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Completed

NCT Number: NCT05446909

Preventing Cognitive Decline

The study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline.

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Key information

Conditions

Cognitive Decline Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IBMT mindfulness

Behavioral

IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management

Health Education

Behavioral

Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Intervention Effects on Brain Function

    Time frame: 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.

  2. Intervention Effects on Brain White Matter

    Time frame: 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.

  3. Intervention Effects on Brain Grey Matter

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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