跳至主要内容
临床试验/CTRI/2025/10/096364
CTRI/2025/10/096364尚未招募不适用

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.

SANGATH3 个研究点 分布在 1 个国家目标入组 1,596 人开始时间: 2028年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,596
试验地点
3
主要终点
(1). Incidence and course of perinatal depression over 24 months (PHQ-9).

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

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

排除标准

  • 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.

结局指标

主要结局

(1). Incidence and course of perinatal depression over 24 months (PHQ-9).

时间窗: 3 months; 12 months and 24 months

(2). Change in depressive symptom severity among women receiving THPP.

时间窗: 3 months; 12 months and 24 months

次要结局

  • Maternal–infant bonding (Postnatal Attachment Questionnaire)(12 months and 24 months)
  • Perceived social support
  • Obstetric and neonatal outcomes(12 months and 24 months)

研究者

发起方
SANGATH
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

RAVINDRA AGRAWAL

Sangath

研究点 (3)

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