Clinical trial NCT02538601: Enhanced Smoking Cessation Intervention for Smokers Exposed to the World Trade Center (WTC) Disaster
Official title: Enhanced Smoking Cessation Intervention for Smokers Exposed to the WTC Disaster
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Post Traumatic Stress Disorder
Signs and Symptoms, Respiratory
Keywords: Post Traumatic Stress Disorder
PTSD
Cigarette Smoking
Lower Respiratory Symptoms
Cognitive Behavioral Therapy
CBT
Transdiagnostic Treatments
World Trade Center
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2015-09-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Session 8 7-day point prevalence cigarette abstinence
timeFrame: Session 8: on average 2 weeks post-quit day
measure: 6-month Follow-up 7-day point prevalence cigarette abstinence
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Change in WTC related post-traumatic stress disorder (PTSD) symptoms
timeFrame: Baseline and 2-weeks post-quit attempt
measure: 6-month change in WTC related post-traumatic stress disorder (PTSD) symptoms
timeFrame: Baseline and 6-month follow-up
measure: Change in lower respiratory symptoms
timeFrame: Baseline and 2-weeks post-quit attempt
measure: 6-month change in lower respiratory symptoms
timeFrame: Baseline and 6-month follow-up
measure: Change in average daily cigarettes smoked
timeFrame: Baseline and 2-weeks post-quit attempt
measure: 6-month change in average daily cigarettes smoked
timeFrame: Baseline and 6-month follow-up
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University, Putnam Hall
state: New York
Study officials:
affiliation: Stony Brook University
name: Roman Kotov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waszczuk MA, Li X, Bromet EJ, Gonzalez A, Zvolensky MJ, Ruggero C, Luft BJ, Kotov R. Pathway from PTSD to respiratory health: Longitudinal evidence from a psychosocial intervention. Health Psychol. 2017 May;36(5):429-437. doi: 10.1037/hea0000472. Epub 2017 Mar 9.