EndeavorOTC® Research Study in College Students

Akili Interactive Labs

Status: Active, not recruiting

Conditions: University Students; Cognition; Attention

Treatments: Device: EndeavorOTC®

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06376032

Akili-068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Owns a personal Android or iOS device to access AKL-T01 treatment
• Provides informed consent to participate in this study
• Is 18 years of age or older

Exclusion criteria

• Known photosensitive epilepsy, color blindness, and any physical limitation that would make engagement with an app-based digital intervention difficult
• Has participated in the same study in previous semesters

Pregnant and nursing people are eligible to participate.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Group 1

Experimental group

Description:

Participants receive immediate 12-week access to EndeavorOTC.

Treatment:

Device: EndeavorOTC®

Group 2

Experimental group

Description:

Participants receive 12-week access to EndeavorOTC 6-weeks after Group 1.

Treatment:

Device: EndeavorOTC®