| CTRI Number |
CTRI/2025/04/084009 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to test if a mobile app called MITRA-C helps improve treatment outcomes in patients with schizophrenia. |
|
Scientific Title of Study
|
Evaluating the Efficacy of MITRA-C Mobile Application Based Intervention in Improving Treatment Outcomes among Patients with Schizophrenia – A Randomised Control Trial |
| Trial Acronym |
MITRA-C RCT (Mobile-based Intervention for Treatment Response and Adherence in Schizophrenia – Controlled Trial) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharni Souganthi S |
| Designation |
POST GRADUATE (MD Psychiatry) |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Dr.Sharni Souganthi S
Saveetha medical college and hospital
Saveetha Nagar,
Thandalam,
Chennai - 602105,
Tamil Nadu, India
Chennai
TAMIL NADU
602105
India |
| Phone |
9944788428 |
| Fax |
|
| Email |
sharnisethiram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sharni Souganthi S |
| Designation |
POST GRADUATE |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Dr.Sharni Souganthi S
2nd yr post graduate
Saveetha medical college and hospital
Chennai
TAMIL NADU
602105
India |
| Phone |
9944788428 |
| Fax |
|
| Email |
sharnisethiram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharni Souganthi S |
| Designation |
POST GRADUATE |
| Affiliation |
Saveetha medical college and hospital |
| Address |
3rd yr post graduate
Saveetha medical college and hospital
Saveetha Nagar,
Thandalam,
Chennai - 602105,
Tamil Nadu, India
Chennai
TAMIL NADU
602105
India |
| Phone |
9944788428 |
| Fax |
|
| Email |
sharnisethiram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college & hospital |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Saveetha Nagar,
Thandalam,
Chennai - 602105,
Tamil Nadu, India |
| 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 sharni souganthi |
Saveetha medical college & hospital |
Ic 1
Department of psychiatry
Saveetha medical college & hospital
Saveetha Nagar,
Thandalam,
Chennai - 602105,
Tamil Nadu, India
Chennai
TAMIL NADU |
9944788428
sharnisethuram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee SMCH IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile-Based Intervention for Treatment Adherence in Chronic Mental Illness - Schizophrenia. |
A smartphone application that provides medication reminders, symptom tracking, motivational messages, psychoeducation, progress feedback, and secure communication with healthcare providers to improve treatment adherence and outcomes in patients with schizophrenia |
| Comparator Agent |
Standard care for patients with Schizophrenia |
Type: Standard psychiatric care
Description: Participants will receive routine outpatient care, including pharmacotherapy, follow-up visits, and general psychoeducation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of Schizophrenia:
Participants must have a confirmed diagnosis of schizophrenia according to the DSM-5 criteria, with either acute or chronic symptoms that are stable enough to allow participation in the study (without requiring immediate hospitalization). This ensures the study targets the intended population with schizophrenia.
Sources: Diagnostic and Statistical Manual of Mental Disorders (DSM-5), American Psychiatric Association, 2013.
Age Range:
Participants should be aged 18 years or older but not exceeding 60 years, as the app and intervention may be more effective in adults and may not be appropriate for elderly populations with specific health complications.
Sources: Velligan et al., 2004; Muench & Hamer, 2010.
Ability to Provide Informed Consent:
Participants must have the mental capacity to provide informed consent for participation in the study, ensuring they understand the nature of the intervention and their role in the research. This is a standard criterion for all clinical trials.
Sources: Ethical guidelines for clinical research, World Health Organization (WHO). |
|
| ExclusionCriteria |
| Details |
1. Severe Cognitive Impairment: Participants with significant cognitive impairments, such as those with a Mini-Mental State Examination (MMSE) score lower than 24 or severe executive dysfunction, should be excluded. This ensures that participants can understand and use the mobile app, which may be challenging for those with severe cognitive deficits.
2. Recent Psychiatric Hospitalization or Acute Psychotic Episodes: Participants who have been hospitalized for acute psychosis or severe exacerbations of schizophrenia in the last 30 days should be excluded. Acute episodes could impair their ability to engage with the study intervention effectively.
3. Severe Medical or Neurological Conditions: Participants with significant neurological disorders (e.g., severe epilepsy) or uncontrolled medical conditions (e.g., diabetes, cardiovascular disease) that could interfere with the study or treatment adherence should be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Medication Adherence Rates: Via questionnaires
2.Reduction in Relapse Rates
3.Symptom Severity |
0 weeks,8 weeks,12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Quality of life.
2. Engagement with App. |
Zero months, one month and three months |
|
|
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)
|
20/04/2025 |
| 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="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
|
Objective The primary aim of this study is to assess the effectiveness of MITRA-C, a mobile-based intervention for treatment adherence in chronic mental illness schizophrenia, in improving treatment adherence and overall mental health outcomes in patients with schizophrenia.
Intervention MITRA-C MITRA-C is a mobile application designed to enhance medication adherence, monitor symptoms, and provide psychoeducation and motivational support to patients with schizophrenia. It includes features such as medication reminders, symptom tracking, motivational content, and secure communication with healthcare providers to improve engagement with treatment.
Study Design This is a randomized controlled trial with a parallel design, where patients are randomly assigned to either the intervention group MITRA-C or the control group which receives standard care. Treatment outcomes will be assessed at baseline, one month, and three months, focusing on medication adherence, symptom severity, and relapse rates.
Primary Outcome The primary outcome of the study is to measure medication adherence using objective measures such as pill counts or medication event monitoring systems, along with changes in symptom severity and relapse rates.
Significance This study addresses a common issue in schizophrenia treatment: poor medication adherence, which can lead to relapse and hospitalization. By utilizing a mobile-based intervention, the study aims to provide a more accessible and effective method to improve patient outcomes, with the potential to reduce relapse rates and improve quality of life.
|