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The BrainHealth Project - Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04621240
Recruitment Status : Completed
First Posted : November 9, 2020
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
The University of Texas at Dallas

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.


Condition or disease Intervention/treatment Phase
Healthy Behavioral: Online SMART & Stress Solutions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The BrainHealth Project - Pilot Study
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: Online SMART Intervention & Stress Solutions
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
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.




Primary Outcome Measures :
  1. Complex Abstraction [ Time Frame: 3 months ]
    We will assess change on a measure of complex abstraction on the Test of Strategic Learning (TOSL) from Time 1 to Time 2. [Min value = 0, Max value = 10, higher score = better outcome)

  2. Functional Magnetic Resonance Imaging (fMRI) Measure of Neural Correlations [ Time Frame: 3 months ]
    We will assess change in regional cerebral brain blood flow (using fMRI) in correlation with gains in complex abstraction from Time 1 to Time 2. (higher correlation = better outcome)


Secondary Outcome Measures :
  1. Emotional Well-Being [ Time Frame: 3 months ]
    We will assess change on a measure of emotional well-being with the Depression, Anxiety, Stress Scale (DASS-21) from Time 1 to Time 2.[Min value = 0, Max value = 41, lower score = better outcome)

  2. Sleep [ Time Frame: 3 months ]
    We will assess change on a measure of sleep with the Pittsburgh Sleep Quality Index (PSQI) from Time 1 to Time 2.[Min value = 0, Max value = 21, lower score = better outcome)

  3. Social Support [ Time Frame: 3 months ]
    We will assess change on a measure of social support (Social Support Survey) from Time 1 to Time 2.[Min value = 0, Max value = 95, higher score = better outcome)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621240


Locations
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United States, Texas
UTD Center for BrainHealth
Dallas, Texas, United States, 75235
Sponsors and Collaborators
The University of Texas at Dallas
Investigators
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Principal Investigator: Sandra Chapman, PhD The Center for BrainHealth, University of Texas at Dallas
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Responsible Party: The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT04621240    
Other Study ID Numbers: 20-32
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No