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

Trial Summary

What is the purpose of this trial?

For an overview of the study and link TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/ The BrainHealth Project is a ten-year, longitudinal study focused on identifying determinants of brain health and performance. Participants will have the opportunity to complete semi-annual (twice a year) online assessments to track their performance over time. In between semi-annual assessments, participants will have access to online trainings and ongoing supplemental content regarding ways to optimize brain health and performance. Online one-on-one coaching sessions will be offered to participants to answer questions and provide support in applying the information to their daily lives. A small portion of participants will be invited to participate in the brain imaging portion of this study. 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 and performance.

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 data supports the effectiveness of the treatment Brain Health Training for Healthy Individuals?

Research shows that online health services, including stress management and resilience training, can help reduce stress and improve mental well-being. A study found that technology-based programs are effective for treating anxiety and depression, and another study confirmed improvements in stress-related outcomes with online interventions. ^{1 2 3 4 5}

How does this brain health training treatment differ from other treatments for brain health?

This brain health training treatment is unique because it focuses on self-directed and multimedia-based stress management and resilience training, which can be done without in-person sessions. Unlike traditional face-to-face cognitive-behavioral therapy, this approach uses online platforms to make stress management more accessible and convenient for healthy individuals. ^{1 4 6 7 8}

Research Team

Sandra B Chapman, PhD

Principal Investigator

Center for BrainHealth

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Bibliotherapy to decrease stress and anxiety and increase resilience and mindfulness: a pilot trial. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Mindfulness Using a Wearable Brain Sensing Device for Health Care Professionals During a Pandemic: A Pilot Program. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[Online Health Services for the Prevention of Stress-associated Psychological Impairments at the Workplace]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a self-guided, multimedia, stress management and resilience training program. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]

6. United States 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Stress Gym: Feasibility of deploying a web-enhanced behavioral self-management program for stress in a military setting. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Internet- and App-Based Stress Intervention for Distance-Learning Students With Depressive Symptoms: Protocol of a Randomized Controlled Trial. [2020]