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Clinical Trials/CTRI/2025/12/099905
CTRI/2025/12/099905
Not yet recruiting
Phase 3

A Randomised Controlled Trial To Evaluate the Effect Of Antenatal Psychoeducation on Postpartum Depression among Pregnant Women in Virudhunagar district, Tamil Nadu

Indian Council of Medical Research1 site in 1 country250 target enrollmentStarted: January 6, 2026Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Enrollment
250
Locations
1
Primary Endpoint
To evaluate the effect of structured psychoeducational intervention conducted during the antenatal period on the incidence of postpartum depression.

Overview

Brief Summary

This randomized controlled trial will evaluate the effectiveness of a structured, non-pharmacological antenatal psychoeducation module in reducing postpartum depression among pregnant women in Virudhunagar district, Tamil Nadu. A total of 250 antenatal mothers attending selected PHCs will be recruited and randomized into intervention and control groups. The intervention group will receive a single-session psychoeducation module on emotional changes in pregnancy, stress management, coping skills, family support, and early identification of depressive symptoms, whereas the control group will receive routine antenatal care. The primary outcome is postpartum depression measured using the Edinburgh Postnatal Depression Scale (EPDS) at baseline and at 6 weeks postpartum. This low-cost, community-deliverable intervention aims to determine whether antenatal psychoeducation can serve as an effective preventive strategy for reducing postpartum depression at the primary healthcare level. No drugs or invasive procedures are involved in this trial.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Pregnant women in their third trimester, more than 35 weeks of gestation Pregnant women aged above 18yrs Natural pregnancy Willing to provide written informed consent.

Exclusion Criteria

  • History of any diagnosed psychiatric disorder High-risk pregnancy requiring intensive management Inability to comprehend the intervention content.

Outcomes

Primary Outcomes

To evaluate the effect of structured psychoeducational intervention conducted during the antenatal period on the incidence of postpartum depression.

Time Frame: Edinburgh postnatal depression scale scoring at 6 weeks postpartum

Secondary Outcomes

  • To evaluate baseline knowledge and awareness regarding postpartum depression among participating antenatal mothers.

Investigators

Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Yuva Sandhya P

Government Medical College Virudhunagar

Study Sites (1)

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