- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06075329
Dementia Caregivers and Contemplative Practice: A Pilot Study
April 3, 2025 updated by: Nirmala Lekhak, PhD, University of Nevada, Las Vegas
The goal of this study is to test the contemplative practice is feasible and acceptable among informal dementia caregivers population at all stages.
Study Overview
Detailed Description
It will also examine the benefits of this intervention and compare the outcomes between two groups (intervention and wait-list control).
Study Type
Interventional
Enrollment (Actual)
113
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nevada
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Las Vegas, Nevada, United States, 89154
- University of Nevada Las Vegas
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Dementia Family Caregivers
- At least cared for dementia care receipient more than 6 months
Exclusion Criteria:
- If they have meditated less than 2 months ago
- Cognitive or language barrier that would make it difficult to understand and sign the informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Contemplative Practice
Maitribodh Sambodh (MSD) is a unique form of contemplative practice which combines breath watch, mantra or vibrational sound chant, focused meditation followed by loving kindness or a gratitude exercise at the end.
|
Contemplative practice included Maitribodh Sambodh Dhyaan (MSD), which was designed to increase feeling of love and connection by including most of components of different contemplative practices such as breath watch, mantra or vibrational sound chant, focused meditation, and visualization followed by loving-kindness or a gratitude exercise at the end.
|
|
Other: Waitlist Control
The arm will eventually get the intervention.
|
Contemplative practice included Maitribodh Sambodh Dhyaan (MSD), which was designed to increase feeling of love and connection by including most of components of different contemplative practices such as breath watch, mantra or vibrational sound chant, focused meditation, and visualization followed by loving-kindness or a gratitude exercise at the end.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Loneliness
Time Frame: baseline, at 10 days and 21 days of Matribodh Sambodh Dhyaan practice (meditation), and at 30 days and 60 days follow-up.
|
The UCLA 3-item Loneliness scale will be used to measure loneliness.
The scores on this scale range from 3 to 9, the highest scores indicative of a higher level of loneliness.
The scale is called UCLA 3-item scale but UCLA is representative of University of California Los Angeles.
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baseline, at 10 days and 21 days of Matribodh Sambodh Dhyaan practice (meditation), and at 30 days and 60 days follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nirmala Lekhak, PhD, University of Nevada, Las Vegas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 24, 2024
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
October 3, 2023
First Submitted That Met QC Criteria
October 3, 2023
First Posted (Actual)
October 10, 2023
Study Record Updates
Last Update Posted (Actual)
April 4, 2025
Last Update Submitted That Met QC Criteria
April 3, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNLV-2023-395
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.