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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Yoga arm

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560029
      • National Institute of Mental Health and Neurosciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Schizophrenia Subject

1. ICD (International Classification of Diseases) 10 diagnosis of schizophrenia
2. capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research
3. no other current comorbid axis I diagnosis (except nicotine abuse/dependence) and no general impaired intellectual functioning

Healthy volunteers:

1. Males and females between 18 and 45 years
2. Capacity to provide informed consent
3. absence of past or present psychiatric illnesses including substance abuse 4) no general impaired intellectual functioning (MMSE above24)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Yoga arm; 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; Yoga module developed for patients with Schizophrenia
NO_INTERVENTION: Control arm; Healthy volunteers who will not receive yoga.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Institute of Mental Health and Neuro Sciences, India
• Collaborators: SCARF (Schizophrenia Research Foundation ,India) Schizophrenia
• Investigators: Principal Investigator: Naren P Rao, MD, National Institute of Mental Health and Neuro Sciences, India

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2016
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (ACTUAL): December 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Schizophrenia; Yoga; fMRI
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: DST/002/208/2016/00892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No