NCT06075329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

July 24, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

October 3, 2023

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, at 10 days and 21 days of Matribodh Sambodh Dhyaan practice (meditation), and at 30 days and 60 days follow-up.

Study Arms (2)

Contemplative Practice

EXPERIMENTAL

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

Waitlist Control

OTHER

The arm will eventually get the intervention.

Behavioral: Contemplative Practice

Interventions

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.

Contemplative PracticeWaitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dementia Family Caregivers
  • At least cared for dementia care receipient more than 6 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

Location

Study Officials

  • Nirmala Lekhak, PhD

    University of Nevada, Las Vegas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 10, 2023

Study Start

July 24, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations