CPT and Smoking Cessation
Primary Purpose
Stress Disorders, Post-Traumatic, Smoking
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy (CPT)
Bupropion
nicotine replacement therapy (NRT)
Integrated Care for Smoking Cessation (ICSC)
smokefreeVET
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Smoking Cessation, Stress Disorders, Post-Traumatic, Psychotherapy
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.
Sites / Locations
- Durham VA Medical Center, Durham, NC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CPT+ICSC
ICSC only
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01901848
First Posted
July 12, 2013
Last Updated
August 13, 2018
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01901848
Brief Title
CPT and Smoking Cessation
Official Title
Combined Smoking Cessation and Cognitive Processing Therapy for PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 11, 2013 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Smoking
Keywords
Smoking Cessation, Stress Disorders, Post-Traumatic, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPT+ICSC
Arm Type
Experimental
Arm Description
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.
Arm Title
ICSC only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy (CPT)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Zyban
Intervention Description
Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
Intervention Type
Drug
Intervention Name(s)
nicotine replacement therapy (NRT)
Other Intervention Name(s)
Nicoderm, Nicorette
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Care for Smoking Cessation (ICSC)
Intervention Description
ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
Intervention Type
Behavioral
Intervention Name(s)
smokefreeVET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up.
Description
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
Title
Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric A Dedert, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30664539
Citation
Dedert EA, Resick PA, Dennis PA, Wilson SM, Moore SD, Beckham JC. Pilot Trial of a Combined Cognitive Processing Therapy and Smoking Cessation Treatment. J Addict Med. 2019 Jul/Aug;13(4):322-330. doi: 10.1097/ADM.0000000000000502.
Results Reference
derived
Learn more about this trial
CPT and Smoking Cessation
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