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Mindfulness based stress reduction (MBSR) refers to a particular type of attention focused on the present moment, non-judgmental awareness, and acceptance of that experience with openness and curiosity. Mindfulness training was designed to enhance the range and use of coping skills, decrease levels of stress, improve mood, and reduce tendencies to react in maladaptive ways 1-3. Investigators are evaluating a new program, called the Mindfulness Based Dementia-Care (MBDC) in caregivers (CG) for dementia, which combines the traditional approaches with education. The overall objective of this study is to evaluate the program and explore the potential benefits of the Mindfulness Based Dementia-Care (MBDC) program. Investigators are conducting a prospective, pre-post, observational study with members participating in the MBDC program.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Pre-post Scores on the Perceived Stress Scale (PSS) | The Perceived Stress Scale (PSS) scores on a total score. The range of the PSS is 0-40 points. A lower score is indicative of lower stress. | baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pre-post Scores on the Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D scores on a total score. The range of the CES-D is 0-60 points. A higher score is indicative of the presence of more depression symptoms. | baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pre-post Scores on the Self-Compassion Scale (SCS) | The SCS scores on a mean score. The range of the SCS is 1-5 points. A higher score is indicative higher self-compassion. | baseline, 8 weeks |
| Change in Pre-post Scores on the Resilience Scale |
Inclusion Criteria:
Exclusion Criteria:
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The study population is anyone who is willing and able to attend the MBDC Program.
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| Name | Affiliation | Role |
|---|---|---|
| Bhavani Kashyap, MBBS, PhD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | United States |
There is no plan to share individual participant data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants of the MBDC Program | Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants of the MBDC Program | Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Change in Pre-post Scores on the Perceived Stress Scale (PSS) | The Perceived Stress Scale (PSS) scores on a total score. The range of the PSS is 0-40 points. A lower score is indicative of lower stress. | Posted | Mean | Standard Deviation | score on a scale | baseline, 8 weeks |
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5 months
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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 | Participants of the MBDC Program | Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bhavani Kashyap, MBBS, PhD | HealthPartners Institute | 651-495-6363 | Bhavani.X.Kashyap@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 | Aug 16, 2019 | Feb 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001927 | Brain Diseases |
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The Resilience Scale scores on a total score. The range of The Resilience Scale is 14-98 points. A higher score is indicative of higher resilience.
| baseline, 8 weeks |
| Change in Pre-post Scores on the Zarit Caregiver Burden Scale. | The Zarit Caregiver Burden Scale scores on a total score. The range of the Zarit range is 0-88 points. A higher score is indicative of the presence of a higher level of caregiver burden. | baseline, 8 weeks |
| Change in Pre-post Scores on the Brief Coping Orientation to Problems Experienced (COPE) | The Brief COPE scores on fourteen subscale scores. Sub-scores are totaled to give a total range [14-112]. Higher scores indicate increased utilization of coping strategy. | baseline, 8 weeks |
| Change in Pre-follow-up Scores on the Perceived Stress Scale (PSS) | The Perceived Stress Scale (PSS) scores on a total score. The range of the PSS is 0-40 points. A lower score is indicative of lower stress. | baseline, 5 months |
| Change in Pre-follow-up Scores on the Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D scores on a total score. The range of the CES-D is 0-60 points. A higher score is indicative of the presence of more depression symptoms. | baseline, 5 months |
| Change in Pre-follow-up Scores on the Resilience Scale | The Resilience Scale scores on a total score. The range of The Resilience Scale is 14-98 points. A higher score is indicative of higher resilience. | baseline, 5 months |
| Change in Pre-follow-up Scores on the Zarit Caregiver Burden Scale | The Zarit Caregiver Burden Scale scores on a total score. The range of the Zarit range is 0-88 points. A higher score is indicative of the presence of a higher level of caregiver burden. | baseline, 5 months |
| Change in Pre-follow-up Scores on the Brief Coping Orientation to Problems Experienced (COPE). | The Brief COPE scores on fourteen subscale scores. Sub-scores are totaled to give a total range [14-112]. Higher scores indicate increased utilization of coping strategy. | baseline, 5 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Change in Pre-post Scores on the Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D scores on a total score. The range of the CES-D is 0-60 points. A higher score is indicative of the presence of more depression symptoms. | Posted | Mean | Standard Deviation | score on a scale | baseline, 8 weeks |
|
|
|
| Other Pre-specified | Change in Pre-post Scores on the Self-Compassion Scale (SCS) | The SCS scores on a mean score. The range of the SCS is 1-5 points. A higher score is indicative higher self-compassion. | Posted | Mean | Standard Deviation | score on a scale | baseline, 8 weeks |
|
|
|
| Other Pre-specified | Change in Pre-post Scores on the Resilience Scale | The Resilience Scale scores on a total score. The range of The Resilience Scale is 14-98 points. A higher score is indicative of higher resilience. | Posted | Mean | Standard Deviation | score on a scale | baseline, 8 weeks |
|
|
|
| Other Pre-specified | Change in Pre-post Scores on the Zarit Caregiver Burden Scale. | The Zarit Caregiver Burden Scale scores on a total score. The range of the Zarit range is 0-88 points. A higher score is indicative of the presence of a higher level of caregiver burden. | Posted | Mean | Standard Deviation | score on a scale | baseline, 8 weeks |
|
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| Other Pre-specified | Change in Pre-post Scores on the Brief Coping Orientation to Problems Experienced (COPE) | The Brief COPE scores on fourteen subscale scores. Sub-scores are totaled to give a total range [14-112]. Higher scores indicate increased utilization of coping strategy. | Posted | Mean | Standard Deviation | score on a scale | baseline, 8 weeks |
|
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|
| Other Pre-specified | Change in Pre-follow-up Scores on the Perceived Stress Scale (PSS) | The Perceived Stress Scale (PSS) scores on a total score. The range of the PSS is 0-40 points. A lower score is indicative of lower stress. | Posted | Mean | Standard Deviation | score on a scale | baseline, 5 months |
|
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|
| Other Pre-specified | Change in Pre-follow-up Scores on the Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D scores on a total score. The range of the CES-D is 0-60 points. A higher score is indicative of the presence of more depression symptoms. | Posted | Mean | Standard Deviation | score on a scale | baseline, 5 months |
|
|
|
| Other Pre-specified | Change in Pre-follow-up Scores on the Resilience Scale | The Resilience Scale scores on a total score. The range of The Resilience Scale is 14-98 points. A higher score is indicative of higher resilience. | Posted | Mean | Standard Deviation | score on a scale | baseline, 5 months |
|
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| Other Pre-specified | Change in Pre-follow-up Scores on the Zarit Caregiver Burden Scale | The Zarit Caregiver Burden Scale scores on a total score. The range of the Zarit range is 0-88 points. A higher score is indicative of the presence of a higher level of caregiver burden. | Posted | Mean | Standard Deviation | score on a scale | baseline, 5 months |
|
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|
| Other Pre-specified | Change in Pre-follow-up Scores on the Brief Coping Orientation to Problems Experienced (COPE). | The Brief COPE scores on fourteen subscale scores. Sub-scores are totaled to give a total range [14-112]. Higher scores indicate increased utilization of coping strategy. | Posted | Mean | Standard Deviation | score on a scale | baseline, 5 months |
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |