| CTRI Number |
CTRI/2025/09/095300 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving Medication Adherence in Depression Using a Gamified Mobile Health App |
|
Scientific Title of Study
|
Development of a gamified app to improve adherence to medication regimens in patients with depression |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHANAAPRIYA D |
| Designation |
PG student |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Integrated clinic 3,Department of psychiatry,Saveetha medical college hospital, Thandalam , Chennai.
TAMIL NADU
602105 India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9952101455 |
| Fax |
|
| Email |
mohanaapriya177@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR INIYAN S |
| Designation |
Professor of Psychiatry |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Department of psychiatry, Saveetha medical college hospital, Thandalam , Chennai.
TAMIL NADU
602105 India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9894514942 |
| Fax |
|
| Email |
iniyanmbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR INIYAN S |
| Designation |
Professor of Psychiatry |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Department of psychiatry, Saveetha medical college hospital, Thandalam , Chennai.
TAMIL NADU
602105 India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9894514942 |
| Fax |
|
| Email |
iniyanmbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital (Saveetha Institute of Medical and Technical Sciences),Thandalam Post, Kanchipuram District, Chennai, Tamil Nadu 602105, India. |
|
|
Primary Sponsor
|
| Name |
Saveetha Institute of Medical and Technical Sciences SIMATS Saveetha Medical College Hospital |
| Address |
Thandalam, 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 Mohanaapriya DPostgraduate student of psychiatry |
Saveetha medical college and research institute |
Integrated clinic 3,Department of Psychiatry,. Saveetha Medical College & Hospital, Saveetha Institute of Medical and Technical Sciences (SIMATS),Thandalam, Chennai-602105, Tamil Nadu, India.
Kancheepuram
TAMIL NADU |
09952101455
mohanaapriya177@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, (2) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gamified App to Improve Adherence to Medication Regimens in Patients with Depression
|
Patients will receive pharmacotherapy (antidepressants as per treating psychiatrist’s discretion) and supportive psychotherapy, along with the gamified mobile health app intervention. The app will provide medication reminders, adherence tracking, and motivational feedback.
Frequency: Daily use of the app, with reminders twice per day.
Total Duration: 12 weeks from baseline to end of study follow-up. |
| Comparator Agent |
Pharmacotherapy and psychotherapy |
Patients will receive pharmacotherapy (antidepressants as per treating psychiatrist’s discretion) and supportive psychotherapy. Follow-up visits will be conducted once every 2 weeks or as clinically required, for a total duration of 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with major depressive disorder as per DSM-5 criteria ,prescribed antidepressant medication for at least 6 weeks,owning a smartphone with internet access |
|
| ExclusionCriteria |
| Details |
Severe psychiatric comorbidities (e.g., bipolar disorder, schizophrenia)
Cognitive impairments or intellectual disabilities that may hinder app usage
Participation in other clinical trials
Inability to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Medication Adherence: Measured using the Morisky Medication-Taking Adherence Scale (MMAS) which are self-reported questionnaires assessing the frequency of adherence behaviors. |
Day 0(Baseline),4 weeks, 8 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Depression Severity: Assessed using the Hamilton Depression Rating Scale (HAM-D). This clinician-administered scale measures the severity of depressive symptoms.
User Engagement: Tracked through app usage data, including frequency of logins, time spent on the app, & number of completed tasks.
|
Day 0 (Baseline), Week 4, Week 8, Week 12 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
04/10/2025 |
| 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 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 study aims to develop and evaluate a gamified app to improve medication adherence in patients with depression through a randomized controlled trial. By leveraging the principles of gamification and digital health, the app seeks to make medication management more engaging and effective. The outcomes of this study could pave the way for innovative approaches to enhance treatment adherence in mental health, ultimately leading to better clinical outcomes and improved quality of life for patients with depression.
|