Behavioral Activation for Smoking Cessation in PTSD
- Conditions
- Tobacco DependencePTSD
- Registration Number
- NCT01995123
- Lead Sponsor
- VA Office of Research and Development
- 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.
- Detailed Description
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.
After an initial phone screen, in-person screening, and baseline assessment, enrolled participants will be randomized to either behavioral activation therapy and standard smoking cessation treatment (BA+ST) or health and smoking education and standard smoking cessation treatment (HSE+ST). Both groups will meet with a therapist once a week for 8 weeks to receive either BA+ST or HSE+ST. Participants' mood and smoking outcomes will be monitored throughout the 8 weeks of treatment and at 2 follow-up visits and 2 follow-up phone calls.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Abstained From Smoking 26 weeks post target quit date 7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day
- Secondary Outcome Measures
Name Time Method Time to Smoking Relapse 26 weeks post target quit date Days to first relapse after the target quit date
Clinician Administered PTSD Scale Score 4 weeks post target quit date (end of treatment) PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS). Minimum score = 0, maximum score = 80. Higher scores indicate greater severity of symptoms.
Related Research Topics
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Trial Locations
- Locations (1)
William S. Middleton Memorial Veterans Hospital, Madison, WI
🇺🇸Madison, Wisconsin, United States
William S. Middleton Memorial Veterans Hospital, Madison, WI🇺🇸Madison, Wisconsin, United States