Dementia Caregivers and Contemplative Practice: A Pilot Study

Sponsor

University of Nevada, Las Vegas (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06075329

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

33.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Loneliness	Behavioral: Contemplative Practice	N/A

Detailed Description

It will also examine the benefits of this intervention and compare the outcomes between two groups (intervention and wait-list control).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dementia Caregivers and Contemplative Practice: A Pilot Study

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

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.	Behavioral: Contemplative Practice 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.	Behavioral: Contemplative Practice 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.

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.

Behavioral: Contemplative Practice

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.

Behavioral: Contemplative Practice

Outcome Measures

Primary Outcome Measures

Change in Loneliness [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nevada Las Vegas	Las Vegas	Nevada	United States	89154

Sponsors and Collaborators

University of Nevada, Las Vegas

Investigators

Principal Investigator: Nirmala Lekhak, PhD, University of Nevada, Las Vegas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nirmala Lekhak, PhD, Assistant Professor, University of Nevada, Las Vegas

ClinicalTrials.gov Identifier:

NCT06075329

Other Study ID Numbers:

UNLV-2023-395

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 12, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of Oct 12, 2023