Caregiver Stress
Conditions
Brief summary
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.
Interventions
BEHAVIORALMindfulness-based Cognitive Coping
Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.
Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.
Sponsors
Photozig, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiological Studies Depression Scale | 3 months | 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. |
| Perceived Stress Scale | 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caring Mind Mobile App Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program. | 88 |
| Traditional Educational Program Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources. | 86 |
| Total | 174 |
Baseline characteristics
| Characteristic | Caring Mind Mobile App | Traditional Educational Program | Total |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 11.8 | 58.1 years STANDARD_DEVIATION 9.4 | 57.6 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants | 81 Participants | 164 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Female | 79 Participants | 79 Participants | 158 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 86 |
| other Total, other adverse events | 0 / 88 | 0 / 86 |
| serious Total, serious adverse events | 0 / 88 | 0 / 86 |
Outcome results
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caring Mind Mobile App | Center for Epidemiological Studies Depression Scale | 17.1 score on a scale | Standard Deviation 9.66 |
| Traditional Educational Program | Center for Epidemiological Studies Depression Scale | 21.98 score on a scale | Standard Deviation 12.48 |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caring Mind Mobile App | Perceived Stress Scale | 17.12 score on a scale | Standard Deviation 7.58 |
| Traditional Educational Program | Perceived Stress Scale | 19.38 score on a scale | Standard Deviation 6.97 |