Brain Health Training for Healthy Individuals

Overseen By Erin C, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Dallas

Disqualifiers: Neurodegenerative disease, Stroke, Brain injury, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how to maintain brain health and performance as individuals age. Participants will engage in online assessments and training sessions to evaluate how lifestyle and cognitive exercises can enhance brain function. The study seeks English speakers with internet access who do not have a history of certain brain-related conditions. It offers an opportunity to learn practical strategies for boosting memory and reducing stress. Some participants may join a special group that undergoes brain imaging. The training includes Online SMART & Stress Solutions, part of the BrainHealth Project Interventions. As an unphased trial, this study provides a unique opportunity to explore and enhance cognitive health through innovative strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Online SMART & Stress Solutions interventions are safe?

Research has shown that the online SMART (Strategic Memory Advanced Reasoning Training) and Stress Solutions programs are generally easy to use. Participants reported feeling less depressed, anxious, and stressed after using the program, indicating improved mental health.

Studies have not identified any serious side effects from the treatment, suggesting it is safe. This program is part of a larger effort to understand brain health and aims to enhance thinking skills and mental performance.

While these findings are encouraging, consulting a healthcare professional is advisable to determine if joining this kind of trial is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brain Health Training treatments because they focus on enhancing cognitive skills through an innovative online approach. Unlike traditional methods that might rely on medications or in-person therapy sessions, these treatments leverage Strategic Memory Advanced Reasoning Training (SMART) to teach meta-cognitive strategies, helping individuals improve their daily performance. This method empowers participants to actively engage in their brain health from the comfort of their homes, making cognitive enhancement more accessible and personalized.

What evidence suggests that the Online SMART & Stress Solutions interventions are effective for improving brain health?

Research shows that the Online SMART & Stress Solutions, provided to participants in this trial, can improve mental health. In a previous study, participants reported feeling less depressed, anxious, and stressed after using the online SMART strategies. These strategies help manage information by focusing on main ideas rather than memorizing everything. Another study found that video-based lessons effectively teach these thinking strategies. These findings suggest the program might enhance brain health and reduce stress through simple, everyday techniques. ^{1 2 3 4 6}

Who Is on the Research Team?

Sandra B Chapman, PhD

Principal Investigator

Center for BrainHealth

Are You a Good Fit for This Trial?

The BrainHealth Project is for English-speaking individuals who have internet access and a device, and are able to read information and hear sounds. There's no specific health condition required; it's open to healthy participants.

Inclusion Criteria

You can read and hear.

English-speaking

You have an internet connection and a device that can access the internet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants complete semi-annual online assessments to track brain health and performance

10 years

2 visits (virtual) per year

Training and Coaching

Participants engage in online trainings and optional coaching sessions to optimize brain health

10 years

Follow-up

Participants are monitored for changes in cognitive, social, and emotional well-being

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Online SMART & Stress Solutions

Trial Overview

This study tests the effectiveness of brain health training over ten years. Participants will do online assessments twice a year, engage in online trainings, receive supplemental content on optimizing brain health, and may get one-on-one coaching sessions.

How Is the Trial Designed?

Group I: Online SMART Intervention & Stress Solutions Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials

71

Recruited

108,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

University of California, Santa Barbara

Collaborator

Trials

33

Recruited

3,100+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

Georgia State University

Collaborator

Trials

71

Recruited

33,600+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Inova Health Care Services

Collaborator

Trials

80

Recruited

22,700+

Methodist Healthcare

Collaborator

Trials

8

Recruited

860+

Published Research Related to This Trial

A self-directed Stress Management and Resiliency Training (SMART) program using only written materials was effective in improving stress, resilience, mindfulness, anxiety, and quality of life among 37 employees over a 12-week period.

Out of the 37 participants, 34 completed the study, showing that the program can be successfully implemented without in-person training, making it accessible for wider use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bibliotherapy to decrease stress and anxiety and increase resilience and mindfulness: a pilot trial. Sharma, V., Sood, A., Prasad, K., et al.[2014]

The study will evaluate the effectiveness of an Internet- and App-based stress management intervention for 200 distance-learning students with elevated depression levels, using cognitive-behavioral techniques over eight sessions.

The primary outcome will measure changes in depression levels post-treatment, with results expected to inform the acceptance and effectiveness of online stress interventions for students who have limited access to traditional health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet- and App-Based Stress Intervention for Distance-Learning Students With Depressive Symptoms: Protocol of a Randomized Controlled Trial. Harrer, M., Apolinário-Hagen, J., Fritsche, L., et al.[2020]

The Internet-based self-help program 'Stress Gym' was successfully completed by 142 military personnel, showing high user satisfaction and positive evaluations of its interface and content.

Participants experienced significant reductions in stress ratings while using the program, indicating that 'Stress Gym' is an effective and feasible cognitive-behavioral intervention for managing stress in military settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Gym: Feasibility of deploying a web-enhanced behavioral self-management program for stress in a military setting. Williams, A., Hagerty, BM., Brasington, SJ., et al.[2019]

A study involving 145 generally healthy adults showed that online delivery of the Strategic Memory Advanced Reasoning Training (SMART) significantly reduced symptoms of depression, anxiety, and stress after 12 weeks, as measured by the DASS-21 scale.

Improvements in mental health symptoms were not only observed immediately after the training but were also maintained or continued to improve 6 months later, suggesting that online SMART could be a sustainable and effective mental health intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of online brain training on self-reported mental health symptoms for generally healthy adults during the Covid-19 pandemic. Laane, SA., Cook, LG., Spence, JS., et al.[2023]

Out of 13 randomized controlled trials (RCTs) reviewed, some online health services, particularly those involving movement, relaxation exercises, and cognitive-behavioral approaches, showed improvements in stress-related outcomes for employees, especially in high-quality studies.

While some interventions were effective, the overall evidence is mixed, and no definitive conclusions can be made about which specific type of intervention works best, although longer interventions (at least 12 weeks) and those combining multiple strategies tended to be more successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Online Health Services for the Prevention of Stress-associated Psychological Impairments at the Workplace]. von Hofe, I., Latza, U., Lönnfors, S., et al.[2018]

The SMART-OP program, a self-guided multimedia stress management training, was found to significantly reduce stress and increase perceived control over stress in a study of 66 healthy participants compared to an attention control group.

Participants using SMART-OP showed better physiological recovery from stress during the Trier Social Stress Test, indicating its effectiveness in managing stress compared to traditional educational materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a self-guided, multimedia, stress management and resilience training program. Rose, RD., Buckey, JC., Zbozinek, TD., et al.[2022]

The RehaCom computerized cognitive training program significantly improved attention and memory functions in 50 brain injury patients after 60 training sessions, with all patients showing enhanced performance in the targeted areas.

The program was well-tolerated, with no reported negative effects such as mental fatigue, headache, or eye irritation, indicating its safety for use in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. Fernández, E., Bringas, ML., Salazar, S., et al.[2022]

The pilot study involving 40 healthcare professionals demonstrated that using the MUSE-S™ wearable brain sensing device for guided mindfulness significantly reduced stress and improved resilience, quality of life, and cognition over 90 days.

Participants reported high adherence to the device, using it an average of 23.8 times in 30 days, with no adverse effects noted, indicating that the device is safe and well-accepted among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Using a Wearable Brain Sensing Device for Health Care Professionals During a Pandemic: A Pilot Program. Ghosh, K., Nanda, S., Hurt, RT., et al.[2023]

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Study Details | NCT04869111 | The BrainHealth Project

Trainings include strategies to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize Training will ...

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The BrainHealth Project

Brain imaging data will be used with the online data to help understand the brain mechanisms driving individual differences in brain health changes over time.

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pmc.ncbi.nlm.nih.gov

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BrainHealth Research Demonstrates Positive Impact of ...

SMART training features strategies to strengthen the brain's frontal networks and achieve significant, measurable brain changes and improvements ...