Trial Outcomes & Findings for Mindfulness-based Cognitive Coping for ADRD Caregivers (NCT NCT05979922)

NCT ID: NCT05979922

Last Updated: 2025-07-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 174 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2025-07-28

Participant Flow

Participant milestones

Measure	Caring Mind Mobile App Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.	Traditional Educational Program Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.
Overall Study STARTED	88	86
Overall Study COMPLETED	59	58
Overall Study NOT COMPLETED	29	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness-based Cognitive Coping for ADRD Caregivers

Baseline characteristics by cohort

Measure	Caring Mind Mobile App n=88 Participants Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.	Traditional Educational Program n=86 Participants Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.	Total n=174 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 11.8 • n=5 Participants	58.1 years STANDARD_DEVIATION 9.4 • n=7 Participants	57.6 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	79 Participants n=7 Participants	158 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=5 Participants	81 Participants n=7 Participants	164 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Caring Mind Mobile App n=59 Participants Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.	Traditional Educational Program n=58 Participants Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.
Center for Epidemiological Studies Depression Scale	17.1 score on a scale Standard Deviation 9.66	21.98 score on a scale Standard Deviation 12.48

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Caring Mind Mobile App n=59 Participants Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.	Traditional Educational Program n=58 Participants Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.
Perceived Stress Scale	17.12 score on a scale Standard Deviation 7.58	19.38 score on a scale Standard Deviation 6.97

Adverse Events

Caring Mind Mobile App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Educational Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bruno Kajiyama

Photozig, Inc.

Phone: 6506947595

Email: info@photozig.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place