| CTRI Number |
CTRI/2025/11/097928 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| 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
|
Yoga as a complementary intervention for children and adolescents with depression |
|
Scientific Title of Study
|
Yoga as a complementary intervention for children and adolescents with depression: a randomized controlled 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 Mirza Sarwar Baig |
| Designation |
Senior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Child and Adolescent Psychiatry Unit, Department of Psychiatry, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8586962489 |
| Fax |
|
| Email |
dr.sarwarbaig@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Sharma |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Department of Psychiatry,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
06239124451 |
| Fax |
|
| Email |
drakhileshsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh Sharma |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Department of Psychiatry,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
06239124451 |
| Fax |
|
| Email |
drakhileshsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Chandigarh, India |
|
|
Primary Sponsor
|
| Name |
Dr Mirza Sarwar Baig Principal Investigator |
| Address |
Child and Adolescent Psychiatry Unit, Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India, PIN - 160012 |
| Type of Sponsor |
Other [] |
|
|
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 Mirza Sarwar Baig |
Child and Adolescent Psychiatry OPD and IPD, PGIMER, Chandigarh |
Room no. 224, Child and Adolescent Psychiatry OPD, Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India, PIN - 160012
Chandigarh
CHANDIGARH |
8586962489
dr.sarwarbaig@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: F32||Major depressive disorder, singleepisode, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Treatment as usual |
Antidepressants and/or anxiolytics and/or psychoeducation and/or psychotherapy and/or relaxation exercises |
| Intervention |
Yoga |
Sukshma and Sthula Vyayama
Griva Shakti Vikasaka - 1 & 2 - Neck exercises – 2 minutes
Manibandha Shakti Vikasaka - Wrist rotation – 1 minute
Kaphoni Shakti Vikasaka - Elbow movement – 1 minute
Bhuja Valli Vikasaka - Arms movement – 1 minute
Janu Shakti Vikasaka - Knee movement – 1 minute
Gulpha, Pada Prista, Padatala Shakti Vikasaka - Ankle and feet movements – 2 minutes
Kati Shakti Vikasaka – Twisting – 1 minute
Kundalini Shakti Vikasaka - Jogging (slow, fast, forward, backward, side) - 2 minutes
Mukha-dhauti - Air cleaning through the mouth - 15 seconds
Suryanamaskara
Suryanamaskara - Sun salutations – 10 minutes
Shavasana - Corpse pose – 2 minutes
Standing Asana
Ardha Cakrasana - Half wheel pose – 2 minutes
Sitting Asana
Ushtrasana - Camel pose – 2 minutes
Paschimattanasana - Posterior stretching pose – 2 minutes
Prone Postures
Bhujangasana - Serpent pose – 2 minutes
Supine Postures
Pavanamuktasana - Wind releasing pose - 2 minutes
Viparitakarani Mudra - Supported shoulder stand – 2 minutes
Sethubandhasana - Bridge pose – 2 minutes
Shavasana - Quick relaxation technique – 4 minutes
Kriya for Depression
Kapalabhati - Skull brightening breath – 2 minutes
Pranayama for Depression
Surya Anuloma Viloma - Right nostril breathing – 2 minutes
Ujjayi Pranayama – The Ocean breath – 2 minutes
Bhastrika - Cleansing action breathing – 2 minutes
Meditation for Depression
Nadanusandhana - Sound resonance technique (AA Kara, UU Kara, MM Kara, AUM Kara) - 5 minutes
Total session duration = 54 minutes and 15 seconds
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Children and adolescents from the ages of 8 to 17 years
2. Patients having an established clinical diagnosis of major depressive disorder as per
DSM-5 criteria, with mild to severe depression, without active suicidal ideation or
behaviour, and without psychotic symptoms. The clinician’s diagnosis of depression
shall be confirmed on K-SADS-PL.
3. Access to internet-based video-conferencing applications.
4. Ability to understand, read and write English, Hindi and/or Punjabi.
5. Written informed consent from the parents/guardians and assent from the study
participants. |
|
| ExclusionCriteria |
| Details |
1. Psychiatric comorbidity such as bipolar disorder, psychosis, active anxiety disorders,
substance use disorders, eating disorders, neurodevelopmental disorders.
2. Active suicidal ideation to the extent that it may interfere with the administration of
yoga.
3. Major depressive disorder with psychotic features.
4. Severe medical or neurological conditions which limit the ability to do yoga.
5. History of participation in yoga in the past six months.
6. Inability to take part in the scheduled intervention sessions because of logistical
challenges. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in depression symptoms as measured on validated rating scales for depression, such as the DASS-Y (Depression Anxiety Stress Scales – Youth Version) and CES-DC (Center for Epidemiological Studies Depression Scale for Children), after 8 weeks of yoga intervention |
Baseline and 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the intervention’s impact on depression symptoms. |
For the yoga intervention group:
Baseline assessment at the start of the intervention. The efficacy of the yoga intervention will be evaluated at 8 weeks
after the start of the yoga intervention (post-intervention).
For the control group:
Baseline assessment of depressive symptoms will be carried out at the start of phase II. At 8 weeks after recruitment, changes in the depressive symptoms will be evaluated.
|
| To assess the intervention’s impact on quality of life of children and adolescents with depression, and to document any adverse effects of the yoga intervention. |
For the yoga intervention group:
Baseline assessment of quality of life parameters will be carried out at the start of the intervention. Assessments regarding safety shall be carried out after each session. The changes in the quality of life parameters will be evaluated at 8 weeks after the start of the yoga intervention (post-intervention).
For the control group: Baseline assessment of quality of life parameters will be carried out at the start of phase II. Assessments regarding safety shall be carried out after each session. At 8 weeks after recruitment, changes in the quality of life symptoms will be evaluated.
|
|
|
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)
|
03/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - 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 - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.sarwarbaig@gmail.com].
- For how long will this data be available start date provided 02-07-2026 and end date provided 02-07-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The planned study aims to evaluate yoga as a complementary
therapy for the treatment of depression in children and adolescents. Depression
in young people is linked to developmental, cognitive, and social difficulties,
as well as an increased risk of self-harm and persistence into adulthood. Pharmacological
treatments, though effective, are limited by concerns regarding side effects
such as increased suicidal ideation and behavior. Psychotherapeutic
interventions remain resource-intensive, requiring trained professionals and
regular sessions, which restricts their accessibility in low- and middle-income
settings. Yoga, an ancient Indian practice, has emerged as a promising
complementary approach for mental health conditions, including depression. It
integrates physical postures (asanas), controlled breathing (pranayama), and mindfulness-based
practices, providing a holistic balance of physical and psychological
well-being. However, research evaluating its use in children and adolescents
within clinical settings remains limited. This study therefore seeks to assess
the efficacy of an 8-week yoga intervention as a complementary therapy for
depression in children and adolescents. The yoga intervention will be delivered
alongside standard care, compared against a control group receiving only
standard care. By addressing current research gaps, the study aims to establish
yoga as a culturally relevant, scalable, and accessible mental health
intervention for youth depression.
|