Enhancing Attention and Wellbeing Using Digital Therapeutics

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397469
• Other study ID #: AG076668
• Secondary ID: 5R01AG076668
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 2029

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: David Ziegler, PhD
• Phone: 4154762164
• Email: david.ziegler[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: June 2029
• Est. primary completion date: June 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

Inclusion Criteria:

• 60+ years old (adult)

• English language fluency

• owning a smartphone or tablet

Exclusion Criteria:

• Under 60 years old (minor)

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction
• MCI

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	baseline, immediate follow-up, and at a 6 month follow-up
Other	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.	baseline, immediate follow-up, and at a 6 month follow-up
Other	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.	baseline, immediate follow-up, and at a 6 month follow-up
Other	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.	baseline, immediate follow-up, and at a 6 month follow-up
Other	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.	baseline, immediate follow-up, and at a 6 month follow-up
Other	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.	baseline, immediate follow-up, and at a 6 month follow-up
Other	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.	baseline, immediate follow-up, and at a 6 month follow-up
Other	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.	baseline, immediate follow-up, and at a 6 month follow-up
Other	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.	baseline, immediate follow-up, and at a 6 month follow-up
Other	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.	baseline, immediate follow-up, and at a 6 month follow-up
Primary	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	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.	baseline, immediate follow-up, and at a 6 month follow-up