Examining the Effectiveness of Cognitive Training

NCT04344028 | Completed Results

• 4 other identifiers: 2019-13781R56AG063952-01A487400L&S/PSYCHOLOGY
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 3

Brief Summary

The present study addresses whether placebo effects can possibly account for previous findings in the field, as well as ascertains whether placebo-based mechanisms can be deliberately harnessed for impact. The design is a 2 (positive expectations/negative expectations) x 2 (true cognitive training intervention x control cognitive training intervention) Randomized Controlled Trial (RCT). Participants will be recruited from site-affiliated participant pools or email lists. Participants will first undergo a pre-test battery where various cognitive abilities are assessed via computerized programs. They will also fill out various surveys about personality traits/internal dispositions that may predict the extent to which they are susceptible to placebo effects. After pre-testing, participants will be randomized to an expectations group (positive/negative) and a training protocol (active/control). Participants are then given their group appropriate expectation script. In the positive expectations group, participants receive training described as having previous research supporting its use as a method to enhance cognitive abilities. In the negative expectations group, participants receive training described as having previous research suggesting that it is unlikely to change cognitive abilities or may even decrease cognitive abilities. The participants will then be given instructions regarding how to do their training task. Participants will be asked to complete 10 sessions of training within 15 days. The active training will be a standard working memory (N-back) training task. The control training will be a trivia/quiz training task. After they have completed 10 sessions, participants will complete a "mid-test" session to undergo a battery of perceptual/cognitive tasks. Participants will be told that the perceptual/cognitive tests are identical to those that they took at pre-test. However, in reality, for participants in the "positive expectations" groups, these will be altered to actually be easier than they were at pre-test. For participants in the "negative expectations" groups the tasks will be made more difficult. Participants will then be asked to complete another set of 10 training sessions on their devices within 15 days before completing the post-test. The post-test will be identical to the pre-test. All participants will then be extensively debriefed (e.g., all deceptions will be made clear). On a separate day, participants will then complete a second post-test that is identical to the pre-test and first-post test.

Conditions

Cognitive Change

Keywords

Cognitive Training

Outcome Measures

Primary Outcomes (12)

• Proportion of Correct Targets Identified Minus False Identifications in the n-Back Task

  The n-Back Task is a measure of working memory. The participant is sequentially shown a series of letters and is asked to indicate whether the current letter matches the letter presented "n" items before. The n levels range between 1- and 3-back. Each level of n-back has 17-19 letters, with 5 target letters. The dependent measure is the proportion of correctly identified targets minus the proportion of incorrectly identified non-targets. Scores range from 0-1. Higher scores indicate better performance.

  post-test 1 at 25 days, post-test 2 at 34 days

• Number of Correctly Recalled Letter Sets in the O-Span Task

  The O-Span Task is a measure of working memory. In each trial, the participant is alternately presented with a simple math equation and a letter and then is asked to recall the sequence of letters in order. The participant will complete 15 trials, which vary between 3-7 math problem/letter pairs. The dependent measure is the total number of letters in correctly recalled trials. Scores range from 0 to 75. Higher scores indicate better performance.

  post-test 1 at 25 days, post-test 2 at 34 days

• Difference in Response Time Between Switch Trials and Non-switch Trials (Switch Cost) in the Task Switching Task

  The Task Switching task is a measure of cognitive flexibility. On each trial, participants view a letter and a digit. The location of the pair instructs the participants to either categorize the letter as a consonant or vowel or else categorize the digit as even or odd. Trials can be either "non-switch trials" - in which the participant is asked to perform the same task as on the previous trial - or "switch trials" - in which the participant is asked to perform the opposite task as on the previous trial. The participant will complete 48 trials. A "switch cost" is calculated by subtracting the average response time for non-switch trials from the average response time for switch trials (milliseconds). Lower scores indicate better performance.

  post-test 1 at 25 days, post-test 2 at 34 days

• Difference in Response Time Between Switch Trials and Non-switch Trials (Switch Cost) in the Countermanding Task

  The Countermanding task is a measure of cognitive flexibility. Participants are presented with two types of stimuli on either the right or the left side of the screen and are required to tap on one of two buttons on either the same side as the stimulus or on the opposite side of the stimulus. Trials can be either "non-switch trials" - in which the participant is asked to perform the same task as on the previous trial - or "switch trials" - in which the participant is asked to perform the opposite task as on the previous trial. The participant will complete 48 trials. A switch cost is calculated by subtracting the average response time for non-switch trials from the average response time for switch trials (in milliseconds). Lower scores indicate better performance.

  post-test 1 at 25 days, post-test 2 at 34 days

• Threshold of Response Time in the Useful Field of View (UFOV) Task

  The UFOV is a measure of visual selective attention. Participants are briefly presented with a display consisting of 24 items (3 on each of the four radial spokes and the four obliques; evenly spaced). One of the items is a target, while the remaining items are distractors. The participants' task is to indicate upon which of the 8 spokes the target appeared. The display times vary between 16-500ms. The task uses an adaptive staircase procedure, in which the display times increase or decrease based on the participant's performance, to calculate the participant's response threshold in milliseconds. Lower threshold scores indicate better performance

  post-test 1 at 25 days, post-test 2 at 34 days

• Difference in Response Time of Compatible Trials and Incompatible Trials in the Attentional Network Task (ANT)

  The ANT is a measure of visual selective attention. On each trial, participants view a center arrow that faces either left or right. The arrow can be flanked on either side by either response compatible arrows (i.e., arrows facing in the same direction as the center arrow) or response incompatible arrows (i.e., facing the other direction). The participants' task is to indicate the direction that the center arrow is pointing. Participants will complete 96 trials. The compatibility effect is calculated by subtracting the average response time of compatible trials from the average response time of incompatible trials (in milliseconds). Lower scores indicate better performance.

  post-test 1 at 25 days, post-test 2 at 34 days

• Proportion of Correct Responses on the Mental Rotation Task

  The mental rotation task is a measure of spatial cognition. Each trial displays two 2-D images, and the participant is asked whether the image on the right is a rotated version or a mirror-reserved and rotated version of the image on the left. The participant will complete 36 trials.

  post-test 1 at 25 days, post-test 2 at 34 days

• Proportion of Correct Responses in the Paper Folding Task

  The Paper Folding task is a measure of mental rotation. Participants are shown 2-4 images depicting a piece of paper being folded with a hole being punched after the last fold. The participant is asked to imagine and indicate what the paper would look like unfolded. The participant will complete 10 trials.

  post-test 1 at 25 days, post-test 2 at 34 days

• Proportion of Correct Responses in Raven's Advanced Progressive Matrices Task

  Raven's Advanced Progressive Matrices task is a measure of fluid intelligence. The participant is presented with a grid of elements with one of the elements missing and is asked to identify the missing element that completes the grid pattern. The participant will complete 14 trials.

  post-test 1 at 25 days, post-test 2 at 34 days

• Proportion of Correct Responses in the UC Matrix Reasoning Task

  The UC Matrix Reasoning task is a measure of fluid intelligence. The participant is presented with a grid of elements with one of the elements missing and is asked to identify the missing element that completes the grid pattern. The participant will complete 16 trials.

  post-test 1 at 25 days, post-test 2 at 34 days

• Proportion of Correct Responses in the Mill-Hill Vocabulary Scale

  In this vocabulary task, participants are asked to select the appropriate synonym for a target word among several alternatives for 25 words.

  post-test 1 at 25 days, post-test 2 at 34 days

• Proportion of Correct Responses in the Shipley Institute of Living Scale

  Participants will complete Part I of the Shipley Institute of Living Scale, which is a measure of vocabulary. Participants are asked to select the appropriate synonym for a target word among several alternatives for 15 words.

  post-test 1 at 25 days, post-test 2 at 34 days

Study Arms (4)

True Cognitive Training Placebo

EXPERIMENTAL

Participants will receive a positive expectation message (e.g., "Previous research has shown that training with this program improves performance on other tasks.") and will complete approximately 7 hours of a cognitive training program that has previously been shown to improve cognition.

Behavioral: True Cognitive Training Program; Behavioral: Positive Expectation Induction

True Cognitive Training Nocebo

ACTIVE COMPARATOR

Participants will receive a negative expectation message (e.g., "Previous research has shown that training with this program decreases performance on other tasks.") and will complete approximately 7 hours of a cognitive training program that has previously been shown to improve cognition.

Behavioral: True Cognitive Training Program; Behavioral: Negative Expectation Induction

Control Cognitive Training Placebo

PLACEBO COMPARATOR

Participants will receive a positive expectation message (e.g., "Previous research has shown that training with this program increases performance on other tasks.") and will complete approximately 7 hours of control training program that has not previously been shown to improve cognition.

Behavioral: Control Cognitive Training Program; Behavioral: Positive Expectation Induction

Control Cognitive Training Nocebo

SHAM COMPARATOR

Participants will receive a negative expectation message (e.g., "Previous research has shown that training with this program decreases performance on other tasks.") and will complete approximately 7 hours of control training program that has not previously been shown to improve cognition.

Behavioral: Control Cognitive Training Program; Behavioral: Negative Expectation Induction

Interventions

True Cognitive Training Program BEHAVIORAL

The training program is a personal device-based adaptive version of a visual N-back task.

True Cognitive Training Nocebo; True Cognitive Training Placebo

Control Cognitive Training Program BEHAVIORAL

The training program is a personal device-based adaptive version of a knowledge task (control).

Control Cognitive Training Nocebo; Control Cognitive Training Placebo

Positive Expectation Induction BEHAVIORAL

The message given to the participants emphasizes that the given training results in a positive change in cognitive abilities.

Control Cognitive Training Placebo; True Cognitive Training Placebo

Negative Expectation Induction BEHAVIORAL

The message given to the participants emphasizes that the given training results in a negative change in cognitive abilities.

Control Cognitive Training Nocebo; True Cognitive Training Nocebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported normal or corrected-to-normal vision
• No known neurological impairments (this includes any neurological impairments that would negatively impact participants' ability to perform perceptual or cognitive tasks or to complete long-term cognitive training; this could include neurological damage due to stroke in various brain areas; seizure conditions that would preclude the ability to view flashing images; motor control issues that preclude the ability to respond via button presses; etc.).
• Access to the internet, a computer, and a hand-held device, such as a cell phone or tablet (online version only)

You may not qualify if:

• Self-reported non-normal or non-corrected-to-normal vision
• Neurological impairments
• No access to the internet, a computer, or a hand-held device (online version only)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• University of California, Riverside: collaborator
• University of California, Irvine: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

University of California, Irvine

Irvine, California, 92697, United States

Location

University of California, Riverside

Riverside, California, 92521, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

Location

Related Publications (28)

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Results Point of Contact

• Title: Dr. C. Shawn Green
• Organization: University of Wisconsin - Madison

csgreen2@wisc.edu

(608) 263-4868

Study Officials

• Aaron Seitz, PhD

  University of California, Riverside

  PRINCIPAL INVESTIGATOR

• Susanne Jaeggi, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Researchers and participants will be blind to the conditions assigned to the participant.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The design is a 2 (positive expectations/negative expectations) x 2 (true cognitive training intervention x control cognitive training intervention) randomized controlled trial.

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 14, 2020
• Study Start: May 11, 2020
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: May 6, 2025
• Results First Posted: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available persistently at the conclusion of the study.
• Access Criteria: There are no access criteria.

Locations

US (3)