CPT and Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
Posttraumatic stress disorder (PTSD) and cigarette smoking are both associated with significant impairment in Veterans and cost to the Veterans' Affairs (VA) system. Though research suggests smoking is linked with PTSD symptoms, existing smoking cessation treatments targeting PTSD smokers do not include PTSD treatment. The purpose of this study is to examine a treatment that combines evidence based treatment for PTSD (cognitive processing therapy, or CPT) with smoking cessation treatment for PTSD and a mobile text messaging program. The study objectives are to evaluate feasibility of the treatment and to examine effectiveness of CPT and smoking cessation treatment combined compared to smoking cessation treatment without CPT. Fifty Veteran smokers with PTSD will participate in fourteen study sessions, ending with the final follow-up session six months after the scheduled quit date.

Detailed Description
-----------------
Posttraumatic stress disorder (PTSD) and cigarette smoking are both associated with significant impairment in Veterans and cost to the Veterans' Affairs (VA) system. Though naturalistic and laboratory studies suggest smoking is linked with PTSD symptoms, existing smoking cessation treatments targeting PTSD smokers have not utilized standardized, evidence-based PTSD treatment. The most effective smoking cessation approach to date for PTSD smokers, Integrated Care for Smoking Cessation (ICSC), relies on delivery of smoking cessation treatment by the individual's PTSD treatment provider. In a recent trial comparing ICSC to VA specialty Smoking Cessation Clinic care, ICSC produced significantly better prolonged smoking abstinence. However, ICSC was associated with only modest improvements in PTSD symptoms, with no difference between ICSC and smoking cessation treatment alone, suggesting a likely avenue for improving ICSC. The investigators have developed an intervention that combines evidence based treatment for PTSD [cognitive processing therapy (CPT-C)] with evidence based smoking cessation for PTSD [Integrated Care for Smoking Cessation (ICSC)] and a mobile text messaging program. The primary aim of the proposed study is to evaluate the integration of CPT-C and smoking cessation treatment in an individual 12-session PTSD protocol as compared to a protocol including the same smoking cessation treatment for individuals with PTSD, but without CPT-C. This intervention will be evaluated with the following hypotheses: Compared to the smoking cessation alone protocol, the smoking cessation + concurrent CPT-C protocol will result in reduced frequency and intensity of PTSD symptoms. Compared to the smoking cessation alone protocol, the smoking cessation + concurrent CPT-C protocol will result in reduced depressive symptoms. The smoking cessation + concurrent CPT-C protocol will result in decreased smoking rates, relative to published data on VA smoking cessation usual care. Greater PTSD symptom reduction during the smoking cessation + concurrent CPT-C treatment will result in longer duration to smoking lapse and relapse. Exploratory research question: Will candidate genes described earlier predict treatment response in smokers with PTSD? Exploratory research question: Will use of automated text messaging as an adjunct to smoking cessation be feasible, and will it impact quit rates? The development of a combined CPT-C/ICSC intervention with established empirical support would benefit the many Veterans with PTSD who smoke by providing them with treatment of two pervasive problems with significant associated impairment. In addition, this treatment could substantially reduce the cost of administering two individual treatments separately by administering them in combination.

Official Title
-----------------
Combined Smoking Cessation and Cognitive Processing Therapy for PTSD

Conditions
-----------------
Smoking, Stress Disorders, Post-Traumatic

Intervention / Treatment
-----------------
* Behavioral: Cognitive Processing Therapy (CPT)
* Drug: Bupropion
* Drug: nicotine replacement therapy (NRT)
* Behavioral: Integrated Care for Smoking Cessation (ICSC)
* Behavioral: smokefreeVET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be U.S. Veteran Smoke at least ten cigarettes a day Meet criteria for current PTSD Speak and write fluent conversational English Be between 18 and 65 years of age Be willing to attempt smoking cessation Must have access to a phone capable of receiving text messages Exclusion Criteria: Not stable on medications for the study period History of myocardial infarction in the past 6 months Contraindication to NRT and inability to get medical clearance from primary care provider Use of other forms of nicotine such as cigars, pipes, or chewing tobacco. Pregnancy Inability to complete study measures and tasks independently Dementia or other brain disorder, schizophrenia, current manic syndrome, or substance abuse/dependence in the preceding 3 months. Currently receiving trauma-focused psychotherapy. Currently living in court-ordered residential substance abuse treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPT+ICSC<br>This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy. | Behavioral: Cognitive Processing Therapy (CPT)<br>* CPT is based on a social cognitive theory of PTSD that includes primary emotional responses to traumatic events such as fear, anger, and sadness, as well as secondary emotions resulting from a patient's faulty interpretations of the traumatic event. CPT addresses PTSD by facilitating affective expression so that affective components of the trauma memory can be altered. In addition, faulty beliefs about the trauma are challenged and modified using Socratic questioning.<br>Drug: Bupropion<br>* Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.<br>* Other names: Zyban;Drug: nicotine replacement therapy (NRT)<br>* NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.<br>* Other names: Nicoderm, Nicorette;Behavioral: Integrated Care for Smoking Cessation (ICSC)<br>* ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.<br>Behavioral: smokefreeVET<br>* SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking.<br>|
| Active Comparator: ICSC only<br>This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy. | Drug: Bupropion<br>* Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.<br>* Other names: Zyban;Drug: nicotine replacement therapy (NRT)<br>* NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.<br>* Other names: Nicoderm, Nicorette;Behavioral: Integrated Care for Smoking Cessation (ICSC)<br>* ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.<br>Behavioral: smokefreeVET<br>* SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up. | 7-day point prevalence abstinence is defined as participant reporting no smoking occasions in the 7 days preceding the 6-month follow-up appointment. The 6-month follow-up occurs 6 months after the initial scheduled quit date. | 6-month follow-up | 
| Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million. | Self-reported 7-day point prevalence smoking abstinence was bioverified by breath carbon monoxide level of < 4 parts per million at the 6-month follow-up. | 6-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking Cessation, Stress Disorders, Post-Traumatic, Psychotherapy