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 Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,596
- Locations
- 3
- Primary Endpoint
- (1). Incidence and course of perinatal depression over 24 months (PHQ-9).
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Pregnant women residing in the catchment areas of ASHAs trained under the program.
- •Women who provide informed consent to participate in the study.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
(1). Incidence and course of perinatal depression over 24 months (PHQ-9).
Time Frame: 3 months; 12 months and 24 months
(2). Change in depressive symptom severity among women receiving THPP.
Time Frame: 3 months; 12 months and 24 months
Secondary Outcomes
- Maternal–infant bonding (Postnatal Attachment Questionnaire)(12 months and 24 months)
- Perceived social support
- Obstetric and neonatal outcomes(12 months and 24 months)
Investigators
RAVINDRA AGRAWAL
Sangath