| CTRI Number |
CTRI/2026/01/101425 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| 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
|
A study to see whether breathing based yoga improves anxiety and mood in patients with anxiety disorders |
|
Scientific Title of Study
|
Efficacy of an 8-week Pranayama-Based Yoga Intervention Versus Active Control in Patients with Anxiety Disorders: A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Kumar |
| Designation |
PhD Student |
| Affiliation |
Department of Integrative Medicine, NIMHANS |
| Address |
2nd floor, New Yoga Centre Building, Department of Integrative Medicine, NIMHANS, Bangalore, Karnataka, India.
Bangalore
KARNATAKA
560029
India |
| Phone |
7906552917 |
| Fax |
|
| Email |
ashish.kumar768@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Bhargav |
| Designation |
Associate Professor of Yoga |
| Affiliation |
Department of Integrative Medicine, NIMHANS |
| Address |
Room no.5,First floor, Ayurveda Block, Department of Integrative Medicine, NIMHANS, Bangalore, Karnataka, India.
Bangalore
KARNATAKA
560029
India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish kumar |
| Designation |
PhD Student |
| Affiliation |
Department of Integrative Medicine, NIMHANS |
| Address |
2nd floor, New Yoga Centre Building, Department of Integrative Medicine, NIMHANS, Bangalore, Karnataka, India.
Bangalore
KARNATAKA
560029
India |
| Phone |
7906552917 |
| Fax |
|
| Email |
ashish.kumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Collaborative Centre for Mind-Body interventions through Yoga (CCMBIY) by CCRYN, Ministry of AYUSH, Department of Integrative Medicine, NIMHANS |
|
|
Primary Sponsor
|
| Name |
Department of Integrative Medicine NIMHANS |
| Address |
NIMHANS, Bangalore, Karnataka 560029, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Collaborative Centre for Mind Body interventions through Yoga CCMBIY by CCRYN |
Department of Integrative Medicine, NIMHANS Campus, Hosur Road, Bengaluru, Karnataka 560029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ashish Kumar |
National Institute of Mental Health and Neurosciences(NIMHANS) |
Room no 2, 2nd floor, New Yoga Centre Building, Department of Integrative Medicine and Department of Psychiatry, NIMHANS, Bangalore, Karnataka 560029, India
Bangalore
KARNATAKA |
7906552917
ashish.kumar768@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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F419||Anxiety disorder, unspecified, (2) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Breathe Watch intervention(CTAU) |
Participants in the active control group will receive a breath watch practice in addition to Treatment as Usual (TAU). The breath watch practice involves passive observation of natural breathing without intentional alteration of breath rate, depth, or rhythm.
The intervention will be delivered over a period of 8 weeks. It will begin with an in-person supervised session at NIMHANS, followed by a 1-week supervised training phase conducted by a trained yoga therapist. Participants will subsequently perform daily home-based breath watch practice for 20 minutes over 7 weeks using pre-recorded instructional videos.
A once-weekly live online booster session will be conducted for supervision and correction and will also include brief mental health education modules. The intervention will be standardized across participants, with fidelity ensured through supervised sessions and uniform instructional materials.
All participants will continue to receive Treatment as Usual, including benzodiazepines and/or SSRI/SNRI medications as prescribed by the treating psychiatrist, based on clinical indications. |
| Intervention |
Pranayama-Based Yoga Intervention (PTAU) |
Participants in the experimental group will receive a structured pranayama-based yoga intervention in addition to Treatment as Usual (TAU). The intervention is based on a validated yoga module routinely used at the NIMHANS Yoga Centre. Each session includes preparatory loosening practices, followed by pranayama practices, and concludes with Dhyana. The total duration of each session is approximately 20 minutes.
The intervention will be delivered over a period of 8 weeks, with the initial session conducted in person at NIMHANS by a trained yoga therapist, followed by a 1-week supervised training phase. Participants will subsequently continue daily home-based self-practice for 7 weeks using pre-recorded instructional videos, with a once-weekly online booster session for supervision and correction, which will also include brief yoga philosophy discussions.
The intervention will be standardized across participants using uniform instructional materials, and fidelity will be ensured through supervised sessions conducted by trained personnel.
All participants will continue to receive Treatment as Usual, including benzodiazepines and/or SSRI/SNRI medications as prescribed by the treating psychiatrist, based on clinical indications. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with Generalized Anxiety Disorder (GAD) or Other/Unspecified Anxiety Disorder according to DSM-5 criteria.
Participants with at least mild anxiety symptoms (GAD-7 score more than or equals to 5).
Participants with or without pharmacotherapy.
If on pharmacotherapy, then participants willing to keep dosage of medications stable during the trial period.
Able and willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
History of bipolar disorder, schizophrenia, substance use or dependence (excluding tobacco), obsessive-compulsive disorder (OCD), severe depression, psychosis, phobias, or panic disorder.
Pregnancy.
Any severe medical comorbidities.
Participation in structured yoga therapy or online/offline pranayama or any mind-body technique at least once per week in last 3 months.
Participation in structured cognitive behavioral therapy (CBT) for anxiety within the past 3 months.
Not on a stable pharmacological dose for at least 4 weeks prior to enrolment.
Nasal abnormalities (e.g., nasal septum deviation, polyps).
Contraindications for fMRI (e.g., metal implants, claustrophobia, inability to remain still) will be assessed using a fMRI safety checklist before the scan. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Self-reported anxiety severity measured by PROMIS
Positive and Negative affect measured by PANAS |
Baseline (pre-intervention), weekly assessments during Weeks 1–8, with final assessment at the end of Week 8. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Clinician-rated anxiety severity assessed using the Hamilton Anxiety Rating Scale (HAM-A).
|
Baseline and end of Week 8 (post-intervention).
|
| Intrinsic functional connectivity will be assessed and resting-state functional MRI will be done. |
Baseline and end of Week 8 (post-intervention). |
| Autonomic nervous system function assessed using heart rate variability (HRV) measures. |
Baseline and end of Week 8 (post-intervention). |
Cognitive performance trends assessed using mobile-based cognitive tasks delivered via the MyCap application.
|
Weekly during the 8-week intervention period. |
| Individual constitutional and personality traits assessed using the Brief Prakriti Inventory (BPI) and Vedic Personality Inventory (VPI). |
Baseline only. |
|
|
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)
|
15/02/2026 |
| 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)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [drbhargav.nimhans@gmail.com].
- For how long will this data be available start date provided 01-07-2030 and end date provided 31-12-2035?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a parallel-group, outcome assessor–blinded, randomized controlled trial designed to evaluate the efficacy of a pranayama-based yoga intervention in patients with anxiety disorders who have residual symptoms despite stable pharmacological treatment. Sixty participants will be randomized to receive either pranayama-based yoga with Treatment as Usual (TAU) or breath-watch practice with TAU. The intervention will be delivered over 8 weeks, including a 1-week supervised training phase followed by 7 weeks of home-based practice using pre-recorded videos, with one weekly live online booster session. Booster sessions will include either yoga philosophy discussions or mental health education, depending on group allocation. The primary outcomes are changes in self-reported anxiety measured using the PROMIS Anxiety questionnaire and affective states assessed using the Positive and Negative Affect Schedule (PANAS). Assessments will be conducted at baseline and at the end of Week 8, with additional weekly monitoring during the intervention period. |