Preventing Cognitive Decline

NCT05446909 | Completed Results DMC

• 2 other identifiers: 2022 IBMT SCD3R61AT010138-03S1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).

Secondary Outcomes (3)

• 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 Arms (2)

IBMT mindfulness

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Behavioral: health education

Interventions

IBMT mindfulness BEHAVIORAL

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

IBMT mindfulness

health education BEHAVIORAL

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

health education

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Yi-Yuan Tang
• Organization: Arizona State University

yiyuan@asu.edu

4807903577

Study Officials

• YiYuan Tang

  Arizona State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: mindfulness vs. health education

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: July 7, 2022
• Study Start: February 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: October 29, 2024
• Results First Posted: October 29, 2024

Record last verified: 2024-10

Locations

US (1)