Mindfulness-based Cognitive Coping for ADRD Caregivers

July 25, 2025 updated by: Photozig, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Campbell, California, United States, 95008-5570
        • Photozig, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale
Time Frame: 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.
3 months
Center for Epidemiological Studies Depression Scale
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Photozig, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Actual)

June 17, 2024

Study Completion (Actual)

June 17, 2024

Study Registration Dates

First Submitted

July 30, 2023

First Submitted That Met QC Criteria

July 30, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Pz-A108a
  • R44AG058277 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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