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Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

Primary Purpose

Dementia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Dementia Caregiving
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring Caregivers, Mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HealthPartners Neuroscience Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MBDC course

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
Questionnaire specific response rate
Completeness of questionnaires given over the course of the study. Completeness is defined as answering all questions.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 7, 2022
Last Updated
October 11, 2023
Sponsor
HealthPartners Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05617300
Brief Title
Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms
Official Title
Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Caregivers, Mindfulness

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MBDC course
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Dementia Caregiving
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participation Rate
Description
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.
Time Frame
Baseline
Title
Completion Rate
Description
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.
Time Frame
16 weeks
Title
Questionnaire specific response rate
Description
Completeness of questionnaires given over the course of the study. Completeness is defined as answering all questions.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in Care Partner Burden
Description
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.
Time Frame
16 weeks
Title
Change in Symptoms of Depression
Description
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.
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Change in self-compassion
Description
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.
Time Frame
16 weeks
Title
Change in mindful attention awareness
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leah R Hanson, PhD
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Neuroscience Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

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