Mindfulness-based Cognitive Coping for ADRD Caregivers

Caregiver Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05979922
• Other study ID #: Pz-A108a
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 27, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: Photozig, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Stress

Intervention

Behavioral:
• Mindfulness-based Cognitive Coping
Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.
• Traditional Educational/Resources Program
Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.

Locations

Country	Name	City	State
United States	Photozig, Inc.	Campbell	California

Sponsors (1)

Lead Sponsor	Collaborator
Photozig, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 months
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.	3 months