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Clinical Trials/CTRI/2025/12/099088
CTRI/2025/12/099088Not yet recruitingNot Applicable

A study to assess the efficacy of the multi-modal intervention on the severity of psychotic symptoms, medication adherence, and quality of life among schizophrenic patients admitted to a tertiary care hospital in Central India: A randomized Controlled trial

Not provided1 site in 1 country30 target enrollmentStarted: December 25, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Locations
1

Study Overview

Brief Summary

Schizophrenia is linked to psychosis and significant challenges in personal, family, social, educational, and professional aspects of life. Individuals affected by schizophrenia often face stigma, discrimination, and human rights abuses. Unfortunately, despite the existence of appropriate care, a majority of people with psychosis worldwide—over two-thirds—lack access to specialized mental health services. On a positive note, with adequate treatment, about one-third of those diagnosed with schizophrenia can fully recover.

Given the significant challenges associated with schizophrenia, the researcher aims to develop a multi-model intervention. This strategy will evaluate the effectiveness of combining pharmacological therapy with non-pharmacological approaches to reduce psychotic symptoms, improve medication adherence, and enhance patients’ quality of life in tertiary care hospitals in India.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Understand Hindi or English
  • An established diagnosis of Schizophrenia based on ICD-11/ICD-
  • CGI-Severity score of less than or equal to 4
  • Stable Antipsychotic regimen for equal to or more than 4 weeks
  • Capacity to provide informed consent
  • Medical Clearance for moderate activity.

Exclusion Criteria

  • CGI-S score between 5 and 7
  • Alcohol or drug dependence within the last 6 months
  • Active suicidal ideation or attempt in the last 6 months
  • Uncontrolled hypertension, severe cardiac disease, epilepsy, or significant head trauma.

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

Dr Rajratan

All India Institute of Medical Sciences Bhopal

Study Sites (1)

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