| CTRI Number |
CTRI/2025/12/099088 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
14/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Multi model intervention ( Exercsie Yoga & Psychoeducation)] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy Of Multi-Modal Intervention On Severity Of Psychotic Symptoms, Medication Adherence, And Quality Of Life Among Schizophrenic Patients |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajratan |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Psychiatric Nursing, Nursing College, All India Institute of Medical Sciences, Bhopal
Saket Nagar
Bhopal, Madhya Pradesh,462 020, India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9845869630 |
| Fax |
|
| Email |
ratanraj2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajratan |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Psychiatric Nursing, Nursing College, All India Institute of Medical Sciences, Bhopal
Saket Nagar
Bhopal, Madhya Pradesh,462 020, India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9845869630 |
| Fax |
|
| Email |
ratanraj2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajratan |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Psychiatric Nursing, Nursing College, All India Institute of Medical Sciences, Bhopal
Saket Nagar
Bhopal, Madhya Pradesh,462 020, India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9845869630 |
| Fax |
|
| Email |
ratanraj2@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhopal
Saket Nagar
Bhopal, Madhya Pradesh,462 020, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajratan |
All India Institute of Medical Sciences Bhopa |
All India Institute of Medical Sciences Bhopal
Saket Nagar
Bhopal, Madhya Pradesh, 462 020, India
Bhopal
MADHYA PRADESH |
9845869630
ratanraj2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC, AIIMS BHOPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multi-Modal Intervention |
This multi-modal intervention consists of Gentle dynamic stretching, Yoga, Breathing Exercises, and Light exercises- brisk walking in place. It also includes psychoeducation sessions on Understanding Schizophrenia, Stress Management, Coping Strategies, Healthy lifestyle, Social Skills, Relapse prevention, and future planning on Days 1, 3, 6, 9, and 12 |
| Comparator Agent |
Standard Treatment |
Patients in the control group will be receiving the standard treatment in the psychiatric unit. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Understand Hindi or English
2. An established diagnosis of Schizophrenia based on ICD-11/ICD-10.
3. CGI-Severity score of less than or equal to 4
4. Stable Antipsychotic regimen for equal to or more than 4 weeks
5. Capacity to provide informed consent
6. Medical Clearance for moderate activity |
|
| ExclusionCriteria |
| Details |
1. CGI-S score between 5 and 7
2. Alcohol or drug dependence within the last 6 months
3. Active suicidal ideation or attempt in the last 6 months
4. Uncontrolled hypertension, severe cardiac disease, epilepsy, or significant head trauma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy Of Multi-Modal Intervention On Severity Of Psychotic Symptoms, Medication Adherence And Quality Of Life Among Schizophrenic Patients |
Day 0 and Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
25/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/12/2025 |
| 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 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
|
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. |