- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04869111
The BrainHealth Project
The BrainHealth Project, a Longitudinal Study in Generally Healthy Adults
The BrainHealth Project is a longitudinal study designed to identify factors associated with brain health and cognitive performance across the lifespan. Participants complete online assessments approximately twice per year to measure changes in cognitive, behavioral, and lifestyle-related domains.
Between assessments, participants have access to digital training modules, educational resources, and optional coaching sessions. A subset of participants may be invited to participate in additional components, including neuroimaging.
For an overview of the study and link TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Description of Study:
The BrainHealth Project is a longitudinal study designed to examine factors associated with brain health, including both maintenance and changes in cognitive function across the lifespan. Additionally, researchers aim to identify more personalized practices for promoting brain health.
The study design is informed by prior longitudinal research, namely the Framingham study, demonstrating the value of large-scale, repeated assessments in identifying modifiable factors associated with health outcomes. The goal of this study is to characterize determinants of brain health and support future research on prevention and intervention strategies.
Participants complete online assessments approximately twice per year to measure changes in cognitive performance and related domains over time. Between assessment time points, participants may engage in digital training modules, educational resources, and optional coaching sessions.
Assessments:
BrainHealth Index (~70 min) - An online battery of cognitive measures and questionnaires. The Clarity section looks at complex thinking capacities such as reasoning, flexibility and strategy. In this section, you will be asked to complete different cognitive tasks. The questionnaires measure other aspects of life that relate to brain health, such as emotional well-being, quality of life, happiness, social support systems, and sleep. In this section, you will rate these aspects of your own life. Participants will also complete a 5 minute assessment with BrainHQ to measure processing speed.
The small group of participants who are invited to complete the brain imaging portion of the study will undergo annual brain imaging and will also complete brain gauge (in-person computer assessment). We will offer participants additional sub-studies, and they will have the opportunity to participate or not.
Additional and Exploratory Assessments:
Participants may be invited to complete additional optional surveys or behavioral tasks administered online to further characterize brain health and related behavioral, lifestyle, and biological domains. These additional assessments are exploratory in nature and are not designated as primary or secondary outcome measures.
Online Trainings, habits, and resources:
Trainings can be accessed through the online dashboard and include videos, exercises, and application opportunities. Trainings include strategies to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize Training will also include strategies for stress management and healthy sleep routines, as well as other brain health education and resources. Most trainings are no more than 10 minutes a day.
Online Coaching:
Online coaching sessions will be offered to participants. Participants can elect to take advantage of this offer to the extent they chose.
For an overview of the study and LINK TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Erin C, MS
- Phone Number: 9728833208
- Email: erin.venza@utdallas.edu
Study Contact Backup
- Name: Margaret Chaplin, MA
- Phone Number: (972) 883-3347
- Email: brainhealthproject@utdallas.edu
Study Locations
-
-
Texas
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Dallas, Texas, United States, 75235
- Recruiting
- The Center for BrainHealth at The University of Texas at Dallas
-
Contact:
- Margaret Chaplin, MA
- Phone Number: (972) 883-3347
- Email: brainhealthproject@utdallas.edu
-
Contact:
- Erin Venza, MS
- Phone Number: 9728833208
- Email: brainhealthproject@utdallas.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English-speaking
- Access to an internet connect and device
- Able to read information and hear sounds
Exclusion Criteria:
- Diagnosed neurodegenerative disease
- History of stroke, concussion, or brain injury that currently hinders you from functioning at your prior level
- Diagnosed with Autism Spectrum Disorder and not functioning independently
For an overview of the study and LINK TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BrainHealth Intervention Protocol
Participants will engage in a BrainHealth app-based program tailored for this study. The program includes ongoing microlearning modules focused on supporting brain health through evidence-informed approaches, such as thinking strategies, cognitive exercises, lifestyle practices, stress management techniques, and other brain-healthy behaviors. Participants can access educational resources on the broad topic of brain health and can utilize tools to support habit formation. Participants can complete (optional) coaching calls designed to support goal setting, accountability, and application of concepts learned through the program. |
Participants will engage in a BrainHealth app-based program tailored for this study. The program includes ongoing microlearning modules focused on supporting brain health through evidence-informed approaches, such as thinking strategies, cognitive exercises, lifestyle practices, stress management techniques, and other brain-healthy behaviors. Participants can access educational resources on the broad topic of brain health and can utilize tools to support habit formation. Participants can complete (optional) coaching calls designed to support goal setting, accountability, and application of concepts learned through the program. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BrainHealth Index (BHI)
Time Frame: Every 6 months until end of study
|
Longitudinal change in overall brain health as measured by the BrainHealth Index (BHI), a multidimensional assessment that integrates cognitive performance, social-emotional functioning, well-being, purpose, and lifestyle-related factors.
Analyses will evaluate changes in BHI scores (composite and factors) over time.
Higher scores indicate better brain health.
|
Every 6 months until end of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neural and Physiological Markers of Brain Health
Time Frame: baseline, 6 months, then annually until study end
|
For the subset of participants completing in-person study visits, we will measure longitudinal change in neural and physiological markers of brain health, including neuroimaging-derived measures (e.g., cerebral blood flow, functional connectivity, and diffusion metrics) and physiological indicators (e.g., heart rate variability, sleep patterns, and physical activity measured through wearable devices). Relationships between these markers and BrainHealth Index scores will be evaluated over time. This outcome includes multiple measures with differing scales and interpretations; therefore, the meaning of higher or lower values depends on the specific marker being evaluated. |
baseline, 6 months, then annually until study end
|
|
Engagement in Intervention
Time Frame: From enrollment through study completion
|
Participant engagement with study intervention will be measured through training completion, coaching participation, and overall app utilization.
Higher values generally indicate greater engagement with the intervention.
Associations between engagement metrics and longitudinal changes in brain health outcomes will be evaluated throughout the study.
|
From enrollment through study completion
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exploratory Participant-Reported and Task-Based Measures
Time Frame: Collected at varying intervals throughout participation
|
Participants may complete optional exploratory surveys and tasks assessing demographic, behavioral, lifestyle, health, cognitive, psychosocial, and life-experience factors that may be associated with brain health outcomes. Specific measures may be added or modified during the study to address emerging research questions. This outcome includes multiple measures with differing scales and interpretations; therefore, the meaning of higher or lower values depends on the specific measure being evaluated. |
Collected at varying intervals throughout participation
|
|
Exploratory Wearable Device Metrics
Time Frame: Collected continuously and/or at varying intervals throughout participation
|
Participants may optionally link personal wearable or fitness devices to the BrainHealth app. Shared data may include measures such as physical activity, sleep, heart rate, heart rate variability, and other health-related metrics available through connected devices. Relationships between wearable device metrics and brain health outcomes, including BrainHealth Index scores, will be evaluated over time. This outcome includes multiple measures with differing scales and interpretations; therefore, the meaning of higher or lower values depends on the specific metric being evaluated. |
Collected continuously and/or at varying intervals throughout participation
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sandra B Chapman, PhD, Center for BrainHealth
Publications and helpful links
General Publications
- Chapman SB, Aslan S, Spence JS, Hart JJ Jr, Bartz EK, Didehbani N, Keebler MW, Gardner CM, Strain JF, DeFina LF, Lu H. Neural mechanisms of brain plasticity with complex cognitive training in healthy seniors. Cereb Cortex. 2015 Feb;25(2):396-405. doi: 10.1093/cercor/bht234. Epub 2013 Aug 28.
- Chapman SB, Mudar RA. Enhancement of cognitive and neural functions through complex reasoning training: evidence from normal and clinical populations. Front Syst Neurosci. 2014 Apr 28;8:69. doi: 10.3389/fnsys.2014.00069. eCollection 2014.
- Chapman SB, Fratantoni JM, Robertson IH, D'Esposito M, Ling GSF, Zientz J, Vernon S, Venza E, Cook LG, Tate A, Spence JS. A Novel BrainHealth Index Prototype Improved by Telehealth-Delivered Training During COVID-19. Front Public Health. 2021 Mar 16;9:641754. doi: 10.3389/fpubh.2021.641754. eCollection 2021.
- Chapman SB, Aslan S, Spence JS, Keebler MW, DeFina LF, Didehbani N, Perez AM, Lu H, D'Esposito M. Distinct Brain and Behavioral Benefits from Cognitive vs. Physical Training: A Randomized Trial in Aging Adults. Front Hum Neurosci. 2016 Jul 18;10:338. doi: 10.3389/fnhum.2016.00338. eCollection 2016.
- Chapman SB, Spence JS, Aslan S, Keebler MW. Enhancing Innovation and Underlying Neural Mechanisms Via Cognitive Training in Healthy Older Adults. Front Aging Neurosci. 2017 Oct 9;9:314. doi: 10.3389/fnagi.2017.00314. eCollection 2017.
- Motes MA, Yezhuvath US, Aslan S, Spence JS, Rypma B, Chapman SB. Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial. Neurobiol Aging. 2018 Feb;62:72-81. doi: 10.1016/j.neurobiolaging.2017.10.003. Epub 2017 Oct 12.
- Han K, Davis RA, Chapman SB, Krawczyk DC. Strategy-based reasoning training modulates cortical thickness and resting-state functional connectivity in adults with chronic traumatic brain injury. Brain Behav. 2017 Apr 10;7(5):e00687. doi: 10.1002/brb3.687. eCollection 2017 May.
- Vas A, Chapman S, Aslan S, Spence J, Keebler M, Rodriguez-Larrain G, Rodgers B, Jantz T, Martinez D, Rakic J, Krawczyk D. Reasoning training in veteran and civilian traumatic brain injury with persistent mild impairment. Neuropsychol Rehabil. 2016 Aug;26(4):502-31. doi: 10.1080/09602011.2015.1044013. Epub 2015 May 27.
- Das N, Spence JS, Aslan S, Vanneste S, Mudar R, Rackley A, Quiceno M, Chapman SB. Cognitive Training and Transcranial Direct Current Stimulation in Mild Cognitive Impairment: A Randomized Pilot Trial. Front Neurosci. 2019 Apr 12;13:307. doi: 10.3389/fnins.2019.00307. eCollection 2019.
- Han K, Martinez D, Chapman SB, Krawczyk DC. Neural correlates of reduced depressive symptoms following cognitive training for chronic traumatic brain injury. Hum Brain Mapp. 2018 Jul;39(7):2955-2971. doi: 10.1002/hbm.24052. Epub 2018 Mar 23.
- Venza EE, Chapman SB, Aslan S, Zientz JE, Tyler DL, Spence JS. Enhancing Executive Function and Neural Health in Bipolar Disorder through Reasoning Training. Front Psychol. 2016 Nov 1;7:1676. doi: 10.3389/fpsyg.2016.01676. eCollection 2016.
- Gallen CL, Baniqued PL, Chapman SB, Aslan S, Keebler M, Didehbani N, D'Esposito M. Modular Brain Network Organization Predicts Response to Cognitive Training in Older Adults. PLoS One. 2016 Dec 22;11(12):e0169015. doi: 10.1371/journal.pone.0169015. eCollection 2016.
- Cook LG, Spence JS, Chang Z, Venza EE, Tate A, Robertson IH, D'Esposito M, Ling GSF, Wigginton JG, Chapman SB. Measuring and increasing the brain health span across adulthood: a public health imperative. Sci Rep. 2026 May 2. doi: 10.1038/s41598-026-51403-3. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 23-745
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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