Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Mindfulness-Based Dementia Caregiving

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meghan E O'Brien, MPH; Phone Number: 651-495-6777; Email: Meghan.E.OBrien@HealthPartners.com
• Study Contact Backup: Name: Research Coordinator; Phone Number: 651-495-6363; Email: ClincialTrials@HealthPartners.com

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55130
      • HealthPartners Neuroscience Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MBDC course; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-compassion	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.	16 weeks
Change in mindful attention awareness	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.	16 weeks

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Investigators: Principal Investigator: Leah R Hanson, PhD, HealthPartners Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Estimated): March 20, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness; Caregivers
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Depression; Dementia
• Other Study ID Numbers: A21-117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No