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

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT02461693

Acronym / sponsor ID

F150410009

Conditions

Caffeine, Affect, Cognitive Ability, General, Mood

Keywords

Vigilance, Mood, Randomized Controlled Trial, Probability

Study type

Interventional

Recruitment status

Completed

Enrolment

205 participants (actual)

Lead sponsor

University of Alabama at BirminghamUniversity, hospital or other

Study start

Jun 2015

Primary completion

Oct 2015 (actual)

Study completion

Oct 2015 (actual)

First posted

3 Jun 2015 (estimated)

Results

Posted 12 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Other

Allocation

Randomised

Intervention model

Parallel groups

Masking

Double blind (participant, investigator)

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Mood State Score on POMS-2 Test

   Time frame: 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.

2. Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60)

   Time frame: 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

3. Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits

   Time frame: 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

4. Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit

   Time frame: 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

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Results publication: PubMed 28406674George BJ, Li P, Lieberman HR, Pavela G, Brown AW, Fontaine KR, Jeansonne MM, Dutton GR, Idigo AJ, Parman MA, Rubin DB, Allison DB. Randomization to randomization probability: Estimating treatment effects under actual conditions of use. Psychol Methods. 2018 Jun;23(2):337-350. doi: 10.1037/met0000138. Epub 2017 Apr 13.
• Individual participant dataSharing planned: Yes. Raw de-identified data will be posted as a replication data set on ICPSR after publication of results in a journal. Data will be free to download and accessible to anyone with access to ICPSR replication data sets.

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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.