| CTRI Number |
CTRI/2025/11/097881 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Phone Calls and Positive Mobile Messages to Support New Mothers and Reduce Postnatal Depression |
|
Scientific Title of Study
|
Effectiveness of a Mobile-Based Intervention Using Telephonic Support and Digital Media Messaging in Reducing Postpartum Depression: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abdul Rahman Akbar |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Gondia |
| Address |
Government Medical College, Gondia Maharashtra
Gondiya MAHARASHTRA 441601 India |
| Phone |
7305279368 |
| Fax |
|
| Email |
akbarabdulrahman1996@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Abhay Kumar Ambilkar |
| Designation |
Assisstant Proffessor |
| Affiliation |
Government Medical College, Gondia |
| Address |
Government Medical College, Gondia Maharashtra
Gondiya MAHARASHTRA 441601 India |
| Phone |
7305279368 |
| Fax |
|
| Email |
akbarabdulrahman1996@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abdul Rahman Akbar |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Gondia |
| Address |
Government Medical College, Gondia Maharashtra
Gondiya MAHARASHTRA 441601 India |
| Phone |
7305279368 |
| Fax |
|
| Email |
akbarabdulrahman1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Gondia Maharashtra PIN CODE 441601 India |
|
|
Primary Sponsor
|
| Name |
Government Medical College Gondia |
| Address |
Near Indra Gandhi Stadium Neru Chowk Gondia Maharashtra Pin code 441601 INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 Abdul Rahman Akbar |
Government medical College, Gondia |
Department of community medicine Bai Ganga Bhai hospital Gondiya MAHARASHTRA |
7305279368
akbarabdulrahman1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government medical College, Gondia institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Females more than 18 years those in the postpartum period |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile-based health messaging intervention |
Participants in the intervention arm will receive 6 weeks of intervention: mobile-based health messages related to mental health awareness, coping strategies, stress management, and adherence reminders. Messages will be delivered through SMS/WhatsApp at a predefined frequency (e.g., once daily/weekly) for the duration of the study. The aim of the intervention is to reduce depressive symptoms as assessed by PHQ-9 and related scales. |
| Comparator Agent |
Usual care / No mobile-based messaging |
Participants in the comparator arm will receive usual care and no mobile-based health messages. They will not receive any intervention during the study period. Their depressive symptoms will be assessed at the same time points using PHQ-9 and other relevant scales to compare outcomes with the intervention arm. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1 Postpartum females within 4 weeks of delivery
2 Aged 18 years or older
3 Able to provide informed consent and participate in WhatsApp groups
|
|
| ExclusionCriteria |
| Details |
1 Pre-existing psychiatric disorders.
2 Severe medical comorbidities.
3 Currently undergoing psychotherapy or pharmacological treatment for depression.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in postpartum depression scores (EPDS) |
At baseline six weeks 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in maternal self-efficacy (confidence and ability in managing postpartum demands) |
6, 12, and 24 weeks after enrollment/intervention |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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)
|
10/12/2025 |
| 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="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study aims to assess the effectiveness of a mobile-based intervention comprising telephonic support and positive reinforcement messages through digital messaging platform in reducing postpartum depression among mothers. By integrating digital communication into maternal healthcare, the study seeks to contribute to sustainable, community-based strategies that enhance emotional well-being and early recovery in the postpartum period. Null hypothesis: There will be no significant difference in postpartum depression scores between the intervention and control group at the end of the follow-up period. |
Alternate hypothesis: The mobile-based intervention will produce a significant reduction in postpartum depression scores compared to standard care. |