Affect, Caffeine, Cognitive Ability, General, Mood
Conditions
Keywords
Vigilance, Mood, Randomized Controlled Trial, Probability
Brief summary
The purpose of this project is to examine the effect of expectancy on mood and alertness after consumption of caffeine treatment or placebo control pill, given that participants know their probability for receiving the caffeine versus placebo pill. Participants will be randomly assigned a probability (ranging from 0-100%) of receiving caffeine vs. placebo, and this probability will be revealed to them before consumption of the assigned pill and subsequent cognitive testing. At the time of consumption, neither study staff administering the intervention nor participants will know for certain which pill is given to each participant. Pill assignment will depend on pre-determined randomization probabilities, which will be provided and assigned by the study statistician. By revealing participants' individual probability of receiving the caffeine pill, we will induce positive or negative expectancies regarding likelihood for receipt of the caffeine pill. These experimental manipulations will: 1) estimate the effect of expectancy on cognitive and affective outcomes, and 2) allow for a more direct estimate of the effect of the caffeine pill under real-world conditions than would a conventional randomized trial.
Interventions
200mg delivered as pill; one-time dose
Lactose-based pill; one-time dose
Sponsors
Study design
Masking description
Participants, study personnel interacting with participants, and investigators were blinded. Only the study statistician knew treatment assignments.
Eligibility
Inclusion criteria
* 18 years-old or older * available to participate on the dates specified * willing to take a caffeine or placebo pills at study session * willingness to abstain from caffeine for 12 hours prior to study visit (8:30pm-8:30am) * UAB employees or students with some college education (including current enrollment)
Exclusion criteria
* self-reported use of ADHD medication * self-reported use of anxiety medication * self-reported use of sleep medication * self-reported use of nicotine products * self-reported lactose intolerance * self-reported uncorrected vision * self-reported pregnancy or trying to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mood State Score on POMS-2 Test | 30 minutes post pill consumption | Profile of Mood States (POMS-2)- Volunteers rated a series of 65 mood-related adjectives with regard to how they were feeling right now on a scale of 0 (not at all) to 4 (extremely). The adjectives factor into six mood sub-scales: Tension-Anxiety; Depression-Dejection; Anger-Hostility; Vigor-Activity; Fatigue-Inertia; Confusion-Bewilderment and a Total Mood Disturbance score which aggregates the six sub-scales into a single variable. - from our publication. The minimum and maximum possible raw scores were: 0 and 40 for Tension-Anxiety, 0 and 52 for Depression-Dejection, 0 and 44 for Anger-Hostility, 0 and 36 for Vigor-Aactivity, 0 and 24 for Fatigue-Inertia, 0 and 40 for Confusion-Bewilderment, -36 and 200 for Total Mood Disturbance, and 0 and 24 for Friendliness. For Friendliness and Vigor-Activity, the more positively a person feels, the higher the score. For all other sub-scales and Total Mood Disturbance, the more negatively a person feels, the higher the score. |
| Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60) | 45 to 105 minutes post pill consumption | Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication |
| Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits | 45 to 105 minutes post pill consumption | Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication |
| Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit | 45 to 105 minutes post pill consumption | Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caffeine One-time treatment with 200mg caffeine pill
Caffeine: 200mg delivered as pill; one-time dose | 100 |
| Placebo One-time treatment with lactose-based placebo pill
Placebo | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Placebo | Total | Caffeine |
|---|---|---|---|
| Age, Continuous | 29.75 years STANDARD_DEVIATION 11.39 | 31.79 years STANDARD_DEVIATION 12.91 | 33.83 years STANDARD_DEVIATION 14.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 8 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 159 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 18 Participants | 33 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 28 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 89 Participants | 39 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) White | 30 Participants | 69 Participants | 39 Participants |
| Sex: Female, Male Female | 61 Participants | 123 Participants | 62 Participants |
| Sex: Female, Male Male | 39 Participants | 77 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 103 | 0 / 102 |
| serious Total, serious adverse events | 0 / 103 | 0 / 102 |
Outcome results
Mood State Score on POMS-2 Test
Profile of Mood States (POMS-2)- Volunteers rated a series of 65 mood-related adjectives with regard to how they were feeling right now on a scale of 0 (not at all) to 4 (extremely). The adjectives factor into six mood sub-scales: Tension-Anxiety; Depression-Dejection; Anger-Hostility; Vigor-Activity; Fatigue-Inertia; Confusion-Bewilderment and a Total Mood Disturbance score which aggregates the six sub-scales into a single variable. - from our publication. The minimum and maximum possible raw scores were: 0 and 40 for Tension-Anxiety, 0 and 52 for Depression-Dejection, 0 and 44 for Anger-Hostility, 0 and 36 for Vigor-Aactivity, 0 and 24 for Fatigue-Inertia, 0 and 40 for Confusion-Bewilderment, -36 and 200 for Total Mood Disturbance, and 0 and 24 for Friendliness. For Friendliness and Vigor-Activity, the more positively a person feels, the higher the score. For all other sub-scales and Total Mood Disturbance, the more negatively a person feels, the higher the score.
Time frame: 30 minutes post pill consumption
Population: Results are of raw data as presented in our publication
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caffeine | Mood State Score on POMS-2 Test | Fatigue-Inertia | 4.44 units on a scale | Standard Error 0.49 |
| Caffeine | Mood State Score on POMS-2 Test | Confusion-Bewilderment | 6.23 units on a scale | Standard Error 0.48 |
| Caffeine | Mood State Score on POMS-2 Test | Friendliness | 13.47 units on a scale | Standard Error 0.47 |
| Caffeine | Mood State Score on POMS-2 Test | Anger-Hostility | 2.19 units on a scale | Standard Error 0.38 |
| Caffeine | Mood State Score on POMS-2 Test | Tension-Anxiety | 5.53 units on a scale | Standard Error 0.52 |
| Caffeine | Mood State Score on POMS-2 Test | Depression-Dejection | 1.87 units on a scale | Standard Error 0.35 |
| Caffeine | Mood State Score on POMS-2 Test | Vigor-Activity | 16.35 units on a scale | Standard Error 0.73 |
| Caffeine | Mood State Score on POMS-2 Test | Total Mood Displacement | 2.63 units on a scale | Standard Error 1.98 |
| Placebo | Mood State Score on POMS-2 Test | Vigor-Activity | 13.13 units on a scale | Standard Error 0.69 |
| Placebo | Mood State Score on POMS-2 Test | Anger-Hostility | 2.54 units on a scale | Standard Error 0.46 |
| Placebo | Mood State Score on POMS-2 Test | Confusion-Bewilderment | 7.00 units on a scale | Standard Error 0.53 |
| Placebo | Mood State Score on POMS-2 Test | Depression-Dejection | 3.15 units on a scale | Standard Error 0.61 |
| Placebo | Mood State Score on POMS-2 Test | Fatigue-Inertia | 6.65 units on a scale | Standard Error 0.68 |
| Placebo | Mood State Score on POMS-2 Test | Friendliness | 12.97 units on a scale | Standard Error 0.44 |
| Placebo | Mood State Score on POMS-2 Test | Tension-Anxiety | 5.81 units on a scale | Standard Error 0.52 |
| Placebo | Mood State Score on POMS-2 Test | Total Mood Displacement | 14.08 units on a scale | Standard Error 2.86 |
Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit
Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication
Time frame: 45 to 105 minutes post pill consumption
Population: One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caffeine | Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit | 0.74 seconds | Standard Error 0.03 |
| Placebo | Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit | 0.88 seconds | Standard Error 0.03 |
Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits
Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication
Time frame: 45 to 105 minutes post pill consumption
Population: One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caffeine | Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits | Number correct (out of 60) | 55.9 counts | Standard Error 0.85 |
| Caffeine | Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits | Number of False Alarm Hits | 4.21 counts | Standard Error 0.67 |
| Placebo | Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits | Number correct (out of 60) | 53.3 counts | Standard Error 1 |
| Placebo | Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits | Number of False Alarm Hits | 5.80 counts | Standard Error 1.01 |
Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60)
Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication
Time frame: 45 to 105 minutes post pill consumption
Population: One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caffeine | Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60) | 0.932 Proportion correct | Standard Error 0.014 |
| Placebo | Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60) | 0.888 Proportion correct | Standard Error 0.017 |