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

Status

Completed

Conditions

Intervention / Treatment

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

    • Nevada
      • Las Vegas, Nevada, United States, 89154
        • University of Nevada Las Vegas

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.
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.

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

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.

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