Enhancing Attention and Wellbeing Using Digital Therapeutics
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT06397469
- Status
- Recruiting
Conditions
- Aging
- Cognitive Decline
- MCI
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - 99 Years
- Healthy Volunteers
- Accepted
Interventions
- MediTrain — DEVICEMediTrain is a tablet-based, meditation-inspired, cognitive training game aimed at improving self-regulation of internal attention and distractions. It was developed in collaboration with meditation thought-leader Jack Kornfield, and Zynga, a world-class video game company. It was created to make benefits of concentrative meditation more easily accessible to anyone, including complete novices. This is achieved by creating a game that yields quantifiable and attainable goals, provides feedback, and includes an adaptive algorithm to gradually increase difficulty as users improve.
- Worder — DEVICEWorder was designed to enhance visual motor and visual spatial skills in individuals of all ages and cognitive abilities. Visual processing is required for all cognitive abilities that involve vision including attention, working memory, and task management. Worder's goal is to improve cognitive function more broadly by developing this critical skill underlying multiple abilities.
Study Details
The goals of the proposed research are to first determine the minimal and/or optimal dose of a digital intervention required for cognitive enhancement, and then to examine the impact of several potential moderators of treatment effects (i.e., cognitive decline, AD polygenic hazard score, cardiovascular risk, and race/ethnicity). This knowledge gained from his high-impact study with transform the field of cognitive interventions, paving the way for a precision medicine model for cognitive enhancing interventions that improve quality of life for older adults and individuals with cognitive deficits at risk of developing dementia.
Key Dates
- Start date
- Apr 1, 2024
- Status verified
- Feb 2026
- Primary completion
- Jan 31, 2029
- Completion
- Jun 30, 2029
Study Design
- Enrollment
- 4,000 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: MediTrain 30m/day for 6wksParticipants will engage with a digital meditation app for the time listed above.
- Experimental: MediTrain 15m/day for 6wksParticipants will engage with a digital meditation app for the time listed above.
- Experimental: MediTrain 30m/day for 3wksParticipants will engage with a digital meditation app for the time listed above.
- Experimental: MediTrain 15m/day for 3wksParticipants will engage with a digital meditation app for the time listed above.
- Active Comparator: Active Control GroupAn active control application will be used for this arm. The total training experience here will be for 6 weeks (5 days/week), with each training session lasting \~30 minutes (not including self-paced breaks). Here an app that is matched in terms of expectancy of benefits compared to our training groups will be determined by questioning 100 naïve individuals to predict their expected improvement on each cognitive domain across a multitude of possible applications.
Primary Outcome Measure
Change on the Mobile Continuous Performance Task (CPT) over time [ Time Frame: baseline, immediate follow-up, and at a 6 month follow-up ]
Central Contacts
- David Ziegler, PhD4154762164
- Monique de Villa, MS, MPH209-233-3878
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94158 |
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