Behavioral Activation for Smoking Cessation in Veterans With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Abstained From Smoking
研究概览
简要总结
The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.
详细描述
The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.
After an initial phone screen, in-person screening, and baseline assessment, enrolled participants will be randomized to either behavioral activation therapy and standard smoking cessation treatment (BA+ST) or health and smoking education and standard smoking cessation treatment (HSE+ST). Both groups will meet with a therapist once a week for 8 weeks to receive either BA+ST or HSE+ST. Participants' mood and smoking outcomes will be monitored throughout the 8 weeks of treatment and at 2 follow-up visits and 2 follow-up phone calls.
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 (Investigator, 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
- •Report smoking an average of 10 or more cigarettes daily for at least six months
- •Report a desire to quit smoking
- •Meet criteria for current PTSD
- •Speak and read English
- •Agree to participate in the study
- •Be 18 years old
- •Be a veteran
排除标准
- •Meeting criteria for psychotic or bipolar disorder
- •Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
- •Inability to give informed, voluntary, written consent to participate
- •Current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
- •Use of non-cigarette tobacco products as a primary form of tobacco use
- •Being currently suicidal or homicidal
- •Being medically unable to use the nicotine patch or nicotine gum/lozenge
- •Psychotropic medication changes within 3 months of study initiation and during active treatment
- •Current engagement in evidence-based therapies for PTSD or depression
- •Pregnant or trying to become pregnant
- •Incarceration
研究组 & 干预措施
Behavioral Activation Therapy
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
干预措施: Behavioral Activation Therapy (Behavioral)
Behavioral Activation Therapy
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
干预措施: Standard Smoking Cessation Therapy (Behavioral)
Health and Smoking Education
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
干预措施: Health and Smoking Education (Behavioral)
Health and Smoking Education
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
干预措施: Standard Smoking Cessation Therapy (Behavioral)
结局指标
主要结局
Percentage of Participants Who Abstained From Smoking
时间窗: 26 weeks post target quit date
7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day
次要结局
- Time to Smoking Relapse(26 weeks post target quit date)
- Clinician Administered PTSD Scale Score(4 weeks post target quit date (end of treatment))