Behavioral Activation for Smoking Cessation in PTSD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Behavioral Activation for Smoking Cessation in Veterans With PTSD

Conditions
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Tobacco Dependence, PTSD

Intervention / Treatment
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* Behavioral: Behavioral Activation Therapy
* Behavioral: Health and Smoking Education
* Behavioral: Standard Smoking Cessation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Activation Therapy<br>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. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge. | Behavioral: Behavioral Activation Therapy<br>* 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.<br>Behavioral: Standard Smoking Cessation Therapy<br>* Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.<br>|
| Active Comparator: Health and Smoking Education<br>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. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge. | Behavioral: Health and Smoking Education<br>* 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.<br>Behavioral: Standard Smoking Cessation Therapy<br>* Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Smoking Relapse | Days to first relapse after the target quit date | 26 weeks post target quit date | 
| Clinician Administered PTSD Scale Score | PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS). Minimum score = 0, maximum score = 80. Higher scores indicate greater severity of symptoms. | 4 weeks post target quit date (end of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco dependence, PTSD, Behavioral Activation Therapy