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CTRI Number  CTRI/2026/02/103304 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Brief Motivational Interview for Metabolic Abnormalities in Schizophrenia : A Pilot Randomized Controlled Trial 
Scientific Title of Study   Effectiveness of Brief Motivational Interview to Improve Metabolic Abnormalities in Patients with Schizophrenia and other Primary Psychotic Disorder: A Pilot 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  Vijay Kumar Saini 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS), Jodhpur 
Address  Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9460869846  
Fax    
Email  vsaini344@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vijay Kumar Saini 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS), Jodhpur 
Address  Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9460869846  
Fax    
Email  vsaini344@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vijay Kumar Saini 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS), Jodhpur 
Address  Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9460869846  
Fax    
Email  vsaini344@gmail.com  
 
Source of Monetary or Material Support  
This is Intramural Project, financial support from All India Institute of Medical Sciences, Basni Phase 2,Jodhpur, Rajasthan, India 342005 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  MIA, Basni, Phase 2, Jodhpur, Rajasthan, India 342005 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrVijay Kumar Saini  All India Institute of Medical Sciences  Room no 143, Department of Psychiatry,AIIMS OPD, MIA, Basni, Phase 2, Jodhpur
Jodhpur
RAJASTHAN 		 9460869846

vsaini344@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AII India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F200||Paranoid schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brief Motivational Interview  Brief Motivational Interview will be developed and validated after consensus from expert psychiatrist and clinical psychologists. Brief Motivational Interviewing (BMI) module will be based on FRAMES model and will include key concepts such as empathy, developing discrepancy, self efficacy, Positive feedback to facilitate engagement in healthy behaviors.  
Comparator Agent  Treatment as usual   Treatment as usual (TAU) group in which participants will receive standard care which include Psycho-education and lifestyle modification advice. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults aged 18-60 years diagnosed with schizophrenia and other primary psychotic disorder according to ICD -11 criteria  
 
ExclusionCriteria 
Details  Presence of co-morbid psychiatric disorders, or organic brain syndromes Presence of co-morbid chronic physical illness except Diabetes, Hypertension and Dyslipidemia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Metabolic parameter: change in weight, BMI, waist circumference, blood pressure, lipid profile, S. Insulin and fasting blood glucose.   1 month 2 month 3 month 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
Well-being of patients: Measured using the WHO-5.
Functional Status: Assessed by the Global Assessment of Functioning (GAF) scale
Level of physical activity
 		 1 month 2 month 3 month 6 month 
 
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   Phase 1 
Date of First Enrollment (India)   23/02/2026 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to email ID vsaini344@gmail.com

  6. For how long will this data be available start date provided 30-10-2025 and end date provided 29-10-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

It will be pilot randomized controlled trial with aimed to assess the effect of Brief Motivational Interviewing on adherence to advised lifestyle modification and on metabolic parameters in patients with schizophrenia and other primary psychotic disorder. After applying Inclusion and Exclusion criteria, Participants will be randomized into 2 groups – Intervention group and treatment as usual group. Intervention group in which participants will receive semi structured Brief Motivational Interview session/s along with standard care.Treatment as usual (TAU) group in which participants will receive standard care which include Psycho-education and lifestyle modification advice. Brief Motivational Interviewing session will be given to participants in Intervention group to increase adherence to lifestyle modification to reduce metabolic abnormalities in patients with Schizophrenia and other primary psychotic disorder.  Changes in anthropometric measurement will be assessed at 1 month, 2 month, 3 month and 6 month and changes in biochemical parameters (FBS, Lipid Profile, S. Insulin) at 3 months and 6 months will be assessed.

 

 
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