Mindfulness-based Cognitive Coping for ADRD Caregivers

Study Overview
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Brief Summary
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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.

Official Title
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Mindfulness-based Cognitive Coping Mobile App Intervention for Caregivers of Individuals With Alzheimer's Disease

Conditions
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Caregiver Stress

Intervention / Treatment
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* Behavioral: Mindfulness-based Cognitive Coping
* Behavioral: Traditional Educational/Resources Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Care for an individual with Alzheimer's Disease or Related Dementia (ADRD). Own a smartphone or tablet and have Internet access. Minimum age of 18 years old. Able to read and speak English. Spend at least 8 hours/week caring for a person with dementia. Plan to stay in the area for six months. Exclusion Criteria: Severe psychological or physical illness. Cognitive impairment or any serious medical problem that interferes with caregiving role. Caring for ADRD patient with a life expectancy less than six months. Unwillingness to participate in all aspects of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caring Mind mobile app<br>Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program. | Behavioral: Mindfulness-based Cognitive Coping<br>* Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.<br>|
| Active Comparator: Traditional educational program<br>Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources. | Behavioral: Traditional Educational/Resources Program<br>* Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |