An interventional study of IBMT mindfulness and health education in Cognitive Decline, sponsored by Arizona State University. Completed at 1 site in United States. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Arizona State University · Not applicable, Interventional, and Prevention
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).
3,842 studies on the registry are indexed under Cognitive Dysfunction; 1,099 are open to participants now.
This study's enrollment of 40 is below the median of 65 across 2,807 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Arizona State University is the lead sponsor of 234 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
Behavioral: health education
IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
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).
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).
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).
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).
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).
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).
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).
| Milestone | IBMT Mindfulness | Health Education |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
The percentage of trials correct on N-back working memory test; higher percentage of trials correct mean a better outcome.
| percentage of correct trials | IBMT Mindfulness | Health Education |
|---|---|---|
| Baseline | 87.69 ± 0.15 | 91.57 ± 0.14 |
| Post-Intervention | 88.01 ± 0.16 | 91.68 ± 0.17 |
The composite measures of cognition such as subjective cognitive decline; the minimum and maximum values (1 and 27); higher scores mean a worse outcome.
| score on a scale | IBMT Mindfulness | Health Education |
|---|---|---|
| Baseline | 5.34 ± 1.18 | 4.96 ± 1.02 |
| Post-Intervention | 5.29 ± 1.17 | 4.87 ± 1.03 |
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.
| score on a scale | IBMT Mindfulness | Health Education |
|---|---|---|
| Baseline | 5.71 ± 0.83 | 5.23 ± 1.12 |
| Post-Intervention | 5.50 ± 1.21 | 4.94 ± 0.84 |
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.
| score on a scale | IBMT Mindfulness | Health Education |
|---|---|---|
| Baseline | 2.92 ± 0.29 | 2.87 ± 0.32 |
| Post-Intervention | 3.92 ± 0.49 | 3.39 ± 0.50 |
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.
| arbitrary units | IBMT Mindfulness | Health Education |
|---|---|---|
| Baseline | 0.47 ± 0.31 | 0.51 ± 0.39 |
| Post-intervention | 0.53 ± 0.33 | 0.49 ± 0.35 |
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.
| arbitrary units | IBMT Mindfulness | Health Education |
|---|---|---|
| Baseline | 0.42 ± 0.04 | 0.39 ± 0.05 |
| Post-intervention | 0.43 ± 0.04 | 0.37 ± 0.04 |
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.
| cm^3 | IBMT Mindfulness | Health Education |
|---|---|---|
| Baseline | 589.23 ± 69.3 | 569.39 ± 67.32 |
| Post-intervention | 570.42 ± 62.11 | 576.87 ± 64.28 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IBMT Mindfulness | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Health Education | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | IBMT Mindfulness | Health Education | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 20 | 40 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | IBMT Mindfulness | Health Education | Total |
|---|---|---|---|
| Female | 18 | 17 | 35 |
| Male | 2 | 3 | 5 |
| Race/Ethnicity, Customized(Participants) | IBMT Mindfulness | Health Education | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 18 | 19 | 37 |
| Unknown/Not Reported Ethnicity | 0 | 0 | 0 |
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Arizona State University