Dementia
Conditions
Keywords
Caregivers, Mindfulness
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).
Interventions
BEHAVIORALMindfulness-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.
Sponsors
HealthPartners Institute
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate | 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. |
| Participation Rate | 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. |
| Questionnaire Specific Response Rate | 16 weeks | Completeness of questionnaires given over the course of the study. Completeness is defined percent of complete questionnaires. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptoms of Depression | 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. |
| Change in Care Partner Burden | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-compassion | 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. |
| Change in Mindful Attention Awareness | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 130 |
| Total | 130 |
Baseline characteristics
| Characteristic | MBDC Course |
|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 11.4 |
| Education 8th grade or less | 0 Participants |
| Education College degree | 42 Participants |
| Education Graduate studies | 72 Participants |
| Education High school diploma or GED | 0 Participants |
| Education Some college | 9 Participants |
| Education Some high school | 0 Participants |
| Education Technical training or Associate degree | 6 Participants |
| Education Unknown or not reported | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Occupation A homemaker | 3 Participants |
| Occupation A student | 2 Participants |
| Occupation Employed for wages | 23 Participants |
| Occupation Out of work for 1 year or more | 5 Participants |
| Occupation Out of work for less than 1 year | 0 Participants |
| Occupation Retired | 83 Participants |
| Occupation Self-employed | 10 Participants |
| Occupation Unable to work | 2 Participants |
| Occupation Unknown or not reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 108 Participants |
| Sex/Gender, Customized Female | 108 Participants |
| Sex/Gender, Customized Male | 19 Participants |
| Sex/Gender, Customized Unknown/Not Reported | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 124 |
| other Total, other adverse events | 0 / 124 |
| serious Total, serious adverse events | 0 / 124 |
Outcome results
Primary
Completion Rate
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MBDC Course | Completion Rate | 94.0 percentage of participants |
Primary
Participation Rate
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.
Time frame: Baseline
Population: Includes only participants who attended virtual MBDC program (n=124). Six participants were in live, in person course and not analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MBDC Course | Participation Rate | 84 Participants |
Primary
Questionnaire Specific Response Rate
Completeness of questionnaires given over the course of the study. Completeness is defined percent of complete questionnaires.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBDC Course | Questionnaire Specific Response Rate | 96.8 percentage of complete questionnaires | Standard Deviation 2.2 |
Secondary
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.
Time frame: baseline, post-course at 8 weeks, follow-up at 20 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MBDC Course | Change in Care Partner Burden | pre- to post-course | -1.1 score on a scale |
| MBDC Course | Change in Care Partner Burden | pre-course to follow-up | -0.8 score on a scale |
Secondary
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.
Time frame: baseline, post-course at 8 weeks, follow-up at 20 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MBDC Course | Change in Symptoms of Depression | pre- to post-course | 0.11 score on a scale |
| MBDC Course | Change in Symptoms of Depression | pre-course to follow-up | 0.09 score on a scale |
Other Pre-specified
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.
Time frame: baseline, post-course at 8 weeks, follow-up at 20 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MBDC Course | Change in Mindful Attention Awareness | pre- to post-course | 0.3 score on a scale |
| MBDC Course | Change in Mindful Attention Awareness | pre-course to follow-up | 0.5 score on a scale |
Other Pre-specified
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.
Time frame: baseline, post-course at 8 weeks, follow-up at 20 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MBDC Course | Change in Self-compassion | pre- to post-course | 0.4 score on a scale |
| MBDC Course | Change in Self-compassion | pre-course to follow-up | 0.4 score on a scale |