| 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
|
|
|
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
|
|
|
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
|
|
|
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. |