Cognitive ChangeNCT04344028
Examining the Effectiveness of Cognitive Training
A study testing True Cognitive Training Program, Positive Expectation Induction and Negative Expectation Induction in people with Cognitive Change, run by University of Wisconsin, Madison at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- True Cognitive Training Program, Positive Expectation Induction and Negative Expectation Induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 May 2020to 9 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California, Irvine
Irvine, California, 92697
University of Wisconsin - Madison
Madison, Wisconsin, 53706
University of California, Riverside
Riverside, California, 92521
About this study
Official title: Examining the Potential for Placebo Effects in Cognitive Training
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.
Read more
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.
Read the detailed description
This study examines the extent to which working memory training may give rise to cognitive benefits and the extent to which these effects can be explained by, or augmented by, placebos.
It is predicted that:
- Significant placebo effects will be found in cognitive training, both at the immediate post-test and the second post-test after participants were debriefed about the placebo effects.
- Adaptive N-back training will produce larger gains than adaptive Knowledge training.
Participants will be assigned to either an online or in-person version of the study depending upon the guidelines for participant interactions that are in force at the time (if only one version is allowable under current guidelines participants will be assigned to the allowable version).
Pre-Test Cognitive Assessments: For each domain, two separate measures will be utilized to ensure that any observed results are not specific to a given tasks, but are more generally representative for the six cognitive domains below.
- Working Memory: The two measures will be a non-trained version of the N-back task and the O-Span task. In the N-back task, participants view a series of letters and are asked to indicate whether the current letter is the same as the letter "N" items back. The N-back levels will vary between 1- and 4-back. In the O-Span task, participants alternate between completing simple math problems (e.g., 3+(2x2)) and viewing single letters. At the end of a given sequence, the participants are asked to recall all of the letters that they had seen in the correct order. The number of letters to be recalled will range between 3 and 7.
- Cognitive Flexibility: The two measures will be a standard task-switching paradigm and countermanding task. In the task switching task, 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. In the countermanding task, participants are presented with two types of stimuli (e.g., dogs or monkeys) 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 (e.g., dog; congruent trials) or on the opposite side of the stimulus (e.g., monkey; incongruent trials).
- Visual Selective Attention: The two measures will be the Useful Field of View (UFOV) task and the Attentional Network Test (ANT; executive control trials only). In the UFOV, 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 (a sheriff's badge), while the remaining items are distractors (open boxes). The participants' task is to indicate upon which of the 8 spokes the target appeared. In the ANT, 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.
- Spatial Cognition: The two measures will be a standard mental rotation test and paper folding test. In the mental rotation task, participants are shown two images side by side. The images are either identical, but with one rotated relative to the other, or else are mirror-reversed and rotated copies of one another. The participants' task is to indicate whether the two items are identical or are mirror-reversed copies. In the paper-folding task, the participant is shown a depiction of a piece of paper being folded various ways before a hole is punched in the paper. The participants' task is to indicate what the paper will look like when it is unfolded.
- Fluid Intelligence: The two measures of fluid intelligence will be the Raven's Advanced Progressive Matrices and a new matrix task (UCMRT) developed and implemented by PIs Jaeggi and Seitz. In each test item, 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.
- Vocabulary (control): Vocabulary will be assessed using the Mill-Hill vocabulary and the Shipley Institute of Living scales. These require participants to select the appropriate synonym for a target word among several alternatives.
Pre-Test Individual Differences Surveys: At Pre-test, participants will complete a series of surveys to assess demographic variables (e.g., age, gender, race/ethnicity, SES) as well as other individual difference factors that may be predictive of placebo-responsiveness. These include: Big 5 Personality Traits, Work and Family Orientation Scale (WOFO), Grit, Behavioral Avoidance/Inhibition scales (BIS/BAS), theories of intelligence, Schutte Self-Report Emotional Intelligence Test, and Meta-Cognitive Skills Scale.
Training Conditions: Participants will be assigned to either an experimental training condition (N-back training, which previous research has shown is associated with enhancements in general cognitive function) or a control training condition (explicit knowledge training, which previous research has shown is not associated with enhancements in general cognitive function). The cognitive training task will be an adaptive version of a visual N-back task used previously. Participants will be presented with a series of objects and will be asked to indicate whether the current stimulus matches the one presented n positions back in the sequence. An active knowledge training task (control) will be used in which participants will be asked to answer Graduate Record Examination-type (GRE) general knowledge, vocabulary, and trivia questions selected from a pool of approximately 5,000 questions. For every question, participants are required to pick one of four answer alternatives presented below the question and after their response are given the correct answer.
Explicit Expectation Induction: Participants will be assigned to either positive or negative expectations induction, which will be delivered via a slideshow. All instructions and descriptions of the to-be-trained task in the Positive Expectations groups will be designed to maximize participant belief in the effectiveness of the given training in inducing positive change in cognitive abilities or minimize participant belief in the Negative Expectations groups.
Associative Learning Mid-Tests: For the associative learning mid-tests, the same basic cognitive tasks employed at Pre-test will be altered to either provide evidence to the participant of "improved cognitive performance" (positive associative learning) or "diminished cognitive performance" (negative associative learning).
- Working Memory Mid-Test Associative Learning Manipulations: O-Span: In the O-Span Associative Learning Mid-Test, task difficulty will be manipulated by either lessening the difficulty of the interleaved math problems (e.g., by using problems that only contain small numbers) or increasing the difficulty of the interleaved math problems.
- Cognitive Flexibility Mid-Test Associative Learning Manipulation: Task-switching: In the task-switching test, several factors make the test more difficult. First is the number of task switches - fewer switch trials results in overall better performance. Second are the digits themselves. For instance, in the high/low task, digits closer to 5 are responded to more slowly than digits further from 5. Thus, in the Task-Switching Associative Learning Mid-Tests, the switch rate will be reduced (easier) or increased (harder) relative to the true assessments, and the distribution of digits that are displayed will include a greater or lesser percentage of easier items. Countermanding: In the Countermanding test, difficulty is most strongly associated with the presence of incongruent trials as well as switch trials. Thus, the Countermanding Mid-Test will have decreased or increased proportions of incongruent and switch trials from 50% to 30%/70%, respectively.
- Visual Selective Attention Mid-Test Associative Learning Manipulation: UFOV: In the case of the UFOV, the simplest method to decrease difficulty is to increase presentation duration. Thus, in the UFOV Associative Learning Mid-tests, the proportion of long presentation duration trials will be increased (easier) or decreased (more difficult). ANT: In the case of the ANT, the Associative Learning Mid-tests will be made easier by increasing the proportion of neutral trials or made more difficult by decreasing the proportion of neutral trials and increasing the proportion of incompatible (most difficult) trials.
- Spatial Cognition Mid-Test Associative Learning Manipulation: Mental Rotation: Difficulty in mental rotation is monotonically related to the degree of rotation between the two items (larger rotations = more difficult). The Mental Rotation Associative Learning Mid-tests will thus be constructed to contain a disproportionate number of items with either small (easier) or large (more difficult) orientation differences. Paper Folding: In the paper folding task, more difficult trials involve not only more total folds, but more partial folds and more angled partial folds. The Paper Folding Associative Learning Mid-tests will thus contain a disproportionate number of low total folds/low partial folds trials (easier) or high total folds/high partial folds trials (more difficult).
- Fluid Intelligence Mid-Test Associative Learning Manipulation: All matrix items that will be utilized have a known level of difficulty. Thus, the Fluid Intelligence Associative Learning Mid-test sets will be created by mixing in a disproportionate number of easier/more difficult items for both Raven's and new matrix task created by PIs Seitz and Jaeggi.
- Vocabulary Mid-Test Associative Learning Manipulation: As with the fluid intelligence test, the items have known levels of difficulty, and thus, the Associative Learning Mid-test will have a disproportionate number of easier/more difficult items for both the Mill-Hill vocabulary and the Shipley Institute of Living scales.
Knowledge of the Hypothesis Scales: Prior to Post-Test1, participants will be given two measures - the Perceived Awareness of the Research Hypothesis scale and the Expectation Assessment scale. Both measures are designed to assess the extent to which participants have internalized/believed the expectations that were meant to be induced.
Unblinding: Participants in all groups will be given a thorough debriefing after Post-Test1 and before Post-Test2 as to the goals of the study, the conditions, and any deception that they may have been subject to.
Post-Test1 and 2 will be identical to the Pre-test cognitive tests (new trials/items will be used in all cases).
- Conditions
- Cognitive Change
- Being tested
- True Cognitive Training Program, Control Cognitive Training Program, Positive Expectation Induction, Negative Expectation Induction
- Keywords
- Cognitive Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True Cognitive Training ProgramBehavioural
The training program is a personal device-based adaptive version of a visual N-back task.
Control Cognitive Training ProgramBehavioural
The training program is a personal device-based adaptive version of a knowledge task (control).
Positive Expectation InductionBehavioural
The message given to the participants emphasizes that the given training results in a positive change in cognitive abilities.
Negative Expectation InductionBehavioural
The message given to the participants emphasizes that the given training results in a negative change in cognitive abilities.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Control Cognitive Training Program; Behavioral: Negative Expectation Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: post-test 1 at 25 days, post-test 2 at 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start11 May 2020
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Riverside, University of California, Irvine, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Aaron Seitz, PhD, Principal investigator, University of California, RiversideSusanne Jaeggi, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344028
- Sponsor's protocol ID
- 2019-1378
- Other IDs
- 1R56AG063952-01, A487400, L&S/PSYCHOLOGY
- Status last verified
- Oct 2022
- First submitted
- 7 Apr 2020
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (anonymized).
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.
Jaeggi SM, Buschkuehl M, Jonides J, Shah P. Short- and long-term benefits of cognitive training. Proc Natl Acad Sci U S A. 2011 Jun 21;108(25):10081-6. doi: 10.1073/pnas.1103228108. Epub 2011 Jun 13.
PubMed 21670271Conway AR, Kane MJ, Engle RW. Working memory capacity and its relation to general intelligence. Trends Cogn Sci. 2003 Dec;7(12):547-52. doi: 10.1016/j.tics.2003.10.005.
PubMed 14643371Unsworth N, Heitz RP, Schrock JC, Engle RW. An automated version of the operation span task. Behav Res Methods. 2005 Aug;37(3):498-505. doi: 10.3758/bf03192720.
PubMed 16405146Strobach T, Frensch PA, Schubert T. Video game practice optimizes executive control skills in dual-task and task switching situations. Acta Psychol (Amst). 2012 May;140(1):13-24. doi: 10.1016/j.actpsy.2012.02.001. Epub 2012 Mar 14.
PubMed 22426427Davidson MC, Amso D, Anderson LC, Diamond A. Development of cognitive control and executive functions from 4 to 13 years: evidence from manipulations of memory, inhibition, and task switching. Neuropsychologia. 2006;44(11):2037-78. doi: 10.1016/j.neuropsychologia.2006.02.006. Epub 2006 Mar 31.
PubMed 16580701Ball KK, Beard BL, Roenker DL, Miller RL, Griggs DS. Age and visual search: expanding the useful field of view. J Opt Soc Am A. 1988 Dec;5(12):2210-9. doi: 10.1364/josaa.5.002210.
PubMed 3230491Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.
PubMed 11970796Cooper 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
Pahor A, Stavropoulos T, Jaeggi SM, Seitz AR. Validation of a matrix reasoning task for mobile devices. Behav Res Methods. 2019 Oct;51(5):2256-2267. doi: 10.3758/s13428-018-1152-2.
PubMed 30367386Raven 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Potential for Placebo Effects in Cognitive Training
- ClinicalTrials.gov ID
- NCT04344028
- Acronym / sponsor ID
- 2019-1378
- Conditions
- Cognitive Change
- Keywords
- Cognitive Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- University of California, Riverside, University of California, Irvine, National Institute on Aging (NIA)
- Study start
- 11 May 2020 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Posted 20 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study examines the extent to which working memory training may give rise to cognitive benefits and the extent to which these effects can be explained by, or augmented by, placebos.
It is predicted that:
- Significant placebo effects will be found in cognitive training, both at the immediate post-test and the second post-test after participants were debriefed about the placebo effects.
- Adaptive N-back training will produce larger gains than adaptive Knowledge training.
Participants will be assigned to either an online or in-person version of the study depending upon the guidelines for participant interactions that are in force at the time (if only one version is allowable under current guidelines participants will be assigned to the allowable version).
Pre-Test Cognitive Assessments: For each domain, two separate measures will be utilized to ensure that any observed results are not specific to a given tasks, but are more generally representative for the six cognitive domains below.
- Working Memory: The two measures will be a non-trained version of the N-back task and the O-Span task. In the N-back task, participants view a series of letters and are asked to indicate whether the current letter is the same as the letter "N" items back. The N-back levels will vary between 1- and 4-back. In the O-Span task, participants alternate between completing simple math problems (e.g., 3+(2x2)) and viewing single letters. At the end of a given sequence, the participants are asked to recall all of the letters that they had seen in the correct order. The number of letters to be recalled will range between 3 and 7.
- Cognitive Flexibility: The two measures will be a standard task-switching paradigm and countermanding task. In the task switching task, 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. In the countermanding task, participants are presented with two types of stimuli (e.g., dogs or monkeys) 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 (e.g., dog; congruent trials) or on the opposite side of the stimulus (e.g., monkey; incongruent trials).
- Visual Selective Attention: The two measures will be the Useful Field of View (UFOV) task and the Attentional Network Test (ANT; executive control trials only). In the UFOV, 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 (a sheriff's badge), while the remaining items are distractors (open boxes). The participants' task is to indicate upon which of the 8 spokes the target appeared. In the ANT, 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.
- Spatial Cognition: The two measures will be a standard mental rotation test and paper folding test. In the mental rotation task, participants are shown two images side by side. The images are either identical, but with one rotated relative to the other, or else are mirror-reversed and rotated copies of one another. The participants' task is to indicate whether the two items are identical or are mirror-reversed copies. In the paper-folding task, the participant is shown a depiction of a piece of paper being folded various ways before a hole is punched in the paper. The participants' task is to indicate what the paper will look like when it is unfolded.
- Fluid Intelligence: The two measures of fluid intelligence will be the Raven's Advanced Progressive Matrices and a new matrix task (UCMRT) developed and implemented by PIs Jaeggi and Seitz. In each test item, 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.
- Vocabulary (control): Vocabulary will be assessed using the Mill-Hill vocabulary and the Shipley Institute of Living scales. These require participants to select the appropriate synonym for a target word among several alternatives.
Pre-Test Individual Differences Surveys: At Pre-test, participants will complete a series of surveys to assess demographic variables (e.g., age, gender, race/ethnicity, SES) as well as other individual difference factors that may be predictive of placebo-responsiveness. These include: Big 5 Personality Traits, Work and Family Orientation Scale (WOFO), Grit, Behavioral Avoidance/Inhibition scales (BIS/BAS), theories of intelligence, Schutte Self-Report Emotional Intelligence Test, and Meta-Cognitive Skills Scale.
Training Conditions: Participants will be assigned to either an experimental training condition (N-back training, which previous research has shown is associated with enhancements in general cognitive function) or a control training condition (explicit knowledge training, which previous research has shown is not associated with enhancements in general cognitive function). The cognitive training task will be an adaptive version of a visual N-back task used previously. Participants will be presented with a series of objects and will be asked to indicate whether the current stimulus matches the one presented n positions back in the sequence. An active knowledge training task (control) will be used in which participants will be asked to answer Graduate Record Examination-type (GRE) general knowledge, vocabulary, and trivia questions selected from a pool of approximately 5,000 questions. For every question, participants are required to pick one of four answer alternatives presented below the question and after their response are given the correct answer.
Explicit Expectation Induction: Participants will be assigned to either positive or negative expectations induction, which will be delivered via a slideshow. All instructions and descriptions of the to-be-trained task in the Positive Expectations groups will be designed to maximize participant belief in the effectiveness of the given training in inducing positive change in cognitive abilities or minimize participant belief in the Negative Expectations groups.
Associative Learning Mid-Tests: For the associative learning mid-tests, the same basic cognitive tasks employed at Pre-test will be altered to either provide evidence to the participant of "improved cognitive performance" (positive associative learning) or "diminished cognitive performance" (negative associative learning).
- Working Memory Mid-Test Associative Learning Manipulations: O-Span: In the O-Span Associative Learning Mid-Test, task difficulty will be manipulated by either lessening the difficulty of the interleaved math problems (e.g., by using problems that only contain small numbers) or increasing the difficulty of the interleaved math problems.
- Cognitive Flexibility Mid-Test Associative Learning Manipulation: Task-switching: In the task-switching test, several factors make the test more difficult. First is the number of task switches - fewer switch trials results in overall better performance. Second are the digits themselves. For instance, in the high/low task, digits closer to 5 are responded to more slowly than digits further from 5. Thus, in the Task-Switching Associative Learning Mid-Tests, the switch rate will be reduced (easier) or increased (harder) relative to the true assessments, and the distribution of digits that are displayed will include a greater or lesser percentage of easier items. Countermanding: In the Countermanding test, difficulty is most strongly associated with the presence of incongruent trials as well as switch trials. Thus, the Countermanding Mid-Test will have decreased or increased proportions of incongruent and switch trials from 50% to 30%/70%, respectively.
- Visual Selective Attention Mid-Test Associative Learning Manipulation: UFOV: In the case of the UFOV, the simplest method to decrease difficulty is to increase presentation duration. Thus, in the UFOV Associative Learning Mid-tests, the proportion of long presentation duration trials will be increased (easier) or decreased (more difficult). ANT: In the case of the ANT, the Associative Learning Mid-tests will be made easier by increasing the proportion of neutral trials or made more difficult by decreasing the proportion of neutral trials and increasing the proportion of incompatible (most difficult) trials.
- Spatial Cognition Mid-Test Associative Learning Manipulation: Mental Rotation: Difficulty in mental rotation is monotonically related to the degree of rotation between the two items (larger rotations = more difficult). The Mental Rotation Associative Learning Mid-tests will thus be constructed to contain a disproportionate number of items with either small (easier) or large (more difficult) orientation differences. Paper Folding: In the paper folding task, more difficult trials involve not only more total folds, but more partial folds and more angled partial folds. The Paper Folding Associative Learning Mid-tests will thus contain a disproportionate number of low total folds/low partial folds trials (easier) or high total folds/high partial folds trials (more difficult).
- Fluid Intelligence Mid-Test Associative Learning Manipulation: All matrix items that will be utilized have a known level of difficulty. Thus, the Fluid Intelligence Associative Learning Mid-test sets will be created by mixing in a disproportionate number of easier/more difficult items for both Raven's and new matrix task created by PIs Seitz and Jaeggi.
- Vocabulary Mid-Test Associative Learning Manipulation: As with the fluid intelligence test, the items have known levels of difficulty, and thus, the Associative Learning Mid-test will have a disproportionate number of easier/more difficult items for both the Mill-Hill vocabulary and the Shipley Institute of Living scales.
Knowledge of the Hypothesis Scales: Prior to Post-Test1, participants will be given two measures - the Perceived Awareness of the Research Hypothesis scale and the Expectation Assessment scale. Both measures are designed to assess the extent to which participants have internalized/believed the expectations that were meant to be induced.
Unblinding: Participants in all groups will be given a thorough debriefing after Post-Test1 and before Post-Test2 as to the goals of the study, the conditions, and any deception that they may have been subject to.
Post-Test1 and 2 will be identical to the Pre-test cognitive tests (new trials/items will be used in all cases).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| True Cognitive Training Placebo | Experimental | Behavioral: True Cognitive Training Program, Behavioral: Positive Expectation InductionParticipants 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. |
| True Cognitive Training Nocebo | Active comparator | Behavioral: True Cognitive Training Program, Behavioral: Negative Expectation InductionParticipants 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. |
| Control Cognitive Training Placebo | Placebo comparator | Behavioral: Control Cognitive Training Program, Behavioral: Positive Expectation InductionParticipants 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. |
| Control Cognitive Training Nocebo | Sham comparator | Behavioral: Control Cognitive Training Program, Behavioral: Negative Expectation InductionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True Cognitive Training ProgramThe training program is a personal device-based adaptive version of a visual N-back task. | Behavioural | True Cognitive Training Nocebo, True Cognitive Training Placebo |
| Control Cognitive Training ProgramThe training program is a personal device-based adaptive version of a knowledge task (control). | Behavioural | Control Cognitive Training Nocebo, Control Cognitive Training Placebo |
| Positive Expectation InductionThe message given to the participants emphasizes that the given training results in a positive change in cognitive abilities. | Behavioural | Control Cognitive Training Placebo, True Cognitive Training Placebo |
| Negative Expectation InductionThe message given to the participants emphasizes that the given training results in a negative change in cognitive abilities. | Behavioural | Control Cognitive Training Nocebo, True Cognitive Training Nocebo |
Primary outcome
Proportion of Correct Targets Identified Minus False Identifications in the n-Back Task
Time frame: post-test 1 at 25 days, post-test 2 at 34 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 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.
Number of Correctly Recalled Letter Sets in the O-Span Task
Time frame: post-test 1 at 25 days, post-test 2 at 34 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. The dependent measure is the total number of letters in correctly recalled trials. Scores range from 0 to 75. Higher scores indicate better performance.
Difference in Response Time Between Switch Trials and Non-switch Trials (Switch Cost) in the Task Switching Task
Time frame: post-test 1 at 25 days, post-test 2 at 34 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 non-switch trials from the average response time for switch trials (milliseconds). Lower scores indicate better performance.
Difference in Response Time Between Switch Trials and Non-switch Trials (Switch Cost) in the Countermanding Task
Time frame: post-test 1 at 25 days, post-test 2 at 34 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 non-switch trials from the average response time for switch trials (in milliseconds). Lower scores indicate better performance.
Threshold of Response Time in the Useful Field of View (UFOV) Task
Time frame: post-test 1 at 25 days, post-test 2 at 34 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 in milliseconds. Lower threshold scores indicate better performance
Difference in Response Time of Compatible Trials and Incompatible Trials in the Attentional Network Task (ANT)
Time frame: post-test 1 at 25 days, post-test 2 at 34 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 (in milliseconds). Lower scores indicate better performance.
Proportion of Correct Responses on the Mental Rotation Task
Time frame: post-test 1 at 25 days, post-test 2 at 34 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.
Proportion of Correct Responses in the Paper Folding Task
Time frame: post-test 1 at 25 days, post-test 2 at 34 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.
Proportion of Correct Responses in Raven's Advanced Progressive Matrices Task
Time frame: post-test 1 at 25 days, post-test 2 at 34 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.
Proportion of Correct Responses in the UC Matrix Reasoning Task
Time frame: post-test 1 at 25 days, post-test 2 at 34 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.
Proportion of Correct Responses in the Mill-Hill Vocabulary Scale
Time frame: post-test 1 at 25 days, post-test 2 at 34 days
In this vocabulary task, participants are asked to select the appropriate synonym for a target word among several alternatives for 25 words.
Proportion of Correct Responses in the Shipley Institute of Living Scale
Time frame: post-test 1 at 25 days, post-test 2 at 34 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundJaeggi 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.
- Background: PubMed 21670271Jaeggi SM, Buschkuehl M, Jonides J, Shah P. Short- and long-term benefits of cognitive training. Proc Natl Acad Sci U S A. 2011 Jun 21;108(25):10081-6. doi: 10.1073/pnas.1103228108. Epub 2011 Jun 13.
- Background: PubMed 14643371Conway AR, Kane MJ, Engle RW. Working memory capacity and its relation to general intelligence. Trends Cogn Sci. 2003 Dec;7(12):547-52. doi: 10.1016/j.tics.2003.10.005.
- Background: PubMed 16405146Unsworth N, Heitz RP, Schrock JC, Engle RW. An automated version of the operation span task. Behav Res Methods. 2005 Aug;37(3):498-505. doi: 10.3758/bf03192720.
- Background: PubMed 22426427Strobach T, Frensch PA, Schubert T. Video game practice optimizes executive control skills in dual-task and task switching situations. Acta Psychol (Amst). 2012 May;140(1):13-24. doi: 10.1016/j.actpsy.2012.02.001. Epub 2012 Mar 14.
- Background: PubMed 16580701Davidson MC, Amso D, Anderson LC, Diamond A. Development of cognitive control and executive functions from 4 to 13 years: evidence from manipulations of memory, inhibition, and task switching. Neuropsychologia. 2006;44(11):2037-78. doi: 10.1016/j.neuropsychologia.2006.02.006. Epub 2006 Mar 31.
- Background: PubMed 3230491Ball KK, Beard BL, Roenker DL, Miller RL, Griggs DS. Age and visual search: expanding the useful field of view. J Opt Soc Am A. 1988 Dec;5(12):2210-9. doi: 10.1364/josaa.5.002210.
- Background: PubMed 11970796Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.
- BackgroundCooper 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.
- BackgroundLovett A, Forbus K. Modeling Spatial Ability in Mental Rotation and Paper-Folding. Proceedings of the 35th Annual Meeting of the Cognitive Science Society. 2013
- BackgroundRaven 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
- Background: PubMed 30367386Pahor A, Stavropoulos T, Jaeggi SM, Seitz AR. Validation of a matrix reasoning task for mobile devices. Behav Res Methods. 2019 Oct;51(5):2256-2267. doi: 10.3758/s13428-018-1152-2.
- Individual participant dataSharing planned: Yes. All individual participant data (anonymized).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Seitz, PhD principal investigator
University of California, Riverside
Susanne Jaeggi, PhD principal investigator
University of California, Irvine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True Cognitive Training Program, Positive Expectation Induction and Negative Expectation Induction in people with Cognitive Change, run by University of Wisconsin, Madison at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Correct Targets Identified Minus False Identifications in the n-Back Task (time frame: post-test 1 at 25 days, post-test 2 at 34 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344028, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.