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

Post Traumatic Stress Disorder Clinical Trial

Official title:

Enhanced Smoking Cessation Intervention for Smokers Exposed to the WTC Disaster

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538601
• Other study ID #: 2011-1605
• Status: Completed
• Phase: N/A
• First received: August 12, 2015
• Last updated: September 1, 2015
• Start date: February 2012
• Est. completion date: November 2014

Study information

• Verified date: September 2015
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking
• Post Traumatic Stress Disorder
• Signs and Symptoms
• Signs and Symptoms, Respiratory
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• CBT-A
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
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.

Locations

Country	Name	City	State
United States	Stony Brook University, Putnam Hall	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Session 8 7-day point prevalence cigarette abstinence	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.	Session 8: on average 2 weeks post-quit day	No
Primary	6-month Follow-up 7-day point prevalence cigarette abstinence	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	No
Secondary	Change in WTC related post-traumatic stress disorder (PTSD) symptoms	Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)	Baseline and 2-weeks post-quit attempt	No
Secondary	6-month change in WTC related post-traumatic stress disorder (PTSD) symptoms	Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)	Baseline and 6-month follow-up	No
Secondary	Change in lower respiratory symptoms	Assessed via self-report	Baseline and 2-weeks post-quit attempt	No
Secondary	6-month change in lower respiratory symptoms	Assessed via self-report	Baseline and 6-month follow-up	No
Secondary	Change in average daily cigarettes smoked	Average number of cigarettes smoke per day in the past 7 days assessed via Time Line Follow-Back (TLFB) for Daily Cigarette Use	Baseline and 2-weeks post-quit attempt	No
Secondary	6-month change in average daily cigarettes smoked	Average number of cigarettes smoke per day in the past 7 days assessed via Time Line Follow-Back (TLFB) for Daily Cigarette Use	Baseline and 6-month follow-up	No