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Recruiting

NCT Number: NCT06397469

Enhancing Attention and Wellbeing Using Digital Therapeutics

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.

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Key information

Age range

60 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94158, United States

Location status: Recruiting

Location contact

David Ziegler, PhD

CONTACT

[email protected]

415-476-2164

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Under 60 years old (minor)

Treatment and study plan

MediTrain

Device

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

Device

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.

Primary outcomes

  1. 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').

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Ziegler, PhD

CONTACT

[email protected]

4154762164

Monique de Villa, MS, MPH

CONTACT

[email protected]

209-233-3878

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
May 3, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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