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

Study Overview
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Brief Summary
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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.

Official Title
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Examination of Therapeutic Efficacy and Potential Mechanisms of Yoga Treatment in Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Yoga arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Yoga arm<br>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<br>* Yoga module developed for patients with Schizophrenia<br>|
| No Intervention: Control arm<br>Healthy volunteers who will not receive yoga. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI changes | Schizophrenia patients receiving yoga will have higher activation in Medial prefrontal cortex after yoga therapy compared to baseline and compared to those in the wait-list group at 12 weeks. | At the end of 12weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Yoga, fMRI