SchizophreniaNCT01879709
Yoga as Cognitive Remediation in Schizophrenia
A study testing Yoga Training, Physical Exercise and Treatment as Usual in people with Schizophrenia, run by Dr. Ram Manohar Lohia Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Yoga Training, Physical Exercise and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM IV diagnosis of SZ
- Age 18 years or greater
- Residents of Delhi (to facilitate regular attendance and avoid dropouts)
Who cannot join
- 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
About this study
Official title: The Impact of Yoga Supplementation on Cognitive Function Among Indian Outpatients With Schizophrenia
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:
- Yoga enhances attention, as well as related cognitive function among persons with schizophrenia.
- Yoga has beneficial effects on the short term functional outcome of schizophrenia
Read the 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:
- Yoga enhances attention, as well as related cognitive function among persons with schizophrenia.
- 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.
- Conditions
- Schizophrenia
- Being tested
- Yoga Training, Physical Exercise, Treatment as Usual
- Keywords
- schizophrenia, Cognition, Independent living skills
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga TrainingBehavioural
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.
Physical ExerciseBehavioural
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).
Treatment as UsualOther
Placebo Comparator: Treatment as Usual Group
Participants who will continue in the department with clinical treatment as usual. No supplementation will be provided
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: 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. Receives: Behavioral: Physical Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Changes in symptoms from baseline to 21 days intervention, three months and after six months after completing intervention will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startAug 2010
- Primary completionSep 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ram Manohar Lohia Hospital
- Sponsor type
- Other government
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Dr Triptish Bhatia, Dr. Ram Manohar Lohia Hospital
- Investigators
- Triptish Bhatia, PhD, Principal investigator, GRIP-Yoga Study, Dept. of Psychiatry, PGIMER-Dr.R.M.L.Hospital, New Delhi, IndiaSmita N Deshpande, Ph.D., Principal investigator, PGIMER-Dr.R.M.L.Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879709
- Sponsor's protocol ID
- R01TW008289
- Other IDs
- R01TW008289
- Status last verified
- Nov 2016
- First submitted
- 13 Jun 2013
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Yoga Supplementation on Cognitive Function Among Indian Outpatients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01879709
- Acronym / sponsor ID
- R01TW008289
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, Cognition, Independent living skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Dr. Ram Manohar Lohia HospitalOther government
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- Aug 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Yoga enhances attention, as well as related cognitive function among persons with schizophrenia.
- 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:
- Yoga enhances attention, as well as related cognitive function among persons with schizophrenia.
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga Training Group | Experimental | Behavioral: Yoga TrainingYoga 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). |
| Treatment as Usual Group | Placebo comparator | Other: Treatment as UsualParticipants who will continue in the department with clinical treatment as usual. No supplementation will be provided |
| Physical Exercise Group | Active comparator | Behavioral: Physical ExercisePhysical 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DSM IV diagnosis of SZ
- Age 18 years or greater
- Residents of Delhi (to facilitate regular attendance and avoid dropouts)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga TrainingParticipants 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. | Behavioural | Yoga Training Group |
| Physical ExerciseThis 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). | Behavioural | Physical Exercise Group |
| Treatment as UsualPlacebo Comparator: Treatment as Usual Group Participants who will continue in the department with clinical treatment as usual. No supplementation will be provided | Other | Treatment as Usual Group |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Triptish Bhatia, PhD principal investigator
GRIP-Yoga Study, Dept. of Psychiatry, PGIMER-Dr.R.M.L.Hospital, New Delhi, India
Smita N Deshpande, Ph.D. principal investigator
PGIMER-Dr.R.M.L.Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Training, Physical Exercise and Treatment as Usual in people with Schizophrenia, run by Dr. Ram Manohar Lohia Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.