The purpose of this study is to test the effects of a group smoking cessation program. The study will also examine individual differences in response to the intervention program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
356
The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity.
The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol).
University of Miami
Coral Gables, Florida, United States
H Lee Moffitt Cancer Center
Tampa, Florida, United States
The Number of Participants Reporting 7 Day Point Prevalence Abstinence
Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence
Time frame: 12-months
Change in Perceived Stress Scores
The Perceived Stress Scale (PSS) is a 10-item questionnaire with scores ranging from 0-40 with higher scores indicated greater stress.
Time frame: Baseline, 4 weeks
Change in Depressive Symptoms Scores
Depressive scores based on Center for Epidemiologic Studies Depression Scale (CESD). CESD has a total score ranging from 0-60 with a higher score indicating greater depressive symptoms.
Time frame: Baseline, 4 weeks
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Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations.