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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBDC course | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | 16 weeks |
| Questionnaire Specific Response Rate | Completeness of questionnaires given over the course of the study. Completeness is defined percent of complete questionnaires. | 16 weeks |
| 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. | baseline, post-course at 8 weeks, follow-up at 20 weeks |
| 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. | baseline, post-course at 8 weeks, follow-up at 20 weeks |
| Change in Mindful Attention Awareness |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leah R Hanson, PhD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Includes only participants who attended virtual MBDC program (n=124). Six participants were in live, in person course and not analyzed. | Posted | Count of Participants | Participants | Baseline |
|
16 weeks
Includes only participants who attended virtual MBDC program (n=124). Six participants were in live, in person course and not analyzed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leah Hanson, PhD | HealthPartners Neuroscience Research | 6514956352 | Leah.R.Hanson@HealthPartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2023 | Oct 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
| 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. | 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. |
| baseline, post-course at 8 weeks, follow-up at 20 weeks |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Occupation | Count of Participants | Participants |
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| 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. | Includes only participants who attended virtual MBDC program (n=124). Eight participants were in live, in person courses and were not analyzed. | Posted | Number | percentage of participants | 16 weeks |
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| Primary | Questionnaire Specific Response Rate | Completeness of questionnaires given over the course of the study. Completeness is defined percent of complete questionnaires. | Posted | Mean | Standard Deviation | percentage of complete questionnaires | 16 weeks |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, post-course at 8 weeks, follow-up at 20 weeks |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, post-course at 8 weeks, follow-up at 20 weeks |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, post-course at 8 weeks, follow-up at 20 weeks |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, post-course at 8 weeks, follow-up at 20 weeks |
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| 0 |
| 124 |
| 0 |
| 124 |
| 0 |
| 124 |
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| D001523 | Mental Disorders |