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CTRI Number  CTRI/2023/05/052534 [Registered on: 11/05/2023] Trial Registered Prospectively
Last Modified On: 20/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Cognitive enhancement by yoga for people who had depression 
Scientific Title of Study   A RANDOMIZED CONTROL TRIAL INVOLVING YOGA INTERVENTION FOR COGNITIVE ENHANCEMENT IN PERSONS WITH REMITTED UNIPOLAR DEPRESSION 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Daiveek PG 
Designation  Senior Resident 
Affiliation  National Institute of Mental Health and Neuroscience 
Address  Department of Integrative Medicine, NIMHANS, Bengaluru
St. Johns National Academy of Health Sciences, Bengaluru
Bangalore
KARNATAKA
560029
India 
Phone  9482023658  
Fax    
Email  daiveek1991@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Triptish Bhatia  
Designation  Senior Research Scientist 
Affiliation  Dr. Ram Manohar Lohia Hospital, New Delhi 
Address  Department of Psychiatry Centre of Excellence in Mental Health, ABVIMS, Dr. Ram Manohar Lohia Hospital

New Delhi
DELHI
110001
India 
Phone  9910107210  
Fax    
Email  bhatiatriptish@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Daiveek PG 
Designation  Senior Resident 
Affiliation  National Institute of Mental Health and Neuroscience 
Address  Department of Integrative Medicine, NIMHANS, Bengaluru
St. Johns National Academy of Health Sciences, Bengaluru
Bangalore
KARNATAKA
560029
India 
Phone  9482023658  
Fax    
Email  daiveek1991@gmail.com  
 
Source of Monetary or Material Support  
Advanced In-Country Research Award, under PRIIIA (a Fogarty International Centre - NIH funded project) 
 
Primary Sponsor  
Name  St. Johns National Academy of Health Sciences 
Address  John Nagara, Bengaluru - 34 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
National Institute of Mental Health and Neurosciences  Hombegowda Nagara, Bengaluru - 29 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Daiveek PG  National Institute of Mental Health and Neurosciences   NIMHANS Centre for Yoga, Department of Integrative Medicine, Hombegowda Nagara, Hosur road,
Bangalore
KARNATAKA 
9482023658

daiveek1991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Comittee for Research in AYUSH and Integrative Medicine (HECAIM)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F334||Major depressive disorder, recurrent, in remission,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Treatment as usual  NIL 
Intervention  YOGA with treatment as usual  A validated yoga module for cognitive enhancement for about an hour 6 days a week for 6 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1)Age more than 18years and less than 60 years
2)H/o at least one depressive episode which is under remission and at the time of examination and throughout the study duration,
3)Ability provide valid consent
 
 
ExclusionCriteria 
Details  1)Comorbid Psychosis, OCD, Bipolar disorder
2)Comorbid ADHD, IDD
3)Comorbid substance dependence (except tobacco)
4)Comorbid major or minor cognitive impairment,
5)Bi temporal ECT within 6 months
6)Past yoga practice - regularly for 1 month within 3 months
7)Pregnancy
8)Any serious medical illness 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary endpoint – cognitive performances as assessed by the above tests
(Digit span, Trail A and B, Stoop color test) are significantly better in yoga group than in treatment-as-usual group at the end of 6 weeks.


 
6th week

 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary endpoint – cognitive enhancement sustained further for 4 weeks after 6 weeks of supervised yoga intervention.  10th week 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [daiveek1991@gmail.com].

  6. For how long will this data be available start date provided 30-06-2024 and end date provided 30-06-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Depression is the most common mental health problem through-out the world including India. It has significant burden on public health in India with prevalence of 4.4% and & 7.1% of total years lived with disability. Although, more focus is on mood symptoms in depression, presence of cognitive deficits is a matter of concern, according to the evidence. Research shows that, cognitive deficits are exclusively responsible for functional impairment and disabilities leading to poor quality of life and unemployment. Though the role of pharmacotherapy in remitting mood and physical symptoms is well known, cognitive deficits do persist, even after remission; especially in the domains of executive function, working memory and attention. This indicates that even the individuals are out of apparent depression, their ability to perform optimally in their roles in the society, is hindered. Since there is no standard, evidence-based solution for this issue, we, in this randomized controlled trial, aim at employing yoga as an adjuvant intervention in improving cognitive deficits. In this study 76 patients with remitted unipolar depression will be randomly assigned to yoga intervention and treatment as usual group. Both the groups will be assessed for cognitive functions at baseline, after intervention and 1 month later. The performance in cognitive tests will be compared across timeline and between two groups.  Previous studies have shown that yoga has positive effect on cognition in healthy and across various psychiatric disorders. Hence, if yoga is found to be effective in our current target population, it can serve as an implicit cognitive training intervention for cognitive deficits in remission phase of unipolar depression, which is well accepted, easily accessible and cost effective.

 
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