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Completed

NCT Number: NCT02538601

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

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.

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Key information

Conditions

Cigarette Smoking Behavior Mental Disorders Pathological Conditions, Signs and Symptoms Post Traumatic Stress Disorder Signs and Symptoms Signs and Symptoms, Respiratory Smoking Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Tobacco Smoking Tobacco Use Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University, Putnam Hall

Stony Brook, New York, 11794, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CBT-A

Behavioral

CBT-A was an 8-session (1.5 hours/session) group treatment for quitting smoking comprised of an optimized protocol that incorporated all elements of the CBT-S treatment plus skills for reducing PTSD/anxiety symptoms and improving tolerance to withdrawal. The CBT-A intervention included skills based on a transdiagnostic approach: (1) repeated interoceptive exposures to feared bodily sensations (e.g., dizziness, racing heart); (2) corrective information about anxiety and cognitive restructuring of catastrophic misinterpretations of somatic sensations (e.g., "I will lose control."); and (3) use of graduated in-vivo exposure to feared and avoided situational experiences related to anxiety, WTC-related PTSD triggers, and smoking (e.g., going to lower Manhattan; driving without smoking).

CBT-S

Behavioral

CBT-S was an adapted group-based CBT smoking cessation treatment delivered in 8 sessions (1.5 hours/session) based on the most recent clinical practice guidelines from the United States Department of Health and Human Services (USDHHS), Treating Tobacco Use and Dependence. Standard cessation elements included psychoeducation on reasons for smoking and barriers to quitting, enlisting social support, monitoring and tapering cigarette use, and counseling regarding high-risk smoking situations and unhelpful ways of thinking about smoking and abstinence. The treatment was similar to protocols used in other smoking cessation research.

Primary outcomes

  1. Session 8 7-day point prevalence cigarette abstinence

    Time frame: 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.

  2. 6-month Follow-up 7-day point prevalence cigarette abstinence

    Time frame: 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 outcomes

  1. Change in WTC related post-traumatic stress disorder (PTSD) symptoms

    Time frame: Baseline and 2-weeks post-quit attempt

    Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)

  2. 6-month change in WTC related post-traumatic stress disorder (PTSD) symptoms

    Time frame: Baseline and 6-month follow-up

    Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)

  3. Change in lower respiratory symptoms

    Time frame: Baseline and 2-weeks post-quit attempt

    Assessed via self-report

  4. 6-month change in lower respiratory symptoms

    Time frame: Baseline and 6-month follow-up

    Assessed via self-report

  5. Change in average daily cigarettes smoked

    Time frame: 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. 6-month change in average daily cigarettes smoked

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • National Institute for Occupational Safety and Health (NIOSH/CDC)

Registry information

Official study title

Enhanced Smoking Cessation Intervention for Smokers Exposed to the WTC Disaster

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2015
Registry last updated
Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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