Mindfulness-based Cognitive Coping for ADRD Caregivers

Sponsor

Photozig, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05979922

Collaborator

(none)

150

Enrollment

Location

Arms

12.2

Anticipated Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caregiver Stress	Behavioral: Mindfulness-based Cognitive Coping Behavioral: Traditional Educational/Resources Program	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 27, 2023

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Caring Mind mobile app

Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.

Behavioral: Mindfulness-based Cognitive Coping

Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.

Active Comparator: Traditional educational program

Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.

Behavioral: Traditional Educational/Resources Program

Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Photozig, Inc.	Campbell	California	United States	95008-5570

Sponsors and Collaborators

Photozig, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Photozig, Inc.

ClinicalTrials.gov Identifier:

NCT05979922

Other Study ID Numbers:

Pz-A108a

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 7, 2023