- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02538601
Enhanced Smoking Cessation Intervention for Smokers Exposed to the World Trade Center (WTC) Disaster
September 1, 2015 updated by: Stony Brook University
Enhanced Smoking Cessation Intervention for Smokers Exposed to the 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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Stony Brook, New York, United States, 11794
- Stony Brook University, Putnam Hall
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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-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).
|
ACTIVE_COMPARATOR: CBT-S
An 8-session, CBT-based, traditional group CBT based smoking cessation program.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Session 8: on average 2 weeks post-quit day
|
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.
|
6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline and 2-weeks post-quit attempt
|
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)
|
Baseline and 6-month follow-up
|
Change in lower respiratory symptoms
Time Frame: Baseline and 2-weeks post-quit attempt
|
Assessed via self-report
|
Baseline and 2-weeks post-quit attempt
|
6-month change in lower respiratory symptoms
Time Frame: Baseline and 6-month follow-up
|
Assessed via self-report
|
Baseline and 6-month follow-up
|
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
|
Baseline and 2-weeks post-quit attempt
|
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
|
Baseline and 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roman Kotov, PhD, Stony Brook University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (ACTUAL)
November 1, 2014
Study Completion (ACTUAL)
November 1, 2014
Study Registration Dates
First Submitted
August 12, 2015
First Submitted That Met QC Criteria
September 1, 2015
First Posted (ESTIMATE)
September 2, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
September 2, 2015
Last Update Submitted That Met QC Criteria
September 1, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-1605
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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