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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPT+ICSC | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy (CPT) | Behavioral | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric A Dedert, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30664539 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CPT+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. Cognitive Processing Therapy (CPT): 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: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment. nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, |
| FG001 | Present-focused 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. Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment. nicotine replacement therapy (NRT): 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. Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling. smokefreeVET: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized and Treated |
|
| ||||||||||||||||||
| Removed From Analyses |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | CPT+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. Cognitive Processing Therapy (CPT): In CPT, faulty beliefs about the trauma are challenged and modified using Socratic questioning. Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment. nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 6-month follow-up |
|
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.
n/a; clinicaltrials.gov definition used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CPT+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. Cognitive Processing Therapy (CPT): In CPT, faulty beliefs about the trauma are challenged and modified using Socratic questioning. Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment. nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to alcohol intoxication/withdrawal | Psychiatric disorders | Systematic Assessment | Due to pre-existing substance use disorder; not study-related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased anxiety | Psychiatric disorders | Systematic Assessment | Reported increased anxiety and irritability. Potentially study-related, as anxiety is known feature of PTSD. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Dedert, Ph.D. | Durham Veterans Health Care System | 919-384-8582 | 4055 | eric.dedert@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 9, 2017 | Jun 14, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| D000095488 | Nicotine Replacement Therapy |
| D009538 | Nicotine |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D004358 | Drug Therapy |
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|
| Bupropion | Drug | Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment. |
|
|
| nicotine replacement therapy (NRT) | Drug | 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. |
|
|
| Integrated Care for Smoking Cessation (ICSC) | Behavioral | ICSC is a manualized treatment for smoking cessation involving six sessions of counseling. |
|
| smokefreeVET | Behavioral | 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. |
|
| NOT COMPLETED |
|
|
| BG001 | Present-focused 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. Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment. nicotine replacement therapy (NRT): 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. Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling. smokefreeVET: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Present-focused 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. Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment. nicotine replacement therapy (NRT): 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. Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling. smokefreeVET: 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 | 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. | Posted | Count of Participants | Participants | 6-month follow-up |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 5 |
| 15 |
| EG001 | Present-focused 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. Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment. nicotine replacement therapy (NRT): 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. Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling. smokefreeVET: 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. | 0 | 25 | 2 | 25 | 4 | 25 |
|
| Hospitalization due to antibiotic reaction | General disorders | Systematic Assessment | Pt. was given antibiotics for bee sting, had negative reaction to prescribed meds. Not study related. |
|
|
| Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Reported increased congestion. Possible study related, because is side effect of quitting smoking. |
|
| Cervicalgia | Reproductive system and breast disorders | Systematic Assessment | Pre-existing condition, not study related |
|
| Stomach pain/flank pain | Gastrointestinal disorders | Systematic Assessment | Not study related |
|
| Flu-like symptoms | General disorders | Systematic Assessment | Not study related |
|
| Increased arthritis symptoms | Musculoskeletal and connective tissue disorders | Systematic Assessment | Due to pre-existing condition, not study-related |
|
| Itchiness/skin irritation at site of nicotine patch | Skin and subcutaneous tissue disorders | Systematic Assessment | Itchiness/skin irritation is a known side effect of nicotine patch use. |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Nausea is known potential side effect of nicotine replacement therapies. |
|
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| D015438 | Health Behavior |
| D013812 |
| Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |