safety and usefulness of using balancing postures in patients with schizophrenia

Not yet recruiting

Conditions: Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders,

Registration Number: CTRI/2022/08/044558

Lead Sponsor: SVyasa

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): NIMHANS
🇮🇳
Bangalore, KARNATAKA, India
NIMHANS
🇮🇳Bangalore, KARNATAKA, India
DrHemant Bhargav
Principal investigator
080-26995730
drbhargav@nimhans.ac.in