Adaptation and Initial Evaluation of Transdiagnostic CBT for Anxious and Depressed Smokers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Short- and long-term point prevalence abstinence (PPA).
研究概览
简要总结
This study will look at the effectiveness of a new treatment protocol for anxious and depressed smokers. Participants with clinically significant anxiety or depression will receive either the standard smoking cessation treatment or the Unified Protocol for Smoking Cessation Treatment. This study will demonstrate that a single treatment protocol can effectively address both smoking and the complex emotional comorbidities that are widespread in smokers will provide a novel, impactful, and highly disseminable treatment option missing from today's smoking cessation arsenal.
详细描述
The present proposal aims to develop a new and efficient treatment for smokers with clinically significant anxiety or depression. In Phase I, the investigators will complete the development of a new treatment protocol (Unified Protocol for Smoking Cessation Treatment; UP-ST) that integrates current best practices of cognitive behavioral smoking cessation treatments and nicotine replacement therapy with the recently developed UP treatment protocol that has been shown to effectively treat both anxiety disorders and depression and to impact specific mechanisms (e.g., neuroticism) that are relevant to both smoking and anxiety/depression remission. In Phase II, 60 smokers with clinically significant anxiety or depression will be recruited and randomly assigned to either: (1) the UP-ST or (2) standard smoking cessation treatment (ST) based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services. The investigators will examine the UP-ST relative to ST on smoking, anxiety/depression, and mechanisms of change. Demonstrating that a single treatment protocol can effectively address both smoking and the complex emotional comorbidities that are widespread in smokers will provide a novel, impactful, and highly disseminable treatment option missing from today's smoking cessation arsenal.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for the study include 1) being 18-65 years of age, 2) daily smoking of at least 5 cigarettes per day for at least one year and biochemically confirmed at least 10 ppm at baseline. Participants must be 3) motivated to quit smoking in the next month 4) have clinically significant anxiety or depression defined as >=8 on the OASIS or ODIS, 5) must be willing and able to attend all the appointments, and 6) must be willing to quit smoking as the sixth treatment session.
排除标准
- •Exclusion criteria include 1) Use of other tobacco products 2) Report of current or intended participation in a concurrent substance abuse treatment, 3) Ongoing psychotherapy of any duration targeting anxiety or depression, 4) Current non-nicotine substance dependence, 5) Not being fluent in English, 6) Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers, 7) Legal status that will interfere with participation, 8) Positive pregnancy test at baseline, 9) Active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis.
研究组 & 干预措施
Active- UP-ST
The intervention will be the UP-ST therapy sessions. Treatment will be delivered using the new UP-ST protocol that will be developed in Phase I by integrating components of smoking cessation treatments (e.g. using the nicotine patch) with the theoretical model and treatment components of the existing UP treatment protocol, which includes both a therapist14 and patient12 manual. The UP-ST will maintain the same focus on transdiagnostic mechanisms of change as in the original UP, but will be adapted to integrate the smoking cessation focus and concurrent use of NRT. Thus, the investigators can successfully adapt and develop the new UP-ST to be delivered in eight 90-minute sessions and will be able to incorporate content from each of the 8 modules of the UP in the new UP-ST protocol.
干预措施: UP-ST Therapy (Behavioral)
Control- Standard
The Intervention will be the standard therapy sessions. Participants will receive a standard smoking cessation treatment based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use and Dependence19. The investigative team has considerable expertise in developing and evaluating behavioral and pharmacological treatments for smoking cessation. Treatment will be delivered in eight, 90-minute sessions over an eight-week period.
干预措施: Standard Therapy (Behavioral)
Active- UP-ST
The intervention will be the UP-ST therapy sessions. Treatment will be delivered using the new UP-ST protocol that will be developed in Phase I by integrating components of smoking cessation treatments (e.g. using the nicotine patch) with the theoretical model and treatment components of the existing UP treatment protocol, which includes both a therapist14 and patient12 manual. The UP-ST will maintain the same focus on transdiagnostic mechanisms of change as in the original UP, but will be adapted to integrate the smoking cessation focus and concurrent use of NRT. Thus, the investigators can successfully adapt and develop the new UP-ST to be delivered in eight 90-minute sessions and will be able to incorporate content from each of the 8 modules of the UP in the new UP-ST protocol.
干预措施: Nicotine Patch (Device)
结局指标
主要结局
Short- and long-term point prevalence abstinence (PPA).
时间窗: 12 months
In three separate follow up appointments, one 3 months after the end of treatments, one 6 months after and one 12 months after, The investigators will ask participants various questions about their abstinence. The investigators will measure the length of time between when treatment ends and when/ if they start smoking again. The unit of measure will be length of time in days. The investigators expect that point prevalence abstinence will be higher, both in the short term and long term, in the UP-ST condition than in the ST condition. Similarly, The investigators expect the rate of decline in abstinence over time to be shallower (smaller) in UP-ST than in ST.
次要结局
- Tobacco craving(12 months)
- Tobacco withdrawal(12 months)
- Time to first smoking lapse and time to relapse(12 months)
- Tobacco dependence(12 months)
研究者
Michael J. Zvolensky, Ph.D.
Professor
University of Houston