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CTRI Number  CTRI/2025/11/097316 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study aims at developing a yoga module for biopolar affective disorder and testing its efficacy on clincial severity of the illness  
Scientific Title of Study   Development Validation and Feasibility testing of a yoga based intervention for bipolar affective disorder 
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 Hemant Bhargav 
Designation  Associate Professor  
Affiliation  National Institute of Mental Health and Neuro Sciences  
Address  Department of Integrative Medicine National Institute of Mental Health and Neuro Sciences Hosur Road Lakkasandra Wilson Garden Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  8762019348  
Fax    
Email  drbhargav.nimhans@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemant Bhargav 
Designation  Associate Professor  
Affiliation  National Institute of Mental Health and Neuro Sciences  
Address  Department of Integrative Medicine National Institute of Mental Health and Neuro Sciences Hosur Road Lakkasandra Wilson Garden Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  8762019348  
Fax    
Email  drbhargav.nimhans@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ranjitha R 
Designation  Assistant Professor  
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Swami Vivekananda Yoga Anusandhana Samsthana Prashanti Kutiram Vivekananda Road Kalluballu Post Jigani Anekal Bengaluru

Bangalore
KARNATAKA
560105
India 
Phone  9611389605  
Fax    
Email  ranjusharadha313@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Ranjitha R 
Address  Swami Vivekananda Yoga Anusandhana Samsthana Prashanti Kutiram Vivekananda Road Kalluballu Post Jigani Anekal Bengaluru 
Type of Sponsor  Other [Self] 
 
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 Hemant Bhargav  National Institute of Mental Health and Neuro Sciences  Department of Integrative Medicine National Institute of Mental Health and Neuro Sciences Hosur Road Lakkasandra Wilson Garden Bengaluru
Bangalore
KARNATAKA 
8762019348

drbhargav.nimhans@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
iecsvyasa  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F310||Bipolar disorder, current episodehypomanic, (2) ICD-10 Condition: F313||Bipolar disorder, current episodedepressed, mild or moderate severity, (3) ICD-10 Condition: F316||Bipolar disorder, current episodemixed, (4) ICD-10 Condition: F317||Bipolar disorder, currently in remission,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated Yoga Module along with tele-yoga practice as an add-on to standard treatment  The intervention program will be consisting of loosening exercises, suryanamaskara, asanas, pranayama and relaxation techniques, mantra chantings. The duration of yoga module is 60 min (1 hour) which included practice duration and relaxation of 15-20sec between each individual practices. 10 yoga sessions will be conducted under direct supervision, distributed over 2 weeks and then subjects are asked to join regular tele-yoga sessions every morning before breakfast for next 12 months. Once a week yoga philsosphy based discussions on most suited paths of yoga based lifestyle for buidling mental reslience.  
Comparator Agent  Treatment as usual   This group will follow their usual routine and standard treatment  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1 Diagnosis of BPAD according to International classification of diseases 10
2 Patients with
a) Subclinical Mania
b) Mild Mania
c) Subclinical Depression
d) Mild Depression
e) Moderate Depression
4) Those with ability to read and write in English/Kannada. 
 
ExclusionCriteria 
Details  1 Patients with
a. Severe mania
b. Moderate mania
c. Severe Depression with psychotic symptoms
d. Those with suicidal ideations
e. Moderate to severe mania with psychotic symptoms
2 Mental Retardation
3 Acute Psychosis
4 Comorbid substance use disorders except Nicotine
5 Cerebrovascular accidents
6 Epilepsy
7 Recent fractures
8 Major surgery
9 Decompensated cardiac function
10 Psychotic disorders other than BPAD.
11 Yoga practice for 3 months before the date of recruitment. 
 
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 
(a) time to recurrence of an episode of bipolar disorder of sufficient severity to reach DSM–V criteria for major depressive, hypomania, mania or mixed episode, based on the SCID interview

(b) a longitudinal severity rating of overall symptom levels for each week since the last assessment interview (2 months), based on the Longitudinal Interval Follow-up Evaluation (LIFE–II; Keller et al, Reference Keller, Lavori and Friedman1987, Reference Keller, Lavori and Kane1992). Two LIFE scores were included, one for mania and one for depression and both employed a six-point scale (1=no symptoms, through to 6=DSM–V major depressive episode or mania with psychotic symptoms or severe impairment of function);Yoga Performance Assessment Scale, Secondary - social adjustment and quality of life 
0, 3 months, 6 months, 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   01/12/2025 
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="3"
Months="0"
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 - NO
Brief Summary  

This prospective study is designed to develop, validate, and assess the feasibility of a structured yoga-based intervention tailored for individuals with Bipolar Affective Disorder (BPAD). The yoga module will be developed through a comprehensive review of both classical and contemporary yoga literature. Following its development, the draft module will be subjected to expert validation. Qualified yoga experts meeting predefined inclusion criteria will be invited to review the module and rate each practice for its relevance and appropriateness. Content Validity Ratio for each practice will be calculated using Lawshe’s formula. Practices meeting the required CVR threshold will be retained in the final version of the module. Feasibility testing will be conducted on a cohort of 20 patients diagnosed with BPAD, as per DSM-5 diagnostic criteria, confirmed by a qualified psychiatrist. The feasibility phase will follow a single-group, pre-post design, with baseline assessments conducted prior to the intervention and post-assessments following its completion. Participants will undergo a total of 10 yoga sessions over 2 weeks. 

This will be followed by efficacy testing of the developed module on (a) time to recurrence of an episode of bipolar disorder of sufficient severity to reach DSM–V criteria for major depressive, hypomania, mania or mixed episode, based on the SCID interview 

(b) a longitudinal severity rating of overall symptom levels for each week since the last assessment interview (2 months), based on the Longitudinal Interval Follow-up Evaluation (LIFE–II; Keller et al, Reference Keller, Lavori and Friedman1987, Reference Keller, Lavori and Kane1992). Two LIFE scores will be included, one for mania and one for depression and both employed a six-point scale (1=no symptoms, through to 6=DSM–V major depressive episode or mania with psychotic symptoms or severe impairment of function); secondary outcome variables of social adjustment and quality of life and yoga performance scale.

 
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