Trial Outcomes & Findings for The BrainHealth Project - Pilot Study (NCT NCT04621240)

Last Updated: 2024-09-23

Results Overview

The BrainHealth Index is a composite score of 22 individual measures encompassing four components of brain health, including (1) cognitive performance, (2) mental well-being, (3) daily life functioning (e.g., sleep, fitness, activities), and (4) social interactions/engagement. \[Composite score min value = 30, Composite score max value = 82, higher composite score = better outcome\]

Recruitment status

COMPLETED

Study phase

Target enrollment

180 participants

Primary outcome timeframe

3 months

Results posted on

2024-09-23

Participant Flow

Recruitment was all online and took place between March - Aug 2020

200 participants were screened and 180 were enrolled

Participant milestones

Participant milestones
Measure	Online SMART Intervention & Stress Solutions Strategic Memory Advanced Reasoning Training (SMART) teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance Online SMART \& Stress Solutions: 1. On-line SMART - (Strategic Memory Advanced Reasoning Training) is a curriculum that teaches strategies of how to use the brain better, in such a way that may improve brain health and performance. SMART strives to achieve optimal cognitive function realized by the brain's ability to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize details, and to prioritize the information in order to attend to the most relevant parts. 2. Stress Solutions - provides individuals with practical tools to enhance performance, reduce stress, build resilience and improve quality of life.
Overall Study STARTED	180
Overall Study BrainHealth Index #1	180
Overall Study Online Training	174
Overall Study BrainHealth Index #2	144
Overall Study COMPLETED	144
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Online SMART Intervention & Stress Solutions Strategic Memory Advanced Reasoning Training (SMART) teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance Online SMART \& Stress Solutions: 1. On-line SMART - (Strategic Memory Advanced Reasoning Training) is a curriculum that teaches strategies of how to use the brain better, in such a way that may improve brain health and performance. SMART strives to achieve optimal cognitive function realized by the brain's ability to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize details, and to prioritize the information in order to attend to the most relevant parts. 2. Stress Solutions - provides individuals with practical tools to enhance performance, reduce stress, build resilience and improve quality of life.
Overall Study Withdrawal by Subject	36

Baseline Characteristics

The BrainHealth Project - Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Online SMART Intervention & Stress Solutions n=180 Participants Strategic Memory Advanced Reasoning Training (SMART) teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance Online SMART \& Stress Solutions: 1. On-line SMART - (Strategic Memory Advanced Reasoning Training) is a curriculum that teaches strategies of how to use the brain better, in such a way that may improve brain health and performance. SMART strives to achieve optimal cognitive function realized by the brain's ability to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize details, and to prioritize the information in order to attend to the most relevant parts. 2. Stress Solutions - provides individuals with practical tools to enhance performance, reduce stress, build resilience and improve quality of life.
Age, Continuous	55.0 years n=5 Participants
Sex: Female, Male Female	129 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	150 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	11 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	19 Participants n=5 Participants
Region of Enrollment United States	180 participants n=5 Participants
BrainHealth Index	54 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Of the 180 generally healthy adults who completed their online baseline assessments, 144 completed their 3-month follow-up assessments.

Outcome measures

Outcome measures
Measure	Online SMART Intervention & Stress Solutions n=144 Participants Strategic Memory Advanced Reasoning Training (SMART) teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance Online SMART \& Stress Solutions: 1. On-line SMART - (Strategic Memory Advanced Reasoning Training) is a curriculum that teaches strategies of how to use the brain better, in such a way that may improve brain health and performance. SMART strives to achieve optimal cognitive function realized by the brain's ability to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize details, and to prioritize the information in order to attend to the most relevant parts. 2. Stress Solutions - provides individuals with practical tools to enhance performance, reduce stress, build resilience and improve quality of life.
The BrainHealth Index	54 score on a scale Interval 30.0 to 82.0

Adverse Events

Online SMART Intervention & Stress Solutions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Erin Venza

Center for BrainHealth at the University of Texas at Dallas

Phone: 972-883-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place