CPT and Smoking Cessation

Phase 2

Completed

Conditions: Stress Disorders, Post-Traumatic
Smoking

Interventions: Behavioral: Cognitive Processing Therapy (CPT)
Drug: Bupropion
Drug: nicotine replacement therapy (NRT)
Behavioral: Integrated Care for Smoking Cessation (ICSC)
Behavioral: smokefreeVET

Registration Number: NCT01901848

Lead Sponsor: VA Office of Research and Development

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:

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 69

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPT+ICSC	Integrated Care for Smoking Cessation (ICSC)	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.
CPT+ICSC	Cognitive Processing Therapy (CPT)	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.
CPT+ICSC	Bupropion	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.
CPT+ICSC	smokefreeVET	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.
ICSC only	Bupropion	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.
ICSC only	Integrated Care for Smoking Cessation (ICSC)	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.
ICSC only	smokefreeVET	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.
CPT+ICSC	nicotine replacement therapy (NRT)	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.
ICSC only	nicotine replacement therapy (NRT)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up.	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.
Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million.	6-month follow-up	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.

Secondary Outcome Measures