| CTRI Number |
CTRI/2025/08/092656 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
"Can Mindfulness Help Reduce Work Stress in ASHA Workers? A Study from Kolar" |
|
Scientific Title of Study
|
Mindfulness Vs Health Education For Workplace Burnout Among Accredited Social Health Activist (ASHA) In Kolar: A Cluster Randomized Controlled Trial. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Keerthi T |
| Designation |
Post Graduate |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Department of Community Medicine, Sri Devaraj Urs Medical College, Tamaka, Kolar-563101
Kolar
KARNATAKA
563101
India |
| Phone |
9003970259 |
| Fax |
|
| Email |
keerthi.thangar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep TS |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room No 23, 2nd Floor, College building
Department Of Community Medicine
Sri Devaraj Urs Medical College and Research, Tamaka, Kolar, Karnataka, India. 563101
Kolar
KARNATAKA
563101
India |
| Phone |
7892950465 |
| Fax |
|
| Email |
dr.pradeep.ts@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep TS |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room 25, Second Floor, College Building
Department of Community Medicine,
Sri Devaraj Urs Medical College and Research, Tamaka, Kolar, Karnataka, India. 563101
Kolar
KARNATAKA
563101
India |
| Phone |
7892950465 |
| Fax |
|
| Email |
dr.pradeep.ts@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri DevARAJ Urs Mrdical College, SDUAHER,
Tamaka,Kolar,Karnataka, India - 563101 |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Medical College |
| Address |
Sri Devaraj Urs Medical College, SDUAHER,
Tamaka, Kolar, Karnataka, India
Pincode - 563101 |
| Type of Sponsor |
Private medical college |
|
|
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 Keerthi T |
Sri Devaraj Urs Medical College |
Sri DevARAJ Urs Mrdical College, SDUAHER,
Tamaka,Kolar,Karnataka, India - 563101
Kolar
KARNATAKA |
9003970259
keerthi.thangar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee SDUAHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Occupational stress and burnout among community health workers (ASHA) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Health Education |
8 weekly sessions (20–30 minutes each) delivered in-person using visual aids, flip charts, and group discussions in the local language. Topics include definition and causes of burnout, recognizing stress symptoms, benefits of physical activity, role of sleep and nutrition, stress management techniques (non-mindfulness), time management, and peer support. The final session includes a review and Q&A. Sessions are conducted once per week for 8 weeks. |
| Intervention |
Mindfulness Intervention |
8 weekly mindfulness sessions (20 minutes each) conducted in group settings. Includes breathing exercises, body scan, walking meditation, and seated mindfulness. Participants also instructed to practice daily at home. Follow-up sessions held weekly. Intervention lasts for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Registered ASHA who has at least one year of work experience |
|
| ExclusionCriteria |
| Details |
ASHA’s with family members (blood related) who are under treatment or no treatment as for any mental illness diagnosed by a psychiatrist |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in workplace burnout measured by Maslach Burnout Inventory (MBI) after 8 weeks of Mindfulness Intervention |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a cluster
randomized controlled trial being conducted among Accredited Social Health
Activists (ASHAs) in Kolar district, Karnataka, to compare the effectiveness
of mindfulness-based intervention versus structured health
education in reducing workplace burnout.
ASHAs, the backbone of
India’s community health delivery system, often experience high levels of
occupational stress due to workload, lack of support, and emotional labor.
Chronic exposure to such stress can lead to psychological burnout, affecting
both their well-being and the quality of services they provide.
The study will include
320 ASHA workers selected from six taluks in Kolar district. Taluks will serve
as clusters, and will be randomized into two groups:
- Intervention Group: Receives weekly
20-minute mindfulness sessions for 8 weeks.
- Control Group: Receives weekly 20–30
minute structured health education sessions for 8 weeks.
The primary outcome will
be the reduction in burnout levels, assessed using the Maslach
Burnout Inventory (MBI) before and after the intervention. Data analysis
will follow an intention-to-treat approach, with Difference-in-Difference
analysis used to evaluate effectiveness.
The findings will help
determine whether mindfulness is more effective than health education in
improving the psychological well-being of ASHA workers, with implications for
future mental health support policies for frontline health workers in India. |