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CTRI Number  CTRI/2023/04/052025 [Registered on: 26/04/2023] Trial Registered Prospectively
Last Modified On: 25/04/2023
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 trial to explore the effects of online Yoga intervention on anxiety symptoms in patients with anxiety disorders 
Scientific Title of Study   The Add-on Effect of Tele-Yoga on Generalized Anxiety Disorder: A Randomized Controlled Trial on Efficacy and Mechanisms 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lakshmi Nishitha 
Designation  Scientist-B 
Affiliation  Department of Integrative Medicine, NIMHANS 
Address  Room No.1, 1st Floor, Department of Integrative Medicine, NIMHANS, Hosur Mainroad, Bengaluru
Hosur road,Lakkasandra
Bangalore
KARNATAKA
560029
India 
Phone  08762150803  
Fax    
Email  nishitha.jasti910@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemant Bhargav 
Designation  Assistant Professor 
Affiliation  Department of Integrative Medicine, NIMHANS 
Address  Room No.3, 1st Floor, Department of Integrative Medicine, NIMHANS, Hosur Mainroad, Bengaluru
Hosur road,Lakkasandra
Bangalore
KARNATAKA
560029
India 
Phone  08762019348  
Fax    
Email  drbhargav.nimhans@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Lakshmi Nishitha 
Designation  Scientist-B 
Affiliation  Department of Integrative Medicine, NIMHANS 
Address  Room No.1, 1st Floor, Department of Integrative Medicine, NIMHANS, Hosur Mainroad, Bengaluru
Hosur road,Lakkasandra
Bangalore
KARNATAKA
560029
India 
Phone  08762150803  
Fax    
Email  nishitha.jasti910@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru 
 
Primary Sponsor  
Name  National Institute of Mental Health and Neurosciences 
Address  Room No.1, 1st Floor, Department of Integrative Medicine, NIMHANS, Hosur Mainroad, Bengaluru 
Type of Sponsor  Other [Research Institute and Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lakshmi Nishitha J  Department of Integrative Medicine, National Institute of Mental Health and Neurosciences  Room No.1, 1st Floor, Department of Integrative Medicine, NIMHANS, Hosur Mainroad, Bengaluru
Bangalore
KARNATAKA 		 8762150803

nishitha.jasti910@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F411||Generalized anxiety disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mental Health Education  Instructor-led mental health education modules that will include educating the subjects about stress, stress management, anxiety, maladaptive coping styles, coping strategies, emotion culturing, resilience building, conventional lifestyle advices, importance of sleep, wellbeing and positive mental health. Interactive dialogue will be encouraged between instructor and subjects. The 30-minute sessions will be scheduled for 3 days/ week for 8 weeks (Total 24 sessions). They will also continue the dose of medication (Benzodiazepine or SSRI or SNRI) as prescribed by the treating psychiatrist.  
Intervention  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, NIMHANS. This will be followed by live tele-sessions. Live supervised tele yoga sessions will be offered three days/ week for 8 weeks (Total 24 sessions). Once a week supervised session will include a 10-minute discussion on yoga-based lifestyle principles useful for GAD as per the validated program. In addition, the subjects will continue to take the medication prescribed (Benzodiazepine or SSRI or SNRI) by the treating psychiatrist. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
i. To examine the effects of add-on tele-yoga intervention on the severity of anxiety symptoms on GADSS and CGI-I
scale 		 at baseline, 4 weeks and 8 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
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
 		 baseline and at 8 weeks 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   25/05/2023 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The current study aims at assessing the effect of 8-week tele- yoga intervention on the clinical outcomes in patients with generalized anxiety disorders.

 

AIM

To evaluate the effects of add-on Tele-Yoga intervention in patients with Generalized Anxiety Disorder (GAD) on clinical outcomes and underlying mechanisms

 

  PRIMARY OBJECTIVES

i.        To assess the feasibility of the Tele adaptation of validated yoga module for GAD

ii.      To examine the effects of add-on tele-yoga intervention on clinical outcomes in patients with GAD

 SECONDARY OBJECTIVES

                                            i.            To examine the effects of add-on tele-yoga intervention on heart rate variability  during stress test in patients with GAD

                                          ii.            To examine the effects of add-on tele-yoga intervention on galvanic skin response  during stress test in patients with GAD

                                        iii.            To examine the effects of add-on tele-yoga intervention on DLPFC functional connectivity using functional near infrared spectroscopy (fNIRS) in patients with GAD

                                        iv.            To examine the effects  of add-on tele-yoga intervention on salivary cortisol levels during stress test in patients with GAD

                                          v.            To examine the effects of add-on tele-yoga intervention on sleep quality (PSQI) in patients with GAD

·         Design: Randomized controlled assessor blind parallel arm trial

·         Number of groups: 2

Consecutive consenting eligible subjects with GAD will be randomly assigned to any one of the 2 groups (1:1 allocation ratio), using computer-generated random numbers

1)      Intervention group [Tele-Yoga (TY) + standard care]: TY group

2)      Control group [Mental Health Education group + standard care]: MHE group

·         Allocation concealment will be assured by using sequentially numbered opaque sealed envelopes

·         Blinding: assessor blinded; the rater will be blinded to reduce bias

·         Sample size: N=88 (44 each in experimental group and control group)

·         Sampling: Convenient sampling

INCLUSION CRITERIA

•      Out-patients or in-patients with a primary psychiatric diagnosis of generalized anxiety disorder with or without co-morbid neurotic disorders

•      18 years to 60 years of age

•      Both gender

•      CGI-severity score of 3 to 5

•      Those with or without medications for GAD. If ON medication, current medication dose should have been stable for a minimum of 4 weeks.

•      Willingness and ability to perform the yoga intervention and to comply with the requirements of the study protocol.

EXCLUSION CRITERIA

•      Subjects with primary diagnosis of other anxiety disorders excluding GAD

•      Unable to understand study procedures and participate in the informed consent process.

•      Subjects who are currently on antipsychotics

•      Serious medical illness and co-morbidities such as uncontrolled diabetes, hypertension, thyroid disorders.

•      Significant current suicidal ideation or suicidal behaviors within the past 6 months

•      Posttraumatic stress disorder/substance use disorder (except nicotine)/eating disorder/organic mental disorders

•      Psychotic disorder, bipolar disorder, or developmental disorder

•      Practice of yoga and meditation in last 6 months.

•      Concomitant psychotherapy  such as cognitive behavioral therapy

•      Pregnant women

          INTERVENTION

          Yoga group; a validated yoga module for anxiety disorders will be given 3 days a week for 8 weeks through tele-mode

          Mental Health Education group: educational sessions on anxiety disorders will be given 3 days a week for 8 weeks through tele-mode

 

         OUTCOME MEASURES

           1. Generalized anxiety disorder rating scale

           2. Clinical global improvement

           3. Heart rate variability

           4. Galvanic skin resistance

           5. Salivary cortisol levels

           6. dorsolateral prefrontal connectivity through functional near-infrared spectroscopy

           7. Pittsburg sleep quality index

           8. Yoga Performance Assessment

 

       The above assessments will be performed at the baseline and after 8 weeks of the intervention. data will be extracted and appropriate statistical analyses will be performed.

          
 
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