| CTRI Number |
CTRI/2025/12/099905 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to See if Health awareness and guidance During Pregnancy Can Reduce Depression After Childbirth in Virudhunagar, Tamil Nadu |
|
Scientific Title of Study
|
A Randomised Controlled Trial To Evaluate the Effect Of Antenatal Psychoeducation on Postpartum Depression among Pregnant Women in Virudhunagar district, Tamil Nadu |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yuva Sandhya P |
| Designation |
MBBS student |
| Affiliation |
Government Medical College Virudhunagar |
| Address |
Department of Community Medicine, Government Medical College,Virudhunagar.
1,Collectorate Master Plan Complex,
Kooraikundu Village,
Virudhunagar
Virudhunagar
TAMIL NADU
626002
India |
| Phone |
9790867437 |
| Fax |
|
| Email |
p.sandy11905@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Vijay |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Virudhunagar |
| Address |
Department of Community Medicine,
Government Medical College,Virudhunagar.
1,Collectorate Master Plan Complex,
Kooraikundu Village,
Virudhunagar
Virudhunagar
TAMIL NADU
626002
India |
| Phone |
9841063221 |
| Fax |
|
| Email |
calldrvijay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yuva Sandhya P |
| Designation |
MBBS student |
| Affiliation |
Government Medical College Virudhunagar |
| Address |
Department of Community Medicine,
Government Medical College,Virudhunagar.
1,Collectorate Master Plan Complex,
Kooraikundu Village,
Virudhunagar
Virudhunagar
TAMIL NADU
626002
India |
| Phone |
9790867437 |
| Fax |
|
| Email |
p.sandy11905@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical research, V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Vijay |
Government Medical College,Virudhunagar. |
Department of Community Medicine, 1,Collectorate Master Plan Complex,
Kooraikundu Village,
Virudhunagar - 626 002.
Virudhunagar
TAMIL NADU |
9841063221
calldrvijay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee, Government Medical College Virudhunagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
pregnant women who receive only routine antenatal care with no additional psychoeducation session |
Participants( pregnant women) in the control group will receive routine antenatal care as per existing Tamil Nadu and national guidelines. No additional psychoeducation module will be provided. |
| Intervention |
psychoeducation session (non pharmacological, behavioural or health education intervention |
A single interactive psychoeducation session (20–30 minutes) delivered during the antenatal visit. The session includes information on emotional changes in pregnancy, stress management techniques, coping strategies, role of family support, self-care, and early recognition of depressive symptoms. Educational leaflets will be provided. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
History of any diagnosed psychiatric disorder
High-risk pregnancy requiring intensive management
Inability to comprehend the intervention content
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of structured psychoeducational intervention conducted during the antenatal period on the incidence of postpartum depression.
|
Edinburgh postnatal depression scale scoring at 6 weeks postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate baseline knowledge and awareness regarding postpartum depression among participating antenatal mothers.
|
at the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
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. |