PCS1 Trial Outline
The figure below illustrates the temporal sequence of Pittsburgh Cold Study 1 (PCS1) study procedures. See the table below for a more detailed description of the measures taken during each study phase.
Figure 1. Temporal sequence of PCS1 study activities. >>Download PowerPoint Slide<<
PCS1 Measures by Study Phase
Study Phase | Measures Collected |
6 weeks Pre-Quarantine |
• Physical exam (screening) • Urine sample for urinalysis; pregnancy test • First day of last menstrual period (LMP) (#1) • Questionnaire Set 1 |
2 weeks Pre-Quarantine |
• 33-ml blood draw: o HIV, o serum chemistry; o CBC with differentials (#1); o lymphocyte subsets & NK cell cytotoxicity (#1); o plasma cortisol (#1) • LMP (#2) • Questionnaire Set 2 • Life stressor interview (1/2 sample) |
1 week Pre-Quarantine |
• 31-ml blood draw: o viral-specific serum Ab; o lymphocyte subsets & NK cell cytotoxicity (#2); o CBC with differentials (#2); o plasma cortisol (#2) • Questionnaire Set 3 • Life stressor interview (1/2 sample) |
Quarantine Day 0 (Baseline) |
• 24-hour urine collection: catecholamines; cortisol • Urine pregnancy test • LMP (#3) • Nasal wash: viral isolation • Spirometry • General physical exam • Ear, nose, and throat (ENT) exam • Upper respiratory illness (URI) symptoms (self-report) • Daily affect & health practices • Diet questionnaire |
End Quarantine Day 0 |
Inoculation with Virus (i.e., Viral Challenge) |
Quarantine Days 1 through 5 |
• Questionnaire Set 4 (Quarantine Day 1) • Nasal wash: viral isolation/quantification & cytokines • Spirometry • URI indicators of pathophysiology • General physical exam • ENT exam • URI symptoms (self-report) • Daily affect & health practices |
End Quarantine Day 5 |
• Exit physical examination |
4 weeks Post-Challenge |
• 10-ml blood sample for viral-specific serum Ab • LMP (#4) |
Study Questionnaire Sets
Questionnaire Set 1
Demographics
Objective Socioeconomic Status
Social Network Index
History and Current Status of Smoking
Alcohol Consumption Questionnaire
Paffenbarger Activity Questionnaire
Pittsburgh Sleep Quality Index
Recent Cold History
Questionnaire Set 2
Trait Affect Scale (#1)
Affect Circumplex Scale (trait) (#1)
Stress-Arousal Circumplex Scale (trait) (#1)
Goldberg’s Adjective Scale (#1)
Perceived Stress Scale (#1)
Sickness Expectations (#1)
Questionnaire Set 3
Trait Affect Scale (#2)
Affect Circumplex Scale (trait) (#2)
Stress-Arousal Circumplex Scale (trait) (#2)
Goldberg’s Adjective Scale (#2)
Perceived Stress Scale (#2)
Sickness Expectations (#2)
Questionnaire Set 4
State Affect Scale
Affect Circumplex Scale (state)
Stress-Arousal Circumplex Scale (state)
Life Effort Questionnaire
Life Orientation Test
Goldberg’s Adjective Scale (state measure)
Perceived Stress Scale (#3)
Handedness
Likelihood of Cold