CPT and Smoking Cessation
Condition: Stress Disorders, Post-Traumatic; Smoking
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2/Phase 3

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:

        1. Compared to the smoking cessation alone protocol, the smoking cessation + concurrent
           CPT-C protocol will result in reduced frequency and intensity of PTSD symptoms.

        2. Compared to the smoking cessation alone protocol, the smoking cessation + concurrent
           CPT-C protocol will result in reduced depressive symptoms.

        3. The smoking cessation + concurrent CPT-C protocol will result in decreased smoking
           rates, relative to published data on VA smoking cessation usual care.

        4. Greater PTSD symptom reduction during the smoking cessation + concurrent CPT-C treatment
           will result in longer duration to smoking lapse and relapse.

        5. Exploratory research question: Will candidate genes described earlier predict treatment
           response in smokers with PTSD?

        6. 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.
    

Intervention name(s): Cognitive Processing Therapy (CPT); Bupropion; nicotine replacement therapy (NRT); Integrated Care for Smoking Cessation (ICSC); smokefreeVET
Intervention type(s): Behavioral; Drug; Drug; Behavioral; Behavioral
Intervention description(s): 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.; Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.; 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.; ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.; 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.
Other intervention name(s): Zyban; Nicoderm, Nicorette
Intervention MeSH terms: Bupropion; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking Cessation; Stress Disorders, Post-Traumatic; Psychotherapy