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临床试验/NCT01753141
NCT01753141已完成不适用

Smoking Treatment and Anxiety Management Program

Florida State University2 个研究点 分布在 1 个国家目标入组 378 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
378
试验地点
2
主要终点
Anxiety Sensitivity Index

研究概览

简要总结

The Smoking Treatment and Anxiety Management Program (STAMP) is a treatment program focused on helping people manage their anxiety while quitting smoking. The study involves coming in to our clinic for 4 treatment sessions, with follow-ups for up to 2 years (a week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up). Participants will be paid $142.50 for their full participation as well as receive 6 weeks of free nicotine replacement patches.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Anxiety Sensitivity Index greater than 15
  • Daily smoker for at least 1 year
  • Less than 45 years old
  • Currently smoke at least 8 cigarettes per day
  • Report a motivation to quit smoking

排除标准

  • History of panic disorder
  • Psychotropic medication use (if not stable for 3 months)
  • History of significant medical condition
  • Current use of smoking cessation pharmacology
  • Use of other tobacco products
  • Planning to move in the next 6 months

结局指标

主要结局

Anxiety Sensitivity Index

时间窗: up to 2 years

The ASI is a 16-item self-report measure that assesses the fear of consequences of bodily sensations associated with anxiety. Items are rated on a five-point Likert-type scale ranging from 0 (very little) to 4 (very much) and a total score is computed by summing all items. The ASI is hierarchical in structure with one higher order factor (AS) and three subfactors (physical, cognitive, and social concerns). The physical concerns subscale includes items related to the fear of consequences or presence of specific physical sensations (e.g. "When I notice that my heart is beating rapidly, I worry that I might have a heart attack"). The cognitive concerns subscale includes items related to potential mental health implications of sensations (e.g. "When I cannot keep my mind on a task, I worry that I might be going crazy"). The social concerns subscale includes items related to the potential social consequences of physical sensations (e.g. "It is important to me not to appear nervous").

次要结局

  • Smoking Status(week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Norman Schmidt

Professor

Florida State University

研究点 (2)

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