Yoga as Cognitive Remediation in Schizophrenia

NCT01879709 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2016-11-29

No results posted yet for this study

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. 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

Conditions

Interventions

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.

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).

OTHER

Treatment as Usual

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

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH
  • Dr. Ram Manohar Lohia Hospital

    lead OTHER_GOV

Principal Investigators

  • Triptish Bhatia, PhD · GRIP-Yoga Study, Dept. of Psychiatry, PGIMER-Dr.R.M.L.Hospital, New Delhi, India

  • Smita N Deshpande, Ph.D. · PGIMER-Dr.R.M.L.Hospital

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2015-09-30
Completion
2016-07-31

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01879709 on ClinicalTrials.gov