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Completed

NCT Number: NCT05617300

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).

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Based Dementia Caregiving

Behavioral

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 outcomes

  1. Participation Rate

    Time frame: 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.

  2. Completion Rate

    Time frame: 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.

  3. Questionnaire Specific Response Rate

    Time frame: 16 weeks

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

Secondary outcomes

  1. Change in Care Partner Burden

    Time frame: 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.

  2. Change in Symptoms of Depression

    Time frame: 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.

Other outcomes

  1. Change in Self-compassion

    Time frame: baseline, post-course at 8 weeks, follow-up at 20 weeks

    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.

  2. Change in Mindful Attention Awareness

    Time frame: baseline, post-course at 8 weeks, follow-up at 20 weeks

    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.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 15, 2022
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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