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CTRI Number  CTRI/2025/12/098461 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   A new mobile app to help people with mental health problems do their daily activities will be developed and it will be tested by people with long-term mental health problems and they will provide feedback on the app and their improvement in daily routine performance will be taken from the app. 
Scientific Title of Study   Development and Testing of a Mobile based Application to address Occupational Engagement among Individuals with Serious Mental Illness 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khadeeja Said Ali  
Designation  Post graduate student  
Affiliation  Manipal College of Health Professions 
Address  Department of Occupational Therapy Manipal College of Health Professions MAHE Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  7902481018  
Fax    
Email  khadeeja.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinita A Acharya 
Designation  Additional Professor  
Affiliation  Manipal College of Health Professions 
Address  Department of Occupational Therapy Manipal College of Health Professions MAHE Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9986071111  
Fax    
Email  vinita.acharya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vinita A Acharya 
Designation  Additional Professor  
Affiliation  Manipal College of Health Professions 
Address  Department of Occupational Therapy Manipal College of Health Professions MAHE Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9986071111  
Fax    
Email  vinita.acharya@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, MAHE, Madhav Nagar, Manipal 576104, Udupi, Karnataka, Indian  
 
Primary Sponsor  
Name  Manipal College of Health Professions 
Address  Manipal College of Health Professions, MAHE, Madhav Nagar, Manipal 576104, Udupi, Karnataka, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinita A Acharya   Department of Occupational Therapy, Kasturba Hospital  Department of Occupational Therapy,Kasturba Hospital MAHE, Madhav Nagar, Manipal- 576104, Udupi, Karnataka, India
Udupi
KARNATAKA 		 9986071111

vinita.acharya@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F31||Bipolar disorder, (2) ICD-10 Condition: F33||Major depressive disorder, recurrent, (3) ICD-10 Condition: F20||Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable   NIL 
Intervention  Pilot Study  A Mobile based application will be downloaded in the participants phone. The app contains daily activity schedule, weekly feedback, Achievement page and Psychoeducational content. the participants are requested to use the app for 4 weeks and answer the mHealth App Usability Questionnaire at the end of the 4th week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major Depressive disorder; age 18 years and above. Individuals who can read and speak Kannada or Malayalam or English. Individuals who own a smartphone and have internet access. Individuals who are stable.  
 
ExclusionCriteria 
Details  Individuals whose psychiatric medication dosage has been changed within the past 2 weeks due to unstable symptoms.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To develop, test and evaluate the usability of the mobile application with individuals with serious mental illness.

To test the mobile app with individuals with serious mental
illness.
To evaluate the usability of the developed app among individuals with serious mental illness 		 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
User engagement with the app by analysing the frequency of check-ins, the number of activities engaged and time use.
Perceived effectiveness of occupational engagement using weekly subjective feedback.  		 4 weeks  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/12/2025 
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="1"
Months="0"
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 design, develop, and test a mobile application that facilitates occupational engagement for individuals with serious mental illness. The study consists of two phases. 
The first involves a scoping review of literature to identify common issues in occupational engagement among people with SMI. Based on this review, a list of essential features, such as activity scheduling, reminders, progress tracking and psychoeducation, will be finalised in consultation with Computer Science faculty for feasibility. 
The second phase includes app development and testing. The app will incorporate identified features and a web interface for therapists to monitor user engagement. Validation will be conducted by an occupational therapist, followed by a 4-week feasibility study with participants who get discharged from the psychiatric unit at Kasturba Hospital. Participants will receive training on app usage before discharge and will use the app post-discharge to engage in planned activities. Engagement metrics such as user check-ins, task completion and time use will be monitored via the web interface, and user feedback will be collected through an in-app survey. The app and data will be securely stored in a password-protected storage space, and the user will be logged out of the app after the study period. 
 
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