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A trial to explore the effects of online Yoga intervention on anxiety symptoms in patients with anxiety disorders

The Add-on Effect of Tele-Yoga on Generalized Anxiety Disorder: A Randomized Controlled Trial on Efficacy and Mechanisms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/052025
Enrollment
88
Registered
2023-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F411- Generalized anxiety disorder

Interventions

Intervention1: Tele-Yoga: Validated yoga module for anxiety disorders will be taught. first session will be direct at the NIMHANS Integrated Centre for Yoga, Department of Integrative Medicine, NIMHAN

Sponsors

National Institute of Mental Health and Neurosciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Out-patients with a primary psychiatric diagnosis of generalized anxiety disorder with or without co-morbid neurotic disorders 2) CGI-severity score of 3 to 5 3) Those with or without medications for GAD. If ON medication, current medication dose should have been stable for a minimum of 4 weeks. 4) Willingness and ability to perform the yoga intervention and to comply with the requirements of the study protocol.

Exclusion criteria

Exclusion criteria: 1) Subjects with primary diagnosis of other anxiety disorders excluding GAD 2) Unable to understand study procedures and participate in the informed consent process. 3) Subjects who are currently on anti psychotics 4) Serious medical illness and co-morbidities such as uncontrolled diabetes, hypertension, thyroid disorders. 5) Significant current suicidal ideation or suicidal behaviors within the past 6 months 6) Posttraumatic stress disorder/substance use disorder (except nicotine)/eating disorder/organic mental disorders 7) Psychotic disorder, bipolar disorder, or developmental disorder 8) Practice of yoga and meditation in last 6 months. 9) Concomitant psychotherapy such as cognitive behavioral therapy 10) Pregnant women

Design outcomes

Primary

MeasureTime frame
i. To examine the effects of add-on tele-yoga intervention on the severity of anxiety symptoms on GADSS and CGI-I scaleTimepoint: at baseline, 4 weeks and 8 weeks

Secondary

MeasureTime frame
i.To examine the effects of add-on tele-yoga intervention on heart rate variability during triers stress test ii.To examine the effects of add-on tele-yoga intervention on galvanic skin response during stress test iii.To examine the effects of add-on tele-yoga intervention on DLPFC functional connectivity using functional near infrared spectroscopy (fNIRS) iv.To examine the effects of add-on tele-yoga intervention on salivary cortisol levels during stress test v.To examine the effects of add-on tele-yoga intervention on sleep quality through actigrapghy and on Pittsburgh sleep quality index Timepoint: baseline and at 8 weeks

Countries

India

Contacts

Public ContactDr Lakshmi Nishitha

Department of Integrative Medicine, NIMHANS

drbhargav.nimhans@gmail.com08762019348

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026