Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Behavioral: Mindfulness-Based Dementia Caregiving

• Registration Number: NCT05617300
• Lead Sponsor: HealthPartners Institute

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-07
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-15
• Status Verified: 2023-12
• Primary Completion: 2023-12-15
• Study Completion: 2024-03-20
• Results First Submitted: 2024-10-08
• Results First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Results First Posted: 2025-01-10
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MBDC course	Mindfulness-Based Dementia Caregiving	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.

Primary Outcome Measures

Name	Time	Method
Participation Rate	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.
Completion Rate	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.
Questionnaire Specific Response Rate	16 weeks	Completeness of questionnaires given over the course of the study. Completeness is defined percent of complete questionnaires.

Secondary Outcome Measures

Name	Time	Method
Change in Care Partner Burden	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.
Change in Symptoms of Depression	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.

Trial Locations

Locations (1)

HealthPartners Neuroscience Center; 🇺🇸 Saint Paul, Minnesota, United States