Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376032
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-04-17
Brief Title:
EndeavorOTC Research Study in College Students
Sponsor:
Akili Interactive Labs Inc
Organization:
Akili Interactive Labs Inc
Study Overview
Official Title:
EndeavorOTC Research Study in College Students
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the impact of a digital therapeutic EndeavorOTC also known as AKL-T01A on clinical symptoms of executive and cognitive functioning in a real-world sample of university students This study aims to answer whether EndeavorOTC represents a useful intervention for targeting broad cognitive and emotional health among university students
Detailed Description:
University students face an increased risk of mental health challenges as well as elevated stress due to the demands of managing coursework and social stress during a formative developmental period with increased independence Consequently there is a need for scalable evidence-based interventions that can help university students manage their cognitive and emotional health Through a partnership between Akili Interactive Labs and participating colleges free 12-week access to AKL-T01 will be provided to any student interested in treatment for the duration of an academic semester up to an N of 500 per site This study will evaluate changes in participants across a range of clinical and functional outcomes including cognitive functioning academic outcomes social functioning attention and associated symptoms and quality of life The study will also evaluate user feedback and information on the usability of AKL-T01 through both quantitative and qualitative methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None