Yoga as Cognitive Remediation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

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
    

Detailed description: 
      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.
    

Intervention name(s): Yoga Training; Physical Exercise; Treatment as Usual
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): 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.; 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).; Placebo Comparator: Treatment as Usual Group
Participants who will continue in the department with clinical treatment as usual. No supplementation will be provided
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: schizophrenia; Cognition; Independent living skills