Study on Examination of Therapeutic Efficacy and Potential Mechanisms of Yoga Treatment in Schizophrenia

NCT03379480 | Completed

• 1 other identifier: DST/002/208/2016/00892
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to examine whether yoga is efficacious as an add-on treatment for negative symptoms of schizophrenia in a randomized multi-centric trial and also to examine functional brain changes associated with self-reflection after treatment with yoga.

Conditions

Schizophrenia

Keywords

Schizophrenia; Yoga; fMRI

Outcome Measures

Primary Outcomes (1)

• Improvement in negative symptoms in patients with schizophrenia

  Schizophrenia patients receiving yoga as add-on treatment will have significant improvement in negative symptoms after yoga therapy compared to those in the wait-list group as reflected by a greater decrease in Scale for Assessment of negative symptoms score. This scale measures negative symptoms on a 25 item, 6-point scale. Items are listed under the five domains of affective blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. A higher score indicates greater severity.

  At the end of 12 weeks of yoga

Secondary Outcomes (1)

• fMRI changes

  At the end of 12weeks

Study Arms (2)

Yoga arm

ACTIVE COMPARATOR

Patients with Schizophrenia will undergo 12 sessions of yoga. According to randomization one group of patients will start yoga immediately after recruitment ,whereas another group will go into wait list for 12 weeks after which they will also undergo Yoga treatment.

Behavioral: Yoga arm

Control arm

NO INTERVENTION

Healthy volunteers who will not receive yoga.

Interventions

Yoga arm BEHAVIORAL

Yoga module developed for patients with Schizophrenia

Yoga arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Schizophrenia Subject
• ICD (International Classification of Diseases) 10 diagnosis of schizophrenia
• capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research
• no other current comorbid axis I diagnosis (except nicotine abuse/dependence) and no general impaired intellectual functioning
• Healthy volunteers:
• Males and females between 18 and 45 years
• Capacity to provide informed consent
• absence of past or present psychiatric illnesses including substance abuse 4) no general impaired intellectual functioning (MMSE above24)

You may not qualify if:

• Other current comorbid axis I diagnosis (except nicotine abuse/dependence) and general impaired intellectual functioning
• History of alcohol or substance abuse or dependence in the last 12 months (with the exception of nicotine)
• Any Contraindication to MRI like metal implants or paramagnetic objects within the body or claustrophobia (only for patients undergoing fMRI at NIMHANS)
• Past history of head injury resulting in loss of consciousness or neurosurgery
• Concomitant severe medical conditions
• Change in dose of antipsychotic medication or Electroconvulsive therapy in the past 6weeks
• Pregnant or lactating -

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead
• SCARF (Schizophrenia Research Foundation ,India) Schizophrenia: collaborator

Study Sites (1)

National Institute of Mental Health and Neurosciences

Bangalore, Karnataka, 560029, India

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Naren P Rao, MD

  National Institute of Mental Health and Neuro Sciences, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor ,Department of Psychiatry, NIMHANS

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 20, 2017
• Study Start: November 11, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

IN (1)