakar road Inside Maa Shakti Moll Malakhedi Narmadapuram (Hoshangabad) Pin code 461001
Hoshangabad
MADHYA PRADESH 
9424480318

vandana.shukla@sangath.in 
Nityasri Sankha   Sangath Raisen District Office  House no 53, Bharat Nagar, Sanchi Road, Raisen, MP 464551
Raisen
MADHYA PRADESH 
6361506071

nityasri.sankha@sangath.in 
Madhuri Jengathe  Sangath Ujjain District Office  61, Kshapnak Marg, Freeganj
Ujjain
MADHYA PRADESH 
9881735288

madhuri.jengathe@sangath.in 
Satendra Bairagi  Sangath Vidisha District Office  Behind District Jail, Royal City 115, Vidisha , MP, 464001
Vidisha
MADHYA PRADESH 
8103023832

satendra.bairagi@sangath.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SANGATH INSTITUTIONAL REVIEW BOARD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Pregnant women residing in the catchment areas of ASHAs trained under the program.

Women who provide informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  Pregnant Women residing outside the catchment areas of ASHAs trained under the program.

Pregnant Women who refuse or are unable to provide informed consent.

Pregnant Women identified with severe mental health conditions requiring specialist care (such as postpartum psychosis or acute suicidal intent) — these participants will be referred to the public health system and excluded from the study assessments.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
(1). Incidence and course of perinatal depression over 24 months (PHQ-9).
(2). Change in depressive symptom severity among women receiving THPP.
 
3 months; 12 months and 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal–infant bonding (Postnatal Attachment Questionnaire)  12 months and 24 months 
Perceived social support

 
3 months; 12 months and 24 months 
Obstetric and neonatal outcomes  12 months and 24 months 
 
Target Sample Size   Total Sample Size="1596"
Sample Size from India="1596" 
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   N/A 
Date of First Enrollment (India)   01/11/2028 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Perinatal depression or depression that occurs during pregnancy or after childbirth, is a common but under-recognised health concern that can deeply affect mothers, their babies, and families. It may lead to emotional distress, difficulties in bonding with the baby, and poorer physical health outcomes. Understanding what puts women at risk, what protects them, and how early support can make a difference is vital to improving maternal well-being.

This study will follow 1,596 pregnant women from rural districts of Madhya Pradesh, India, recruited between the 4th and 9th months of pregnancy. These women will be observed over two years, from pregnancy through the postnatal period, to understand the onset, course, and outcomes of perinatal depression. At each stage, participants will complete brief assessments on their mood, social support, life stress, and family environment.

Women who experience depressive symptoms will be offered the Thinking Healthy Program – Peer Delivered (THPP), a brief, home-based counselling program provided by trained community health workers (Accredited Social Health Activists – ASHAs). Those who choose not to receive counselling will continue to be followed, allowing us to understand differences in recovery and well-being in real-world conditions.

Within this larger cohort, a case–control study will also be conducted: women who develop perinatal depression (“cases”) will be compared with those who do not (“controls”) to identify key risk and protective factors such as poverty, social support, intimate partner violence, or previous mental health difficulties.

By combining the cohort and case–control approaches, this research will provide a comprehensive understanding of how social, psychological, and health factors interact to shape maternal mental health. The findings will guide the design of effective, scalable, and community-based strategies to prevent and manage perinatal depression in low-resource settings — helping mothers, families, and future generations thrive.

 
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