| 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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [daiveek1991@gmail.com].
- 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.
- 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. |