The BrainHealth Project - Pilot Study

NCT04621240 | Completed Results

• 1 other identifier: 20-32
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed project is a pilot study in preparation for a larger study called The BrainHealth Project. The BrainHealth Project will be a prospective, longitudinal (10 yr) study focused on identifying determinants of brain health. Over the 4-month time commitment of this pilot study, 200 participants will complete online cognitive testing \& functional magnetic resonance imaging (fMRI) at 2 time points (pre- and post-intervention). Up to 200 participants will complete online cognitive testing at 2 time points (pre- and post-intervention) and no fMRI. In between those time points, all participants will participate in online training and education regarding ways to optimize brain health, as well as overall health. Online training that will be recommended to participants include the following: (1) Strategic Memory Advanced Reasoning Training (SMART) teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance; and (2) Stress Solutions provides individuals with practical tools to reduce stress, build resilience and improve quality of life. The main objectives are: (i) to characterize lifestyle, cognitive, and behavioral markers related to an individual's cognitive function from adolescent to elderly ages, (ii) to assess the neural/biological determinants predictive of maintenance of brain health, and (iii) to evaluate the impact of available cognitive and lifestyle interventions on improving and maintaining brain health.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The BrainHealth Index

  The BrainHealth Index is a composite score of 22 individual measures encompassing four components of brain health, including (1) cognitive performance, (2) mental well-being, (3) daily life functioning (e.g., sleep, fitness, activities), and (4) social interactions/engagement. \[Composite score min value = 30, Composite score max value = 82, higher composite score = better outcome\]

  3 months

Study Arms (1)

Online SMART Intervention & Stress Solutions

EXPERIMENTAL

Strategic Memory Advanced Reasoning Training (SMART) teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance

Behavioral: Online SMART & Stress Solutions

Interventions

Online SMART & Stress Solutions BEHAVIORAL

1\. On-line SMART - (Strategic Memory Advanced Reasoning Training) is a curriculum that teaches strategies of how to use the brain better, in such a way that may improve brain health and performance. SMART strives to achieve optimal cognitive function realized by the brain's ability to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize details, and to prioritize the information in order to attend to the most relevant parts. 2. Stress Solutions - provides individuals with practical tools to enhance performance, reduce stress, build resilience and improve quality of life.

Online SMART Intervention & Stress Solutions

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum age of 18
• internet access and device
• fluent English speaker

You may not qualify if:

• Children are excluded from this study
• Individuals who do not speak or read English
• If individuals have undergone an in-person BrainHealth Index (previously BrainHealth Physical), they will need to wait 6 months have passed to participate.
• Individuals who will complete the imaging component must pass an fMRI screener and score a 26 or above on the TICS (Telephone Interview Cognitive Status)-M.
• A history of neurological disorders, injuries or disabilities (dementia, multiple sclerosis, Parkinson's, traumatic brain injury, stroke)
• A history of psychiatric disorders (schizophrenia, bipolar disorder, or others related to anxiety, depression, panic)
• A history of uncontrolled health issues (substance abuse, hypertension, hypo- or hyper-thyroidism)

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

UTD Center for BrainHealth

Dallas, Texas, 75235, United States

Location

Limitations and Caveats

Limitations include the following: (1) only one approach to cognitive training was examined in this study; others could be added for broader impact; (2) trainings and metrics around lifestyle factors will be enhanced with wearable technologies; (3) impact on broader cultural and socio-economic groups not well-understood; (4) not a randomized controlled trial.

Results Point of Contact

• Title: Erin Venza
• Organization: Center for BrainHealth at the University of Texas at Dallas

erin.venza@utdallas.edu

972-883-3208

Study Officials

• Sandra Chapman, PhD

  The Center for BrainHealth, University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: November 9, 2020
• Study Start: March 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: March 31, 2021
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Locations

US (1)