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Evaluating the Role of Expectations in Response to Caffeine Consumption: An RCT

Evaluating the Role of Expectations in Response to Caffeine Consumption: A Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02461693
Enrollment
205
Registered
2015-06-03
Start date
2015-06-30
Completion date
2015-10-31
Last updated
2017-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Affect, Caffeine, Cognitive Ability, General, Mood

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

DRUGCaffeine

200mg delivered as pill; one-time dose

DRUGPlacebo

Lactose-based pill; one-time dose

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Masking description

Participants, study personnel interacting with participants, and investigators were blinded. Only the study statistician knew treatment assignments.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Mood State Score on POMS-2 Test30 minutes post pill consumptionProfile 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 consumptionScanning 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 Hits45 to 105 minutes post pill consumptionScanning 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 Hit45 to 105 minutes post pill consumptionScanning 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

ArmCount
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
Total200

Baseline characteristics

CharacteristicPlaceboTotalCaffeine
Age, Continuous29.75 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 Participants8 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
75 Participants159 Participants84 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
18 Participants33 Participants15 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
12 Participants28 Participants16 Participants
Race (NIH/OMB)
Black or African American
50 Participants89 Participants39 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants14 Participants6 Participants
Race (NIH/OMB)
White
30 Participants69 Participants39 Participants
Sex: Female, Male
Female
61 Participants123 Participants62 Participants
Sex: Female, Male
Male
39 Participants77 Participants38 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1030 / 102
serious
Total, serious adverse events
0 / 1030 / 102

Outcome results

Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
CaffeineMood State Score on POMS-2 TestFatigue-Inertia4.44 units on a scaleStandard Error 0.49
CaffeineMood State Score on POMS-2 TestConfusion-Bewilderment6.23 units on a scaleStandard Error 0.48
CaffeineMood State Score on POMS-2 TestFriendliness13.47 units on a scaleStandard Error 0.47
CaffeineMood State Score on POMS-2 TestAnger-Hostility2.19 units on a scaleStandard Error 0.38
CaffeineMood State Score on POMS-2 TestTension-Anxiety5.53 units on a scaleStandard Error 0.52
CaffeineMood State Score on POMS-2 TestDepression-Dejection1.87 units on a scaleStandard Error 0.35
CaffeineMood State Score on POMS-2 TestVigor-Activity16.35 units on a scaleStandard Error 0.73
CaffeineMood State Score on POMS-2 TestTotal Mood Displacement2.63 units on a scaleStandard Error 1.98
PlaceboMood State Score on POMS-2 TestVigor-Activity13.13 units on a scaleStandard Error 0.69
PlaceboMood State Score on POMS-2 TestAnger-Hostility2.54 units on a scaleStandard Error 0.46
PlaceboMood State Score on POMS-2 TestConfusion-Bewilderment7.00 units on a scaleStandard Error 0.53
PlaceboMood State Score on POMS-2 TestDepression-Dejection3.15 units on a scaleStandard Error 0.61
PlaceboMood State Score on POMS-2 TestFatigue-Inertia6.65 units on a scaleStandard Error 0.68
PlaceboMood State Score on POMS-2 TestFriendliness12.97 units on a scaleStandard Error 0.44
PlaceboMood State Score on POMS-2 TestTension-Anxiety5.81 units on a scaleStandard Error 0.52
PlaceboMood State Score on POMS-2 TestTotal Mood Displacement14.08 units on a scaleStandard Error 2.86
Primary

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.

ArmMeasureValue (MEAN)Dispersion
CaffeineVigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit0.74 secondsStandard Error 0.03
PlaceboVigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit0.88 secondsStandard Error 0.03
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
CaffeineVigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm HitsNumber correct (out of 60)55.9 countsStandard Error 0.85
CaffeineVigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm HitsNumber of False Alarm Hits4.21 countsStandard Error 0.67
PlaceboVigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm HitsNumber correct (out of 60)53.3 countsStandard Error 1
PlaceboVigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm HitsNumber of False Alarm Hits5.80 countsStandard Error 1.01
Primary

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.

ArmMeasureValue (MEAN)Dispersion
CaffeineVigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60)0.932 Proportion correctStandard Error 0.014
PlaceboVigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60)0.888 Proportion correctStandard Error 0.017

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026