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
Cognitive impairment is a hallmark of schizophrenia (SZ). It affects the outcome of the
disorder and markedly increases its burden. Various biological and psychological approaches
are being tested to enhance cognitive capacity of these individuals, but the beneficial
effects are modest. Yoga, the ancient Indian science of physical and mental fitness, offers
a holistic approach to healthy life style and cognitive enhancement. Many studies have shown
benefits of yoga for healthy individuals, and a few for psychiatric disorders. Despite its
wide popularity, there are only a limited number of randomized, controlled yoga studies
using objective quantitative outcome measures. Our preliminary studies have shown
significant and substantial improvement in several domains of cognitive functioning among
outpatients with SZ, using a simplified regimen in an open design. It is not clear if the
benefits are due to physical activity alone or the entire yoga process per se. We propose to
evaluate these results further, using a systematic random assignment design.
Explanatory model: The practice of yoga emphasizes body awareness and involves focusing
one's attention on breathing or specific muscles or parts of body. We propose that the
beneficial effects of yoga therapy (YT) observed in our preliminary studies relates to
improvement in attention that extends to other cognitive domains.
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.
Design: A systematic, single blind randomly assigned supplementation of routine outpatient
training with yoga, compared with standard physical exercise and treatment as usual.
Specific Aims:
We propose to evaluate consenting outpatients with SZ undergoing treatment at the Department
of Psychiatry, Postgraduate Institute of Medical Education and Research-Dr Ram Manohar Lohia
Hospital (PGIMER-RMLH), Delhi India (n= 258). Routine clinical management will be randomly
supplemented with Yoga Training (YT, n = 86), directed Physical Exercise (PE, n = 86) or no
supplementation (Treatment As Usual, TAU, n = 86).Treatment supplementation will last 21
days and all participants will be followed up for 6 months after completing supplementation.
1a. Recruitment: Both outpatients and inpatients at RMLH(Dr Ram Manohar Lohia Hospital) with
a clinical diagnosis of SZ, who fulfill inclusion criteria will be approached and written
informed consent obtained.
1b. Diagnosis: All participants will complete an exhaustive evaluation based on the Hindi
version of the Diagnostic Interview for Genetic Studies (DIGS), supplemented with medical
records.
Consensus diagnoses will be established using DSM IV (Diagnostic and Statistical Manual of
Mental Disorders) criteria.
1c. Randomization: The patients will be randomly assigned to one of the following three
groups.
Group assignment and ratings will be carried out by different individuals to enable single
blind evaluations. Three types of supplementation are planned over 21 days.
(i) Yoga Training (YT) (n = 86): Structured, simplified yoga instruction will be provided
and supervised by a trained instructor in a group setting.
(ii) Physical Exercise (PE) (n=86): Structured, physical exercises supervised by a trained
instructor.
(iii) Treatment as usual Group (TAU) (n=86): Participants who will continue in the
department with clinical treatment as usual. No supplementation will be provided.
Clinical treatment, including pharmacotherapy will be carried out as usual in all three
groups. The treating physician will be blind to the type of supplementation.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
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