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| Name | Class |
|---|---|
| University of Wisconsin, Madison | OTHER |
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The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.
The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.
After an initial phone screen, in-person screening, and baseline assessment, enrolled participants will be randomized to either behavioral activation therapy and standard smoking cessation treatment (BA+ST) or health and smoking education and standard smoking cessation treatment (HSE+ST). Both groups will meet with a therapist once a week for 8 weeks to receive either BA+ST or HSE+ST. Participants' mood and smoking outcomes will be monitored throughout the 8 weeks of treatment and at 2 follow-up visits and 2 follow-up phone calls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation Therapy | Experimental | Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge. |
|
| Health and Smoking Education | Active Comparator | Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation Therapy | Behavioral | Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Abstained From Smoking | 7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day | 26 weeks post target quit date |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Smoking Relapse | Days to first relapse after the target quit date | 26 weeks post target quit date |
| Clinician Administered PTSD Scale Score | PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS). Minimum score = 0, maximum score = 80. Higher scores indicate greater severity of symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica M Cook, PhD | William S. Middleton Memorial Veterans Hospital, Madison, WI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40071390 | Derived | Kaye JT, Betts JM, Brubaker E, Webster K, Beckham JC, Baker TB, Cook JW. Behavioral Activation for Smoking Cessation in Veterans with Posttraumatic Stress Disorder: A Randomized Clinical Trial. Nicotine Tob Res. 2025 Aug 22;27(9):1524-1533. doi: 10.1093/ntr/ntaf054. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Activation Therapy | Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge. Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period. |
| FG001 | Health and Smoking Education | Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge. Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Activation Therapy | Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge. Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Missing age data from three participants. |
| 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 | Percentage of Participants Who Abstained From Smoking | 7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day | Posted | Count of Participants | Participants | 26 weeks post target quit date |
|
Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
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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 | Behavioral Activation Therapy | Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge. Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized for chest pain | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Cook, PhD | Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health; William S Middleton Memorial Veterans Hospital | 608-265-9775 | jwcook@ctri.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 5, 2015 | Mar 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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|
| Health and Smoking Education | Behavioral | Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. |
|
| Standard Smoking Cessation Therapy | Behavioral | Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period. |
|
| 4 weeks post target quit date (end of treatment) |
| BG001 | Health and Smoking Education | Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge. Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Missing age data from three participants. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline cigarettes smoked per day | Mean | Standard Deviation | Cigarettes per day |
|
| OG001 | Health and Smoking Education | Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge. Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period. |
|
|
| Secondary | Time to Smoking Relapse | Days to first relapse after the target quit date | Posted | Mean | Standard Deviation | Days | 26 weeks post target quit date |
|
|
|
| Secondary | Clinician Administered PTSD Scale Score | PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS). Minimum score = 0, maximum score = 80. Higher scores indicate greater severity of symptoms. | Outcome Measure assessed at separate study visit. Data reported for participants who were assessed at this visit. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks post target quit date (end of treatment) |
|
|
|
| 1 |
| 63 |
| 7 |
| 63 |
| 33 |
| 63 |
| EG001 | Health and Smoking Education | Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge. Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period. | 1 | 61 | 6 | 61 | 29 | 61 |
| Hospitalized for fall | General disorders | Non-systematic Assessment |
|
| Hospitalized for suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
|
| Hospitalized for shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospitalized for lightheadedness | Nervous system disorders | Non-systematic Assessment |
|
| Hospitalized for TIA | Nervous system disorders | Non-systematic Assessment |
|
| Hospitalized for wound care | Surgical and medical procedures | Non-systematic Assessment |
|
| Hospitalized for pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospitalized for back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Swelling or tingling of the mouth | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Vivid dreams | Psychiatric disorders | Systematic Assessment |
|
| Hiccups | Gastrointestinal disorders | Systematic Assessment |
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| Mouth problems | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Persistent indigestion | Gastrointestinal disorders | Systematic Assessment |
|
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| D000068099 | Trauma and Stressor Related Disorders |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|