Enhancing Attention and Wellbeing Using Digital Therapeutics

Not Applicable

Recruiting

• Conditions: Aging; MCI; Cognitive Decline
• Interventions: Device: MediTrain; Device: Worder

• Registration Number: NCT06397469
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10
• Primary Completion: 2029-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• 60+ years old (adult)
• English language fluency
• owning a smartphone or tablet

Exclusion Criteria

• Under 60 years old (minor)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MediTrain 30m/day for 6wks	MediTrain	Participants will engage with a digital meditation app for the time listed above.
MediTrain 15m/day for 6wks	MediTrain	Participants will engage with a digital meditation app for the time listed above.
MediTrain 30m/day for 3wks	MediTrain	Participants will engage with a digital meditation app for the time listed above.
MediTrain 15m/day for 3wks	MediTrain	Participants will engage with a digital meditation app for the time listed above.
Active Control Group	Worder	An 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 Measures

Name	Time	Method
Change on the Mobile Continuous Performance Task (CPT) over time	baseline, immediate follow-up, and at a 6 month follow-up	The CPT is a 23-minute task, where participants are instructed to respond to target stimuli (squares at the top of the screen) and withhold responses to non-target stimuli (squares at the bottom of the screen). Performance will be quantified as: (1) mean reaction times, (2) standard deviation of reaction times (RTV), and (3) d-prime (comparing correct target detections or 'hits' to incorrect non-target detections or 'false alarms').

Secondary Outcome Measures

Name	Time	Method
Change on the Adaptive Cognitive Evaluation (ACE) over time	baseline, immediate follow-up, and at a 6 month follow-up	The ACE is a mobile cognitive assessment tool, which includes a battery of cognitive control tests for rapid tests of cognition. The sub-tests (or 'modules') in ACE are adapted from standardized tasks to rapidly assess various aspects of cognition, including attention, memory, and multitasking. We will assess response time, accuracy, and response time variability in each case, with faster/more accurate/less variable performance being indicative of improved cognitive control.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States