This study is designed to test the effectiveness of the smoking cessation intervention "Sit to Quit" through a randomized-control trial. This study will compare abstinence outcomes in the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit Line.
This study is designed to test the effectiveness of the smoking cessation intervention "Sit to Quit" through a randomized-control trial. This study will compare abstinence outcomes in the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit Line. This is an investigational study (n=60) designed to test Sit to Quit (STQ) versus Quit Line (QL) through a pilot randomized control trial. The proposed study is designed with double-blind procedures (participants and study staff) for randomization of 60 participants recruited through Duke Smoking Cessation Program into two groups: STQ and QL. STQ participants will receive access to the STQ Instructional Video, the STQ manual, and proactive Quit Coach calls supporting STQ. QL participants will be instructed to contact the NC Quit Line and will receive access to "web Coach" (Alere Well-being site), the Quit Line manual, and proactive Quit Coach calls supporting "Quit for Life." All statistical analysis will be performed under the directions of the statistician designated in key personnel. Outcomes of variables including: demographic variables, evaluation responses, and abstinence rates will be analyzed using general regression models using an ANOVA-based design. The study Principal Investigator Dr. James Davis will ultimately be responsible for data and safety monitoring. Subject data will be collected during visits and captured in the Electronic Medical Record. Data will be collected by phone, and this data will be stored in REDCap. Participants that experience events related to their clinical treatment will be recommended to follow-up with their provider.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Sit to Quit(STQ) is a smoking cessation program adapted from Mindfulness Training for Smokers (MTS) with core content available on the STQ video. STQ contains many elements found in traditional interventions (e.g. instruction on planning and structuring a quit day, garnering support from others, assessment of prior relapse occasions, development of strategies to avoid triggers). In addition, STQ provides instruction in various mindfulness practices and in how to apply mindfulness skills to manage common causes of relapse. Exercises are provided, and it is recommended to learn the skill experientially. STQ requests that participants practice guided meditation each day using an audio recording and employ other mindfulness practices targeted to manage relapse challenges. Participants will also receive the STQ Participant Manual, which provides all the instruction found in the STQ Video, but provides additional discussion of topics for smokers who desire additional material.
Quit for Life integrates telephone counseling, written materials, NRT, and an online program called "Web Coach." Web Coach is an interactive internet-based support system that provides health information on smoking cessation, assistance in the development of quit strategies, and an interactive blog to interact with other smokers. Web Coach is used by approximately 70% of AWI callers. Web Coach is not a complete program, but instead is designed to supplement AWI phone-based therapy. In addition, Quit for Life also provides the "Quit Guide," which is a smoking cessation manual with written instructions on the use of medications, planning a quit day, and cessation-related cognitive skills.
Duke Center for Smoking Cessation
Durham, North Carolina, United States
Biochemically confirmed continuous 30-day abstinence from smoking
Biochemically confirmed 30-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 30 days AND a result of \< 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Time frame: 12 weeks post-Target Quit Day (TQD)
Biochemically confirmed 7-day point prevalence abstinence from smoking
Biochemically confirmed 7-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 7 days AND a result of \< 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Time frame: 12 weeks post-TQD
Biochemically confirmed 7-day point prevalence abstinence from smoking
Biochemically confirmed 7-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 7 days AND a result of \< 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Time frame: 2 weeks post-TQD
Self-reported 7-day point prevalence abstinence rates
7-day point prevalence abstinence as measured by phone-based, single-item self-report
Time frame: 1 week post TQD
Self-reported 7-day point prevalence abstinence rates
7-day point prevalence abstinence as measured by phone-based, single-item self-report
Time frame: 12 weeks post TQD
Self-reported 7-day point prevalence abstinence rates
7-day point prevalence abstinence as measured by phone-based, single-item self-report
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Time frame: 26 weeks post TQD
Self-reported 7-day point prevalence abstinence rates
7-day point prevalence abstinence as measured by phone-based, single-item self-report
Time frame: 6 weeks post TQD
Self-reported 7-day point prevalence abstinence rates
7-day point prevalence abstinence as measured by phone-based, single-item self-report
Time frame: 2 weeks post TQD
Smoking reduction
Smoking reduction as measured by number of cpd measured by phone-based self-report
Time frame: 1 week post-TQD
Smoking reduction
Smoking reduction as measured by number of cpd measured by phone-based self-report
Time frame: 2 weeks post-TQD
Smoking reduction
Smoking reduction as measured by number of cpd measured by phone-based self-report
Time frame: 6 weeks post-TQD
Smoking reduction
Smoking reduction as measured by number of cpd measured by phone-based self-report
Time frame: 12 weeks post-TQD
Smoking reduction
Smoking reduction as measured by number of cpd measured by phone-based self-report
Time frame: 26 weeks post-TQD
Changes in stress
Change in self-reported measures of stress
Time frame: Baseline to 2-week and 12-week post TQD
Changes in anxiety
Change in self-reported measures of anxiety
Time frame: Baseline to 2-week and 12-week post TQD
Changes in depression
Change in self-reported measures of depression
Time frame: Baseline to 2-week and 12-week post TQD
Changes in relapse predictors
Changes in self-reported measures on repeated non-standardized single-item question on stress, urges, and confidence assessed by phone
Time frame: Baseline to 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, 12-week post-TQD, and 26-week post-TQD
Feasibility: attendance records
Feasibility as measured by attendance and completion of STQ and QL assessed by attendance records taken instructors during phone sessions.
Time frame: Up to 12 weeks post-TQD
Feasibility: website usage
Feasibility as measured by website usage by electronically recording login and using a site-based timer to record time accessing the site through each intervention
Time frame: Up to 12 weeks post-TQD
Feasibility: course evaluation
Feasibility as measured by course evaluation
Time frame: Up to 12 weeks post-TQD
Feasibility: demographics
Feasibility as measured by demographics of patients at DSCP
Time frame: 12-weeks post-TQD
Feasibility: Behavioral intervention used
Feasibility as measured by behavioral intervention assignment
Time frame: 12 weeks post-TQD
Feasibility: Attendance at DSCP appointments
Feasibility as measured by attendance at DSCP appointments
Time frame: 12 weeks post-TQD
Feasibility: Referral routes to DSCP
Feasibility as measured by referral routes to DSCP
Time frame: Baseline
Feasibility: Side effects
Feasibility as measured by side effects, as measured by phone assessment
Time frame: 1-week post-TQD, 2-week post-TQD, and 6-week post-TQD
Feasibility: medication adherence
Feasibility as measured by medication adherence, as measured by phone assessment
Time frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD
Feasibility: mindfulness practices
Feasibility as measured by non-standardized phone-based self-report of number of times mindfulness practices are used by experimental group
Time frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD
Feasibility: meditation time
Feasibility as measured by non-standardized phone-based self-report of time spent meditating by experimental group
Time frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD