Yoga as Cognitive Remediation in Schizophrenia

NCT01879709 | Completed DMC

• 1 other identifier: R01TW008289
• Study Type: interventional
• Target: 286
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Yoga enhances attention, as well as related cognitive function among persons with schizophrenia.
2. 2.Yoga has beneficial effects on the short term functional outcome of schizophrenia

Conditions

Schizophrenia

Keywords

schizophrenia; Cognition; Independent living skills

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Symptom assessment General Functioning

  Changes in symptoms from baseline to 21 days intervention, three months and after six months after completing intervention will be assessed.

Other Outcomes (1)

• Independent Living Skills Survey

  Changes in living skills from baseline to 21 days intervention, three months and after six months after completing intervention will be assessed

Study Arms (3)

Yoga Training Group

EXPERIMENTAL

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

Treatment as Usual Group

PLACEBO COMPARATOR

Participants who will continue in the department with clinical treatment as usual. No supplementation will be provided

Other: Treatment as Usual

Physical Exercise Group

ACTIVE COMPARATOR

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

Interventions

Yoga Training BEHAVIORAL

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.

Yoga Training Group

Physical Exercise BEHAVIORAL

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).

Physical Exercise Group

Treatment as Usual OTHER

Placebo Comparator: Treatment as Usual Group Participants who will continue in the department with clinical treatment as usual. No supplementation will be provided

Treatment as Usual Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM IV diagnosis of SZ
• Age 18 years or greater
• Residents of Delhi (to facilitate regular attendance and avoid dropouts)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Ram Manohar Lohia Hospital: lead
• Fogarty International Center of the National Institute of Health: collaborator

MeSH Terms

Conditions

Schizophrenia

Interventions

Exercise; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 18, 2013
• Study Start: August 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: July 1, 2016
• Last Updated: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share