Development of Positive Psychotherapy for Smoking Cessation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 7-day Point Prevalence Smoking Abstinence at 8 Weeks
研究概览
简要总结
The primary objective of this study is to test a manualized adaptation of positive psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability, and efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking cessation treatment. Both treatments will be delivered in individual 6 sessions over 6 weeks, and will include provision of transdermal nicotine patch. The effect size estimates from this Stage 1b research will provide the foundation for a future application to conduct a large-scale, Stage II, randomized clinical trial.
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
- Double (Participant, Outcomes Assessor)
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
- •smoke at least 5 cigarettes per day for longer than one year with no other ongoing tobacco product use
- •willing to use the transdermal nicotine patch
- •report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking.
排除标准
- •are currently experiencing psychotic symptoms, affective disorder (major depression, dysthymia, or mania) or substance use disorder (other than nicotine dependence)
- •taking prescribed psychotropic medication or receiving other forms of psychotherapy
- •concomitantly using other pharmacotherapies for smoking cessation
- •have any contraindications for use of the transdermal nicotine patch.
研究组 & 干预措施
Positive psychotherapy
6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
干预措施: Positive Psychotherapy for smoking cessation (Behavioral)
Positive psychotherapy
6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
干预措施: Nicotine polacrilex (Drug)
Positive psychotherapy
6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
干预措施: Behavioral smoking cessation treatment (Behavioral)
Standard treatment
6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition
干预措施: Nicotine polacrilex (Drug)
Standard treatment
6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition
干预措施: Relaxation training (Behavioral)
Standard treatment
6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition
干预措施: Behavioral smoking cessation treatment (Behavioral)
结局指标
主要结局
7-day Point Prevalence Smoking Abstinence at 8 Weeks
时间窗: 8 weeks
Biochemically verified abstinence from smoking over the past 7 days
7-day Point Prevalence Smoking Abstinence at 16 Weeks
时间窗: 16 Weeks
Biochemically verified abstinence from smoking over the past 7 days
7-day Point Prevalence Smoking Abstinence at 26 Weeks
时间窗: 26 Weeks
Biochemically verified abstinence from smoking over the past 7 days
次要结局
未报告次要终点
研究者
Christopher W. Kahler
Professor of Behavioral and Social Sciences
Brown University