Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

Study Overview
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Brief Summary
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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).

Official Title
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Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Mindfulness-Based Dementia Caregiving


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBDC course<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation Rate | Calculation of the participants who attend the first class of their session/the total number of participants who are enrolled. Enrolled is defined as a participant who is assigned to a course. Range [0-1]. A value closer to 1 is indicative of greater feasibility. | Baseline | 
| Completion Rate | Calculation of the participants who completed course/ participants who attend the first class of their session. Completion is defined as attending a minimum of 6 of the 9 classes. Range [0-1]. A value closer to 1 is indicative of greater feasibility. | 16 weeks | 
| Questionnaire specific response rate | Completeness of questionnaires given over the course of the study. Completeness is defined as answering all questions. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Care Partner Burden | 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. | 16 weeks | 
| Change in Symptoms of Depression | 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. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers, Mindfulness