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| ID | Type | Description | Link |
|---|---|---|---|
| R44AG058277 | U.S. NIH Grant/Contract | View source |
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This project will evaluate the effectiveness of the Mindfulness-based Cognitive Coping (MCC) intervention to alleviate stress and depressive symptoms of caregivers of Individuals with Alzheimer's Disease and Related Dementia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caring Mind mobile app | Experimental | Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program. |
|
| Traditional educational program | Active Comparator | Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based Cognitive Coping | Behavioral | Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Center for Epidemiological Studies Depression Scale | The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome. | 3 months |
| Perceived Stress Scale | The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Photozig, Inc. | Campbell | California | 95008-5570 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Caring Mind Mobile App | Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program. |
| FG001 | Traditional Educational Program | Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caring Mind Mobile App | Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program. |
| BG001 | Traditional Educational Program |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Center for Epidemiological Studies Depression Scale | The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
3 months
Definitions are the same as the ones from clinicaltrials.gov.
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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 | Caring Mind Mobile App | Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruno Kajiyama | Photozig, Inc. | 6506947595 | info@photozig.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 | Jul 24, 2025 | Jul 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Traditional Educational/Resources Program | Behavioral | Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources. |
|
Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Perceived Stress Scale | The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 0 |
| 88 |
| 0 |
| 88 |
| 0 |
| 88 |
| EG001 | Traditional Educational Program | Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources. | 0 | 86 | 0 | 86 | 0 | 86 |
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