This is a pilot research study examining two types of behavioral counseling along with the nicotine patch for smoking cessation. The study is designed to find out whether one of these counseling interventions is more effective for smoking cessation among individuals with sleep problems. The study has three parts: 1) an intake session; 2) a 10-week treatment phase, and 3) a 1-month follow-up.
This is a developmental study to: 1) create and test an integrated cognitive-behavioral smoking cessation and insomnia intervention with 30 smokers who report current insomnia. Participants are randomized to 1 of 2 counseling conditions. The cognitive-behavioral intervention provides standard care smoking counseling along with counseling to address insomnia. The smoking counseling intervention provides standard care smoking counseling adapted from the American Lung Association Freedom from Smoking program. Efficacy data from this trial will be used to determine effect size estimates for biologically confirmed self-reported point prevalence smoking abstinence at the end of treatment and 1 month after completing treatment. Changes in sleep efficiency and self-control to resist smoking urges will also be examined. If the effect size estimates are sufficiently large and medically important to pursue a definitive trial, these data will be used to propose a full scale large study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
19
The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia.
The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program.
Yale University School of Medicine
New Haven, Connecticut, United States
Smoking Abstinence
Smoking abstinence is operationally defined as "no smoking on the last 7 days of the last week of treatment. And no smoking within the last 7 days at the first follow-up visit 4 weeks after completing treatment."
Time frame: 1 Week
Self-Control to Resist Smoking Cues
To develop an effect size estimate for changes in self-control to resist smoking cues from baseline to the day before quitting smoking comparing smokers in the two counseling conditions.
Time frame: 4 Weeks
Sleep Efficiency
Self-reported sleep efficiency subscale of the Pittsburgh Sleep Quality Index. This is calculated as the percentage of total time spent asleep in a night compared to the total time spent in bed, multiplied by 100.
Time frame: Change from Baseline at 4 weeks
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