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 | ||
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 | |||||||
X | X | X | |||||
Acceptability | |||||||
Treatment acceptability (CSQ-8 [81]) | X | ||||||
Potential confounders | |||||||
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 |