| CTRI Number |
CTRI/2025/07/090085 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Yoga-Based Program to Improve Mental Well-being and Reduce Depression in Depressed Adults |
|
Scientific Title of Study
|
HEALTH AUGMENTATION VIA PERSONALIZED POSITIVE PSYCHOLOGY AND YOGA (HAPPY) FOR MAJOR DEPRESSIVE DISORDER |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BRUNDA YADAV P S |
| Designation |
Student of M.Sc Yoga Therapy |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
G13, OPD BUILDING, DEPARTMENT OF INTEGRATIVE MEDICINE, NIMHANS
BENGALURU- 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
7259724234 |
| Fax |
|
| Email |
brundayadav21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HEMANT BHARGAV |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Mental Heath and Neurosciences |
| Address |
G13, OPD BUILDING, DEPARTMENT OF INTEGRATIVE MEDICINE, NIMHANS
BENGALURU- 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HEMANT BHARGAV |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Mental Heath and Neurosciences |
| Address |
G13, OPD BUILDING, DEPARTMENT OF INTEGRATIVE MEDICINE, NIMHANS
BENGALURU- 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
BRUNDA YADAV P S |
| Address |
G-13, OPD Block, Department of Integrative Medicine, NIMHANS Bengaluru,
KARNATAKA
Bangalore
KARNATAKA
560029
India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Brunda Yadav P S |
National Institute of Mental Health and Neuroscience |
Assessment Room 1, Department of Integrative Medicine, Bengaluru- 560029
Bangalore
KARNATAKA |
7259724234
brundayadav21@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (2) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (3) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Arm |
Patients will follow the validated module of yoga for depression |
| Intervention |
HAPPY |
The intervention group will follow the HAPPY protocol, which includes activities of Raja Yoga, Karma Yoga, Jnana Yoga and Bhakti Yoga like ACT meditation, mindful movement, community service, gratitude meditation, and Guna assessments |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with MDD aged between 18 and 50 years
Patients under stable medications for depression in the last 6 weeks
|
|
| ExclusionCriteria |
| Details |
Comorbid with substance use except Nicotine
Comorbid with OCD
Comorbid with psychotic disorders
Cognitive impairment
Organic mood disorders
Patients who have been practising yoga regularly in the last month
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To develop HAPPY Intervention for patients with MDD under the guidance of experts
To validate the developed HAPPY intervention from experts
To check the feasibility of the developed HAPPY Intervention in a pilot controlled trial in MDD patients
|
3 months
3 months
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To check the limited efficacy of the HAPPY intervention by assessing MDD patients pre and post intervention
|
baseline, 2 weeks, follow up at 1 month |
To study the changes in the following variables when HAPPY is added along with pharmacotherapy for patients with MDD:
Depression levels- HAM D
Well-being- WHO Well-being scale
Mindfulness- FFMQ
Sleep quality- Pittsburg sleep quality index
Stress- Perceived stress scale
YPPA- Yoga Practice Performance Assessment |
baseline, 2 weeks, follow up at 1 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/07/2025 |
| 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="1"
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
|
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Brief Summary
|
This study involves two key phases: intervention development and a pilot controlled trial. Phase 1 focuses on the development and content validation of the HAPPY protocol. This will be achieved through expert consultations, literature review, and refinement based on feedback from yoga therapists, psychologists, and psychiatrists. Phase 2 is a pilot controlled trial with 50 participants recruited from NIMHANS’ IPD service in psychiatry and integrative medicine. Participants meeting the inclusion criteria, such as age between 18 and 50 years and being on stable medication for depression for at least six weeks.
The intervention group will follow the HAPPY protocol, which includes activities of Raja Yoga, Karma Yoga, Jnana Yoga and Bhakti Yoga like mindful movement, gratitude meditation, and Guna assessments, while the control group will participate in the validated Depression Yoga module.
The control provides a standard against which the effects of the HAPPY intervention can be measured. By comparing the intervention group (HAPPY) to the control group (using the validated Depression Yoga module), we can assess whether the HAPPY intervention offers additional or unique benefits over the existing standard.
Each participant in HAPPY intervention will have 10-15 minute, therapist-supervised sessions over two weeks, either inpatient or outpatient depending on their preference. The study will measure multiple outcomes using validated assessment tools such as The Hamilton Depression Rating Scale, WHO Well-being Scale, Five Facet mindfulness questionnaire, Pittsburg sleep quality index, Perceived Stress Scale, Yoga Practice Performance Assessment
|