| CTRI Number |
CTRI/2024/02/062804 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Yoga on Depression |
|
Scientific Title of Study
|
Effectiveness of Yoga Intervention on Patients with Mild and Moderate Depression - A Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC-NI/23/AUG/89/88 |
Other |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Mrs. Ayisha Siddeequa M.A. |
| Designation |
Ph D Research Scholar in Clinical Psychology, Department of Psychiatry |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (DU) |
| Address |
No:1, Ramachandra Nagar, Porur, Chennai - Chennai TAMIL NADU 600116 India |
| Phone |
8124612463 |
| Fax |
|
| Email |
ayishasiddeequama.sriher@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suvarna Jyoti Kantipudi |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
G Block, Department of Psychiatry OP Services,
Sri Ramachandra Medical College and Research Institute.
Chennai TAMIL NADU 600116 India |
| Phone |
9047492143 |
| Fax |
|
| Email |
suvarna@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Suvarna Jyoti Kantipudi |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
G Block, Department of Psychiatry - OP Services,
Sri Ramchandra Medical College and Research Institute.
Chennai TAMIL NADU 600116 India |
| Phone |
9047492143 |
| Fax |
|
| Email |
suvarna@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research [Deemed University] |
|
|
Primary Sponsor
|
| Name |
Ayisha Siddeequa M A |
| Address |
1196 Anna Nagar West End Colony Street TS Krishna Colony Chennai 600050 |
| Type of Sponsor |
Other [Self Funding ] |
|
|
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 |
| Ayisha Siddeequa MA |
Sri Ramachandra Institute of higher Education and Research |
G Block, Department of Psychiatry, Link Room
Sri Ramchandra Institute of Higher Education and Research (DU).
No.1 Ramachandra Nagar, Porur Chennai 600 116 Chennai TAMIL NADU |
8124612463 - ayishasiddeequama.sriher@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (2) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Yoga Intervention |
Yoga Intervention For Mild and Moderate Depression, Developed and Validated by Dhamodhini et. al from SRIHER. The participants in the intervention group will be asked to attend the sessions for 12 weeks (each
training session lasting for about an hour) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with mild and moderate level of depression ranging between the age group of 18 -45 years will be recruited for the study.
|
|
| ExclusionCriteria |
| Details |
The depressive patients with intellectual disability, substance abuse disorder (except nicotine and caffeine), dementia, epilepsy or cerebrovascular accidents, history of psychosis or bipolar disorder, patients with suicidal risks or catatonia will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The physiological, psychological, and neuropsychological parameters of the mild and moderate depressive patients ranging between the age group of 18 - 45 years will be measured [pre- test & post test]. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The participants in the intervention group will receive intervention for 12 weeks.
After the post-test, a follow-up for 6 months will be made on the subsamples of the total
samples to measure the long–term effectiveness of the yoga intervention through an in-depth
interview to obtain insights to understand the holistic perspective of the participants and
barriers and facilitators in practicing yoga as a coping strategy. |
Intervention: 12 weeks
Follow-up [ after post-test]:6 months
InDepth Interview: 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
26/02/2024 |
| 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="6" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
After screening, a sample size of 90 participants with mild and moderate levels of depression attending the outpatient service of the Psychiatry Department of Sri Ramachandra Institute of Medical College and Research Institute will be recruited with informed consent before beginning the study and will be equally divided into two groups namely; the control group (45) and the interventional group (45). As the meta-analysis of studies of yoga for depression suggests Cohen’s d within groups was 0.45 for aerobic exercise and 0.38 for yoga training. A power analysis in G power assuming two independent means indicated 38 people per arm are necessary to have 80% power to detect this magnitude of a difference between samples. The sample size has been statistically calculated as (n=90). Though 38 people per arm are needed, however, we are recruiting 45 people per arm by expecting a 20% of dropout rate. Therefore, depressive patients (n=90), with mild and moderate levels of depression ranging between the age group of 18 - 45 years will be recruited for the study, excluding the depressive patients with intellectual disability, substance abuse disorder (except nicotine and caffeine), dementia, epilepsy, or cerebrovascular accidents, history of psychosis or bipolar disorder, and patients with suicidal risks or catatonia. The physiological, psychological, and neuropsychological parameters will be measured and studied with their other psycho-socio-demographic details on both groups. The participants in the control group will be taking conventional treatment and the participants in the interventional group will be taking the conventional treatment&n |