An interventional study of BrainHealth App-Based Program in Healthy, sponsored by The University of Texas at Dallas. Recruiting at 1 site in United States. Open to participants aged 18 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Prevention
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/
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/
The University of Texas at Dallas is the lead sponsor of 59 studies on the registry; 18 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For an overview of the study and LINK TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/
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.
Behavioral: BrainHealth App-Based 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.
BrainHealth Index (BHI)
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.
Time frame: Every 6 months until end of study
Neural and Physiological Markers of Brain Health
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.
Time frame: baseline, 6 months, then annually until study end
Engagement in Intervention
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.
Time frame: From enrollment through study completion
Exploratory Participant-Reported and Task-Based Measures
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.
Time frame: Collected at varying intervals throughout participation
Exploratory Wearable Device Metrics
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.
Time frame: Collected continuously and/or at varying intervals throughout participation
Plan to share: No
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