- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06724887
Brain Health on College Campuses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
ONLINE Procedures
Assessments (3 times over 9 months): BrainHealth Index - An online battery of cognitive measures and questionnaires. Periodic surveys to assess new research questions (as IRB approved) and to assess participant experience
Training, habits, resources (available over 9 months): Micro-learning video modules that include Strategic Memory Advanced Reasoning Tactics (SMART) and other trainings such as stress management, sleep, and lifestyle. The habit tool supports accountability and consistency of building new and personalized habits. Curated resources (articles, podcasts, videos) around the topic of brain health are also available.
Coaching Periodic access to group and one-on-one brain-health related virtual coaching sessions.
Link wearable data Participants have the option to link their wearable data with their data collected through the BrainHealth Platform
IN-PERSON Procedures
The investigators will offer in-person and/or virtual/hybrid educational sessions on a variety of high-interest topics such as stress management, sleep, resilience, and mental well-being, with an emphasis on how practicing and implementing brain healthy strategies can impact everyday life. For faculty/staff, the investigators will also offer interactive workshops on how to create a brain healthy environment and classroom, including ways to implement and provide brain-healthy strategies and resources in their everyday operations involving students (e.g., ways to enhance mental energy and focus in the classroom, brain-based approaches to promoting growth mindset and confidence, etc.).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lori Cook, PhD
- Phone Number: 972-883-3409
- Email: lori.cook@utdallas.edu
Study Contact Backup
- Name: Erin Venza, MS
- Phone Number: 972-883-3208
- Email: erin.venza@utdallas.edu
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75215
- Recruiting
- Dallas College
-
Contact:
- Tracie Lowe, PhD
-
Richardson, Texas, United States, 75080
- Recruiting
- University of Texas at Dallas
-
Contact:
- Erin Venza, MS
- Phone Number: 972-883-3208
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Minimum age of 18
- Either enrolled as a student and/or employed as staff/faculty at UTD or Dallas College
- Internet and device access
- Must be able to hear and read over the computer
- Fluent English speaker
Exclusion Criteria:
- Currently or previously enrolled in The BrainHealth Project (NCT04869111)
- Diagnosed neurodegenerative disease
- History of stroke, concussion, or brain injury that currently hinders participant from functioning at their prior level
- Diagnosed with autism spectrum disorder and not functioning independently
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brain Health Training and Education
Online and in-person training and education around brain-health strategies and lifestyle practices.
|
Initial training strategies cover Strategic Memory Advanced Reasoning Tactics (SMART), and subsequent training extends the SMART principles to other life-applications such as stress management, sleep, and lifestyle.
Virtual and in-person workshops will expand on topics such as stress management, sleep, resilience, and mental well-being, with an emphasis on how practicing and implementing brain healthy strategies can impact everyday life.
For faculty/staff, we will also offer interactive workshops on how to create a brain healthy environment and classroom, including ways to implement and provide brain-healthy strategies and resources in their everyday operations involving students.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BrainHealth Index (BHI)
Time Frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
|
The investigators will assess change on a holistic measure of cognitive, social, well-being, and daily life health on the BrainHealth Index across multiple timepoints.
(Min value = 16, Max value = 1032) (Higher score represents better outcome)
|
Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of Real-Life Responsibilities Survey
Time Frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
|
A qualitative survey of with five sections: home, academic, job, extracurricular, and financial level of responsibilities.
(Min value = 5, Max value = 15) (Higher score represents better outcome)_
|
Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grade Point Average (GPA)
Time Frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
|
A numerical representation of a student's overall academic performance (Min value = 0, Max value = 4.0)(Higher score represents better outcome)
|
Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
|
|
Course Completion
Time Frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
|
Average course completion by student (Min value = 0, Max value = 100)(Higher score represents better outcome)
|
Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
|
|
Program Retention and Completion
Time Frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
|
Average program retention and completion rates (Min value = 0, Max value = 100)(Higher score represents better outcome)
|
Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lori Cook, PhD, University of Texas at Dallas
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, 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.
- Zientz J, Spence JS, Chung SSE, Nanda U, Chapman SB. Exploring how brain health strategy training informs the future of work. Front Psychol. 2023 Sep 12;14:1175652. doi: 10.3389/fpsyg.2023.1175652. eCollection 2023.
- Gamino JF, Chapman SB, Hull EL, Lyon GR. Effects of higher-order cognitive strategy training on gist-reasoning and fact-learning in adolescents. Front Psychol. 2010 Dec 9;1:188. doi: 10.3389/fpsyg.2010.00188. eCollection 2010.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-877
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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