Dementia Caregivers and Contemplative Practice: A Pilot Study
Primary Purpose
Loneliness
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contemplative Practice
Sponsored by
About this trial
This is an interventional treatment trial for Loneliness
Eligibility Criteria
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
Sites / Locations
- University of Nevada Las Vegas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Contemplative Practice
Waitlist Control
Arm Description
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.
The arm will eventually get the intervention.
Outcomes
Primary Outcome Measures
Change in Loneliness
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06075329
First Posted
October 3, 2023
Last Updated
October 9, 2023
Sponsor
University of Nevada, Las Vegas
1. Study Identification
Unique Protocol Identification Number
NCT06075329
Brief Title
Dementia Caregivers and Contemplative Practice: A Pilot Study
Official Title
Dementia Caregivers and Contemplative Practice: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to test the contemplative practice is feasible and acceptable among informal dementia caregivers population at all stages.
Detailed Description
It will also examine the benefits of this intervention and compare the outcomes between two groups (intervention and wait-list control).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loneliness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contemplative Practice
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
The arm will eventually get the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Contemplative Practice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Loneliness
Description
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.
Time Frame
baseline, at 10 days and 21 days of Matribodh Sambodh Dhyaan practice (meditation), and at 30 days and 60 days follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nirmala Lekhak, PhD
Phone
7028955983
Email
nirmala.lekhak@unlv.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirmala Lekhak, PhD
Organizational Affiliation
University of Nevada, Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dementia Caregivers and Contemplative Practice: A Pilot Study
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