| 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
|
|
|
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
|
|
|
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. |