NCT05617300

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 10, 2025

Completed
Last Updated

January 10, 2025

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

November 7, 2022

Results QC Date

October 8, 2024

Last Update Submit

November 25, 2024

Conditions

Keywords

CaregiversMindfulness

Outcome Measures

Primary Outcomes (3)

  • Participation Rate

    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.

    Baseline

  • Completion Rate

    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.

    16 weeks

  • Questionnaire Specific Response Rate

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

    16 weeks

Secondary Outcomes (2)

  • Change in Care Partner Burden

    baseline, post-course at 8 weeks, follow-up at 20 weeks

  • Change in Symptoms of Depression

    baseline, post-course at 8 weeks, follow-up at 20 weeks

Other Outcomes (2)

  • Change in Self-compassion

    baseline, post-course at 8 weeks, follow-up at 20 weeks

  • Change in Mindful Attention Awareness

    baseline, post-course at 8 weeks, follow-up at 20 weeks

Study Arms (1)

MBDC course

EXPERIMENTAL

8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.

Behavioral: Mindfulness-Based Dementia Caregiving

Interventions

Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.

MBDC course

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • Self-identify as being an informal CP providing caregiving to a PLWD
  • Register for an MBDC course through the Presence Care Website

You may not qualify if:

  • Previous participation in an MBDC program.
  • Does not speak and understand either English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Leah Hanson, PhD
Organization
HealthPartners Neuroscience Research

Study Officials

  • Leah R Hanson, PhD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 15, 2022

Study Start

November 7, 2022

Primary Completion

December 15, 2023

Study Completion

March 20, 2024

Last Updated

January 10, 2025

Results First Posted

January 10, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations