Mindfulness Training for Smokers Online Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Biochemical Abstinence Testing
研究概览
简要总结
The Mindfulness Training for Smokers Online Feasibility Study is a pilot study designed to test Mindfulness Training for Smokers in an Internet format with phone counseling.
详细描述
The MTS Online Feasibility Study is funded for through a five-year K23 NIH training grant awarded to Dr. James Davis, the Principal Investigator on this protocol. The study enrollment goal is N=50 adult smokers. MTS Online is an Internet-based smoking cessation intervention that provides access to video material and instructional support for 8 mindfulness classes over a 6-week period. The MTS Online Feasibility Study aims to explore the feasibility of an Internet-based version of MTS, specifically looking at issues of on-line participation and Internet site use, adherence to instructed mindfulness practice regimen, and overall acceptability of MTS Online to a smoking population.
Participants will be recruited for MTS Online through existing recruitment mechanisms already in place for MTS. Specifically, participants who decline or are excluded from the MTS Study due solely to scheduling conflicts will be offered participation in MTS Online. All other inclusion/exclusion criteria are identical to the MTS study and discussed below.
After a decline or exclusion from the MTS Study due to scheduling and no other reason, research assistant will ask the caller if they would like the phone number for the Wisconsin Tobacco Quit Line and will ask the caller if they would like to hear about an online version of the MTS program. If the participant says they are interested, the RA will read a description of the online program and phone screening through the MTS Online Phone Screening Script. This script includes all inclusion and exclusion criteria found in the MTS Study, with the exception of the question on whether the caller can attend all the class meetings. If at the end of the phone script, the caller decides that they would like to come in for an Orientation Meeting, they will be sent an email providing instructions for scheduling their Orientation Meeting.
During the Orientation Meeting/Study Visit 1 MTS staff will provide a general description of the study and review the study consent form. If potential participants choose to join the study they will sign the consent form. After signing consent potential participants will be provided instruction on the use of nicotine patches, smoking calendars and will be provided with intervention materials. Research Assistants will assist participants as they log onto the MTS Online website and create a unique user ID. This ID will be used for all MTS Online features including communicating through the online forum and viewing instructional videos. Potential participants will be given a course schedule with a "class time" for their first class. After this, participants will fill out a Scan Form Questionnaire and proceed to collection of clinical measurements.
Intervention/Study Sign Up: During the Orientation potential participants will be provided with instructions on how to sign up for the intervention and study. This will include the following steps that must be completed through the individual's own Internet access (i.e. not completed at UW-CTRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Age: 18 years or over
- •Participants must express "high" motivation to quit smoking
- •Participants must smoke 5 or more cigarettes per day
排除标准
- •Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week.
- •Self report of using chewing tobacco, snuff or cigars in the last week
- •Severe depression or suicidality as assessed via the Patient Health Questionnaire (see section below for details)
结局指标
主要结局
Biochemical Abstinence Testing
时间窗: 4 and 24 week post quit attempt
Carbon Monoxide Breath Test (CO): CO is expired in detectable levels for up to 48 hours after smoking and can provide verification of tobacco use or abstinence. CO breath test is provided via a calibrated CO breath monitor. Per standard CTRI protocol, a cut-off value of less than 7 ppm will be employed to verify abstinence. Breath testing will be conducted at baseline, at 4 weeks post-quit and at 24 weeks post-quit.
次要结局
- Experiential Avoidance Scale(0, 4, 24 months)
- Depression, Anxiety and Stress Scale(0, 4 and 24 months)
- MTS Online Course Evaluation(4 months post quit)
- Five Factor Mindfulness Questionnaire(baseline, 4 and 24 months post quit)
- Perceived Stress Scale(0, 4, 24 months)