Schizophrenia Clinical Trial
Official title:
The Impact of Yoga Supplementation on Cognitive Function Among Indian Outpatients With Schizophrenia
Cognitive impairment is a key disabling feature of SZ. The impairment affects functional
outcome and employability, resulting in increased burden. Currently, medications offer only
modest benefits for the cognitive dysfunction. Hence, non-pharmacological interventions are
worth consideration. Yoga is known to enhance cognitive abilities in healthy persons. Our
preliminary studies have shown for the first time that there may be remarkable improvement
in selected cognitive domains among outpatients with SZ. The improvement is unlikely to be
due to rater bias, as they were noted using a computerized neurocognitive battery. Since our
preliminary studies involved an open trial, it is necessary to conduct more controlled
studies. To evaluate our results further, we propose to test the effectiveness of yoga
supplementation using a controlled single blind design in India. Outpatients with SZ (N=258)
undergoing treatment at a large academic center in New Delhi, India will be randomly
assigned to one of the three groups- yoga training (YT, N=86), physical exercise (PE, N=86)
or treatment as usual (TAU, N=86). The YT group will undergo 21 days yoga supplementation,
while the PE group will complete a 21 day systematic physical exercise training regime. The
third group will have no such supplementation. Cognitive state, symptom severity and overall
function will be assessed at four time points: just before, immediately after, three months
later and six months after completion of YT/PE supplementation. The evaluations will be
conducted by raters blind to group status.
Hypotheses:
1. Yoga enhances attention, as well as related cognitive function among persons with
schizophrenia.
2. Yoga has beneficial effects on the short term functional outcome of schizophrenia
Status | Completed |
Enrollment | 286 |
Est. completion date | July 2016 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion criteria: - DSM IV diagnosis of SZ - Age 18 years or greater - Residents of Delhi (to facilitate regular attendance and avoid dropouts) Exclusion criteria: - Residence outside Delhi - Prior participation in our Yoga studies (see preliminary studies section) - Mental retardation sufficient to impact understanding of YT - Substance or alcohol dependence for last six months which interferes with diagnosis - Presence of co-morbid conditions which may worsen with exercises (eg, recent myocardial infarction, fractures) - Presence of neurological illnesses such as strokes or head injury that may cause cognitive impairment independent of SZ, or complicates diagnosis/evaluation e.g. epilepsy, stroke - Presence of any physical disability or illness which makes the patient unfit for yoga or physical exercise |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr. Ram Manohar Lohia Hospital | John E. Fogarty International Center (FIC) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Independent Living Skills Survey | Independent Living Skills Survey {Wallace, 2000 #92}: The basic functional living skills (Activities of Daily Living, ADL) of participants will be measured by Independent Living Skills Survey (ILSS) {Wallace, 2000 #92} at every cognitive assessment point. | Changes in living skills from baseline to 21 days intervention, three months and after six months after completing intervention will be assessed | No |
Primary | Cognitive assessment | The key assessment will be based on an efficient, validated computerized battery called the Computerized Neurocognitive Battery (CNB) {Gur, 2001 #38} {Gur, 2001} . The assessment will be supplemented by the Information subscale of Post-graduate Institute Battery of Brain Dysfunction (PGI) (as an indirect assessment of intelligence) {Pershad, 1990} and the Trail Making Test {Horton, 1979}, a pen and paper measure of working memory. |
Changes in cognition from baseline to 21 days intervention, three months and after six months after completing intervention will be assessed. | No |
Secondary | Symptom assessment General Functioning | Symptom assessment: The positive and negative symptoms will be assessed using the Scale for the Assessment of Negative Symptoms (SANS) and Scale for the Assessment of Positive Symptoms (SAPS) at baseline, three months and six months. After yoga/physical exercise SAPS and SANS will be done for the previous three weeks only. . General Functioning: The Global Assessment of Function Scale {Endicott, 1976} will be used to measure the overall functioning of participants. | Changes in symptoms from baseline to 21 days intervention, three months and after six months after completing intervention will be assessed. | No |
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