Carnegie Mellon University

PCS2 Trial Outline

The figure below illustrates the temporal sequence of Pittsburgh Cold Study 2 (PCS2) study procedures.  See the table below for a more detailed description of the measures taken during each study phase.

tabletwo

Figure 1. Temporal sequence of PCS2 study activities.  >>Download PowerPoint Slide<<



PCS2 Measures by Study Phase

Study Phase Measures Collected
7 to 8 weeks Pre-Quarantine

• Screening physical exam

• Urine sample:  urinalysis; pregnancy test

• 25-ml blood draw: 

   o HIV;

   o Complete blood count (CBC) & serum chemistry;

   o viral-specific serum  Ab

• First day of last menstrual period (LMP) (#1)

• Questionnaire Set 1

2 to 4 weeks Pre-Quarantine

• Begin 2-week daily interviews: social interactions and affect

• 2-day repeated salivary cortisol collections (#1 & #2)

• 24-hour urine collection:  catecholamines (#1)

Quarantine Day 0 (Baseline)

• 24-hour urine collection:  catecholamines (#2)

• Urine pregnancy test

• LMP (#2)

• 1-day repeated salivary cortisol collection (#3)

• Nasal wash:  viral isolation

• General physical exam  

• Ear, nose, and throat (ENT) exam

• Upper respiratory illness (URI) symptoms (self-report)

• Daily affect & health practices  

• Questionnaire Sets 2 & 3

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

• URI indicators of pathophysiology

• General physical exam  

• ENT exam

• URI symptoms

• 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 (#3)


Study Questionnaire Sets

Questionnaire Set 1

Social Network Index
Demographics
Objective Socioeconomic Status
Subjective Social Status
Childhood Socioeconomic Status
Goldberg’s Adjective Scale (#1)
Trait Affect Scale (#1)
Affect Circumplex Scale (trait) (#1)
Recent Cold History (#1)

Questionnaire Set 2

History and Current Status of Smoking
Alcohol Consumption Questionnaire
Physical Activity Questionnaire
Pittsburgh Sleep Quality Index
Goldberg’s Adjective Scale (#2)
Trait Affect Scale (#2)
Affect Circumplex Scale (trait) (#2)
Perceived Stress Scale
Revised Block Health Habits and History Questionnaire
Recent Cold History (#2)

Questionnaire Set 3

MacArthur Reactive Responding Scale
Ryff Scales of Psychological Well-Being (items 1-18)
Interpersonal Support Evaluation List

Questionnaire Set 4

Ryff Scales of Psychological Well-Being (items 19-36)
Communal Orientation Scale