Enhanced Smoking Cessation Intervention for Smokers Exposed to the World Trade Center (WTC) Disaster
Primary Purpose
Cigarette Smoking, Post Traumatic Stress Disorder, Signs and Symptoms, Respiratory
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-A
CBT-S
Sponsored by
About this trial
This is an interventional treatment trial for Cigarette Smoking focused on measuring Post Traumatic Stress Disorder, PTSD, Cigarette Smoking, Lower Respiratory Symptoms, Cognitive Behavioral Therapy, CBT, Transdiagnostic Treatments, World Trade Center
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)
Sites / Locations
- Stony Brook University, Putnam Hall
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT-A
CBT-S
Arm Description
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.
An 8-session, CBT-based, traditional group CBT based smoking cessation program.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change in WTC related post-traumatic stress disorder (PTSD) symptoms
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
6-month change in WTC related post-traumatic stress disorder (PTSD) symptoms
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Change in lower respiratory symptoms
Assessed via self-report
6-month change in lower respiratory symptoms
Assessed via self-report
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
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
Full Information
NCT ID
NCT02538601
First Posted
August 12, 2015
Last Updated
September 1, 2015
Sponsor
Stony Brook University
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
1. Study Identification
Unique Protocol Identification Number
NCT02538601
Brief Title
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
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stony Brook University
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-A
Arm Type
Experimental
Arm Description
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.
Arm Title
CBT-S
Arm Type
Active Comparator
Arm Description
An 8-session, CBT-based, traditional group CBT based smoking cessation program.
Intervention Type
Behavioral
Intervention Name(s)
CBT-A
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
CBT-S
Intervention Description
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 Outcome Measure Information:
Title
Session 8 7-day point prevalence cigarette abstinence
Description
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.
Time Frame
Session 8: on average 2 weeks post-quit day
Title
6-month Follow-up 7-day point prevalence cigarette abstinence
Description
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.
Time Frame
6-month follow-up
Secondary Outcome Measure Information:
Title
Change in WTC related post-traumatic stress disorder (PTSD) symptoms
Description
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Time Frame
Baseline and 2-weeks post-quit attempt
Title
6-month change in WTC related post-traumatic stress disorder (PTSD) symptoms
Description
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Time Frame
Baseline and 6-month follow-up
Title
Change in lower respiratory symptoms
Description
Assessed via self-report
Time Frame
Baseline and 2-weeks post-quit attempt
Title
6-month change in lower respiratory symptoms
Description
Assessed via self-report
Time Frame
Baseline and 6-month follow-up
Title
Change in average daily cigarettes smoked
Description
Average number of cigarettes smoke per day in the past 7 days assessed via Time Line Follow-Back (TLFB) for Daily Cigarette Use
Time Frame
Baseline and 2-weeks post-quit attempt
Title
6-month change in average daily cigarettes smoked
Description
Average number of cigarettes smoke per day in the past 7 days assessed via Time Line Follow-Back (TLFB) for Daily Cigarette Use
Time Frame
Baseline and 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Kotov, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University, Putnam Hall
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28277702
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.
Results Reference
derived
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Enhanced Smoking Cessation Intervention for Smokers Exposed to the World Trade Center (WTC) Disaster
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