| CTRI Number |
CTRI/2022/08/044558 [Registered on: 01/08/2022] Trial Registered Prospectively |
| Last Modified On: |
28/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
safety and usefulness of using balancing postures in patients with schizophrenia |
|
Scientific Title of Study
|
Safety and feasibility of balancing postures and its effect on sustained attention in patients with schizophrenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suma Guruprasad |
| Designation |
Student |
| Affiliation |
SVYASA |
| Address |
Room No-2, Yoga center Division, Department of Integrative medicine
No 19,Yoga division, Eknath Bhavan,Department of Yoga Life sciences
Gavipuram,bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9740021062 |
| Fax |
|
| Email |
suma.guruprasad@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hemant Bhargav |
| Designation |
Asst.Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
NIMHANS , NIMHANS Integrative Medicine, PB No 2900,Hosur Main Road
Bangalore
KARNATAKA
560029
India |
| Phone |
080-26995730 |
| Fax |
|
| Email |
drbhargav@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Suma Guruprasad |
| Designation |
Student |
| Affiliation |
SVyasa |
| Address |
Room No2, NIMHANS Yoga Center division, Department of Integrative Medicine
Bangalore
KARNATAKA
560019
India |
| Phone |
9740021062 |
| Fax |
|
| Email |
suma.guruprasad@outlook.com |
|
|
Source of Monetary or Material Support
|
| NIMHANS,Department of Integrative Medicine, Hosur Road
Bengalore 560029 |
|
|
Primary Sponsor
|
| Name |
SVyasa |
| Address |
SVyasa Yoga University,
No 19, Eknath Bhavan,
Gavipuram circle, KG Nagar, Bangalore 560019 |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrHemant Bhargav |
NIMHANS |
Room No 2, NIMHANS Yoga Center Division, Department of Integrative Medicine
Bangalore
KARNATAKA |
080-26995730
drbhargav@nimhans.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HECAIM (Human Ethics Committee for Research in AYUSH and Integrative medicine) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Current Schizophrenia NIMHANS Yoga Module with Non-Balancing Yoga Postures |
The module with Non-balancing yoga postures (the current Schizophrenia NIMHANS Module)20 sessions, each session lasting 30 mins, duration of intervention- 1month |
| Intervention |
Validated Module with Balancing Yoga Postures |
20 sessions of validated Yoga module with Balancing Postures, each session lasting 30mins, duration of intervention- 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of Schizophrenia according to DSM-5 criteria
Subjects on medications
Those with the ability to read and write in any language like English / Kannada /Hindi
Those who give written consent to participate in the study
Subjects capable of following yoga instructions and can perform suggested practices
|
|
| ExclusionCriteria |
| Details |
Patients with severe psychotic symptoms
Other severe co-morbidities and medical illnesses that will prevent the practice of yoga postures, like Cerebrovascular accidents, Epilepsy,Recent fractures, Major surgery, psychotic patients other than schizophrenia,De-compensated cardiac function
Mental retardation,Osteo-arthritis/ knee related problems
Patients who have been exposed to regular yoga in the past 3 months.
Risk of harm to self or others
Pregnancy or postpartum (<6 weeks after delivery).
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Six letter cancellation task
|
Baseline(before intervention), Immediate effect(assessment after 1 session from baseline),
Assessment Post-Intervention (after 20 sessions from baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical outcomes |
Baseline (Pre-intervention), Immediate effect (assessment after 1 session from baseline), Post intervention (assessment after 20 sessions from baseline) |
State trait anxiety invent
Colour trail task
Brief psychiatric rating scale
Socio-occupational functoining scale
Visual anolog scale for clinical symptoms
|
Baseline (Pre-intervention), Immediate effect (assessment after 1 session from baseline), Post intervention (assessment after 20 sessions from baseline) |
|
|
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
|
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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Peer review journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The primary treatment option for schizophrenia has been pharmacological drug therapy, which addresses mainly positive symptoms (e.g., hallucinations and thought disorders which is the core of the disease) but negative symptoms (e.g., flat affect and social withdrawal) and cognitive deficits (e.g., learning and attention disorders) remain untreated. Current pharmacological treatment has a significant limitation of not addressing the cognitive deficits like learning and attention deficits in schizophrenia which we are trying to address through this study.
Yoga therapy which is complimentary to the pharmacological therapy has been proved to help patients with schizophrenia but the effect of balancing postures on them has not been done so far. This study aims at evaluating safety and feasibility of balancing postures in patients with schizophrenia and its effect on sustained attention in them. The main objective is to develop a safe and feasible yoga module to enhance attention span, and also improve their socio-occupational functioning and quality of life with enhanced self-awareness.
The subjects suffering from Schizophrenia as per DSM-5 criteria who are in stable condition to take yoga sessions, will be recruited from out-patient and in-patient departments at NIMHANS, with a sample size of 15 in each group, with Balancing Postures (Intervention module) and Non-balancing Postures (Active Controlled group) as Intervention (In-person) for a period of 1 month or 20 sessions will be given to a total sample size of 30.
The Assessment will be done 3 times, baseline/ Pre-Assessment, Immediate effect (after 1 session from baseline) and Post Intervention (after 20 sessions from baseline).The tools used to assess are Yoga Performance Assessment, Six Letter Cancellation Test ,Visual Analog scale (0- 10 for hearing voices that cannot be heard by others),Socio-occupational function scale ,Brief Psychiatric Rating scale ,State-Trait Anxiety Inventory, Colour Trail Test.
The outcomes will be analysed and compared between both groups as a result of this study.
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