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临床试验/NCT02538601
NCT02538601已完成不适用

Enhanced Smoking Cessation Intervention for Smokers Exposed to the WTC Disaster

Stony Brook University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年2月1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
90
试验地点
1
主要终点
Session 8 7-day point prevalence cigarette abstinence

研究概览

简要总结

The purpose of this study was to test the efficacy of a CBT-based smoking cessation treatment enhanced with transdiagnostic skills for the management of anxiety and fear-based avoidance behaviors (CBT-A) relative to a standard CBT-based smoking cessation treatment (CBT-S) for smokers with elevated PTSD symptoms who were exposed to the 9/11 World Trade Center disaster. The investigators hypothesized that the CBT-A treatment would yield more favorable outcomes with regard to smoking abstinence as well as improvements in PTSD and respiratory symptoms over a 6-month follow-up period.

详细描述

Respiratory illness and post-traumatic stress disorder (PTSD) are the primary health sequelae of the World Trade Center (WTC) disaster on September 11th 2001 and are often comorbid. Cigarette smoking is a modifiable health behavior associated with both lower respiratory symptoms (LRS) and PTSD. Smoking cessation programs are considered the crucial front-line intervention for smokers with pulmonary problems. Unfortunately, trauma exposed smokers with elevated PTSD symptoms have greater difficulty quitting, are more likely to fail standard cessation programs, and are more likely to relapse than smokers with other anxiety disorders and those without mental illness. Interventions that concurrently target mechanisms thought to maintain the comorbidity between PTSD and LRS (e.g., anxious reactivity to nicotine withdrawal, smoking to reduce negative affect) may offer a means of improving smoking quit rates in trauma exposed populations. Thus, the purpose of this study was to test the efficacy of a combined CBT smoking cessation treatment enhanced with transdiagnostic skills for the management of anxiety and fear-based avoidance behaviors (CBT-A). The investigators randomized 90 WTC disaster exposed daily smokers with elevated PTSD symptoms to either CBT-A (N=44) or a standard CBT-based smoking cessation program (CBT-S; N=46). Participants were followed up to six months post-treatment.

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 (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
否

入选标准

  • •smoking at least five cigarettes per day
  • •reporting interest in smoking cessation treatment
  • •direct exposure to the WTC disaster (e.g., responding to the event or witnessing the event in person)
  • •scoring >30 on the Posttraumatic Stress Disorder Checklist

排除标准

  • •current participation in another smoking cessation treatment
  • •alcohol dependence within the last six months
  • •serious mental illness (e.g., psychosis, mania)

研究组 & 干预措施

CBT-A

Experimental

An 8-session, CBT-based group smoking cessation program (CBT-A) enhanced with transdiagnostic skills for the management of anxiety and fear-based avoidance behaviors.

干预措施: CBT-A (Behavioral)

CBT-S

Active Comparator

An 8-session, CBT-based, traditional group CBT based smoking cessation program.

干预措施: CBT-S (Behavioral)

结局指标

主要结局

Session 8 7-day point prevalence cigarette abstinence

时间窗: Session 8: on average 2 weeks post-quit day

A dichotomized outcome (yes/no) configured based on biochemically verified 7 day smoking abstinence via Saliva cotinine (cutoff value of 10 ng/ml) and carbon monoxide (CO) analysis of breath samples with a Vitalograph Breathco CO monitor.

6-month Follow-up 7-day point prevalence cigarette abstinence

时间窗: 6-month follow-up

A dichotomized outcome (yes/no) configured based on biochemically verified 7 day smoking abstinence via Saliva cotinine (cutoff value of 10 ng/ml) and carbon monoxide (CO) analysis of breath samples with a Vitalograph Breathco CO monitor.

次要结局

  • Change in WTC related post-traumatic stress disorder (PTSD) symptoms(Baseline and 2-weeks post-quit attempt)
  • 6-month change in WTC related post-traumatic stress disorder (PTSD) symptoms(Baseline and 6-month follow-up)
  • Change in lower respiratory symptoms(Baseline and 2-weeks post-quit attempt)
  • 6-month change in lower respiratory symptoms(Baseline and 6-month follow-up)
  • Change in average daily cigarettes smoked(Baseline and 2-weeks post-quit attempt)
  • 6-month change in average daily cigarettes smoked(Baseline and 6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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