Carnegie Mellon University

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.

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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