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临床试验/NCT02522156
NCT02522156已完成不适用

Looming Vulnerability and Smoking Cessation Attempts

American University2 个研究点 分布在 1 个国家目标入组 279 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
279
试验地点
2
主要终点
Quit attempt

研究概览

简要总结

Almost one-fifth of US adults are current cigarette smokers. To make further progress in lowering prevalence, it would help to increase the proportion of smokers attempting to quit. This application tests a novel approach to motivating smokers to quit, based on an empirically supported theory of anxiety. The approach uses guided imagery to increase smokers' sense of urgency about preventing the negative health consequences of smoking.

详细描述

Approach Participants and Eligibility Criteria

The investigators plan to enroll 290 participants, recruited via newspaper, radio, and online ads, flyers distributed in the community, and letters to healthcare providers. Ads will recruit adults who smoke at least 10 cigarettes/day and are willing to participate in two sessions four weeks apart but will not mention smoking cessation.

Prospective participants must meet the following criteria at a phone screen:

  1. Adults (age 18 or older).
  2. Daily cigarette smokers (at least 10 cigarettes per day).
  3. Total score of 5 or below on the Modified Mini Screen and score of 0 on the suicidality item.
  4. Fluent in English.
  5. Not planning to leave the Washington, DC area in the next month.

The Modified Mini Screen (MMS) is a safety precaution for the looming vulnerability induction, which on average increases state anxiety. Those scoring 6 or higher on the MMS are considered at moderate to high risk of having anxiety, mood, or psychotic disorders. The MMS is a modification of the MINI and appears to work equally well for men and women and for Caucasians and African Americans; the investigators are using the lowest (most conservative) cutoff score recommended on the basis of research validating the MMS against a full diagnostic interview (SCID). Prospective participants excluded on this basis will be offered therapy in a departmental training clinic, as well as alternate local referrals, outside the context of this research project.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (age 18 or older).
  • Daily cigarette smokers (at least 10 cigarettes per day).
  • Fluent in English. -

排除标准

  • planning to leave the Washington, DC area in the next month.
  • Total score > 5 on the Modified Mini Screen measure of risk for anxiety or mood disorders
  • Score > 0 on the suicidality item (#4) of Modified Mini Screen -

结局指标

主要结局

Quit attempt

时间窗: 4-week follow-up

yes/no, whether or not the participant made a 24-hour (or longer) quit attempt between the date of the main experiment and the date of the 4-week follow-up assessment.

次要结局

  • self-efficacy (Smoking Self-Efficacy Questionnaire; SSEQ)(4-week follow-up)
  • Abstinence(4-week follow-up)
  • Smoking rate(4-week follow-up)
  • Contemplation of quitting(4-week follow-up)
  • outcome expectancies (Smoking Consequences Questionnaire-Adult; SCQ-A)(4-week follow-up)

研究者

发起方
American University
申办方类型
Other
责任方
Principal Investigator
主要研究者

David A. F. Haaga

Professor of Psychology

American University

研究点 (2)

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