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Examining the Effectiveness of Cognitive Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344028
Recruitment Status : Enrolling by invitation
First Posted : April 14, 2020
Last Update Posted : June 30, 2022
Sponsor:
Collaborators:
University of California, Riverside
University of California, Irvine
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment Phase
Cognitive Change Behavioral: True Cognitive Training Program Behavioral: Control Cognitive Training Program Behavioral: Positive Expectation Induction Behavioral: Negative Expectation Induction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The design is a 2 (positive expectations/negative expectations) x 2 (true cognitive training intervention x control cognitive training intervention) randomized controlled trial.
Masking: Double (Participant, Investigator)
Masking Description: Researchers and participants will be blind to the conditions assigned to the participant.
Primary Purpose: Basic Science
Official Title: Examining the Potential for Placebo Effects in Cognitive Training
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Experimental: True Cognitive Training Placebo
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
The training program is a personal device-based adaptive version of a visual N-back task.

Behavioral: Positive Expectation Induction
The message given to the participants emphasizes that the given training results in a positive change in cognitive abilities.

Active Comparator: True Cognitive Training Nocebo
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
The training program is a personal device-based adaptive version of a visual N-back task.

Behavioral: Negative Expectation Induction
The message given to the participants emphasizes that the given training results in a negative change in cognitive abilities.

Placebo Comparator: Control Cognitive Training Placebo
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
The training program is a personal device-based adaptive version of a knowledge task (control).

Behavioral: Positive Expectation Induction
The message given to the participants emphasizes that the given training results in a positive change in cognitive abilities.

Sham Comparator: Control Cognitive Training Nocebo
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
The training program is a personal device-based adaptive version of a knowledge task (control).

Behavioral: Negative Expectation Induction
The message given to the participants emphasizes that the given training results in a negative change in cognitive abilities.




Primary Outcome Measures :
  1. Change in the difference between proportion of correct targets identified and false identifications in the n-Back Task [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    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 4-back. Each level of n-back has 17-19 letters, with 5 target letters.

  2. Change in the sum of correctly recalled letters in the O-Span Task [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    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.

  3. Change in the difference in response time between switch trials and non-switch trials in the Task Switching Task [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    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 switch trials from the average response time for non-switch trials.

  4. Change in the difference in response time between switch trials and non-switch trials in the Countermanding Task [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    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 switch trials from the average response time for non-switch trials.

  5. Change in the threshold of response time in the Useful Field of View (UFOV) Task [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    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.

  6. Change in the difference in response time of compatible trials and incompatible trials in the Attentional Network Task (ANT) [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    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.

  7. Change in the response time on the Mental Rotation Task [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    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.

  8. Change in the percentage of accuracy in the Paper Folding task [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    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.

  9. Change in the percentage of accuracy in Raven's Advanced Progressive Matrices task [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    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.

  10. Change in the percentage of accuracy in the UC Matrix Reasoning task [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    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.

  11. Change in the percentage of accuracy in the Mill-Hill Vocabulary Scale [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    In this vocabulary task, participants are asked to select the appropriate synonym for a target word among several alternatives for 25 words.

  12. Change in the percentage of accuracy in the Shipley Institute of Living Scale [ Time Frame: Pre-test (baseline), post-test2 at 30 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344028


Locations
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United States, California
University of California, Irvine
Irvine, California, United States, 92697
University of California, Riverside
Riverside, California, United States, 92521
United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
University of California, Riverside
University of California, Irvine
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Aaron Seitz, PhD University of California, Riverside
Principal Investigator: Susanne Jaeggi, PhD University of California, Irvine
Publications:
Jaeggi SM, Studer-Luethi B, Buschkuehl M, Su Y, Jonides J, Perrig WJ. The relationship between n-back performance and matrix reasoning - implications for training and transfer. Intelligence. 2010; 38: 625-635.
Cooper L, Shepard R Chronometric studies of the rotation of mental images. In Visual Information Processing, W. Chase, ed. (New York, NY: Academic Press). 1973; 135-142.
Lovett A, Forbus K. Modeling Spatial Ability in Mental Rotation and Paper-Folding. Proceedings of the 35th Annual Meeting of the Cognitive Science Society. 2013
Raven JC, Court JH, Raven J. Manual for Raven's progressive matrices and vocabulary scales: Advanced Progressive Matrices Sets I and H. London: H. K. Lewis. 1983
Raven J, Raven J, Court R. Mill Hill Vocabulary Scale. Oxford: Oxford University Press. 1998.
Shipley WC. Shipley Institute of Living Scale. Los Angeles, CA: Western Psychological Services. 1986.
Rammstedt B, John OP. Measuring personality in one minute or less: A 10-item short version of the Big Five Inventory in English and German. Journal of Research in Personality. 2007; 41: 203-212.
Adams J, Priest RF, Prince HT. Achievement motive: Analyzing the validity of the WOFO. Psychology of Women Quarterly. 1985; 9: 357-369.
Gong X, Paulson SE. Validation of the Schutte Self-Report Emotional Intelligence Scale With American College Students. Journal of Psychoeducational Assessment. 2018; 36: 175-181.
Rubin M. The Perceived Awareness of the Research Hypothesis Scale: Assessing the influence of demand characteristics. 2016. doi: 10.6084/m9.figshare.4315778

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04344028    
Other Study ID Numbers: 2019-1378
1R56AG063952-01 ( U.S. NIH Grant/Contract )
A487400 ( Other Identifier: UW Madison )
L&S/PSYCHOLOGY ( Other Identifier: UW Madison )
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (anonymized).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available persistently at the conclusion of the study.
Access Criteria: There are no access criteria.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Cognitive Training