Enhanced Smoking Cessation Intervention for Smokers Exposed to the World Trade Center (WTC) Disaster
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 12, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedSeptember 2, 2015
September 1, 2015
2.8 years
August 12, 2015
September 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (6)
Change in WTC related post-traumatic stress disorder (PTSD) symptoms
Baseline and 2-weeks post-quit attempt
6-month change in WTC related post-traumatic stress disorder (PTSD) symptoms
Baseline and 6-month follow-up
Change in lower respiratory symptoms
Baseline and 2-weeks post-quit attempt
6-month change in lower respiratory symptoms
Baseline and 6-month follow-up
Change in average daily cigarettes smoked
Baseline and 2-weeks post-quit attempt
- +1 more secondary outcomes
Study Arms (2)
CBT-A
EXPERIMENTALAn 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 COMPARATORAn 8-session, CBT-based, traditional group CBT based smoking cessation program.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- current participation in another smoking cessation treatment
- alcohol dependence within the last six months
- serious mental illness (e.g., psychosis, mania)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stony Brook University, Putnam Hall
Stony Brook, New York, 11794, United States
Related Publications (1)
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.
PMID: 28277702DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roman Kotov, PhD
Stony Brook University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2015
First Posted
September 2, 2015
Study Start
February 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
September 2, 2015
Record last verified: 2015-09