Mindfulness-based Cognitive Coping for ADRD Caregivers

NCT05979922 | Completed Phase 2 Results

• 2 other identifiers: Pz-A108aR44AG058277
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Stress

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Caring Mind mobile app

EXPERIMENTAL

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

Behavioral: Mindfulness-based Cognitive Coping

Traditional educational program

ACTIVE COMPARATOR

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

Behavioral: Traditional Educational/Resources Program

Interventions

Mindfulness-based Cognitive Coping BEHAVIORAL

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

Caring Mind mobile app

Traditional Educational/Resources Program BEHAVIORAL

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

Traditional educational program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Photozig, Inc.: lead

Study Sites (1)

Photozig, Inc.

Campbell, California, 95008-5570, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Bruno Kajiyama
• Organization: Photozig, Inc.

info@photozig.com

6506947595

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 7, 2023
• Study Start: July 27, 2023
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: July 28, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-07

Locations

US (1)