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Preventing Cognitive Decline

Primary Purpose

Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IBMT mindfulness
health education
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IBMT mindfulness

health education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

Intervention effects on brain function
AD-signature cortical connectivity changes such as anterior and posterior cingulate cortex measured by fMRI resting-state imaging
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
Intervention effects on brain grey matter
AD-signature cortical volume changes such as anterior and posterior cingulate cortex measured by fMRI structural imaging

Full Information

First Posted
May 25, 2022
Last Updated
August 9, 2023
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05446909
Brief Title
Preventing Cognitive Decline
Official Title
Modulation Effects of a Novel Body-mind Intervention on Subjective Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
mindfulness vs. health education
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBMT mindfulness
Arm Type
Experimental
Arm Description
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.
Arm Title
health education
Arm Type
Active Comparator
Arm Description
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
Intervention Type
Behavioral
Intervention Name(s)
IBMT mindfulness
Intervention Description
IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
Intervention Type
Behavioral
Intervention Name(s)
health education
Intervention Description
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
Primary Outcome Measure Information:
Title
Intervention effects on working memory
Description
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.
Time Frame
The outcome measures are assessed online or/and in-person at baseline, 2-4 weeks and 3 months
Title
Intervention effects on cognitive decline
Description
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.
Time Frame
The outcome measures are assessed online or/and in-person at baseline, 2-4 weeks and 3 months
Title
Intervention effects on emotion regulation
Description
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
Time Frame
The outcome measures are assessed online or/and in-person at baseline, 2-4 weeks and 3 months
Title
Intervention effects on mindfulness
Description
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.
Time Frame
The outcome measures are assessed online or/and in-person at baseline, 2-4 weeks and 3 months
Secondary Outcome Measure Information:
Title
Intervention effects on brain function
Description
AD-signature cortical connectivity changes such as anterior and posterior cingulate cortex measured by fMRI resting-state imaging
Time Frame
The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Title
Intervention effects on brain white matter
Description
AD-signature cortical white matter changes such as anterior and posterior cingulate cortex measured by fMRI diffusion tensor imaging
Time Frame
The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Title
Intervention effects on brain grey matter
Description
AD-signature cortical volume changes such as anterior and posterior cingulate cortex measured by fMRI structural imaging
Time Frame
The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YiYuan Tang
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

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Preventing Cognitive Decline

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