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Clinical Trials/NCT05446909
NCT05446909
Completed
Not Applicable

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

Arizona State University1 site in 1 country40 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Decline
Sponsor
Arizona State University
Enrollment
40
Locations
1
Primary Endpoint
Percentage of Trials Correct On Working Memory Test
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
February 28, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of Trials Correct On Working Memory Test

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Intervention Effects on Mindfulness

Time Frame: 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.

Secondary Outcomes

  • Intervention Effects on Brain Function(The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).)
  • Intervention Effects on Brain White Matter(The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).)
  • Intervention Effects on Brain Grey Matter(The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).)

Study Sites (1)

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