Trial Outcomes & Findings for Preventing Cognitive Decline (NCT NCT05446909)
NCT ID: NCT05446909
Last Updated: 2024-10-29
Results Overview
The percentage of trials correct on N-back working memory test; higher percentage of trials correct mean a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
Results posted on
2024-10-29
Participant Flow
Participant milestones
| Measure |
IBMT Mindfulness
An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components.
IBMT mindfulness: IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
|
Health Education
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
health education: Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preventing Cognitive Decline
Baseline characteristics by cohort
| Measure |
IBMT Mindfulness
n=20 Participants
An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components.
IBMT mindfulness: IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
|
Health Education
n=20 Participants
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
health education: Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported Ethnicity
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).The percentage of trials correct on N-back working memory test; higher percentage of trials correct mean a better outcome.
Outcome measures
| Measure |
IBMT Mindfulness
n=15 Participants
An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components.
IBMT mindfulness: IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
|
Health Education
n=14 Participants
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
health education: Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
|
|---|---|---|
|
Percentage of Trials Correct On Working Memory Test
Post-Intervention
|
88.01 percentage of correct trials
Standard Deviation 0.16
|
91.68 percentage of correct trials
Standard Deviation 0.17
|
|
Percentage of Trials Correct On Working Memory Test
Baseline
|
87.69 percentage of correct trials
Standard Deviation 0.15
|
91.57 percentage of correct trials
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).The composite measures of cognition such as subjective cognitive decline; the minimum and maximum values (1 and 27); higher scores mean a worse outcome.
Outcome measures
| Measure |
IBMT Mindfulness
n=15 Participants
An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components.
IBMT mindfulness: IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
|
Health Education
n=14 Participants
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
health education: Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
|
|---|---|---|
|
Intervention Effects on Cognitive Decline
Baseline
|
5.34 score on a scale
Standard Deviation 1.18
|
4.96 score on a scale
Standard Deviation 1.02
|
|
Intervention Effects on Cognitive Decline
Post-Intervention
|
5.29 score on a scale
Standard Deviation 1.17
|
4.87 score on a scale
Standard Deviation 1.03
|
PRIMARY outcome
Timeframe: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).The composite measures of executive function such as emotion regulation questionnaire; the minimum and maximum values (4 and 10); higher scores mean a better outcome.
Outcome measures
| Measure |
IBMT Mindfulness
n=15 Participants
An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components.
IBMT mindfulness: IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
|
Health Education
n=14 Participants
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
health education: Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
|
|---|---|---|
|
Intervention Effects on Emotion Regulation
Baseline
|
5.71 score on a scale
Standard Deviation 0.83
|
5.23 score on a scale
Standard Deviation 1.12
|
|
Intervention Effects on Emotion Regulation
Post-Intervention
|
5.50 score on a scale
Standard Deviation 1.21
|
4.94 score on a scale
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).The composite measures of executive function such as Five Facet Mindfulness Questionnaire; the minimum and maximum values (1 and 5); higher scores mean a better outcome.
Outcome measures
| Measure |
IBMT Mindfulness
n=15 Participants
An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components.
IBMT mindfulness: IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
|
Health Education
n=14 Participants
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
health education: Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
|
|---|---|---|
|
Intervention Effects on Mindfulness
Baseline
|
2.92 score on a scale
Standard Deviation 0.29
|
2.87 score on a scale
Standard Deviation 0.32
|
|
Intervention Effects on Mindfulness
Post-Intervention
|
3.92 score on a scale
Standard Deviation 0.49
|
3.39 score on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).Population: Only participants who had usable data with good image quality were analyzed and reported.
Changes in the strength of brain functional connectivity were measured by functional resting-state brain imaging. Higher numerical values represent stronger connectivity/better outcomes and lower values represent weaker connectivity/worse outcomes. Arbitrary units are used and the theoretical range of the values is from 0 to 1.
Outcome measures
| Measure |
IBMT Mindfulness
n=10 Participants
An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components.
IBMT mindfulness: IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
|
Health Education
n=11 Participants
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
health education: Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
|
|---|---|---|
|
Intervention Effects on Brain Function
Baseline
|
0.47 arbitrary units
Standard Deviation 0.31
|
0.51 arbitrary units
Standard Deviation 0.39
|
|
Intervention Effects on Brain Function
Post-intervention
|
0.53 arbitrary units
Standard Deviation 0.33
|
0.49 arbitrary units
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).Population: Only participants who had usable data with good image quality were analyzed and reported.
Changes in AD-signature cortical brain white matter (i.e., level of fractional anisotropy) were measured by diffusion imaging. Higher numerical values represent higher white matter integrity/better outcomes and lower values represent lower white matter integrity/worse outcomes. Arbitrary units are used and the theoretical range of the values is from 0 to 1.
Outcome measures
| Measure |
IBMT Mindfulness
n=10 Participants
An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components.
IBMT mindfulness: IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
|
Health Education
n=11 Participants
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
health education: Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
|
|---|---|---|
|
Intervention Effects on Brain White Matter
Baseline
|
0.42 arbitrary units
Standard Deviation 0.04
|
0.39 arbitrary units
Standard Deviation 0.05
|
|
Intervention Effects on Brain White Matter
Post-intervention
|
0.43 arbitrary units
Standard Deviation 0.04
|
0.37 arbitrary units
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).Population: Only participants who had usable data with good image quality were analyzed and reported.
Changes in AD-signature cortical grey matter volume were measured by MRI structural imaging. Higher numerical values represent greater grey matter volume/better outcomes and lower values represent lower grey matter volume/worse outcomes.
Outcome measures
| Measure |
IBMT Mindfulness
n=10 Participants
An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components.
IBMT mindfulness: IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
|
Health Education
n=11 Participants
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
health education: Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
|
|---|---|---|
|
Intervention Effects on Brain Grey Matter
Baseline
|
589.23 cm^3
Standard Deviation 69.3
|
569.39 cm^3
Standard Deviation 67.32
|
|
Intervention Effects on Brain Grey Matter
Post-intervention
|
570.42 cm^3
Standard Deviation 62.11
|
576.87 cm^3
Standard Deviation 64.28
|
Adverse Events
IBMT Mindfulness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Education
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place