| CTRI Number |
CTRI/2025/04/084554 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Developing yoga therapy manual for therapists to treat depression |
|
Scientific Title of Study
|
Adaptation of the Validated Yoga Module for
Depression: Standardizing delivery through a
Therapist Training Manual with Fidelity,
Competence, and Reliability Testing. |
| 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 Hemant Bhargav |
| Designation |
Associate professor |
| Affiliation |
National Institute of Mental Health and Neurosciences NIMHANS |
| Address |
Department of Integrative Medicine
National Institute of Mental Health and Neurosciences
NIMHANS
Hosur Road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Pilli Devi Vidyasagar |
| Designation |
PhD Student |
| Affiliation |
National Institute of Mental Health and Neurosciences NIMHANS |
| Address |
Department of Integrative Medicine
National Institute of Mental Health and Neurosciences
NIMHANS
Hosur Road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8970556456 |
| Fax |
|
| Email |
sagar.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Bhargav |
| Designation |
Associate professor |
| Affiliation |
National Institute of Mental Health and Neurosciences NIMHANS |
| Address |
Department of Integrative Medicine
National Institute of Mental Health and Neurosciences
NIMHANS
Hosur Road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYUSH Central of Excellence,Ayush Swasthya Yojana, Ministry of AYUSH, Ayush Bhavan, New Delhi, 110023 contact no: 01124648354 |
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
Hosur Road
Bengaluru 560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hemant Bhargav |
NIMHANS Hospital |
Room No 3, NIMHANS Yoga Centre, Department of Integrative Medicine, Hosur Road
Bengaluru, 560029
Bangalore
KARNATAKA |
8762019348
drbhargav.nimhans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee for Research in AYUSH and integrative Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Yoga therapists |
| Patients |
(1) ICD-10 Condition: F30-F39||Mood [affective] disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manualized delivery of Yoga for Depression |
Delivery manual consists of detailed descriptions of yoga practices with visual aids, step-by-step instructions and expected outcomes for each practice to ensure standardization of yoga practice, progressive overloading, personalization, effective supervision and quantifiable performance monitoring. Total 10 sessions, 1 hour per session for 2 weeks |
| Comparator Agent |
Non manualized delivery of Yoga for Depression |
Yoga module will be shared with the therapists without any delivery manual with only the name of the practice, picture and dose of the practices. Total 10 sessions, 1 hour per session for 2 weeks . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
For therapists
1 PGDYT or Bachelors in yoga with a minimum of 2 years’ experience/ Masters in yoga -Freshers or Currently pursuing/ BNYS graduates - Freshers or currently pursuing/ MD yoga - Freshers or currently pursuing.
2 Currently located in Bengaluru
3 Willing to attend the workshop for delivery of yoga therapy using manual
4 Consenting to participate in the study
For Patients with depression
1 Diagnosis of depression according to DSM-5 criteria
2 Severity of depression - mild, moderate and severe
3 Treatment naive or on any standard antidepressant treatment and/or psychological counselling
4 Age group of 18 to 60 years
5 Both male and female
6 Inpatient and Outpatient
7 Yoga naive - not more than 3 structured yoga therapy sessions in the past month.
8 Not involved in any structured yoga therapy in the past 6 months
9 Consenting to participate in the stud |
|
| ExclusionCriteria |
| Details |
For Therapists
1 Yoga instructors’ course/ any short-term certification courses/ yoga training programs/ not involved in yoga therapy for patients.
2 Located outside Bengaluru
3 Not consenting to participate in the study
For patients with depression
1 Co-morbid substance abuse (excluding nicotine dependence), psychosis, suicidal and self-injurious
behaviour, mental retardation, any other DSM IV-TR anxiety disorders, OCD, and related disorders. (This
is only for fidelity testing in objective 2)
2 Severe depression with catatonic symptoms, high suicidal risk, or severe psychomotor retardation,
on electroconvulsive therapy (ECT).
3 Bipolar depression.
4 Currently pregnant or lactating.
5 Subjects with severe physical ailments like general medical conditions like coronary artery disease,
fracture,seizure disorders, and autoimmune disorders, which is contraindicated for the depression module.
6 Already practicing structured yoga/ undergoing yoga therapy on a regular basis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Yoga Trainer’s Assessment Checklist
2. Competences in Clinical Practices (RECOPC-FIS II)
3. Yoga performance assessment scale |
1. Yoga Trainer’s Assessment Checklist - Baseline, after 5 sessions and after 10 sessions
2. Competences in Clinical Practices (RECOPC-FIS II) - Baseline, after 5 sessions and after 10 sessions
3. Yoga performance assessment scale - baseline, after 5 sessions, and
after 10 sessions;
Time line for all above assessments is baseline, 1 week and 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Qualitative feedback from patients, trainees, & experts observing the therapy for depression
2. Yoga Therapy for Depression Module Performance Checklist
3. Visual analog scale for overall therapist performance |
1. Qualitative feedback from patients, trainees, & experts observing the therapy - After 10 yoga sessions
2. Yoga Therapy for Depression Module Performance Checklist - Baseline, after 5 sessions & after 10 sessions
3. Visual analog scale for overall therapist performance - after the 10th yoga session.
Time line for all above assessments is baseline, 1 week & 2 weeks
|
| Qualitative feedback of the trainee, independent observer & the patient |
After 10 yoga sessions
Time line for all above assessments is baseline, 1 week & 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/07/2025 |
| 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="4"
Months="0"
Days="0" |
|
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
|
A validated yoga module is currently being used for patients with depression. However, a systematic delivery approach for teaching the yoga practice to patients does not exist. The study involves development of a therapist manual module for conducting yoga therapy session for patients with depression. In this manual, detailed descriptions with visual aids, step-by-step instructions and expected outcomes for each practice will be given. This will ensure standardization of yoga practice, progressive overloading, personalization, effective supervision and quantifiable performance monitoring. Experts will be consulted to refine and validate the manual. The effectiveness of the manual will be tested on yoga therapists providing therapy to patients with depression. This manual will ensure uniform and standard yoga training to patients making it applicable for research work. |