Cigarette SmokingNCT02538601
Enhanced Smoking Cessation Intervention for Smokers Exposed to the World Trade Center (WTC) Disaster
A study testing CBT-A and CBT-S in people with Cigarette Smoking and Post Traumatic Stress Disorder, run by Stony Brook University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking, Post Traumatic Stress Disorder, Signs and Symptoms, Respiratory
- What is being tested?
- CBT-A and CBT-S
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- current participation in another smoking cessation treatment
- alcohol dependence within the last six months
- serious mental illness (e.g., psychosis, mania)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University, Putnam Hall
Stony Brook, New York, 11794
About this study
Official title: 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.
Read the 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.
- Being tested
- CBT-A, CBT-S
- Keywords
- Post Traumatic Stress Disorder, PTSD, Cigarette Smoking, Lower Respiratory Symptoms, Cognitive Behavioral Therapy, CBT, Transdiagnostic Treatments, World Trade Center
- Medical subject headings
- Cigarette Smoking, Stress Disorders, Post-Traumatic, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-ABehavioural
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-SBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT-A | Experimental | 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. Receives: Behavioral: CBT-A |
| CBT-S | Active comparator | An 8-session, CBT-based, traditional group CBT based smoking cessation program. Receives: Behavioral: CBT-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Session 8: on average 2 weeks post-quit day
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.
Measured: 6-month follow-up
Secondary outcomes (6)
Change in WTC related post-traumatic stress disorder (PTSD) symptoms
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Measured: Baseline and 2-weeks post-quit attempt
6-month change in WTC related post-traumatic stress disorder (PTSD) symptoms
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Measured: Baseline and 6-month follow-up
Change in lower respiratory symptoms
Assessed via self-report
Measured: Baseline and 2-weeks post-quit attempt
6-month change in lower respiratory symptoms
Assessed via self-report
Measured: Baseline and 6-month follow-up
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
Measured: Baseline and 2-weeks post-quit attempt
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
Measured: Baseline and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startFeb 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Sponsor
- Investigators
- Roman Kotov, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538601
- Sponsor's protocol ID
- 2011-1605
- Status last verified
- Sep 2015
- First submitted
- 12 Aug 2015
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28277702
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Smoking Cessation Intervention for Smokers Exposed to the WTC Disaster
- ClinicalTrials.gov ID
- NCT02538601
- Acronym / sponsor ID
- 2011-1605
- Keywords
- Post Traumatic Stress Disorder, PTSD, Cigarette Smoking, Lower Respiratory Symptoms, Cognitive Behavioral Therapy, CBT, Transdiagnostic Treatments, World Trade Center
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Feb 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-A | Experimental | Behavioral: CBT-AAn 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-S | Active comparator | Behavioral: CBT-SAn 8-session, CBT-based, traditional group CBT based smoking cessation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- current participation in another smoking cessation treatment
- alcohol dependence within the last six months
- serious mental illness (e.g., psychosis, mania)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-ACBT-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). | Behavioural | CBT-A |
| CBT-SCBT-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. | Behavioural | CBT-S |
Primary outcome
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.
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 secondary outcomes
Change in WTC related post-traumatic stress disorder (PTSD) symptoms
Time frame: 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
Change in lower respiratory symptoms
Time frame: Baseline and 2-weeks post-quit attempt
6-month change in lower respiratory symptoms
Time frame: Baseline and 6-month follow-up
Change in average daily cigarettes smoked
Time frame: Baseline and 2-weeks post-quit attempt
6-month change in average daily cigarettes smoked
Time frame: Baseline and 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
- Derived from this study: PubMed 28277702Waszczuk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Kotov, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-A and CBT-S in people with Cigarette Smoking and Post Traumatic Stress Disorder, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session 8 7-day point prevalence cigarette abstinence (time frame: Session 8: on average 2 weeks post-quit day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02538601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.