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Table 1 Assessments by time point

From: Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial

 

Screen

Baseline 1

Baseline 2

Each session

12 weeks/end-of-treatment

6, 9, 12 months

18, 24, 30, and 36 months

Screening fully

    Medical diagnosis, current smoking, and other inclusion/exclusion criteria

X

      

    Cognitive functioning (MMSE [43])

X

      

Participant characteristics

    Demographics (age, race, etc.)

 

X

     

    Medical and smoking history

 

X

     

    Nicotine dependence (FTND [50])

 

X

     

    Motivation to quit (contemplation ladder [51])

 

X

X

    

    MN withdrawal scale [52]

  

X

    

Primary outcomes

    Current smoking/smoking since last contact

 

X

X

X

X

X

X

    Use of other tobacco products

 

X

X

X

X

X

X

    Saliva sample for cotinine testing

  

X

 

X

X

 

    Exhaled breath sample for CO testing

  

X

 

X

X

 

    Depressive symptoms (PHQ-9 [53])

 

X

X

 

X

X

X

    Depressive symptoms (CESD-10 [66])

 

X

X

 

X

X

 

Secondary outcomes

    Positive and negative affect (PANAS [57])

 

X

X

 

X

X

X

    Reactive anhedonia (SHAPS [68, 69])

 

X

X

 

X

X

 

    Perceived stress scale (PSS-4 [70])

 

X

  

X

X

 

    Health related quality of life (SF-12 [71])

 

X

  

X

X

 

    Exercise tolerance (DASI [72])

 

X

  

X

X

 

    MACE/mortality

    

X

X

X

    Adverse event monitoring

  

X

X

X

X

X

Hypothesized BA mediators

    Pleasant/valued activities (BADS [76], PES [79, 80])

 

X

  

X

X

 

Acceptability

    Treatment acceptability (CSQ-8 [81])

    

X

  

Potential confounders

    Medication adherence questions [88, 89]

 

X

  

X

X

 

    Diet/exercise questions [92]

 

X

  

X

X

 

    Counseling sessions attended

   

X

   

    Cardiac rehabilitation attendance

    

X

X

 

    Outside of study depression treatment

    

X

X

 

    Outside of study smoking cessation treatment

    

X

X