| CTRI Number |
CTRI/2017/08/009583 [Registered on: 31/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Virtual Yoga for mental disorders |
|
Scientific Title of Study
|
Feasibility and Pilot Testing of Virtual- Yoga sessions for individuals with mental health disorders in the community |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarti Jagannathan |
| Designation |
Assistant Professor |
| Affiliation |
NIMHANS |
| Address |
Room 106, 2nd floor, Govindaswamy Building,
Department of Psychiatric Social Work, NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9448150690 |
| Fax |
08026576465 |
| Email |
jaganaarti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aarti Jagannathan |
| Designation |
Assistant Professor |
| Affiliation |
NIMHANS |
| Address |
Room 106, 2nd floor, Govindaswamy Building,
Department of Psychiatric Social Work, NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9448150690 |
| Fax |
08026576465 |
| Email |
jaganaarti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aarti Jagannathan |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Room 106, 2nd floor, Govindaswamy Building,
Department of Psychiatric Social Work, National Institute of Mental Health and Neurosciences (NIMHANS)
Bangalore
KARNATAKA
560029
India |
| Phone |
9448150690 |
| Fax |
08026576465 |
| Email |
jaganaarti@gmail.com |
|
|
Source of Monetary or Material Support
|
| No source of monetary or material support. Non-Funded Project. |
|
|
Primary Sponsor
|
| Name |
Dr Aarti Jagannathan |
| Address |
Room Number 106, 2nd Floor, Department of Psychiatric Social Work, Govindswamy building,
NIMHANS, Bangalore-560029 |
| Type of Sponsor |
Other [Self] |
|
|
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 Aarti Jagannathan |
National Institute of Mental Health and Neurosciences (NIMHANS) |
Department of Psychiatric Social Work, NIMHANS,Bengaluru
Bangalore
KARNATAKA |
9448150690
91-80-26576465
jaganaarti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F488||Other specified nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Yoga |
1 hour daily for 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a)Mental disorders diagnosed according to ICD-10
b)Recovered patients of severe mental disorders
c)Clinical Global Inventory (CGI) Score less or equal to 4
d)18-60 years
e)Able to read, write and working knowledge of English
f)Patients referred for Yoga to NIMHANS Centre for Well-Being (NCWB)
|
|
| ExclusionCriteria |
| Details |
a)Individuals who do not express willingness to be part of the study.
b)Unable to read, write and working knowledge of English.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Warwick-Edinburgh Mental Well-being Scale (WEMWBS) |
Baseline (Day 0) Interim (Day 15) and Post Intervention (Day 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WHOQOL-BREF |
Baseline (Day 0) Interim (Day 15) and Post Intervention (Day 30) |
| Virtual Yoga Training checklist |
Baseline (Day 0) Interim (Day 15) and Post Intervention (Day 30) |
| Visual Analogue Scale (VAS) |
Baseline (Day 0) Interim (Day 15) and Post Intervention (Day 30) |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Jagannathan A, Bhide SR, Varambally S (2017). Virtual Yoga Services for Persons with Mental Health Disorders. In: Chandra PS and Padmavathy d (Eds). Urban Mental Well-Being Centres - A Replicable NIMHANS Model. NIMHANS Centre for Well Being Publication, Bengaluru |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. Regular practice of yoga is known to produce a number of benefits in physical and mental health. However, individuals with mental health disorders in the community are not able to attend the sessions in tertiary centers of yoga due to time constraint, logistics issues or social barriers and stigmas. Virtual Yoga is a process where webcams are used to relay sessions of yoga from one source to multi-point video conferencing centres using the software “Skype†or “Hangouts†via internet. In this proposed research, we are testing the feasibility of virtual-yoga practice on individuals with mental health disorders in the community. The subjects, under the guidance of a trained yoga therapist will be encouraged to attend yoga sessions at the NIMHANS Centre for Well-Being (NCWB) on a particular time and day of the week for the first 15 days after which they will be encouraged to practice yoga in their respective homes for the next 15 days through virtual yoga classes conducted using Skypee (therapist being in one centre and clients being in their homes. The clients would be assessed on their well-being, quality of life, satisfaction and virtual training experience quantitatively and qualitatively on Day 1, Day 15 and Day 30. Suitable Parametric and Non-Parametric Tests will be used to analyse the quantitative data. Manual Content Analysis will be used to analyse the qualitative data. |