Pilot Study on Mindfulness Training for Smokers Via Web-based Video and Telephone Counseling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Biochemically confirmed continuous 30-day abstinence from smoking
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
North Carolina Quit Line: Quit for Life
Participants will be connected to the 'Quit for Life' program offered through the North Carolina Quit Line.
干预措施: Quit for Life (Behavioral)
Sit to Quit
Participants will be connected to the 'Sit to Quit' program offered through the Duke Smoking Cessation Program.
干预措施: Sit to Quit (Behavioral)
结局指标
主要结局
Biochemically confirmed continuous 30-day abstinence from smoking
时间窗: 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
次要结局
- Changes in anxiety(Baseline to 2-week and 12-week post TQD)
- Changes in depression(Baseline to 2-week and 12-week post TQD)
- Biochemically confirmed 7-day point prevalence abstinence from smoking(2 weeks post-TQD)
- Self-reported 7-day point prevalence abstinence rates(2 weeks post TQD)
- Smoking reduction(26 weeks post-TQD)
- Changes in stress(Baseline to 2-week and 12-week post TQD)
- 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)
- Feasibility: mindfulness practices(1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD)
- Feasibility: meditation time(1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD)
- Feasibility: attendance records(Up to 12 weeks post-TQD)
- Feasibility: website usage(Up to 12 weeks post-TQD)
- Feasibility: course evaluation(Up to 12 weeks post-TQD)
- Feasibility: demographics(12-weeks post-TQD)
- Feasibility: Behavioral intervention used(12 weeks post-TQD)
- Feasibility: Attendance at DSCP appointments(12 weeks post-TQD)
- Feasibility: Referral routes to DSCP(Baseline)
- Feasibility: Side effects(1-week post-TQD, 2-week post-TQD, and 6-week post-TQD)
- Feasibility: medication adherence(1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD)