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| ID | Type | Description | Link |
|---|---|---|---|
| 3R61AT010138-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline.
Subjective cognitive decline (SCD), the self-reported perception of memory or cognitive problems, is a risk factor for the cognitive decline and development of Alzheimer's (AD) and often happens in midlife. Recently, few mind-body interventions have suggested promising effects in preventing cognitive decline. However, these interventions often require longer training time (months to years) to achieve modest benefits, making them less optimal for rapidly learning and achieving desirable outcomes. One mechanism for cognitive decline and AD may involve deficits in self-control networks, and autonomic nervous system (ANS) and these deficits can be ameliorated through body-mind interventions. This study aims to investigate the modulation effects of a novel body-mind intervention on SCD using an evidence-based preventive intervention - integrative body-mind training (IBMT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBMT mindfulness | Experimental | 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. |
|
| health education | Active Comparator | Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBMT mindfulness | Behavioral | IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Trials Correct On Working Memory Test | The percentage of trials correct on N-back working memory test; higher percentage of trials correct mean a better outcome. | The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks). |
| Intervention Effects on Cognitive Decline | The composite measures of cognition such as subjective cognitive decline; the minimum and maximum values (1 and 27); higher scores mean a worse outcome. | The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks). |
| Intervention Effects on Emotion Regulation | 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. | The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks). |
| Intervention Effects on Mindfulness | 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. | The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Effects on Brain Function | 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. | The outcome measures are assessed in-person at baseline and post-intervention (2 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YiYuan Tang | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Phoenix | Arizona | 85004 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Trials Correct On Working Memory Test | The percentage of trials correct on N-back working memory test; higher percentage of trials correct mean a better outcome. | Posted | Mean | Standard Deviation | percentage of correct trials | The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks). |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yi-Yuan Tang | Arizona State University | 4807903577 | yiyuan@asu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 22, 2022 | Mar 26, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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mindfulness vs. health education
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| health education | Behavioral | Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle |
|
| Intervention Effects on Brain White Matter | 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. | The outcome measures are assessed in-person at baseline and post-intervention (2 weeks). |
| Intervention Effects on Brain Grey Matter | 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. | The outcome measures are assessed in-person at baseline and post-intervention (2 weeks). |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 |
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| Primary | Intervention Effects on Cognitive Decline | The composite measures of cognition such as subjective cognitive decline; the minimum and maximum values (1 and 27); higher scores mean a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks). |
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| Primary | Intervention Effects on Emotion Regulation | 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. | Posted | Mean | Standard Deviation | score on a scale | The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks). |
|
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| Primary | Intervention Effects on Mindfulness | 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. | Posted | Mean | Standard Deviation | score on a scale | The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks). |
|
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|
| Secondary | Intervention Effects on Brain Function | 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. | Only participants who had usable data with good image quality were analyzed and reported. | Posted | Mean | Standard Deviation | arbitrary units | The outcome measures are assessed in-person at baseline and post-intervention (2 weeks). |
|
|
|
|
| Secondary | Intervention Effects on Brain White Matter | 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. | Only participants who had usable data with good image quality were analyzed and reported. | Posted | Mean | Standard Deviation | arbitrary units | The outcome measures are assessed in-person at baseline and post-intervention (2 weeks). |
|
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|
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| Secondary | Intervention Effects on Brain Grey Matter | 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. | Only participants who had usable data with good image quality were analyzed and reported. | Posted | Mean | Standard Deviation | cm^3 | The outcome measures are assessed in-person at baseline and post-intervention (2 weeks). |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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