Study on Sit to Quit Phone Intervention
- Conditions
- Nicotine Dependence
- Interventions
- Behavioral: Quit for LifeBehavioral: Sit to Quit
- Registration Number
- NCT02840435
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- Patient being treated at Duke Smoking Cessation Program for tobacco use
- Age 18 years or older
- Actively smoking 5 or more cigarettes per day for at least one year
- Fluency in spoken and written English
- Willing to set a quit date within 2 weeks
- Access to a smart phone or internet and telephone
- Willingness to watch 3 videos on computer, receive 5 counseling calls, and attend investigational visits.
- CO test under 7 ppm during initial screening
- 8 or above on the Alcohol Use Disorders Identification Test (AUDIT-10)
- 6 or above on Drug Abuse Screening Test (DAST-10)
- 3 or above on Patient Health Questionnaire (PHQ-2) Depression Scale
- Daily use of a second form of tobacco or nicotine (e.g. e-cigarettes, cigars, chewing tobacco, snuff)
- Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, Bupropion)
- Intolerable side effects related to, refusal to take, or medical contraindication with nicotine patch
- Symptomatic cognitive or emotive disorder such as untreated schizophrenia, severe untreated depression, or severe untreated anxiety. This is determined by clinical assessment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description North Carolina Quit Line: Quit for Life Quit for Life Participants will be connected to the 'Quit for Life' program offered through the North Carolina Quit Line. Sit to Quit Sit to Quit Participants will be connected to the 'Sit to Quit' program offered through the Duke Smoking Cessation Program.
- Primary Outcome Measures
Name Time Method Biochemically confirmed continuous 30-day abstinence from smoking 12 weeks post-Target Quit Day (TQD) 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
- Secondary Outcome Measures
Name Time Method Changes in anxiety Baseline to 2-week and 12-week post TQD Change in self-reported measures of anxiety
Changes in depression Baseline to 2-week and 12-week post TQD Change in self-reported measures of depression
Biochemically confirmed 7-day point prevalence abstinence from smoking 2 weeks post-TQD 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
Self-reported 7-day point prevalence abstinence rates 2 weeks post TQD 7-day point prevalence abstinence as measured by phone-based, single-item self-report
Smoking reduction 26 weeks post-TQD Smoking reduction as measured by number of cpd measured by phone-based self-report
Changes in stress Baseline to 2-week and 12-week post TQD Change in self-reported measures of stress
Changes in relapse predictors Baseline to 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, 12-week post-TQD, and 26-week post-TQD Changes in self-reported measures on repeated non-standardized single-item question on stress, urges, and confidence assessed by phone
Feasibility: mindfulness practices 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD Feasibility as measured by non-standardized phone-based self-report of number of times mindfulness practices are used by experimental group
Feasibility: meditation time 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD Feasibility as measured by non-standardized phone-based self-report of time spent meditating by experimental group
Feasibility: attendance records Up to 12 weeks post-TQD Feasibility as measured by attendance and completion of STQ and QL assessed by attendance records taken instructors during phone sessions.
Feasibility: website usage Up to 12 weeks post-TQD 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
Feasibility: course evaluation Up to 12 weeks post-TQD Feasibility as measured by course evaluation
Feasibility: demographics 12-weeks post-TQD Feasibility as measured by demographics of patients at DSCP
Feasibility: Behavioral intervention used 12 weeks post-TQD Feasibility as measured by behavioral intervention assignment
Feasibility: Attendance at DSCP appointments 12 weeks post-TQD Feasibility as measured by attendance at DSCP appointments
Feasibility: Referral routes to DSCP Baseline Feasibility as measured by referral routes to DSCP
Feasibility: Side effects 1-week post-TQD, 2-week post-TQD, and 6-week post-TQD Feasibility as measured by side effects, as measured by phone assessment
Feasibility: medication adherence 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD Feasibility as measured by medication adherence, as measured by phone assessment
Trial Locations
- Locations (1)
Duke Center for Smoking Cessation
🇺🇸Durham, North Carolina, United States