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NCT05617300

Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

Completed NA Results posted Last updated 10 January 2025
What this trial tests

NA trial testing Mindfulness-Based Dementia Caregiving in Dementia in 130 participants. Completed in 20 March 2024.

Timeline
7 November 2022
Primary endpoint
15 December 2023
20 March 2024

Quick facts

Lead sponsorHealthPartners Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsequential
Maskingnone
Primary purposehealth services research
Enrollment130
Start date7 November 2022
Primary completion15 December 2023
Estimated completion20 March 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

HealthPartners Institute

Who can join

18 and older, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participation Rate Primary · Baseline

Number of the participants who attend the first class of their session. Enrolled is defined as a participant who is assigned to a course. Range \[0-124\]. A value closer to 124 is indicative of greater feasibility.

GroupValue95% CI
MBDC Course84
Completion Rate Primary · 16 weeks

Percent of the participants who completed courses. Completion is defined as attending a minimum of 6 of the 9 classes. Range \[0-100\]. A value closer to 100 is indicative of greater feasibility.

GroupValue95% CI
MBDC Course94.0
Questionnaire Specific Response Rate Primary · 16 weeks

Completeness of questionnaires given over the course of the study. Completeness is defined percent of complete questionnaires.

GroupValue95% CI
MBDC Course96.8± 2.2
Change in Care Partner Burden Secondary · baseline, post-course at 8 weeks, follow-up at 20 weeks

Measured using Zarit Burden Interview (ZBI-6). Total of 6 questions scored on a 5 point scale (0-4). The sum of the 6 questions in the total score. Range: 0-24. A higher score is indicative of greater caregiver burden. Change in control period compared to change in intervention period.

pre- to post-course
GroupValue95% CI
MBDC Course-1.1-2 – -0.2
pre-course to follow-up
GroupValue95% CI
MBDC Course-0.8-1.8 – 0.2
Change in Symptoms of Depression Secondary · baseline, post-course at 8 weeks, follow-up at 20 weeks

Measured using the Center for Epidemiological Studies Depression Scale (CES-D-10). Total of 10 questions scored on a categorical scale (0-3). The sum of the 10 questions is the total score. Range: 0-30. A total value above 10 is considered to be a sign of depression. A higher score represents a greater degree of depressed mood. Change in control period compared to change in intervention period.

pre- to post-course
GroupValue95% CI
MBDC Course0.110.03 – 0.4
pre-course to follow-up
GroupValue95% CI
MBDC Course0.090.02 – 0.36
Change in Self-compassion Secondary · baseline, post-course at 8 weeks, follow-up at 20 weeks

Measured using "The State Self-Compassion Scale Short Form." Uses a Likert-type scale ranging from 1 to 5. \[Range: 12-60\] Higher scores indicates more self compassion.

pre- to post-course
GroupValue95% CI
MBDC Course0.40.2 – 0.5
pre-course to follow-up
GroupValue95% CI
MBDC Course0.40.2 – 0.6
Change in Mindful Attention Awareness Secondary · baseline, post-course at 8 weeks, follow-up at 20 weeks

Measured using The 5-Item Mindful Attention Awareness Scale - State This is a 5-item scale to indicate at what level they relate to specific experiences, aimed at measuring main characteristics of mindfulness: (scale is 0-"not at all" to 6-"very much"). \[Range: 0-30\] Higher scores indicate elevated levels of mindfulness expression.

pre- to post-course
GroupValue95% CI
MBDC Course0.3-0.1 – 0.6
pre-course to follow-up
GroupValue95% CI
MBDC Course0.50.2 – 0.9

Sponsor's own description

The purpose of this study is to assess the feasibility, acceptability, and fidelity of implementation of the Mindfulness Based Dementia Care (MBDC) program to reduce depressive symptoms in care partners (CPs) of people living with dementia (PLWD).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Dementia

Currently open trials in the same condition.

Other HealthPartners Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05617300.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing