Behavioral Activation for Smoking Cessation in PTSD
1 other identifier
interventional
124
1 country
1
Brief Summary
The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.
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 Sep 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2013
CompletedFirst Posted
Study publicly available on registry
November 26, 2013
CompletedStudy Start
First participant enrolled
September 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2019
CompletedResults Posted
Study results publicly available
April 15, 2020
CompletedApril 15, 2020
March 1, 2020
4.6 years
November 20, 2013
March 31, 2020
March 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Abstained From Smoking
7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day
26 weeks post target quit date
Secondary Outcomes (2)
Time to Smoking Relapse
26 weeks post target quit date
Clinician Administered PTSD Scale Score
4 weeks post target quit date (end of treatment)
Study Arms (2)
Behavioral Activation Therapy
EXPERIMENTALBehavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Health and Smoking Education
ACTIVE COMPARATORHealth and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Interventions
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.
Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
Eligibility Criteria
You may qualify if:
- Report smoking an average of 10 or more cigarettes daily for at least six months
- Report a desire to quit smoking
- Meet criteria for current PTSD
- Speak and read English
- Agree to participate in the study
- Be 18 years old
- Be a veteran
You may not qualify if:
- Meeting criteria for psychotic or bipolar disorder
- Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
- Inability to give informed, voluntary, written consent to participate
- Current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
- Use of non-cigarette tobacco products as a primary form of tobacco use
- Being currently suicidal or homicidal
- Being medically unable to use the nicotine patch or nicotine gum/lozenge
- Psychotropic medication changes within 3 months of study initiation and during active treatment
- Current engagement in evidence-based therapies for PTSD or depression
- Pregnant or trying to become pregnant
- Incarceration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705, United States
Related Publications (1)
Kaye JT, Betts JM, Brubaker E, Webster K, Beckham JC, Baker TB, Cook JW. Behavioral Activation for Smoking Cessation in Veterans with Posttraumatic Stress Disorder: A Randomized Clinical Trial. Nicotine Tob Res. 2025 Aug 22;27(9):1524-1533. doi: 10.1093/ntr/ntaf054.
PMID: 40071390DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jessica Cook, PhD
- Organization
- Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health; William S Middleton Memorial Veterans Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica M Cook, PhD
William S. Middleton Memorial Veterans Hospital, Madison, WI
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2013
First Posted
November 26, 2013
Study Start
September 8, 2014
Primary Completion
March 29, 2019
Study Completion
March 29, 2019
Last Updated
April 15, 2020
Results First Posted
April 15, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share