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CTRI Number  CTRI/2022/07/044479 [Registered on: 29/07/2022] Trial Registered Prospectively
Last Modified On: 27/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Tele yoga v/s in-person yoga for persons with Common Mental Health Disorder 
Scientific Title of Study   “Effect of virtual-yoga and in-person yoga for individuals with common mental health disorders in the community: a randomized controlled trial” 
Trial Acronym   
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 Neurosciences  
Address  Room No. 106, Govindsmay Building, Department Psychiatric Social Work, (NIMHANS)

Bangalore
KARNATAKA
560029
India 
Phone  01126995230  
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 Neurosciences  
Address  Room No. 106, Govindsmay Building, Department Psychiatric Social Work, (NIMHANS)

Bangalore
KARNATAKA
560029
India 
Phone  01126995230  
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 Neurosciences  
Address  Room No. 106, Govindsmay Building, Department Psychiatric Social Work, (NIMHANS)

Bangalore
KARNATAKA
560029
India 
Phone  01126995230  
Fax    
Email  jaganaarti@gmail.com  
 
Source of Monetary or Material Support  
DST Science and Technology of Yoga and Meditation DST SATYAM India 
 
Primary Sponsor  
Name  DST Science and Technology of Yoga and Meditation DST SATYAM India 
Address  Department of Science and Technology Technology Bhawan New Delhi 110 016 
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   Room no. 34, (OPD), Psychiatry, National Institute of Mental Health and Neurosciences   Near Lakshandra wilson garden NIMHANS
Bangalore
KARNATAKA 		 9448150690

jaganaarti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee for Research in AYUSH and integrative Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F48||Other nonpsychotic mental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  In-person Yoga  In-person yoga sessions for 30 participants will be provided in 10-12 supervised sessions (over a period of 1 month,3 sessions in a week) for 45 minutes based on adaptation of Tele Yoga Module for stress reduction.  
Comparator Agent  Virtual Yoga  Virtual-yoga sessions for 30 participants will be provided in 10-12 supervised sessions (over a period of 1 month,3 sessions in a week) for 45 minutes based on adaptation of Tele Yoga Module for stress reduction.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria
1. Common mental health disorder diagnosed to ICD-10(Categories F32.0, F40,F41,F43,F44 and F45).
2. Clinical Global Inventory (CGI)score less than or equal to 4
3. Availability of high internet access (512 Mbps and above) and high definition powerful web-camera facility at the therapist site and subjects house
4. able to read, write and working knowledge of english. 
 
ExclusionCriteria 
Details  Exclusion Criteria:
1) Obsessive Compulsive Disorder (F 42)
2) Severe Depression with or without psychotic symptoms (F 32.3 onwards)
3) Participants who are already practicing yoga regularly for the past 3 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Depressions and anxiety symptoms


 		 Baseline, Day 30, Day 60 and Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Well-being  Baseline, Day 30, Day 60 and Day 90 
Improve quality of life  Baseline, Day 30, Day 60 and Day 90 
 
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   N/A 
Date of First Enrollment (India)   01/08/2022 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    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 - Proposals should be directed to [jaganaarti@gmail.com].

  6. For how long will this data be available start date provided 02-01-2023 and end date provided 01-01-2026?
    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  
The primary objective of project is to compare the effect of Virtual Yoga and in-person yoga sessions in reducing the depressions and anxiety symptoms in participants. The secondary objectives are to effect of Virtual Yoga and in-person yoga sessions in improving the well-being, quality of life in participants. The total (n=60) patients with Common mental health Disorders will recruited from OPD of NIMHANS Bangalore. This patient will be randomized through the computer generated numbers and assigned into any two groups each (Virtual yoga=30) and (In-person-Yoga), as per the code. The inclusion criteria of is both gender both male and female participants with age group of 18-60 years will taken for the study. Patient diagnosed with Common Mental disorders diagnosed according to ICD-10 (Categories F32.0, F40, F41, F43, F44 and F45) and with less clinical global inventory (CGI) Score <= 4. The patients should also able to read, write and working knowledge of English. The patient should have the availability of high-speed internet access (512 Mbps and above) and high definition powerful web-camera facility at the therapist site and subject’s house. The Exclusion Criteria is that patient should not have Obsessive Compulsive Disorder (F 42) or Severe Depression with or without psychotic symptoms (F 32.3 onwards, and the participants who are already practicing yoga regularly for the past 3 months.   Post recruitment, the participants will be explained the purpose of the study and their written informed consent will be obtained. The SRF who is conducting the assessments would hence be unaware of the group status of the participants.  The validated Yoga for Psychiatric Disorders’ Module will be provided for 10 supervised session for 30-40 minutes per day over a period of one month
The assessments would be conducted at Baseline (Day 0), Post Intervention (Day 30), Day 60 (1st Follow-up) and Day 90 (2nd Follow-up). At each follow-up apart from the assessments, the participants would be provided a booster yoga session and their adherence of yoga practice at home would be checked for the previous month. The clinical assessments included in the projects are socio-demographic details and Hamilton Anxiety Rating Scale (HAM-A) : 14 and Hamilton Depression Rating Scale (HDRS): 17 to measures the anxiety and depression. The other assessment such as Edinburgh Mental Wellbeing Scale: 14 items, Quality of Life: (WHOQOL Brief) 26 items, Virtual Yoga Trainers Assessment (VYTA) Qualitative Feedback form. The yoga assessment will be conducted by yoga therapist based on Yoga performance Assessment Scale (YPA): Visual analog scale (VAS). The socio-demographic characteristics will be analyzed using the chi-square and t test. Based on the normality of the data, the differences among groups across timeline from baseline to the end of three months will be analyzed using the RMANOVA. The group differences at a particular follow-up will be analyzed using Independent Sample t test. Manual Content Analysis will be used to analyze the qualitative feedback data.

 

 


 
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