Enhancing Attention and Wellbeing Using Digital Therapeutics

February 20, 2026 updated by: University of California, San Francisco

Optimizing a Closed-loop Digital Meditation Intervention for Remediating Cognitive Decline and Reducing Stress in Older Adults

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 60 years old (minor)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MediTrain 30m/day for 6wks
Participants will engage with a digital meditation app for the time listed above.
Device: MediTrain
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.
Experimental: MediTrain 15m/day for 6wks
Participants will engage with a digital meditation app for the time listed above.
Device: MediTrain
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.
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
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.
Experimental: MediTrain 30m/day for 3wks
Participants will engage with a digital meditation app for the time listed above.
Device: MediTrain
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.
Experimental: MediTrain 15m/day for 3wks
Participants will engage with a digital meditation app for the time listed above.
Device: MediTrain
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on the Mobile Continuous Performance Task (CPT) over time
Time Frame: 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').
baseline, immediate follow-up, and at a 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on the Adaptive Cognitive Evaluation (ACE) over time
Time Frame: 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.
baseline, immediate follow-up, and at a 6 month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change on Everyday Cognition Scale (ECog)
Time Frame: baseline, immediate follow-up, and at a 6 month follow-up
• 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.
baseline, immediate follow-up, and at a 6 month follow-up
Mean Change on Pittsburgh Sleep Quality Index (sleep)
Time Frame: baseline, immediate follow-up, and at a 6 month follow-up
• 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.
baseline, immediate follow-up, and at a 6 month follow-up
Mean Change on Framingham Cardiovascular Risk Score
Time Frame: baseline, immediate follow-up, and at a 6 month follow-up
• 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.
baseline, immediate follow-up, and at a 6 month follow-up
Mean Change on SF-36 (overall health)
Time Frame: baseline, immediate follow-up, and at a 6 month follow-up
• 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.
baseline, immediate follow-up, and at a 6 month follow-up
Mean Change on Cognitive Failures Questionnaire
Time Frame: baseline, immediate follow-up, and at a 6 month follow-up
• 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.
baseline, immediate follow-up, and at a 6 month follow-up
Mean Change on Perceived Stress Scale
Time Frame: baseline, immediate follow-up, and at a 6 month follow-up
• 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.
baseline, immediate follow-up, and at a 6 month follow-up
Mean Change on UCLA 3-item Loneliness Scale
Time Frame: baseline, immediate follow-up, and at a 6 month follow-up
  • 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.
baseline, immediate follow-up, and at a 6 month follow-up
Mean Change on GAD-7 (anxiety)
Time Frame: baseline, immediate follow-up, and at a 6 month follow-up
• 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.
baseline, immediate follow-up, and at a 6 month follow-up
Mean Change on PHQ-9 (depression)
Time Frame: baseline, immediate follow-up, and at a 6 month follow-up
• 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.
baseline, immediate follow-up, and at a 6 month follow-up
Mean Change on Emotional Regulation Questionnaire
Time Frame: baseline, immediate follow-up, and at a 6 month follow-up
• 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.
baseline, immediate follow-up, and at a 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Adam Gazzaley, MD/PhD, University of California, San Francisco
  • Principal Investigator: David Ziegler, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG076668
  • 5R01AG076668 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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