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Study to test if a mobile app called MITRA-C helps improve treatment outcomes in patients with schizophrenia.

Evaluating the Efficacy of MITRA-C Mobile Application Based Intervention in Improving Treatment Outcomes among Patients with Schizophrenia A Randomised Control Trial - MITRA-C RCT (Mobile-based Intervention for Treatment Response and Adherence in Schizophrenia Controlled Trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084009
Enrollment
60
Registered
2025-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G- Mental Health

Interventions

Intervention1: Mobile-Based Intervention for Treatment Adherence in Chronic Mental Illness - Schizophrenia.: A smartphone application that provides medication reminders, symptom tracking, motivational

Sponsors

Saveetha medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1.Medication Adherence Rates: Via questionnaires 2.Reduction in Relapse Rates 3.Symptom SeverityTimepoint: 0 weeks,8 weeks,12 weeks

Secondary

MeasureTime frame
1. Quality of life. 2. Engagement with App.Timepoint: Zero months, one month and three months

Countries

India

Contacts

Public ContactSharni Souganthi S

Saveetha medical college and hospital

sharnisethiram@gmail.com9944788428

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026