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临床试验/NCT03382093
NCT03382093已完成不适用

Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

University of Houston2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2017年8月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
2
主要终点
Evaluate PFI

研究概览

简要总结

This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and anxiety sensitivity (AS). The PFI will focus on feedback about smoking behavior, AS, and adaptive coping strategies.

详细描述

The primary goal of the research study is to investigate the efficacy of a brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills compared to a smoking information only control. To address this aim, we will implement a randomized controlled trial that will employ a longitudinal experimental design and involve three stages: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility), random assignment to a one-session computer-delivered intervention (PFI versus smoking information control with no personalized feedback), and a post-intervention assessment; (c) 1-month follow-up. Assessments will include a multi-method approach, including biological, behavioral, and self-report methods.

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

入选标准

  • Elevated anxiety sensitivity defined as an ASI-III score of at least 17
  • Daily smoking for at least one year (minimum of 5 cigarettes per day and biochemically confirmed via Carbon Monoxide [CO] analysis at least 4 ppm)
  • Not presently engaged in a quit attempt
  • Not currently engaged in mental health treatment
  • Capable of providing informed consent
  • Willing to attend all study visits and comply with the protocol

排除标准

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Students for whom you have direct access to/influence on grades
  • Use of other tobacco products
  • Currently suicidal or high suicide risk
  • Currently psychotic or high psychotic risk
  • Insufficient command of English to participate in assessment or treatment

研究组 & 干预措施

Personalized Feedback Intervention

Active Comparator

A brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills.

干预措施: Personalized Feedback Intervention (Behavioral)

Smoking Information Control

Active Comparator

Standard, computer-delivered smoking cessation treatment/information.

干预措施: Smoking Information Control (Behavioral)

结局指标

主要结局

Evaluate PFI

时间窗: Assessed at 1-month follow-up after the one-session intervention

Evaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey.

次要结局

  • Smoking Motivational Processes(Assessed at 1-month follow-up after the one-session intervention)
  • Mechanisms(Assessed at 1-month follow-up after the one-session intervention)
  • Smoking Behavior(Assessed at 1-month follow-up after the one-session intervention)
  • Affective Processes(Assessed at 1-month follow-up after the one-session intervention)

研究者

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

Lorra Garey

Clinical Psychology Doctoral Student

University of Houston

研究点 (2)

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