Caregiver StressPhase 2NCT05979922
Mindfulness-based Cognitive Coping for ADRD Caregivers
A Phase 2 study testing Mindfulness-based Cognitive Coping and Traditional Educational/Resources Program in people with Caregiver Stress, run by Photozig, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Stress
- What is being tested?
- Mindfulness-based Cognitive Coping and Traditional Educational/Resources Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2023to 17 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Caregiver Stress
- Being tested
- Mindfulness-based Cognitive Coping, Traditional Educational/Resources Program
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Cognitive CopingBehavioural
Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.
Traditional Educational/Resources ProgramBehavioural
Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.
| Study group | Role | What they receive |
|---|---|---|
| Caring Mind mobile app | Experimental | Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program. Receives: 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. Receives: Behavioral: Traditional Educational/Resources Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start27 Jul 2023
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Caregiver StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photozig, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979922
- Sponsor's protocol ID
- Pz-A108a
- Other IDs
- R44AG058277
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2023
- Last updated
- 28 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Cognitive Coping Mobile App Intervention for Caregivers of Individuals With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05979922
- Acronym / sponsor ID
- Pz-A108a
- Conditions
- Caregiver Stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Photozig, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Posted 28 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caring Mind mobile app | Experimental | Behavioral: Mindfulness-based Cognitive CopingParticipants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program. |
| Traditional educational program | Active comparator | Behavioral: Traditional Educational/Resources ProgramParticipants will receive a traditional educational/resources program, containing a downloadable workbook and online resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Cognitive CopingParticipants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program. | Behavioural | Caring Mind mobile app |
| Traditional Educational/Resources ProgramParticipants will receive a traditional educational/resources program, containing a downloadable workbook and online resources. | Behavioural | Traditional educational program |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mindfulness-based Cognitive Coping and Traditional Educational/Resources Program in people with Caregiver Stress, run by Photozig, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center for Epidemiological Studies Depression Scale (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.