| CTRI Number |
CTRI/2025/04/085577 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on the Impact of a Mindfulness and Self-Compassion Training to Reduce Stress and Burden in Caregivers of People with Dementia |
|
Scientific Title of Study
|
The Effect of a Mindful Self-Compassion Module to reduce Stress and Caregiver Burden Among Caregivers of People with Dementia: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V Gayathry |
| Designation |
PhD Research Scholar |
| Affiliation |
Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Psychiatry, Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9497752354 |
| Fax |
|
| Email |
gayathry.kmcmlr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Keshava Pai K |
| Designation |
Professor and H.O.D, Department of Psychiatry |
| Affiliation |
Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Psychiatry, Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448105227 |
| Fax |
|
| Email |
pai.keshava@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
V Gayathry |
| Designation |
PhD Research Scholar |
| Affiliation |
Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Psychiatry, Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9497752354 |
| Fax |
|
| Email |
gayathry.kmcmlr2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education (MAHE), Madhav Nagar, Manipal, Udupi Karnataka, 576104 India |
|
|
Primary Sponsor
|
| Name |
V Gayathry |
| Address |
Department of Psychiatry, Kasturba Medical College, Mangalore, 575001 |
| 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 Keshava Pai K |
Kasturba Medical College Hospital, Attavar Mangalore |
Department of Psychiatry, Room No.14, Attavar, Nandigudda Rd. Attavar, Mangalore
Dakshina Kannada
KARNATAKA |
9448105227
pai.keshava@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of people with Dementia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A Mindful-Self Compassion module |
The intervention group will receive a 10-minute single-session psychoeducation followed by a 6-week Mindful Self-Compassion module. The MSC module consists of weekly one-on-one sessions lasting approximately 45–60 minutes. The total time frame of the intervention is 6 weeks |
| Comparator Agent |
Psychoeducation (Control) |
The comparator group will receive a single-session 10-minute psychoeducation focused on caregiving and stress, without any additional psychological intervention. This serves as the control condition for comparison with the MSC intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Being the family caregiver of an individual with a confirmed medical diagnosis of dementia according to DSM 5, regardless of type
Who provide on average 5 hours of care and supervision per day, at least 5 days a week
Having provided care for at least 1 year
|
|
| ExclusionCriteria |
| Details |
Participants who had learned or practiced mindfulness activities or meditation in the past 6 months.
Those with mental disorders
Individuals who had self-reported suicidal thoughts or attempts in the past 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stress, Caregiver Burden |
6 weeks, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resilience |
6 weeks, 3 months, 6 months |
| Mindfulness |
6 weeks, 3 months, 6 months |
| Self-Compassion |
6 weeks, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
16/05/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study aims to assess the effectiveness of a Mindful Self-Compassion (MSC) module in improving psychological well-being among caregivers of individuals with dementia. The intervention is a six-week MSC program designed to enhance self-compassion, mindfulness, and resilience while reducing stress and caregiver burden. The study follows a pre-post intervention design, measuring changes in stress, caregiver burden, resilience, mindfulness, and self-compassion. The study follows a pre-post intervention design with assessments at baseline, post-intervention, and follow-up, measuring changes in stress, caregiver burden, resilience, mindfulness, and self-compassion. The expected outcome is a significant reduction in stress and burden, alongside improved emotional resilience and quality of life among participants. |