A Phase 2/3 interventional study of Cognitive Processing Therapy (CPT) and Bupropion in Stress Disorders, Post-Traumatic and Smoking, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-09-11.
Sponsored by VA Office of Research and Development · Phase 2/3, Interventional, and Treatment
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.
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:
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 69 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
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Exclusion Criteria:
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) · Drug: Bupropion · Drug: nicotine replacement therapy (NRT) · Behavioral: Integrated Care for Smoking Cessation (ICSC) · Behavioral: 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.
Drug: Bupropion · Drug: nicotine replacement therapy (NRT) · Behavioral: Integrated Care for Smoking Cessation (ICSC) · Behavioral: smokefreeVET
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.
Also known as: Zyban
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.
Also known as: Nicoderm, Nicorette
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.
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.
Time frame: 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.
Time frame: 6-month follow-up
A total of 69 participants consented before the screening session. Nineteen were excluded, and 50 were randomized. As a result, there were 69 who consented, but only 50 are included in the flow diagram for the trial.
| Milestone | CPT+ICSC | Present-focused ICSC |
|---|---|---|
| Started | 25 | 25 |
| Completed | 22 | 19 |
| Not completed | 3 | 6 |
| Withdrew: Lost to follow-up | 3 | 6 |
| Milestone | CPT+ICSC | Present-focused ICSC |
|---|---|---|
| Started | 22 | 19 |
| Completed | 12 | 19 |
| Not completed | 10 | 0 |
| Withdrew: Cpt practice cases to establish fidelity | 10 | 0 |
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.
| Participants | CPT+ICSC | Present-focused ICSC |
|---|---|---|
| Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up. | 2 | 8 |
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.
| Participants | CPT+ICSC | Present-focused ICSC |
|---|---|---|
| Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million. | 2 | 4 |
Collected over For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CPT+ICSC | 0/15 (0%) | 0/15 (0%) | 5/15 (33.3%) |
| Present-focused ICSC | 0/25 (0%) | 2/25 (8%) | 4/25 (16%) |
| Event | CPT+ICSC | Present-focused ICSC |
|---|---|---|
| Hospitalization due to alcohol intoxication/withdrawalPsychiatric disorders | 0/15 | 1/25 |
| Hospitalization due to antibiotic reactionGeneral disorders | 0/15 | 1/25 |
| Event | CPT+ICSC | Present-focused ICSC |
|---|---|---|
| Increased anxietyPsychiatric disorders | 0/15 | 2/25 |
| CongestionRespiratory, thoracic and mediastinal disorders | 0/15 | 2/25 |
| Stomach pain/flank painGastrointestinal disorders | 0/15 | 2/25 |
| NauseaGastrointestinal disorders | 1/15 | 2/25 |
| CervicalgiaReproductive system and breast disorders | 1/15 | 0/25 |
| Flu-like symptomsGeneral disorders | 1/15 | 0/25 |
| Increased arthritis symptomsMusculoskeletal and connective tissue disorders | 1/15 | 0/25 |
| Itchiness/skin irritation at site of nicotine patchSkin and subcutaneous tissue disorders | 1/15 | 0/25 |
Because primary analyses used maximum likelihood to address missing data, participants who were lost to follow-up (n = 3 in CPT+ICSC group, n = 6 in ICSC group) were included in primary analyses.
| Age, Continuous(years) | CPT+ICSC | Present-focused ICSC | Total |
|---|---|---|---|
| Mean | 43.1 ± 10.8 | 53.3 ± 10.8 | 49.5 ± 10.8 |
| Sex: Female, Male(Participants) | CPT+ICSC | Present-focused ICSC | Total |
|---|---|---|---|
| Female | 1 | 6 | 7 |
| Male | 14 | 19 | 33 |
| Race/Ethnicity, Customized(Participants) | CPT+ICSC | Present-focused ICSC | Total |
|---|---|---|---|
| African American | 9 | 14 | 23 |
| Caucasian, not Hispanic | 3 | 7 | 10 |
| Hispanic | 2 | 0 | 2 |
| Multiple Races | 1 | 4 | 5 |
| Region of Enrollment(Participants) | CPT+ICSC | Present-focused ICSC | Total |
|---|---|---|---|
| United States | 15 | 25 | 40 |
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