Clinical trial NCT06375681: Effectiveness of Cognitive Training in Older and Younger Adults
Official title: Examining the Effectiveness of Cognitive Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Change
Keywords: Cognitive Training
Training task
Testing context
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-04-19
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Following Pre-testing, participants randomly assigned into the full study will be further randomly assigned to a total of 9 unique experimental conditions for the full 2x2x2+1 factorial design.

The full description of the study's 9 arms will be registered after data collection is completed to preserve the scientific integrity of the study.
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed study will enroll 1600 participants to examine the effectiveness of cognitive training. Participants will be randomized into different experimental groups and can expect to participate for up to 15 hours of research over 4 to 8 weeks.

Detailed description: Participants will first complete two sessions (\~75 minutes each) where they are asked to view visual stimuli (such as black and white lines, letters, simple shapes like triangles, circles, and squares) presented on a computer or television screen and/or listen to auditory stimuli (such as pure tones) presented via headphone or speakers. They will be asked to make some simple judgments about the stimuli (such as indicating whether the stimulus you observed is the same or different from that on a previous trial), and indicate their judgment decision with a button press on a keyboard, a mouse click, or a movement on a touchpad. They will also be asked to complete a set of questionnaires.

After the initial sessions, participants may be asked to complete two sets of 10 sessions (\~20 minutes) of cognitive tasks either at home or in the lab. Each set of sessions should be completed over a period of no more than 15 days. If asked to do these sessions, instructions will be given regarding the tasks to complete in these training sessions (which will be similar to some of the tasks you complete in the first two sessions, \~20 minutes) prior to these sessions.

After completing the first set of 10 sessions, participants will return to the lab to complete one session (\~75 minutes) of tasks similar to the first sessions. Participants who were not asked to complete the 20-minute sessions will come back to the lab about two weeks after the first two 75-minute sessions.

After this 75-minute session, participants will be asked to come back to the lab after completing the second set of 20-minute sessions, or after about two weeks for those not asked to complete the 20-minute sessions of cognitive tasks.

Finally, after a couple of weeks, participants will come back for two final testing sessions (\~45 minutes each).

The total duration of the study will be around 8 hours if not asked to complete the twenty 20-minute sessions, or 15 hours if asked to complete these sessions. The whole experiment runs over the course of 4 to 8 weeks.

\*To maintain scientific integrity, certain details of this study will not be shared until all data has been collected.

Eligibility criteria: Inclusion Criteria:

* Self-reported normal or corrected-to-normal vision
* No known neurological impairments

Exclusion Criteria

* Abnormal visual acuity prohibitive of training
* History of seizures, focal brain lesion, or head injury with loss of consciousness in the past year
* Physical handicap (motor or perceptual) that would impede training procedures
* Medical illness requiring treatment during the study timeline
* Social, educational or economic hardship prohibitive to training schedule
* Concurrent enrollment in other cognitive training studies
* History of major psychiatric illness, including psychosis, bipolar disorder, alcohol or substance abuse, recent bereavement
* Score of 5 or more (i.e. presence of mild, moderate, or severe depression) on the Patient Health Screening Questionnaire (PHQ-9 Depression Screening); any participants reporting suicidal tendencies will be immediately referred to the site-specific Emergency Psychiatry Services (24-hour availability), and those with high depressive symptoms will be referred to their personal physician
* Current alcohol consumption that exceeds 14 drinks per week
* Illicit drug use
* Plans to travel out of the area for more than 1 week during the intervention period
* Residence too far from the testing site, which would prevent attending the testing sessions (\> 60 miles)
* Not being proficient enough in English that would prevent following and understanding all instructions and completing all testing sessions (typically, participants would need to have learned English before age 11; there might be some exceptions that will be decided on a case-by-case basis).

Additional exclusion criteria for older adults:

* Diagnosis of dementia or other neurological disease, including mild cognitive impairment (MCI)
* Score \< 26 (out of 30) on the Mini Mental State Exam (MMSE)
* Score \< 18 (out of 22) on the Telephone Montreal Cognitive Assessment (T-MoCA).

Primary outcomes:
measure: Change in the difference between the proportion of hits minus false alarms for a given level of the N-back task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the proportion of correctly reported sequences in the Corsi Complex task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the proportion of correctly reported number and letter sets in the Letter-Number task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the difference of response time and accuracy in switch trials minus non-switch trials in the Task Switching Task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the difference of response time in (i) switch trials minus non-switch trials and (ii) congruent minus incongruent trials in the Flanker Task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the proportion of correctly identified targets in the mixed condition of the Cancellation task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the proportion of correct responses on the Useful Field of View (UFOV) Task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the proportion of correct responses on the Multiple Object Tracking (MOT) Task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the response time and percentage of correct responses in the Mental Rotation Task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the percentage of correct responses in the Paper Folding task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the sum of correctly solved items in Raven's Advanced Progressive Matrices task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the sum of correctly solved items in the UC Matrix Reasoning task
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the percentage of accuracy in the Shipley Institute of Living Scale
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
measure: Change in the percentage of accuracy in the Mill-Hill Vocabulary Scale
timeFrame: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days
Secondary outcomes:
measure: Big-5-Inventory 10-item version (BFI-10) Score
timeFrame: Pre-Test
measure: Behavioral Inhibition/Activation System (BIS/BAS) Score
timeFrame: Pre-Test
measure: Grit and Conscientiousness Score
timeFrame: Pre-Test
measure: Meta-Cognition Score
timeFrame: Pre-Test
measure: Theories of Intelligence - Mindset (Fixed vs Growth) Score
timeFrame: Pre-Test
measure: Schutte self-report emotional intelligence test (SSEIT) Score
timeFrame: Pre-Test
measure: Work and Family Orientation (WOFO) Score
timeFrame: Pre-Test
measure: Brief Pittsburgh Sleep Quality Index (B-PSQI) Score
timeFrame: Pre-Test
measure: Participant Experience Measure 1
timeFrame: End of Post-Test (up to 60 days)
measure: Participant Experience Measure 2
timeFrame: End of Post-Test (up to 60 days)
measure: Participant Experience Measure 3
timeFrame: End of Post-Test (up to 60 days)
measure: Participant Experience Measure 4
timeFrame: Beginning of Post-Test (up to 60 days)
measure: Participant Experience Measure 5
timeFrame: Beginning of Post-Test (up to 60 days)
Other outcomes:
Locations:
city: Riverside
country: United States
facility: University of California, Riverside
state: California
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of California, Riverside
name: Aaron R. Seitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeastern University
name: Susanne M. Jaeggi, PhD
role: PRINCIPAL_INVESTIGATOR
References: