Enhanced Smoking Cessation Intervention for Smokers Exposed to the World Trade Center (WTC) Disaster

Not Applicable

Completed

• Conditions: Signs and Symptoms, Respiratory; Cigarette Smoking; Post Traumatic Stress Disorder
• Interventions: Behavioral: CBT-A; Behavioral: CBT-S

• Registration Number: NCT02538601
• Lead Sponsor: Stony Brook University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2015-08-12
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-01
• Last Update Submitted: 2015-09-01
• Study First Posted: 2015-09-02
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-A	CBT-A	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.
CBT-S	CBT-S	An 8-session, CBT-based, traditional group CBT based smoking cessation program.

Primary Outcome Measures

Name	Time	Method
Session 8 7-day point prevalence cigarette abstinence	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in WTC related post-traumatic stress disorder (PTSD) symptoms	Baseline and 2-weeks post-quit attempt	Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
6-month change in WTC related post-traumatic stress disorder (PTSD) symptoms	Baseline and 6-month follow-up	Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Change in lower respiratory symptoms	Baseline and 2-weeks post-quit attempt	Assessed via self-report
6-month change in lower respiratory symptoms	Baseline and 6-month follow-up	Assessed via self-report
Change in average daily cigarettes smoked	Baseline and 2-weeks post-quit attempt	Average number of cigarettes smoke per day in the past 7 days assessed via Time Line Follow-Back (TLFB) for Daily Cigarette Use
6-month change in average daily cigarettes smoked	Baseline and 6-month follow-up	Average number of cigarettes smoke per day in the past 7 days assessed via Time Line Follow-Back (TLFB) for Daily Cigarette Use

Trial Locations

Locations (1)

Stony Brook University, Putnam Hall; 🇺🇸 Stony Brook, New York, United States