| CTRI Number |
CTRI/2025/01/079168 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral
Other (Specify) [Mobile application ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assessing the efficacy of mobile application for early screening and intervention of post partum depression: A prospective intervention study |
|
Scientific Title of Study
|
Assessing the efficacy of mobile application for early screening and intervention of post partum 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 RAMYA B |
| Designation |
Postgraduate student |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Saveetha medical college and hospital department of Obstetrics and Gynaecology OBG opd room . No 150 Poonamallee Poonamallee high road Kuthambakkam Chennai 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
8838840325 |
| Fax |
|
| Email |
baskaranramya27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Nidhi Sharma |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Saveetha medical college and hospital department of Obstetrics and Gynaecology OBG opd room no. 150 Poonamallee high road Kuthambakkam Chennai 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9445560392 |
| Fax |
|
| Email |
nidhisharma.smc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAMYA B |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Saveetha medical college and hospital department of Obstetrics and Gynaecology, 1st floor OBG opd room no. 150 Poonamallee Poonamallee high road Kuthambakkam Chennai India 602105
Tiruchirappalli
TAMIL NADU
602105
India |
| Phone |
8838840325 |
| Fax |
|
| Email |
baskaranramya27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital poonamalle poonamalle high road Kuthambakkam Chennai , India 602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Saveetha medical college and hospital Poonamallee Poonamallee high road Kuthambakkam Chennai 602105 |
| Type of Sponsor |
Private 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 Ramya baskaran |
Saveetha medical college and hospital |
Saveetha medical college and hospital department of Obstetrics and Gynaecology 1st floor OBG OPD no. 150
Kancheepuram
TAMIL NADU |
8838840325
baskaranramya27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college-institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile application |
Mobile application serves as primary intervention tool.
App features screening questionnaires taken up by patients every week ,educational materials, mood tracking done based on their daily input ,chat bot and support resources. All these done for total duration of 6months
|
| Comparator Agent |
Standard care ( control group) |
Paper based self screening tools done every 2 weeks
Routine postpartum check ups verbal counselling or referrals but no digital intervention, done every 2 weeks for a total duration of 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women who recently given birth (within last 6 months)
Age range (18-45years)
Ownership of a smartphone with Internet access
Ability to understand and communicate in the language used in the study material (eg English) |
|
| ExclusionCriteria |
| Details |
Women with a history of severe mental illness (e.g., psychosis). Women with substance abuse disorders.
Women with cognitive impairments that would hinder their ability to participate in the
study.
Women who are currently receiving treatment for postpartum depression or any other mental health condition.
Women with high-risk pregnancies or medical complications requiring intensive medical care. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether the use of the mobile application reduces the severity of postpartum depression symptoms compared to standard care or a control group |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the feasibility and acceptability of the mobile application among postnatal mothers, healthcare providers, and guardians.
To determine the impact of the mobile application on the early detection of postpartum depressive symptoms by comparing the rates of timely identification of symptoms between intervention and control groups |
Baseline [1-2wks] immediate postpartum screening enrollment app on boarding early intervention [tracking ) moods and symptoms trackers , thereafter every 2wks- questionnaire scores ,outcomes reassesed,intervention tracked. At 8wks,12wks postpartum intervention efficacy,app engagement,psychological well being and outcomes assessment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
To assess the efficacy of a mobile application in early detection and intervention for post partum depression through a randomized controlled trial The background of the invention for the mobile application designed for early screening and intervention for postpartum depression lies within the context of the significant burden that postpartum depression (PPD) poses on maternal and infant health. Postpartum depression is a prevalent and debilitating mental health condition that affects a substantial number of women during the perinatal period, typically within the first year after childbirth. It is characterized by persistent feelings of sadness, anxiety, and low mood, which can have profound consequences for maternal well-being, infant care, and family dynamics. To sum up our application involves the following aspects of pyschosocial health â— Addressing a Critical Healthcare Gap â— Harnessing the Power of Technology â— Comprehensive and Personalized Support â— Novel Combination of Features to produce better outcomes |