Enhancing Attention and Wellbeing Using Digital Therapeutics
Optimizing a Closed-loop Digital Meditation Intervention for Remediating Cognitive Decline and Reducing Stress in Older Adults
2 other identifiers
interventional
4,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
April 23, 2024
CompletedFirst Posted
Study publicly available on registry
May 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
February 24, 2026
February 1, 2026
4.8 years
April 23, 2024
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change on the Mobile Continuous Performance Task (CPT) over time
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').
baseline, immediate follow-up, and at a 6 month follow-up
Secondary Outcomes (1)
Change on the Adaptive Cognitive Evaluation (ACE) over time
baseline, immediate follow-up, and at a 6 month follow-up
Other Outcomes (10)
Mean Change on Everyday Cognition Scale (ECog)
baseline, immediate follow-up, and at a 6 month follow-up
Mean Change on Pittsburgh Sleep Quality Index (sleep)
baseline, immediate follow-up, and at a 6 month follow-up
Mean Change on Framingham Cardiovascular Risk Score
baseline, immediate follow-up, and at a 6 month follow-up
- +7 more other outcomes
Study Arms (5)
MediTrain 30m/day for 6wks
EXPERIMENTALParticipants will engage with a digital meditation app for the time listed above.
MediTrain 15m/day for 6wks
EXPERIMENTALParticipants will engage with a digital meditation app for the time listed above.
MediTrain 30m/day for 3wks
EXPERIMENTALParticipants will engage with a digital meditation app for the time listed above.
MediTrain 15m/day for 3wks
EXPERIMENTALParticipants will engage with a digital meditation app for the time listed above.
Active Control Group
ACTIVE COMPARATORAn 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.
Interventions
MediTrain 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 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.
Eligibility Criteria
You may qualify if:
- + years old (adult)
- English language fluency
- owning a smartphone or tablet
You may not qualify if:
- Under 60 years old (minor)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Francisco
San Francisco, California, 94158, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Gazzaley, MD/PhD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
David Ziegler, PhD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2024
First Posted
May 3, 2024
Study Start
April 1, 2024
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share