Trial Outcomes & Findings for Effects Multimodal Mind and Body Approach for MCI (NCT NCT06814483)
NCT ID: NCT06814483
Last Updated: 2026-03-09
Results Overview
Proportion of subjects who complete all assessments from the total number of subjects started the first intervention
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Through study intervention, an average of three months
Results posted on
2026-03-09
Participant Flow
Participant milestones
| Measure |
A Computer-based Multimodal Mind and Body Approach (cbMMBA)
cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation
Experimental: A computer-based multimodal mind and body approach (cbMMBA): cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation.
|
a Standard Cognitive Training
The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
A standard cognitive training group: The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects Multimodal Mind and Body Approach for MCI
Baseline characteristics by cohort
| Measure |
A Computer-based Multimodal Mind and Body Approach (cbMMBA)
n=17 Participants
cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation
Experimental: A computer-based multimodal mind and body approach (cbMMBA): cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation.
|
a Standard Cognitive Training
n=15 Participants
The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
A standard cognitive training group: The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.06 year
STANDARD_DEVIATION 9.91 • n=68 Participants
|
72.73 year
STANDARD_DEVIATION 7.36 • n=69 Participants
|
72.91 year
STANDARD_DEVIATION 8.67 • n=137 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=68 Participants
|
7 Participants
n=69 Participants
|
16 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=68 Participants
|
8 Participants
n=69 Participants
|
16 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=68 Participants
|
15 Participants
n=69 Participants
|
31 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=68 Participants
|
14 Participants
n=69 Participants
|
28 Participants
n=137 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=68 Participants
|
15 participants
n=69 Participants
|
32 participants
n=137 Participants
|
PRIMARY outcome
Timeframe: Through study intervention, an average of three monthsProportion of subjects who complete all assessments from the total number of subjects started the first intervention
Outcome measures
| Measure |
A Computer-based Multimodal Mind and Body Approach (cbMMBA)
n=14 Participants
cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation
Experimental: A computer-based multimodal mind and body approach (cbMMBA): cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation.
|
a Standard Cognitive Training
n=15 Participants
The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
A standard cognitive training group: The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
|
|---|---|---|
|
Retention
|
11 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Through study interventions, an average of three monthssession completed of total 30 classes
Outcome measures
| Measure |
A Computer-based Multimodal Mind and Body Approach (cbMMBA)
n=17 Participants
cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation
Experimental: A computer-based multimodal mind and body approach (cbMMBA): cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation.
|
a Standard Cognitive Training
n=15 Participants
The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
A standard cognitive training group: The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
|
|---|---|---|
|
Fidelity
|
25.6 session
Standard Deviation 7.9
|
29.5 session
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Through study interventions, an average of three monthsaverage score in a 1-5 scale, 5 indicates very satisfied with the intervention
Outcome measures
| Measure |
A Computer-based Multimodal Mind and Body Approach (cbMMBA)
n=14 Participants
cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation
Experimental: A computer-based multimodal mind and body approach (cbMMBA): cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation.
|
a Standard Cognitive Training
n=15 Participants
The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
A standard cognitive training group: The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
|
|---|---|---|
|
Satisfaction to Intervention
|
4.8 points in a 1-5 scale
Standard Deviation 0.42
|
4.5 points in a 1-5 scale
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: Through study interventions, an average of three monthsAdverse events were assessed by participant self-report at each study visit. An adverse event was defined as any unfavorable or unintended sign, symptom, or medical occurrence temporally associated with study participation, regardless of attribution. This outcome reports the number of participants who experienced ≥1 adverse event during the study period (each participant counted once).
Outcome measures
| Measure |
A Computer-based Multimodal Mind and Body Approach (cbMMBA)
n=17 Participants
cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation
Experimental: A computer-based multimodal mind and body approach (cbMMBA): cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation.
|
a Standard Cognitive Training
n=15 Participants
The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
A standard cognitive training group: The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
|
|---|---|---|
|
Number of Participants With Adverse Events
|
2 Participants
|
0 Participants
|
Adverse Events
A Computer-based Multimodal Mind and Body Approach (cbMMBA)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
a Standard Cognitive Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A Computer-based Multimodal Mind and Body Approach (cbMMBA)
n=17 participants at risk
cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation
Experimental: A computer-based multimodal mind and body approach (cbMMBA): cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation.
|
a Standard Cognitive Training
n=15 participants at risk
The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
A standard cognitive training group: The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects
|
|---|---|---|
|
Cardiac disorders
planned heart surgery
|
5.9%
1/17 • Number of events 1 • 6 month
|
0.00%
0/15 • 6 month
|
|
Psychiatric disorders
PTSD recurrence
|
5.9%
1/17 • Number of events 1 • 6 month
|
0.00%
0/15 • 6 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place