Preventing Cognitive Decline

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Modulation Effects of a Novel Body-mind Intervention on Subjective Cognitive Decline

Conditions
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Cognitive Decline

Intervention / Treatment
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* Behavioral: IBMT mindfulness
* Behavioral: health education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: mindfulness vs. health education
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBMT mindfulness<br>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. | Behavioral: IBMT mindfulness<br>* IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management<br>|
| Active Comparator: health education<br>Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle | Behavioral: health education<br>* Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention effects on working memory | Changes in the composite measures of cognition such as N-back working memory; 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, 2-4 weeks and 3 months | 
| Intervention effects on cognitive decline | Changes in 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, 2-4 weeks and 3 months | 
| Intervention effects on emotion regulation | Changes in 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. questionnaire | The outcome measures are assessed online or/and in-person at baseline, 2-4 weeks and 3 months | 
| Intervention effects on mindfulness | Changes in the composite measures of executive function such as Five Facet Mindfulness Questionnaire; the minimum and maximum values (8 and 40); higher scores mean a better outcome. | The outcome measures are assessed online or/and in-person at baseline, 2-4 weeks and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention effects on brain function | AD-signature cortical connectivity changes such as anterior and posterior cingulate cortex measured by fMRI resting-state imaging | The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months | 
| Intervention effects on brain white matter | AD-signature cortical white matter changes such as anterior and posterior cingulate cortex measured by fMRI diffusion tensor imaging | The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months | 
| Intervention effects on brain grey matter | AD-signature cortical volume changes such as anterior and posterior cingulate cortex measured by fMRI structural imaging | The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months |