ClinicalTrials.gg
RecruitingNCT06397469Updated Aug 24, 2026

Enhancing Attention and Wellbeing Using Digital Therapeutics

An interventional study of MediTrain and Worder in Aging, MCI and Cognitive Decline, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 60 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
4,000
Allocation
Randomized
Ages
60 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aging
  • MCI
  • Cognitive Decline

Keywords

  • healthy aging
  • attention
  • cognition
  • dementia
  • intervention
  • digital
  • behavioral
  • prevention
  • decline
  • stress reduction
  • Quality of life
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Under 60 years old (minor)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
4,000 participants (estimated)

Study arms

  • Experimental
    MediTrain 30m/day for 6wks

    Participants will engage with a digital meditation app for the time listed above.

    Device: MediTrain

  • Experimental
    MediTrain 15m/day for 6wks

    Participants will engage with a digital meditation app for the time listed above.

    Device: MediTrain

  • Experimental
    MediTrain 30m/day for 3wks

    Participants will engage with a digital meditation app for the time listed above.

    Device: MediTrain

  • Experimental
    MediTrain 15m/day for 3wks

    Participants will engage with a digital meditation app for the time listed above.

    Device: MediTrain

  • Active comparator
    Active Control Group

    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.

    Device: Worder

Interventions

  • DeviceMediTrain

    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.

  • DeviceWorder

    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.

06

What researchers measure

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').

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

Secondary outcomes

  1. Change on the Adaptive Cognitive Evaluation (ACE) over time

    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.

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

Other outcomes

  1. Mean Change on Everyday Cognition Scale (ECog)

    • Mean Change on Everyday Cognition Scale (ECog) The Everyday Cognition Scale (ECog) measures the ability to perform everyday tasks that demand memory, language, visuospatial abilities, planning, organization, and divided attention. The ECog consists of a global and domain scores for each of the previously described categories, and is scored as follows: 1= better or no change compared to 10 years earlier, 2= questionable/occasionally worse compared to 10 years earlier, 3= consistently a little worse compared to 10 years earlier, 4= consistently much worse compared to 10 years earlier. Thus, the lower the overall score is on this measure at both the global and domain score level, the better one is performing with respect to their cognition.

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

  2. Mean Change on Pittsburgh Sleep Quality Index (sleep)

    • Pittsburgh Sleep Quality Index (sleep) The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Overall scores range from 0 to 21, with lower scores representing healthier sleep quality. We will report change in means over time.

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

  3. Mean Change on Framingham Cardiovascular Risk Score

    • Framingham Cardiovascular Risk Score The Framingham Risk Score is a sex-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. We will use the BMI version of the score. Scores range from 0-100% risk of cardiac event or death. We will report change in means over time.

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

  4. Mean Change on SF-36 (overall health)

    • SF-36 (overall health) The general health and well-being (SF-36) score assesses participant health. The SF-36 score ranges from 0 to 100. The higher the overall score is on this measure, the better one is performing with respect to their health and well-being.

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

  5. Mean Change on Cognitive Failures Questionnaire

    • Cognitive Failures Questionnaire (Distractibility) The Cognitive Failures Questionnaire (CFQ) assesses participant distractibility. The CFQ score ranges from 0 to 100, with the lower the overall score is on this measure, the better one is performing with respect to their cognition.

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

  6. Mean Change on Perceived Stress Scale

    • Perceived Stress Scale A survey that measures the degree to which situations in one's life are perceived as stressful. Scores range from 0 to 40 with higher scores representing more perceived stress. We will report change in means over time.

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

  7. Mean Change on UCLA 3-item Loneliness Scale

    * UCLA 3-item Loneliness Scale This is a very short 3-item measure that assesses how often a person feels disconnected from others. Scores range from 0-3 with 3 representing more loneliness. We will report change in means over time.

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

  8. Mean Change on GAD-7 (anxiety)

    • GAD-7 (anxiety) The GAD-7 is a 7-item screening tool for generalized anxiety disorder. GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety. We will report change in means over time.

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

  9. Mean Change on PHQ-9 (depression)

    • PHQ-9 (depression) The PHQ-9 is a 9-item scale that objectifies the degrees of depression severity a person is experiencing. Scores range from 0-27 with higher scores representing more depression. Scores at or below 4 suggest minimal or no depression. We will report change in means over time.

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

  10. Mean Change on Emotional Regulation Questionnaire

    • Emotional Regulation Questionnaire A survey assessing a person's ability to manage and respond to emotional experiences. Scores range from 6 to 42 with higher scores representing more positive emotions. We will report change in means over time.

    Time frame: baseline, immediate follow-up, and at a 6 month follow-up

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Jan 2029, 57 months after the start.

Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 57 months is above that.

Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2024
First posted
May 3, 2024
StartActual
Apr 1, 2024
Primary completionEst.
Jan 1, 2029
CompletionEst.
Jun 1, 2029
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06397469
Responsible party
Sponsor
First posted
May 3, 2024
Start date
Apr 1, 2024
Primary completion
Jan 1, 2029 (estimated)
Completion
Jun 1, 2029 (estimated)
Last update
Aug 24, 2026

Study contacts

David Ziegler, PhD
Contact
david.ziegler@ucsf.edu
4154762164
Monique de Villa, MS, MPH
Contact
meditrain@ucsf.edu
209-233-3878
Adam Gazzaley, MD/PhD
principal investigator · University of California, San Francisco
David Ziegler, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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