Carnegie Mellon University

PCS3 Trial Outline

The figure below illustrates the temporal sequence of Pittsburgh Cold Study 3 (PCS3) study procedures.  See the table below for a more detailed description of the measures taken during each study phase.

tablethree

Figure 1. Temporal sequence of PCS3 study activities.  >>Download PowerPoint Slide<<



PCS3 Measures by Study Phase

Study Phase Measures Collected
10-12 weeks Pre-Quarantine

• 10-ml blood draw:  viral-specific serum Ab

Screening questionnaires

7-8 weeks Pre-Quarantine

• 25-ml blood draw: 

   o HIV;

   o Complete blood count (CBC & serum chemistry;

   o telomere length (1/3 sample)

• Urine sample: urinalysis; pregnancy test

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

• Screening physical exam   

• Buccal scraping:  genotyping

• Saliva sample:  cotinine

• Hair sample:  cortisol (#1)

• Questionnaire Set 1

6 weeks Pre-Quarantine

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

• LMP (#2)

• Questionnaire Set 2      

5 weeks Pre-Quarantine

• Begin 2-week daily interviews: 

   o social interactions

   o affect

   o health practices

• 4 days of pedometry:  physical activity

3-21 days Pre-Quarantine

• Urine sample:  pregnancy test

• Laboratory acute stress reactivity #1

• Questionnaire Set 3

8-21 days Pre-Quarantine

• 7 days of 24-hr actigraphy:  energy expenditure/sleep

3 to 5 Days Pre-Quarantine

• Questionnaire Set 4

• 10-15-ml blood draw:  viral specific Ab; telomere length (1/3 sample)

Quarantine Day 0 (Baseline)

• Hair samples: cortisol (#2)        

• Questionnaire Sets 5, 6, 7, & 8

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

• Urine sample:  isoprostanes; pregnancy test

• LMP (#3)

• Spirometry

• 15-ml blood draw:  telomere length (1/3 sample)

• Nasal wash: viral isolation         

• General physical exam  

• Ear, nose, and throat (ENT) exam

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

• Daily affect & health practices  

End Quarantine Day 0

Inoculation with Virus (i.e., Viral Challenge)

Quarantine Days 1 through 5

• 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

• Hair sample:  cortisol (#3)

• Exit physical exam

4 weeks Post-Challenge

• Urine pregnancy test     

• LMP (#4)

• Laboratory acute stress reactivity (#2)   

• 10-ml blood draw:  viral-specific serum Ab


Study Questionnaire Sets

Screening Questionnaire

Alcohol Consumption Questionnaire
History and Current Status of Smoking
Paffenbarger Activity Questionnaire
The Pittsburgh Sleep Quality Index
Breakfast
Short Form Health Survey

Questionnaire Set 1

Demographics
Objective Socioeconomic Status
MacArthur Scale of Subjective Social Status
Parents' Age and Vital Status
Clark Marital Intimacy Scale
Social Network Index
Interpersonal Support Evaluation List
Social Convoy Circles
Trait Affect Scale (#1)
Perceived Stress Scale

Questionnaire Set 2

SC Social Participation Measure
SC Perceived Community Scale
Ryff Scales of Psychological Well-Being
Short Loneliness Scale
Negative Interaction Items
Tucker Social Control
Revised Life Orientation Test
Shyness Index

Questionnaire Set 3

IPIP Big-Five Factor Markers (Extroversion & Agreeableness only)
Communal Orientation Scale
Life Events List

Laboratory Questionnaire

Stress Reactivity Questionnaire
Rumination Measure
Emotional Response to Stress Questionnaire

Questionnaire Set 4

Giving Support - Interpersonal Support Evaluation List
Opener Scale
Adult Attachment Questionnaire
Positive and Negative Affect Schedule (items 1-30)
Toronto Alexithymia Scale

Questionnaire Set 5

SC Childhood Interview
Childhood Subjective Social Status

Questionnaire Set 6

Family Environment Scale
Parental Bonding Instrument
Risky Families Questionnaire
Positive and Negative Affect Schedule (items 31-60)

Questionnaire Set 7

Parental Social Participation
SC Places You’ve Lived Interview
Recalled Childhood and Adolescence Perceived Stress

Questionnaire Set 8

IPIP Big-Five Factor Markers
Cook-Medley Hostility Scale
Trait Affect Scale (#2)
Emotion Regulation Questionnaire