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CTRI Number  CTRI/2026/01/102486 [Registered on: 29/01/2026] Trial Registered Prospectively
Last Modified On: 13/08/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Process of Care Changes
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Yoga for Persons with Severe Mental Disorders in Rural India 
Scientific Title of Study   Effectiveness of YES (Yoga-based Extension Services) Intervention for Person with Severe Mental Disorders in Rural India: A Cluster Randomized study 
Trial Acronym  YES 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aarti Jagannathan 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Psychiatric Social work, Govinda Swamy Building, NIMHANS, Bengaluru-29

Bangalore
KARNATAKA
560029
India 
Phone  9448150690  
Fax    
Email  jaganaarti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aarti Jagannathan 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Psychiatric Social work, Govinda Swamy Building, NIMHANS, Bengaluru-29

Bangalore
KARNATAKA
560029
India 
Phone  9448150690  
Fax    
Email  jaganaarti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aarti Jagannathan 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Psychiatric Social work, Govinda Swamy Building, NIMHANS, Bengaluru-29

Bangalore
KARNATAKA
560029
India 
Phone  9448150690  
Fax    
Email  jaganaarti@gmail.com  
 
Source of Monetary or Material Support  
ICMR 
 
Primary Sponsor  
Name  ICMR 
Address  Ramalingaswami Bhawan, Ansari Nagar, New Delhi-110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aarti Jagannathan  NIMHANS  Room No. 106, Department of Psychiatric Social Work, First Floor, M. V. Govindswamy Building, Hosur Road, bangalore-560029
Bangalore
KARNATAKA 		 9448150690

jaganaarti@gmail.com 
 
Details of Ethics Committee  
 
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 
Comparator Agent  control group  Medication and Standard follow-up 
Intervention  YES (Yoga-based Extension Services)  The YES consists of a structured 6-session yoga program (30-45 minutes each) delivered once per month during outpatient follow-up visits at PHCs or Taluk Hospitals for 6 months. It includes yoga asanas, pranayama, relaxation techniques, yogic counselling, and lifestyle guidance. Each session is conducted face-to-face by trained yoga therapists. Participants also receive culturally adapted brochures and videos in the local language for daily home practice. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosis of severe Mental Disorders as per ICD-10 criteria, including Schizophrenia (F20.0-F29), Bipolar Affective Disorder (F31.0-F31.9), Recurrent Depressive Disorder (F33.0-F33.9)
Clinical Global Impression (CGI) Score less than or equal to 4
Ability to read, write and speak Kannada or have working knowledge of Kannada or English
 
 
ExclusionCriteria 
Details  Individuals with comorbid mental retardation or any other developmental disorder.
Individuals with the primary diagnosis of Substance abuse disorders (F.10-19) and other disorders as mentioned in the inclusion criteria as co-morbid disorders.
Obsessive Compulsive Disorder (F 42)
Participants who are already practicing Yoga Regularly for the past 3 months 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), Brief Psychiatric Rating Scale (BPRS), WHO-5 Well-being Index, Social and Occupational Functioning Assessment Scale (SOFAS), Color Trials A & B and N-back 1/2  Baseline, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Symptom Severity- brief psychiatry rating scale (BPRS) and PHQ-SADS
Well-being- WHO- Five wellbeing Index
Socio-occupational functioning-Socio-occupational Functional Assessment Scale (SOFAS)
Cognition- Colour Trails A and B, N-back1 and 2 tests

 		 3 months and 6 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/04/2026 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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

  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 this email: jaganaarti@gmail.com.

  6. For how long will this data be available start date provided 01-01-2029 and end date provided 31-12-2031?
    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   This is a cluster randomized study to assess the feasibility and effectiveness of the Yoga-based Extension Services (YES) intervention as an add-on to routine treatment for persons with Severe Mental Disorder (SMD) in rural India. The intervention includes six face-to-face monthly yoga sessions delivered by trained yoga therapists, with home-based practice supported by videos and printed materials. The study will compare outcomes, including symptom severity, disability, cognitive function, and well-being, between the intervention and waitlist control groups, and will be conducted over 36 months in two rural taluks in Karnataka state. Inclusion criteria are male and female participants aged 18 to 60 years diagnosed according to ICD-10 criteria with schizophrenia, schizotypal and delusional disorders (F20–F29), bipolar affective disorder (F31), recurrent depressive disorder (F33), or severe depression with or without psychotic symptoms (F32.3), having a Clinical Global Impression (CGI) score less than or equal to 4, and able to read, write, and have working knowledge of English. Exclusion criteria are individuals with comorbid Intellectual disability or developmental disorders, individuals with a primary diagnosis of substance use disorders (F10–F19) or obsessive-compulsive disorder (F42), and participants already practising yoga regularly for the past three months..   
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