Yoga as Cognitive Remediation in Schizophrenia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr Triptish Bhatia, Dr. Ram Manohar Lohia Hospital
ClinicalTrials.gov Identifier:
NCT01879709
First received: June 13, 2013
Last updated: May 31, 2015
Last verified: May 2015
  Purpose

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

Condition Intervention
Schizophrenia
Behavioral: Yoga Training
Behavioral: Physical Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: The Impact of Yoga Supplementation on Cognitive Function Among Indian Outpatients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Dr. Ram Manohar Lohia Hospital:

Primary Outcome Measures:
  • Cognitive assessment [ Time Frame: Changes in cognition from baseline to 21 days intervention, three months and after six months after completing intervention will be assessed. ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Symptom assessment General Functioning [ Time Frame: Changes in symptoms from baseline to 21 days intervention, three months and after six months after completing intervention will be assessed. ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Independent Living Skills Survey [ Time Frame: Changes in living skills from baseline to 21 days intervention, three months and after six months after completing intervention will be assessed ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 258
Study Start Date: August 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga Training Group
Yoga Training: Participants will be imparted yoga training for twenty-one days, for one hour a day. This will include postures or Asanas (exercises) and Pranayam (Breathing protocols).
Behavioral: Yoga Training
Participants will be imparted yoga training for twenty-one days, for one hour a day. This will include postures or Asanas (exercises) and Pranayam (Breathing protocols). The training starts with 'Om' chanting followed by warm up exercises and then breathing exercises. The Breathing exercises (Pranayama) are practiced before practice of Asana.
Placebo Comparator: Treatment as Usual Group
Participants who will continue in the department with clinical treatment as usual. No supplementation will be provided
Active Comparator: Physical Exercise Group
Physical Exercise: This group will take part in a general physical exercise program incorporating simple physical exercises for one hour daily, including Saturdays. The schedule will include fifteen minutes of brisk walking followed by light exercises.
Behavioral: Physical Exercise
This group will take part in a general physical exercise program incorporating simple physical exercises for one hour daily, including Saturdays. The schedule will include fifteen minutes of brisk walking followed by light exercises adapted from the National Fitness Corps - Handbook for Middle High and Higher Secondary Schools as used by Duraiswamy et al. (2007).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879709

Locations
India
PGIMER-Dr R.M.L.Hospital
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Dr. Ram Manohar Lohia Hospital
Investigators
Principal Investigator: Triptish Bhatia, PhD GRIP-Yoga Study, Dept. of Psychiatry, PGIMER-Dr.R.M.L.Hospital, New Delhi, India
Principal Investigator: Smita N Deshpande, Ph.D. PGIMER-Dr.R.M.L.Hospital
  More Information

No publications provided

Responsible Party: Dr Triptish Bhatia, Research Consultant, Dr. Ram Manohar Lohia Hospital
ClinicalTrials.gov Identifier: NCT01879709     History of Changes
Other Study ID Numbers: R01TW008289, R01TW008289
Study First Received: June 13, 2013
Last Updated: May 31, 2015
Health Authority: India: Indian Council of Medical Research

Keywords provided by Dr. Ram Manohar Lohia Hospital:
schizophrenia
Cognition
Independent living skills

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 01, 2015