Preparing Those With Significant and Persistent Mental Illness to Quit Smoking
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Acceptance of Wisconsin Tobacco Quit Line Services
研究概览
简要总结
This study tests whether pre-cessation interventions known to be effective in the general population will increase acceptance of evidence-based treatment, engagement and compliance with that treatment and initial quitting success. One hundred and seventy two patients will be recruited from 13 Community Support Programs (CSPs). CSPs provide community based care to those diagnosed with persistent and serious mental illness. All participants will receive two group sessions (40 minutes each) modeled after "Kicking Butts", a group-based quitting preparation program used for the past four years in two Milwaukee CSP programs run by Wisconsin Community Services. Individuals will then be randomly assigned to the experimental and control conditions (n=86 each). Experimental subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each). Attention control subjects will also receive four individual sessions of the same duration. However their individual sessions' content will be a discussion of the personal relevance of the group material and will not include any of the preparatory interventions. Data will be collected via brief surveys taken pre-intervention, at the end of the last individual session, and three months later and from a database provided by the Wisconsin Tobacco Quit Line (WTQL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •current smoker (smoking daily or smoking at least 10 cigarettes per week) (use of other tobacco products permitted such as chew and snuz in addition to smoking)
- •not willing to make a quit attempt
- •willingness to use the nicotine patch
- •plans to remain in the area for the next five four months.
排除标准
- •current use of any cessation medicine (nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler, nicotine nasal spray, bupropion, Wellbutrin, Zyban,Chantix or varenicline)
- •previous serious skin reaction or other allergic reaction to using the nicotine patch
- •stroke, heart attack or abnormal electrocardiogram in past four weeks
- •pregnancy, plans to get pregnant or nursing
- •exclusive use of other tobacco products (non-smoker tobacco user)
- •having a court-ordered guardian, or an activated power of attorney for health or observation by researchers during the consent procedure that suggests diminished decision making capacity
研究组 & 干预措施
Cognitive/Motivational Intervention Group
This arm of the project will address the following questions:
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
干预措施: Cognitive / Motivational Individual Sessions (Behavioral)
Cognitive/Motivational Intervention Group
This arm of the project will address the following questions:
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
干预措施: Nicotine Patch (Drug)
Cognitive/Motivational Intervention Group
This arm of the project will address the following questions:
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?
After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
干预措施: Group Curriculum (Behavioral)
Attention Control Group
This arm of the project will address the following question:
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?
干预措施: Attention Control Individual Sessions (Behavioral)
Attention Control Group
This arm of the project will address the following question:
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?
After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?
干预措施: Group Curriculum (Behavioral)
结局指标
主要结局
Acceptance of Wisconsin Tobacco Quit Line Services
时间窗: 4-6 weeks after study enrollment
The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.
次要结局
未报告次要终点