Stage II Trial of Novel Behavioral Activation Intervention for Smoking Cessation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date
研究概览
简要总结
Depression related vulnerabilities are highly comorbid with smoking behavior and dramatically reduce cessation rates among both community and clinical samples. Previous research has examined the efficacy of cognitive-behavioral treatment for individuals with a history of major depressive disorder (MDD) in standard cessation treatment. A broader health impact can be achieved by targeting individuals with current elevated depressive symptoms to address their association with cessation failure. Thus the objective of the present proposal is to conduct a Stage II randomized controlled trial (RCT) comparing the behavioral activation intervention to standard treatment among a similar community sample of 200 adult smokers with elevated depressive symptoms. Participants will be followed over 52 weeks post-quit date and the larger sample size will allow for more complex analysis of cessation outcomes.
详细描述
This will be a Stage II randomized control trial to examine the efficacy of behavioral activation treatment for smoking (BATS) vs. standard smoking cessation treatment (ST). We will recruit 200 smokers with elevated depressive symptoms who will be randomized into one of two treatment groups. Treatment will be delivered in group format across both the BATS (n = 100) and ST condition (n = 100). All participants will receive 8 weeks of transdermal nicotine patch in addition to their assigned treatment group. We intend to compare the BA treatment for smoking (BATS) to a standard smoking cessation intervention (ST)on abstinence and relapse outcomes. In addition we will examine to what extent depressive symptoms and reward sensitivity prior to quit date will mediate the effects of BATS on improved smoking cessation outcomes relative to ST.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 65 years of age
- •A regular smoker for at least one year
- •Currently smoking an average of at least 10 cigarettes per day
- •Want to quit smoking
- •Report current elevated depressive symptoms
排除标准
- •Current Axis I disorder
- •Psychoactive substance dependence (excluding nicotine dependence) within the past 6 months
- •Current use of psychotropic medication or participation in any form of psychotherapy
- •A history of significant medical condition (e.g., cardiovascular , neurological, gastrointestinal), pregnancy and/or breast feeding, or other systemic illness
- •Current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
研究组 & 干预措施
Standard Treatment (ST)
Participants will receive a standard, group smoking cessation treatment equated for contact time, based on the most recent clinical practice guideline for treating tobacco. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Patients in ST will complete between group exercises and will also keep a weekly written journal throughout treatment elaborating on observations about the day's events, their thoughts, feelings, and insights about their reactions to these events. Participants will also receive 8 weeks of the transdermal nicotine patch.
干预措施: Standard Treatment (Behavioral)
Standard Treatment (ST)
Participants will receive a standard, group smoking cessation treatment equated for contact time, based on the most recent clinical practice guideline for treating tobacco. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Patients in ST will complete between group exercises and will also keep a weekly written journal throughout treatment elaborating on observations about the day's events, their thoughts, feelings, and insights about their reactions to these events. Participants will also receive 8 weeks of the transdermal nicotine patch.
干预措施: Transdermal Nicotine Patch (Drug)
Behavioral Activation for Smoking
Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
干预措施: Behavioral Activation Treatment for Smoking (Behavioral)
Behavioral Activation for Smoking
Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
干预措施: Transdermal Nicotine Patch (Drug)
结局指标
主要结局
Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date
时间窗: 52 weeks post quit date
7 days of smoking abstinence confirmed biochemically at 52 week post quit attempt
次要结局
未报告次要终点
研究者
Laura MacPherson
Dr. Laura MacPherson
University of Maryland, College Park