| CTRI Number |
CTRI/2011/06/001792 [Registered on: 09/06/2011] Trial Registered Retrospectively |
| Last Modified On: |
04/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga on caregivers of patients with Schizoprenia |
|
Scientific Title of Study
|
Efficacy of Brief Yoga Programme for Caregivers of Out-Patients with Schizophrenia |
| Trial Acronym |
YCS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivarama Varambally |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Dharmaram College PO, Hosur Road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
080-26995253 |
| Fax |
080-26576465 |
| Email |
ssv.nimhans@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivarama Varambally |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Dharmaram College PO, Hosur Road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
080-26995253 |
| Fax |
080-26576465 |
| Email |
ssv.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivarama Varambally |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Dharmaram College PO, Hosur Road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
080-26995253 |
| Fax |
080-26576465 |
| Email |
ssv.nimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Yoga and Naturopathy, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Shivarama Varambally |
| Address |
Department of Psychiatry
National Institute of Mental Health and Neurosciences
Dharmaram College PO, Hosur Road, Bangalore - 560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National Institute of Mental Health and Neuro Sciences |
National Institute of Mental Health and Neurosciences
Dharmaram College PO, Hosur Road, Bangalore - 560029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivarama Varambally |
National Institute of Mental Health and Neurosciences |
Department of Psychiatry,
National Institute of Mental Health and Neurosciences,
Dharmaram College PO, Hosur Road, Bangalore - 560029
Bangalore
KARNATAKA |
080-26995253
080-26576465
ssv.nimhans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of patients with schizophrenia are recruited in the study for analysing if yoga influences Caregiver stress, anxiety, and quality of life |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention |
The control group is not given yoga for the trial period. |
| Intervention |
Yoga for Caregivers |
A brief yoga programme consisting of relaxation techniques for 45 mins each session thrice a week for one month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Primary caregivers of out-patients who have been diagnosed with Schizophrenia, caregivers of patients who have been ill at least for a minimum of 3 months, aged 18-60 yrs, knowing kannada or english, and who agree for randomization. |
|
| ExclusionCriteria |
| Details |
Caregivers diagnosed of having severe psychiatric or neurological disorders, caregivers having another relative with psychiatric illness, caregivers who are already practising yoga. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Anxiety and Depression score in Hospital Anxiety Depression Scale |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Quality of Life score in WHO-QOL BREF |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized wait list controlled study of the efficacy of a brief Yoga programme on stress, anxiety, depression and quality of life in caregivers of out-patients with Schizophrenia. Subjects randomized into the Yoga group will be taught a specific Yoga module for 2 weeks and asked to continue doing the yoga for the next 10 weeks. They will be assessed on the Hospital Anxiety and Depression Scale and the WHO-QOL BREF scale at baseline and after 12 weeks. The waitlist group will not receive any specific intervention but will undergo the same assessments at the same time points. The pre and post scores will be compared among the two groups with appropriate statistical tests.
The study aims to assess the mental health status of caregivers of patients with Schizophrenia in India and the usefulness of Yoga as a therapy in this population.
|