Mindfulness-based Cognitive Coping Mobile App Intervention for Caregivers of Individuals With Alzheimer's Disease
Phase: PHASE2
Conditions: Caregiver Stress
Sponsor: Photozig, Inc.

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Trial: 
Mindfulness-based Cognitive Coping for ADRD Caregivers 
 
ClinicalTrials.gov ID: 
 
 
NCT05979922    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date:  
 
07/24/2025 (updated) 
 
 
Investigator: 
Bruno Kajiyama 
 
 
Research Site: 
 
 
 
 
Photozig, Inc. 
 
 
 
NASA Research Park 
 
 
 
PO Box 128 
 
 
 
Moffett Field, CA 94035-0128 
 

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Project Summary 
 
Alzheimer's Disease (AD) is a devastating illness for patients, families, and society. Most of the care 
of AD patients rests on shoulders of informal caregivers, largely untrained to undertake the caregiving 
role, bearing a high level of distress, and suffering deterioration in physical health and psychological 
well-being. 
 
There are millions of Americans providing care to AD patients, experiencing high rates of depressive 
symptoms (30%), stress (59%), associated risks for cardiovascular diseases, and many other 
adverse health effects. For example, in separate studies, hospitalization and emergency department 
visits were more likely for dementia caregivers than any other types of caregivers. 
 
The severity of AD caregiving is influenced by several factors, such as intensity of dementia 
symptoms in AD patients, how challenging distressful situations are perceived by caregivers, and 
available resources. Although information and programs about Alzheimer's Disease are available to 
the public, an essential missing tool is how to deal with depressive symptoms in an effective manner, 
as they are very common and demanding.  
 
In this project we will implement the new Mindfulness-based Cognitive Coping (MCC) intervention, 
and enable easy access with our mobile app, called Caring Mind App (CMA), providing an effective 
cost-effective intervention for caregivers to reduce their stress and depressive symptoms. The MCC 
intervention is built upon the Mindfulness-Based Cognitive Therapy (MBCT), which has been effective 
to treat individuals with major depressive disorder, with the integration of caregiving coping strategies 
from our past studies to help caregivers to overcome stressful situations in their caregiver role.  
 
We will finalize the MCC curriculum, develop the complete app, and evaluate its effectiveness in a 
randomized clinical trial; resulting in a novel intervention that integrates MCC content, an effective 
training to reduce depressive symptoms and psychological stress, and a mobile app to be deployed 
to millions of families struggling with Alzheimer's Disease.  
 

3 
 
Protocol 
 
Overview: 
1. Recruit subjects: caregivers of individuals with Alzheimer’s Disease or other dementia will be 
recruited. 
2. Randomize subjects: participants will be assigned to the study group or the control group. 
3. Collect pre-data: Before intervention, we will collect pre-data to establish the baseline status of 
participants. 
4. Deploy treatments: For both study and control groups, we will send instructions and materials. 
5. Collect post-data: We will collect post-treatment data after 3 months. 
 
Research Participants: 150 dementia family caregivers (planned enrollment) will be recruited: 
 
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. 
 
Informed consent will be obtained, and participants will receive a stipend for their participation. 
 
Methods: The effectiveness investigation of the Caring Mind App (CMA) will be implemented with a 
pre-post randomized trial of 3 months. As it takes 3 months to complete the entire program, post 
testing will happen about 3 months after pre-testing. The trial will have two levels: the CMA treatment 
package; and a control condition comprised of existing educational programs, information for 
caregivers, and other resources. Outcome measures of both groups will be recorded at baseline and 
after 3 months.  
 
 CMA Condition (75 subjects): Participants will receive the Caring Mind mobile app containing 
the MCC curriculum. 
 
 Control Condition (75 subjects): Participants will receive a traditional educational/resources 
program, containing a workbook and online resources. 
 
Procedures: Participants will receive and complete informed consent. After initial assessment, 
subjects will be randomized to either CMA or the control condition, and instructions will be distributed. 
After 3 months, all subjects will be interviewed for the post-intervention assessment. 
 

4 
 
Statistical Analysis Plan 
 
Main study hypothesis: “CMA will alleviate depression (measured by CES-D) and decrease stress 
(measured by PSS)”. 
 
Main Outcome Measures: 
 Depression: level of Depressive Symptoms: their presence and strength will be assessed using the 
Center for Epidemiological Studies Depression scale (CES-D); This is a 20-item measure that asks 
about the frequency of depressive symptoms (affective, psychological, and somatic) within the past 
week. 
 Overall Perceived Psychological Stress: the 10-item Perceived Stress Scale (PSS) measures 
overall appraisals of stress in the past month. 
 
Analysis: Our hypotheses will be tested by analyzing the change scores (subtracting the baseline 
scores from the value obtained at 3 months) for the outcome measure (CES-D and PSS) and 
comparing the results of CMA with the control condition in order to determine the efficacy of the 
intervention. We will determine if subjects in CMA had a significant decrease in level of depression 
and reduced stress, when compared to the control group. We’ll use univariate ANOVA (analysis of 
variance) to determine the level of significance for these measures.