| CTRI Number |
CTRI/2023/11/059896 [Registered on: 16/11/2023] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Yoga Psychology based Mental health promotion program for Adults |
|
Scientific Title of Study
|
Development and pilot testing of a Yoga psychology based Mental health promotion intervention program for community adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Ganer |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Clinical Psychology, NIMHANS, Bengaluru
Hosur Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8552883793 |
| Fax |
|
| Email |
riyaganer123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna Agrawal |
| Designation |
Associate Professor and Guide |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Clinical Psychology, NIMHANS, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995862 |
| Fax |
|
| Email |
jyotsna.agl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyotsna Agrawal |
| Designation |
Associate Professor and Guide |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Clinical Psychology, NIMHANS, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995862 |
| Fax |
|
| Email |
jyotsna.agl@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Grant Commission, New Delhi |
|
|
Primary Sponsor
|
| Name |
University Grant Commission |
| Address |
Bahadur Shah Zafar Marg, New Delhi, 110002 |
| Type of Sponsor |
Government funding agency |
|
|
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 Jyotsna Agrawal |
National Institute of Mental Health and Neuro Sciences |
Department of Clinical Psychology, Hosur Road, Bengaluru
Bangalore
KARNATAKA |
7783805884
jyotsna.agl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals for mental health promotion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mental Health Promotion Program for Adults |
The intervention will be 8-10 weeks long (1 session per week) and will focus on the following components, informed by Patanjali Yogasutra:
1. Developing a yogic perspective towards life and investing in the process of self-discovery (Svadhyaya)
2. Finding inner stability amidst experiences of change (Vairagya/anasakti, Pratyahara,
Dharana etc.)
3. Enhancing self-mastery (Tapas, Pratipaksha-bhavana)
4. Self-care practices (niyama)
5. Cultivating interpersonal harmony (Yama, Maitri, Mudita, Karuna, Upeksha)
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Proficiency of English Language, Minimum 10 years of Formal Education |
|
| ExclusionCriteria |
| Details |
• Individuals diagnosed with axis
I psychiatric disorders and
having an ongoing treatment
• Individuals who have received
any structured psycho-social
intervention in the last 6 months
• Individuals who may not have
access for online intervention
• Individuals with any kind of
physical limitations which make
it difficult for them to
participate in an online
intervention.
• Individuals who may not have
privacy at home for
participating in the intervention |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Well-being & distress |
Baseline & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Psychological capital |
Baseline & 8 weeks |
| Sattva |
Baseline & 8 weeks |
| Psychological flexibility |
Baseline & 8 weeks |
| Non-attachment |
Baseline & 8 weeks |
| Self-regulation |
Baseline & 8 weeks |
| Intolerance to uncertainty |
Baseline & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
30/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/06/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The present study aims at developing a mental health promotion program based on yoga psychology, for improving well-being as well as reducing distress in community adults. For the development of this module, a survey with experienced mental health practitioners as well as community adults will be done initially. In this study, yogic wisdom amongst community adults will also be explored. Subsequently based on these insights and literature review, the module will be developed and validated with experts in the field, before conducting a pilot test of this mental health promotion program with community adults. |