Cognitive Decline
Conditions
Brief summary
The study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline.
Detailed description
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).
Interventions
BEHAVIORALIBMT mindfulness
IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
BEHAVIORALhealth education
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
mindfulness vs. health education
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Able to read/understand English * Normal performance using standardized cognitive tests * Self-reported decline in cognitive capacity such as memory loss * Eligible for non-invasive fMRI * Willing to be randomized * Free of any severe psychiatric diagnoses or medication that may affect participation
Exclusion criteria
* Medical disorders or medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females) * Unable to provide consent or understand study procedures due to mental illness or cognitive limitations * Previous meditation experiences * Evidence of illicit drug use * Participants for blood draws weigh less than 110 lbs * Metal or metallic materials in the body such as pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Effects on Mindfulness | 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. |
| Percentage of Trials Correct On Working Memory Test | 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. |
| Intervention Effects on Cognitive Decline | 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. |
| Intervention Effects on Emotion Regulation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Effects on Brain White Matter | The outcome measures are assessed in-person at baseline and post-intervention (2 weeks). | 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. |
| Intervention Effects on Brain Grey Matter | The outcome measures are assessed in-person at baseline and post-intervention (2 weeks). | 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. |
| Intervention Effects on Brain Function | The outcome measures are assessed in-person at baseline and post-intervention (2 weeks). | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | IBMT Mindfulness | Health Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 18 Participants | 19 Participants | 37 Participants |
| Race/Ethnicity, Customized Unknown/Not Reported Ethnicity | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IBMT Mindfulness | Intervention Effects on Cognitive Decline | Baseline | 5.34 score on a scale | Standard Deviation 1.18 |
| IBMT Mindfulness | Intervention Effects on Cognitive Decline | Post-Intervention | 5.29 score on a scale | Standard Deviation 1.17 |
| Health Education | Intervention Effects on Cognitive Decline | Baseline | 4.96 score on a scale | Standard Deviation 1.02 |
| Health Education | Intervention Effects on Cognitive Decline | Post-Intervention | 4.87 score on a scale | Standard Deviation 1.03 |
p-value: >0.05ANOVA
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.
Time frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IBMT Mindfulness | Intervention Effects on Emotion Regulation | Baseline | 5.71 score on a scale | Standard Deviation 0.83 |
| IBMT Mindfulness | Intervention Effects on Emotion Regulation | Post-Intervention | 5.50 score on a scale | Standard Deviation 1.21 |
| Health Education | Intervention Effects on Emotion Regulation | Baseline | 5.23 score on a scale | Standard Deviation 1.12 |
| Health Education | Intervention Effects on Emotion Regulation | Post-Intervention | 4.94 score on a scale | Standard Deviation 0.84 |
p-value: >0.05ANOVA
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.
Time frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IBMT Mindfulness | Intervention Effects on Mindfulness | Baseline | 2.92 score on a scale | Standard Deviation 0.29 |
| IBMT Mindfulness | Intervention Effects on Mindfulness | Post-Intervention | 3.92 score on a scale | Standard Deviation 0.49 |
| Health Education | Intervention Effects on Mindfulness | Baseline | 2.87 score on a scale | Standard Deviation 0.32 |
| Health Education | Intervention Effects on Mindfulness | Post-Intervention | 3.39 score on a scale | Standard Deviation 0.5 |
p-value: <0.05ANOVA
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.
Time frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IBMT Mindfulness | Percentage of Trials Correct On Working Memory Test | Baseline | 87.69 percentage of correct trials | Standard Deviation 0.15 |
| IBMT Mindfulness | Percentage of Trials Correct On Working Memory Test | Post-Intervention | 88.01 percentage of correct trials | Standard Deviation 0.16 |
| Health Education | Percentage of Trials Correct On Working Memory Test | Baseline | 91.57 percentage of correct trials | Standard Deviation 0.14 |
| Health Education | Percentage of Trials Correct On Working Memory Test | Post-Intervention | 91.68 percentage of correct trials | Standard Deviation 0.17 |
p-value: >0.05ANOVA
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IBMT Mindfulness | Intervention Effects on Brain Function | Baseline | 0.47 arbitrary units | Standard Deviation 0.31 |
| IBMT Mindfulness | Intervention Effects on Brain Function | Post-intervention | 0.53 arbitrary units | Standard Deviation 0.33 |
| Health Education | Intervention Effects on Brain Function | Baseline | 0.51 arbitrary units | Standard Deviation 0.39 |
| Health Education | Intervention Effects on Brain Function | Post-intervention | 0.49 arbitrary units | Standard Deviation 0.35 |
p-value: 0.754ANOVA
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IBMT Mindfulness | Intervention Effects on Brain Grey Matter | Baseline | 589.23 cm^3 | Standard Deviation 69.3 |
| IBMT Mindfulness | Intervention Effects on Brain Grey Matter | Post-intervention | 570.42 cm^3 | Standard Deviation 62.11 |
| Health Education | Intervention Effects on Brain Grey Matter | Baseline | 569.39 cm^3 | Standard Deviation 67.32 |
| Health Education | Intervention Effects on Brain Grey Matter | Post-intervention | 576.87 cm^3 | Standard Deviation 64.28 |
p-value: 0.877ANOVA
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IBMT Mindfulness | Intervention Effects on Brain White Matter | Baseline | 0.42 arbitrary units | Standard Deviation 0.04 |
| IBMT Mindfulness | Intervention Effects on Brain White Matter | Post-intervention | 0.43 arbitrary units | Standard Deviation 0.04 |
| Health Education | Intervention Effects on Brain White Matter | Baseline | 0.39 arbitrary units | Standard Deviation 0.05 |
| Health Education | Intervention Effects on Brain White Matter | Post-intervention | 0.37 arbitrary units | Standard Deviation 0.04 |
p-value: 0.985ANOVA