| CTRI Number |
CTRI/2025/01/079464 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Multidomain Intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Multi-domain intervention (YoCogDiPP) for patients with depression |
|
Scientific Title of Study
|
The effect of multi-domain intervention (YoCogDiPP) on cognitive impairment, heart rate variability, cortisol, inflammatory markers and depression scores in patients with depression: randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashlesh Patil |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
room no 119 1st floor Medical college Physiology department
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9650344666 |
| Fax |
|
| Email |
dr.ashlesh.p@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashlesh Patil |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Room no 119 1st floor Medical college Physiology department
MAHARASHTRA
441108
India |
| Phone |
9650344666 |
| Fax |
|
| Email |
dr.ashlesh.p@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashlesh Patil |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
room no 119 1st floor medical college Physiology department
MAHARASHTRA
441108
India |
| Phone |
9650344666 |
| Fax |
|
| Email |
dr.ashlesh.p@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR INDIAN COUNCIL OF MEDICAL RESEARCH, V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
ICMR INDIAN COUNCIL OF MEDICAL RESEARCH |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashlesh Patil |
AIIMS Nagpur |
Room No 442 OPD 4th Floor, Cognitive Neurophysiology Lab, Department of Physiology, Plot No 2 Sector 20 AIIMS Nagpur Mihan
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
9650344666
dr.ashlesh.p@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multidomain Intervention |
45 min at least 5 times a week for 12 weeks. The intervention will consist of YoCogDiPP (which include 5 components namely Yoga Nidra, Cognitive Training, Diet, Physical Activity & Pharmacology) |
| Comparator Agent |
Pharmacological treatment |
duration same as intervention group i.e. 12 weeks. The control group i.e the other arm will receive standard of care i.e. only pharmacological treatment as advised by the psychiatrist |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-55 years both genders, Diagnosis according to ICD 10 (F32.xx and F33.xx except F32.3 and F33.3) by psychiatrist, HDRS score equal to or more than 8, ongoing treatment for atleast 4 weeks or more, normal or corrected to normal vision (6/6 according to Snellen chart), normal color vision assessed by ishihara chart. |
|
| ExclusionCriteria |
| Details |
Any history brain secondary causes of cognitive impairment (like history of stroke, brain injury, exposure to toxins or neuroleptics, history of neurological disease, dementia, Alzheimer’s disease or any neurological illness with significant cognitive impairment). Dementia will be ruled out with MoCA score ≤18. Patients on any drugs other than antidepressants that can affect cardiac autonomic functions like antihistaminics, cough or cold medications, diuretics, sympathomimetics, parasympathomimetics will be excluded from the study. Any history of cardiac disease, allergy or non-acceptance of diet proposed |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in cognitive, autonomic, inflammatory markers with reduction in depression scores. |
baseline and after 4, 8, and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
03/02/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rationale/ gaps in existing knowledge: Despite the advances in management of depression the strategies have failed in reaching out to the target population and thus failed to reduce the disease prevalence. This is because apart from being a mood disorder depression has a significant cognitive, autonomic, stress and inflammatory components to it. Cognitive impairment links to reduced prefrontal cortex activation. Patients experience autonomic dysfunction with decreased
vagal tone, elevated cortisol (stress) and increased inflammatory markers like IL-6, CRP, and TNF-alpha.
Novelty: This is first study of its kind use multi-domain intervention that include Yoga nidra, Cognitive training and lifestyle modifications (Diet and Physical activity) along with standard of care (Pharmacological treatment) i.e. YoCogDiPP to holistically target cognitive, autonomic, stress and inflammatory components of depression
Objectives: To compare cognitive impairment, heart rate variability, cortisol levels, inflammatory markers, and depression scores in patients with depression before and after 4, 8, and 12 weeks of
multidomain intervention, and to compare these measures between multidomain intervention and only pharmacological treatment.
Methods: This study will follow a 12-week randomized controlled trial design (details in methodology)
Expected outcome: The study results will aid in understanding depression’s pathophysiology, focusing on stress, inflammation, prefrontal cortical involvement, and cognitive impairment. Additionally, it will explore the impact of multidomain intervention. If successful, the study could transform into a digital app, enhancing accessibility for patients at home, addressing compliance issues. This intervention could then reach a broader population, reducing depression-related morbidity, mortality, and financial losses in society.
|