Trial Outcomes & Findings for Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms (NCT NCT05617300)

Last Updated: 2025-01-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

130 participants

Primary outcome timeframe

Baseline

Results posted on

2025-01-10

Participant Flow

Participants were recruited from 3 health care systems in Minnesota, California, and Michigan. Information about the program was shared by clinicians during scheduled visits. Site-specific fliers were posted in public spaces and on institutional websites. A bulk mailing of MBDC fliers targeting non-white/Hispanic Minnesotans with MCI or or dementia was sent. Additionally, a new MBDC instructor was trained recruited an in-person cohort of CPs from her predominately African American Church.

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	130
Overall Study COMPLETED	130
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MBDC Course n=130 Participants 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. 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.
Age, Continuous	65.1 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex/Gender, Customized Female	108 Participants n=5 Participants
Sex/Gender, Customized Male	19 Participants n=5 Participants
Sex/Gender, Customized Unknown/Not Reported	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	108 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Education 8th grade or less	0 Participants n=5 Participants
Education Some high school	0 Participants n=5 Participants
Education High school diploma or GED	0 Participants n=5 Participants
Education Technical training or Associate degree	6 Participants n=5 Participants
Education Some college	9 Participants n=5 Participants
Education College degree	42 Participants n=5 Participants
Education Graduate studies	72 Participants n=5 Participants
Education Unknown or not reported	1 Participants n=5 Participants
Occupation Employed for wages	23 Participants n=5 Participants
Occupation Self-employed	10 Participants n=5 Participants
Occupation Out of work for 1 year or more	5 Participants n=5 Participants
Occupation Out of work for less than 1 year	0 Participants n=5 Participants
Occupation A homemaker	3 Participants n=5 Participants
Occupation A student	2 Participants n=5 Participants
Occupation Retired	83 Participants n=5 Participants
Occupation Unable to work	2 Participants n=5 Participants
Occupation Unknown or not reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Includes only participants who attended virtual MBDC program (n=124). Six participants were in live, in person course and not analyzed.

Outcome measures

Outcome measures
Measure	MBDC Course n=124 Participants 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. 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.
Participation Rate	84 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Includes only participants who attended virtual MBDC program (n=124). Eight participants were in live, in person courses and were not analyzed.

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.

Outcome measures

Outcome measures
Measure	MBDC Course n=124 Participants 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. 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.
Completion Rate	94.0 percentage of participants

PRIMARY outcome

Timeframe: 16 weeks

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

Outcome measures

Outcome measures
Measure	MBDC Course n=124 Participants 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. 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.
Questionnaire Specific Response Rate	96.8 percentage of complete questionnaires Standard Deviation 2.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MBDC Course n=124 Participants 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. 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.
Change in Care Partner Burden pre- to post-course	-1.1 score on a scale Interval -2.0 to -0.2
Change in Care Partner Burden pre-course to follow-up	-0.8 score on a scale Interval -1.8 to 0.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MBDC Course n=124 Participants 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. 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.
Change in Symptoms of Depression pre-course to follow-up	0.09 score on a scale Interval 0.02 to 0.36
Change in Symptoms of Depression pre- to post-course	0.11 score on a scale Interval 0.03 to 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MBDC Course n=124 Participants 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. 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.
Change in Self-compassion pre- to post-course	0.4 score on a scale Interval 0.2 to 0.5
Change in Self-compassion pre-course to follow-up	0.4 score on a scale Interval 0.2 to 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MBDC Course n=124 Participants 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. 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.
Change in Mindful Attention Awareness pre- to post-course	0.3 score on a scale Interval -0.1 to 0.6
Change in Mindful Attention Awareness pre-course to follow-up	0.5 score on a scale Interval 0.2 to 0.9

Adverse Events

MBDC Course

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leah Hanson, PhD

HealthPartners Neuroscience Research

Phone: 6514956352

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place