Efficacy of Different Yoga Techniques on various Symptoms of Schizophrenia, a psychotic illness
- Conditions
- Schizophrenia, unspecified,
- Registration Number
- CTRI/2021/01/030840
- Lead Sponsor
- Sri Balaji Vidyapeeth
- Brief Summary
Trial not started, as the registration procedure is not complete yet and hence no prior publications.
***Brief Summary:***
**Efficacy of Different Yoga Techniques on Negative & Cognitive Symptoms of Schizophrenia – A Comparative Evaluation**
Yoga is a powerful active lifestyle practice. This ancient practice is known to improve and regulate one’s well-being in all dimensions including physical, psychological, social and spiritual. Although there are ancient texts on Hatha Yoga and meditation elaborating the uses of various techniques for wellness promotion, establishing the scientific perspectives is a recent phenomenon. More and more medical professionals have taken up the science of yoga to their heart and dedicated their lives for the propagation of this discipline. Colleges and universities of modern medicine are encouraging the development of Yoga science and therapy by establishing the centres of excellence in yoga and integrating with the core disciplines. The research works of the modern scientific yogacharyas resulted in breaking the communication barriers and building the bridge between esoteric wisdom and evidence-based medical science.
Schizophrenia is one of the important major psychiatric illnesses. Distinct from organic brain syndromes, schizophrenia finds its prominent place along with Bipolar disorders in the hitherto designated functional psychoses. Decades of work has established the genetic and biochemical nature of schizophrenia. Hence it is no more a functional psychosis, but a complex syndrome of bio-psycho-social origin. Even the diagnosis of schizophrenia is based not on any physical parameter but on phenomenology. DSM-5 has laid down certain criteria for systematising research diagnosis.
Clinical features of schizophrenia include Positive symptoms and Negative symptoms. Positive symptoms are those symptoms, which are not originally part of the personality but added to the mental status or behaviour because of schizophrenia. Those are hallucinations, delusions, disorganised thought process, bizarre behaviour including excitement, grandiosity, hostility and paranoid features. Negative symptoms are the result of the diminution of existing normal mental faculties. These are blunted affect, emotional withdrawal, poor rapport, social isolation, alogia, loss of abstraction and stereotyped thinking. Although schizophrenia is primarily not a disorder of Cognitive functions like orientation and memory, subtle changes in cognition are noticed in persons with chronic schizophrenia.
Advances in pharmacotherapy resulted in the identification of various biochemical receptors and their modulation. Except for Clozapine, all other antipsychotic drugs have almost equal efficacy. The variations exist in their side-effect profiles and pharmacokinetics. Among dozens of molecules in usage, no single molecule is known to alleviate the negative symptoms or improve cognitive symptoms completely.
The recent scientific research on yoga provides empirical evidence that certain yoga practices are beneficial for the negative and cognitive symptoms of schizophrenia. Yoga consists of certain postures (asanas) including Suryanamaskaras, regulated breathing techniques (pranayamas), hand poses (mudras), purificatory practices (kriyas) and meditation. There is experiential knowledge on which techniques are appropriate for different physiological and psychological functions.
Among many issues studied on the impact of yoga practice, some are positive promotional issues like improvement of cognitive, sensorimotor and affective skills.4 Some of the personal, family and societal expectations of persons with schizophrenia are likely to be met by yoga techniques. The research problem is to find whether any of the Yoga techniques improve these functions more than a placebo.
The study aims to examine the influence of Yoga techniques on the negative, and cognitive symptoms of persons with Chronic Schizophrenia
**Objectives**
Effect of Yoga Techniques on Negative symptoms & Cognitive Symptoms
1 Effect of Surya Namaskaras
2 Effect of Pranayama
3 Effect of Asanas
4 Effect of Om Japa
5 Effect of Relaxation techniques
6.Effect of a Control group
**Methodology**
Rajamahendravaram is a B class city in Andhra Pradesh. Manasa hospital here is the first private psychiatric hospital for the neighbouring four districts, established in 1980. More than 1,38,000 new psychiatric cases and ten times that number of old or follow-up cases are treated during these 40 years. This hospital is a Janatha hospital meant for treating middle-class people. On average, ten new cases and 90 old cases per day are seen as outpatients, in addition to the in-patients of the hospital licensed for 50 beds. Among the follow-up cases, 20-30 are medication stabilised chronic schizophrenia cases, who come for a follow-up once in 3months.
**Sampling Design**
Persons with Chronic schizophrenia who are the clientele of Manasa hospital and stabilised with medication is the universe of the study. Those who attend the hospital for follow-up during the study recruitment period of three months are considered for the study.
The sample size expected is to be between 500 - 1000.
The sample is divided into six groups
**Tools to be used for measuring the outcomes**
1. D.S.M -5, for diagnosis of schizophrenia.
Diagnostic and Statistical Manual, 5th edition is the publication of the American Psychiatric Association, with worldwide recognition for its research utility.
2. SANS
The Scale for the Assessment of Negative Symptoms (SANS) is the gold standard for assessing the negative symptoms of a person with schizophrenia. It is a 25 item scale with 0-5 grades on a Likert scale.
It does not consume more than 25 minutes, and the rater should be preferably a psychiatrist or psychologist, who is given the training to interview.
3. BACS for testing cognitive functions among persons with schizophrenia
Brief Assessment of Cognition in Schizophrenia. A valid and reliable standardised tool for assessing cognitive functions. The test includes Verbal memory ( List learning),.
Working memory (Digit sequencing task, motor speed), Verbal fluency (Category instances and Controlled oral word association test.), Attention and speed of information processing (Symbol coding) and Executive functions (Tower of London)
(Expert opinion is required to choose OSCAR or TRENDS for testing social cognition in place or in addition to BACS)
4. MMSE for assessment of gross cognitive functions in general
Mini-Mental State Examination is a simple tool, which could be used to screen out persons with gross cognitive deficits (i.e. Dementias) and also for assessing the finer deficits in schizophrenia.
**Men, and Material**
1. Necessary clearance from the Research Ethics committee of nearby GSL medical college, where one of the co-guides is HOD of psychiatry.
2. The Rating Scales are to be translated into Telugu, where necessary and feasible and cross-validated
3. Proformas, checklists and schedules are printed.
4. Sampling Frame is decided.
5. Fifteen Yoga instructors and 15volunteers are recruited from Pranava Yoga Sankalpa Samithi and Friends Service Society. Four psychologists of Manasa hospital are engaged for assessments.
All the cases attending the hospital for follow-up with a stabilised minimum antipsychotic drug are screened for the fulfilment of DSM, inclusion and exclusion criteria. This is done by the psychiatrist.
As all the cases attending OPD during the study period are considered for the study, the question of sampling does not arise for selection.
For allocation of the intervention arm, Cluster random sampling (Block design) will be followed
All the cases registered for study on Monday are taken for Treatment A; Those registered for study on Tuesday are allotted to Treatment B and so on.
6. Pre-intervention assessments of Negative symptoms and cognitive functions are done for all the groups by the psychologists.
7. Appropriate Interventions are taught to the individual of that appropriate assigned group and video sessions, lasting for 30 minutes each on alternate days is continued for three months. The control group is given 30 minutes of placebo exercise on alternate days for three months.
8. Post-intervention assessments are done on the follow-up day after 90 days, but within 100 days
**Statistical Design**
1 Descriptive statistics for classification and presentation of the demographic characteristics
2. Inferential statistics for comparison of the effect of different Yogic interventions compared to placebo using parametric tests like t-test or ANOVA.
Correlation of the effect of different interventions with one another is measured through Karl Pearson’s coefficient test.
**Significance of the proposed research and the expected outcome.**
1. The usefulness of Yoga Techniques for the improvement of persons with chronic schizophrenia, in various spheres, viz., negative symptoms and cognitive functions is elicited.
2. The relative importance of one technique over the other is investigated.
3. This research may unearth unanticipated practical difficulties in incorporating yoga in the psychiatric treatment modules.
4. The implementation of yoga in the departments of Psychiatry will have far-reaching implications not only for the individuals but also for society as a whole.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 500
a) Chronic schizophrenia with more than two years duration b) On the same minimal maintenance dose of a single antipsychotic drug during the last six months c) Yoga-naïve or not practised any yoga technique during the last one year d) Informed consent of the persons and their accompanying persons.
a) Physical disabilities or health problems which may interfere with the practice of any type of Yoga technique b) Religious or cultural factors which are likely to interfere with the practice c) Regular practitioners of yoga d) Those who are undertaking special training for improving psychological skills.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2. BACS score for cognitive symptoms 3 months 1. SANS score for Negative symptoms 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Manasa Hospital
🇮🇳Godavari, ANDHRA PRADESH, India
Manasa Hospital🇮🇳Godavari, ANDHRA PRADESH, IndiaDr Rama Reddy KarriPrincipal investigator9885069777ramareddykarri@rediffmail.com