Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 2
- 主要终点
- Change in Perceived Stress Scores
研究概览
简要总结
The purpose of this study is to test the effects of a group smoking cessation program. The study will also examine individual differences in response to the intervention program.
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
- 是
入选标准
- •Self-identify as African American/Black, Hispanic (any race), or White non-Hispanic
- •Smoke at least 5 cigarettes/day or carbon monoxide (CO) reading of at least 8 ppm
- •be over age 18
- •speak/read English and/or Spanish
排除标准
- •Contraindications for transdermal nicotine patch therapy (TNP)
- •Cognitive or mental health impairment that inhibits group treatment
- •Currently being treated for smoking cessation, alcoholism, or illicit drug use
- •Unable to attend sessions
- •Indications that participant is not appropriate for the study (e.g., aggressive, intoxicated, disruptive, visibly ill)
- •Does not self-identify as African American, Hispanic, or White (non-Hispanic)
研究组 & 干预措施
Group Cognitive Behavioral Therapy
Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].
干预措施: Group Cognitive Behavioral Therapy (Behavioral)
Group Cognitive Behavioral Therapy
Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].
干预措施: Transdermal Nicotine Patch (Drug)
General Health Education
Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].
干预措施: General Health Education (Behavioral)
General Health Education
Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)].
干预措施: Transdermal Nicotine Patch (Drug)
结局指标
主要结局
Change in Perceived Stress Scores
时间窗: Baseline, 4 weeks
The Perceived Stress Scale (PSS) is a 10-item questionnaire with scores ranging from 0-40 with higher scores indicated greater stress.
The Number of Participants Reporting 7 Day Point Prevalence Abstinence
时间窗: 12-months
Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence
Change in Depressive Symptoms Scores
时间窗: Baseline, 4 weeks
Depressive scores based on Center for Epidemiologic Studies Depression Scale (CESD). CESD has a total score ranging from 0-60 with a higher score indicating greater depressive symptoms.
次要结局
未报告次要终点
研究者
David Lee
Associate Professor
University of Miami