N/A
N=287
Examining the Effectiveness of Cognitive Training
Cognitive Change
Bottom Line
View on ClinicalTrials.gov: NCT04344028 ↗Enrolled (actual)
287
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Proportion of Correct Targets Identified Minus False Identifications in the n-Back Task — .80; .70; .68; .21 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- True Cognitive Training Program (Behavioral); Control Cognitive Training Program (Behavioral); Positive Expectation Induction (Behavioral); Negative Expectation Induction (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Correct Targets Identified Minus False Identifications in the n-Back Task |
.80; .70; .68; .21; .70; .69 | — |
| PRIMARY Number of Correctly Recalled Letter Sets in the O-Span Task |
47.07; 43.07; 41.78; 43; 20.22; 19.72 | — |
| PRIMARY Difference in Response Time Between Switch Trials and Non-switch Trials (Switch Cost) in the Task Switching Task |
435.79; 471.14; 384.51; 529.88; 503.74; 529.42 | — |
| PRIMARY Difference in Response Time Between Switch Trials and Non-switch Trials (Switch Cost) in the Countermanding Task |
67.89; 51.89; 47.48; 39.67; 32.53; -11.46 | — |
| PRIMARY Threshold of Response Time in the Useful Field of View (UFOV) Task |
52.60; 50.46; 52.18; 56.71; 123.05; 137.21 | — |
| PRIMARY Difference in Response Time of Compatible Trials and Incompatible Trials in the Attentional Network Task (ANT) |
90.67; 92.12; 90.52; 98.44; 88.66; 80.33 | — |
| PRIMARY Proportion of Correct Responses on the Mental Rotation Task |
.77; .81; .81; .81; .82; .74 | — |
| PRIMARY Proportion of Correct Responses in the Paper Folding Task |
.74; .73; .72; .66; .46; .36 | — |
| PRIMARY Proportion of Correct Responses in Raven's Advanced Progressive Matrices Task |
.67; .58; .65; .54; .42; .36 | — |
| PRIMARY Proportion of Correct Responses in the UC Matrix Reasoning Task |
.74; .69; .73; .67; .44; .39 | — |
| PRIMARY Proportion of Correct Responses in the Mill-Hill Vocabulary Scale |
.58; .59; .58; .59; .66; .70 | — |
| PRIMARY Proportion of Correct Responses in the Shipley Institute of Living Scale |
.80; .79; .77; .77; .86; .91 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT04344028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.