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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-09681 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) | |
| 22634 | Other Identifier | University of California, San Francisco |
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| Name | Class |
|---|---|
| Tobacco Related Disease Research Program | OTHER |
| San Francisco Veterans Affairs Medical Center | FED |
| Northern California Institute of Research and Education | OTHER |
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This project aims to enhance the scalability of an office-based smoking cessation treatment protocol for veterans with PTSD, integrated care (IC), by adapting it to be delivered over the telephone and to incorporate mobile technology components. Mobile technology components include: (1) the Stay Quit Coach (SQC) mobile application (app), and (2) the iCO® mobile Smokerlyzer®, a smart phone-compatible carbon monoxide monitor.
Eighty U.S. military veteran smokers with PTSD, ages 18-45, will be randomized to receive either: (1) the telephone-and technology-facilitated intervention (n=40), or (2) the current standard of care (referral to the VA telephone Quitline) (n=40) as a control. All participants will receive a baseline (Week 0) office visit and will optionally be prescribed nicotine replacement therapy (NRT). Participants in the intervention condition will receive eight 20- to 30-minute video or telephone counseling sessions and be asked to use the SQC app and iCO® Mobile Smokerlyzer®. Control participants will receive up to eight weekly proactive telephone sessions through the VA telephone Quitline. Assessments will occur at baseline (Week 0), treatment end (Week 8), and at three months (Week 12) and six months (Week 24) post-randomization. The primary aims of this pilot randomized controlled trial are: (1) to assess the feasibility and acceptability of the intervention; and (2) to assess the impact of the adapted IC intervention on treatment retention compared to treatment as usual (i.e., VA Quitline).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tech-facilitated IC intervention | Experimental | After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will then receive 8 counseling sessions (video or telephone). The first session lasts 45-60 min, and the remaining 7 sessions last 20-30 min. Participants will be asked to use the Stay Quit Coach (SQC) app between sessions, and the iCO® Smokerlyzer® |
|
| VA Quitline | Active Comparator | After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will also receive weekly proactive telephone sessions through the VA Quitline, a standard of care, proactive telephone quitline available to all veterans for up to eight weeks. Participants will initiate the first call and subsequent calls will be made by the Quitline counselor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tech-Facilitated IC Intervention | Behavioral | The Integrated Care (IC) treatment protocol for smoking cessation is a PTSD-informed intervention that has been adapted to be delivered over video or telephone and to incorporate technological components, including the Stay Quit Coach (SQC) smart phone application (app) which is a public domain, no-cost mobile app designed to complement the IC protocol with evidence-based tools to support smoking cessation. and the coVita Bedfont® Scientific Ltd iCO® Smokerlyzer® device and app which is a mobile carbon monoxide (CO) monitor that provides CO readings in order to self-monitor progress in quitting. The coVita mobile app is compatible with iOS &Android and used with the iCO® Smokerlyzer® to display CO readings. Content of sessions is consistent with that delivered in the IC treatment protocol for veteran smokers with post-traumatic stress disorder (PTSD). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Attending All Intervention Sessions | Number of participants attending all intervention sessions. | over 8-week intervention period; calculated at Week 8 (post-treatment) |
| The Difference in Total Number of Treatment Sessions Attended Between the Experimental Treatment Condition and the Control Condition | The difference in total number of treatment sessions attended between the experimental treatment condition and the control condition. Higher adherence rates suggest greater study/intervention feasibility and acceptability, and a large difference score would indicate greater feasibility/acceptability of one study condition over the other. | over 8-week intervention period; calculated at Week 8 (post-treatment) |
| Acceptability Questionnaire | Participants (in the intervention condition only) will complete a questionnaire developed by the investigators to rate the intervention protocol from 1-10 in terms of perceived helpfulness, understandability, and likelihood of use. The mean score (i.e., average of item ratings) will be reported for the participants in the intervention condition. Higher scores represent greater acceptability. | Week 8 |
| Median Scores on the System Usability Scale (SUS) | The SUS is a brief, reliable and valid instrument to measure perceptions of usability of technology devices. Items are rated on a scale from 0-5. An SUS total score is calculated by summing item ratings, and then multiplied the sum by 2.5. The maximum score on the SUS is 100, with higher scores reflecting greater usability. The SUS will be administered to the intervention condition only. Mean usability score will be reported. | Week 8 |
| Median Scores on the Client Satisfaction Questionnaire-8 (CSQ-8) | The CSQ-8 is an eight-item instrument designed to measure satisfaction with an clinical intervention. Items are rated on a scale from 1-4 and summed to for an CSQ-8 total score. Scores range from 8-32, with higher scores indicating greater satisfaction. The CSQ-8 will be administered to the intervention condition only. Mean satisfaction score will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Cigarettes Smoked in the Past 30 Days at Weeks 0, 8, 12 and 24 | Self-reported use of cigarettes will be assessed with Timeline Follow-Back (TLFB) (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in cigarette use between the experimental treatment condition and the control condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Timeline Follow-Back (TLFB): Other Tobacco Products | Self-reported use of any other tobacco products will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in use of other tobacco products between the experimental treatment condition and the control condition. | Weeks 0, 8, 12, and 24 |
Inclusion Criteria:
Modified inclusion criteria for remote screenings during Coronavirus Disease 2019 (COVID-19) pandemic:
7. Female participants will be required to provide a negative urine pregnancy test if they do not have a verified and reliable form of birth control (at the discretion of the PI). Pregnancy tests will be mailed to the participant and they will be asked to take a photo of the completed test and send it through an encrypted e-mail back to the study team in order to determine eligibility. Participants may also choose to complete urine pregnancy testing at VA lab. This will occur after verbal consent is given.
8. No longer required to be able to attend in-person screening appointment as everything will be done remotely. Potential recruits will need the ability to participate in telephone or secure, 2-way video conferencing "visits" for: Consent and Screening (Week 0), 8 weekly sessions, follow-up sessions at Weeks 12 and 24, and monthly nicotine replacement check-ins.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Herbst, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center | San Francisco | California | 94121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tech-facilitated IC Intervention | After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at Week 0, per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will then receive 8 counseling sessions (telehealth). The first session lasts 45-60 min, and the remaining 7 sessions last 20-30 min. Participants will be asked to use the Stay Quit Coach (SQC) app between sessions, and the iCO® Smokerlyzer® Tech-Facilitated IC Intervention: The Integrated Care (IC) treatment protocol for smoking cessation is a PTSD-informed intervention that has been adapted to be delivered over video or telephone and to incorporate technological components, including the Stay Quit Coach (SQC) smart phone application which is a public domain, no-cost mobile app designed to complement the IC protocol with evidence-based tools to support smoking cessation. and the coVita Bedfont® Scientific Ltd iCO® Smokerlyzer® device and app which is a mobile carbon monoxide (CO) monitor that provides CO readings in order to self-monitor progress in quitting. The coVita mobile app is compatible with iOS &Android and used with the iCO® Smokerlyzer® to display CO readings. Content of sessions is consistent with that delivered in the IC treatment protocol for veteran smokers with post-traumatic stress disorder. |
| FG001 | VA Quitline | After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will also receive weekly proactive telephone sessions through the VA Quitline, a standard of care, proactive telephone quitline available to all veterans for up to eight weeks. Participants will initiate the first call and subsequent calls will be made by the Quitline counselor. VA Quitline: The SFVAMC's standard of care referral service, known as the VA Quitline which involves weekly telephone sessions through the VA's proactive telephone Quitline, available to all veterans for up to 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tech-facilitated IC Intervention | After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at Week 0, per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will then receive 8 counseling sessions (telehealth). The first session lasts 45-60 min, and the remaining 7 sessions last 20-30 min. Participants will be asked to use the Stay Quit Coach (SQC) app between sessions, and the iCO® Smokerlyzer® Tech-Facilitated IC Intervention: The Integrated Care (IC) treatment protocol for smoking cessation is a PTSD-informed intervention that has been adapted to be delivered over video or telephone and to incorporate technological components, including the Stay Quit Coach (SQC) smart phone application which is a public domain, no-cost mobile app designed to complement the IC protocol with evidence-based tools to support smoking cessation. and the coVita Bedfont® Scientific Ltd iCO® Smokerlyzer® device and app which is a mobile carbon monoxide (CO) monitor that provides CO readings in order to self-monitor progress in quitting. The coVita mobile app is compatible with iOS &Android and used with the iCO® Smokerlyzer® to display CO readings. Content of sessions is consistent with that delivered in the IC treatment protocol for veteran smokers with post-traumatic stress disorder. |
| 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 Attending All Intervention Sessions | Number of participants attending all intervention sessions. | Posted | Count of Participants | Participants | over 8-week intervention period; calculated at Week 8 (post-treatment) |
|
24 Weeks
There were no adverse events to report in this study.
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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 | Tech-facilitated IC Intervention | After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at Week 0, per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will then receive 8 counseling sessions (telehealth). The first session lasts 45-60 min, and the remaining 7 sessions last 20-30 min. Participants will be asked to use the Stay Quit Coach (SQC) app between sessions, and the iCO® Smokerlyzer® Tech-Facilitated IC Intervention: The Integrated Care (IC) treatment protocol for smoking cessation is a PTSD-informed intervention that has been adapted to be delivered over video or telephone and to incorporate technological components, including the Stay Quit Coach (SQC) smart phone application which is a public domain, no-cost mobile app designed to complement the IC protocol with evidence-based tools to support smoking cessation. and the coVita Bedfont® Scientific Ltd iCO® Smokerlyzer® device and app which is a mobile carbon monoxide (CO) monitor that provides CO readings in order to self-monitor progress in quitting. The coVita mobile app is compatible with iOS &Android and used with the iCO® Smokerlyzer® to display CO readings. Content of sessions is consistent with that delivered in the IC treatment protocol for veteran smokers with post-traumatic stress disorder (PTSD). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Herbst, MD | San Francisco Veterans Affairs Medical Center | 415-221-4810 | 24926 | Ellen.Herbst@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 | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2018 | Dec 17, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 20, 2019 | Feb 24, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
| VA Quitline | Behavioral | The SFVAMC's standard of care referral service, known as the VA Quitline which involves weekly telephone sessions through the VA's proactive telephone Quitline, available to all veterans for up to 8 weeks. |
|
| Week 8 (post-treatment) |
| Weeks 0, 8, 12, and 24 |
| Timeline Follow-Back (TLFB): E-cigarettes | Self-reported use of e-cigarettes will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in e-cigarette use between the experimental treatment condition and the control condition. | Weeks 0, 8, 12, and 24 |
| Timeline Follow-Back (TLFB): Chewing Tobacco | Self-reported use of chewing tobacco will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in chewing tobacco use between the experimental treatment condition and the control condition. | Weeks 0, 8, 12, and 24 |
| Change in Scores on the Fagerström Test for Nicotine Dependence (FTND) | The FTND is a validated, 6-item self-report instrument that evaluates the intensity of physical addiction to nicotine. Three items are rated yes/no (0/1), and the other three items are rated on a scale from 0-3. Items are summed to yield a total score of 0-10, with higher scores reflecting greater nicotine dependence. This outcome variable will be reported as the difference in FTND total score between the experimental treatment condition and the control condition. | Weeks 0, 8, 12, and 24 |
| Biochemically Verified Point Prevalent Abstinence: 7-day | Seven-day point prevalence abstinence rates will be confirmed by salivary cotinine levels. This outcome variable will be reported as the difference in abstinence rates between the experimental treatment condition and the control condition | Weeks 12 and 24 |
| Biochemically Verified Point Prevalence Abstinence: 30-day | 30-day point prevalence abstinence rates will be confirmed by salivary cotinine levels. This outcome variable will be reported as the difference in abstinence rates between the experimental treatment condition and the control condition | Weeks 12 and 24 |
| Change in Scores on the PTSD Checklist for DSM 5 (PCL-5) | The PCL-5 is a 20-item self-report measure that assesses the severity of the twenty DSM-V symptoms of PTSD. Items are rated on a 1-5 scale and summed to compute a total score, with higher scores representing greater severity of PTSD symptoms. The total score can range from 0 to 80. This outcome variable will be reported as the difference in PCL-5 total score between the experimental treatment condition and the control condition. | Weeks 0, 8, 12, and 24 |
| Proportion of Participants Recruited Based on Region | The difference in recruitment rates among residents of rural versus urban areas. Higher recruitment rates suggest greater study and intervention feasibility, and a large difference score would indicate greater feasibility based on type of residential area. | over 8-week intervention period; calculated at Week 8 (post-treatment) |
| BG001 | VA Quitline | After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will also receive weekly proactive telephone sessions through the VA Quitline, a standard of care, proactive telephone quitline available to all veterans for up to eight weeks. Participants will initiate the first call and subsequent calls will be made by the Quitline counselor. VA Quitline: The SFVAMC's standard of care referral service, known as the VA Quitline which involves weekly telephone sessions through the VA's proactive telephone Quitline, available to all veterans for up to 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Sexual Orientation | Count of Participants | Participants |
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| OG001 | VA Quitline | After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will also receive weekly proactive telephone sessions through the VA Quitline, a standard of care, proactive telephone quitline available to all veterans for up to eight weeks. Participants will initiate the first call and subsequent calls will be made by the Quitline counselor. VA Quitline: The SFVAMC's standard of care referral service, known as the VA Quitline which involves weekly telephone sessions through the VA's proactive telephone Quitline, available to all veterans for up to 8 weeks. |
|
|
|
| Primary | The Difference in Total Number of Treatment Sessions Attended Between the Experimental Treatment Condition and the Control Condition | The difference in total number of treatment sessions attended between the experimental treatment condition and the control condition. Higher adherence rates suggest greater study/intervention feasibility and acceptability, and a large difference score would indicate greater feasibility/acceptability of one study condition over the other. | Posted | Mean | Standard Deviation | Sessions | over 8-week intervention period; calculated at Week 8 (post-treatment) |
|
|
|
|
| Primary | Acceptability Questionnaire | Participants (in the intervention condition only) will complete a questionnaire developed by the investigators to rate the intervention protocol from 1-10 in terms of perceived helpfulness, understandability, and likelihood of use. The mean score (i.e., average of item ratings) will be reported for the participants in the intervention condition. Higher scores represent greater acceptability. | Posted | Median | Standard Deviation | score on a scale | Week 8 |
|
|
|
| Primary | Median Scores on the System Usability Scale (SUS) | The SUS is a brief, reliable and valid instrument to measure perceptions of usability of technology devices. Items are rated on a scale from 0-5. An SUS total score is calculated by summing item ratings, and then multiplied the sum by 2.5. The maximum score on the SUS is 100, with higher scores reflecting greater usability. The SUS will be administered to the intervention condition only. Mean usability score will be reported. | Posted | Median | Standard Deviation | score on a scale | Week 8 |
|
|
|
| Primary | Median Scores on the Client Satisfaction Questionnaire-8 (CSQ-8) | The CSQ-8 is an eight-item instrument designed to measure satisfaction with an clinical intervention. Items are rated on a scale from 1-4 and summed to for an CSQ-8 total score. Scores range from 8-32, with higher scores indicating greater satisfaction. The CSQ-8 will be administered to the intervention condition only. Mean satisfaction score will be reported. | Posted | Median | Standard Deviation | score on a scale | Week 8 (post-treatment) |
|
|
|
| Secondary | Average Number of Cigarettes Smoked in the Past 30 Days at Weeks 0, 8, 12 and 24 | Self-reported use of cigarettes will be assessed with Timeline Follow-Back (TLFB) (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in cigarette use between the experimental treatment condition and the control condition. | Number analyzed at each session varies because not all participants attended all sessions. | Posted | Mean | Standard Deviation | Cigarettes smoked in the past 30 days | Weeks 0, 8, 12, and 24 |
|
|
|
|
| Secondary | Timeline Follow-Back (TLFB): E-cigarettes | Self-reported use of e-cigarettes will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in e-cigarette use between the experimental treatment condition and the control condition. | The number analyzed varies because not all participants attended all sessions. | Posted | Mean | Standard Deviation | Days of e-cigarette use in the past 30 | Weeks 0, 8, 12, and 24 |
|
|
|
|
| Secondary | Timeline Follow-Back (TLFB): Chewing Tobacco | Self-reported use of chewing tobacco will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in chewing tobacco use between the experimental treatment condition and the control condition. | The number analyzed varies because not all participants attended all sessions. | Posted | Mean | Standard Deviation | Days of chewing tobacco use | Weeks 0, 8, 12, and 24 |
|
|
|
|
| Secondary | Change in Scores on the Fagerström Test for Nicotine Dependence (FTND) | The FTND is a validated, 6-item self-report instrument that evaluates the intensity of physical addiction to nicotine. Three items are rated yes/no (0/1), and the other three items are rated on a scale from 0-3. Items are summed to yield a total score of 0-10, with higher scores reflecting greater nicotine dependence. This outcome variable will be reported as the difference in FTND total score between the experimental treatment condition and the control condition. | The number analyzed varies because not all participants attended all sessions. | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 8, 12, and 24 |
|
|
|
|
| Secondary | Biochemically Verified Point Prevalent Abstinence: 7-day | Seven-day point prevalence abstinence rates will be confirmed by salivary cotinine levels. This outcome variable will be reported as the difference in abstinence rates between the experimental treatment condition and the control condition | The number analyzed varies because not all participants attended all sessions. | Posted | Count of Participants | Participants | Weeks 12 and 24 |
|
|
|
|
| Secondary | Biochemically Verified Point Prevalence Abstinence: 30-day | 30-day point prevalence abstinence rates will be confirmed by salivary cotinine levels. This outcome variable will be reported as the difference in abstinence rates between the experimental treatment condition and the control condition | The number analyzed varies because not all participants attended all sessions. | Posted | Count of Participants | Participants | Weeks 12 and 24 |
|
|
|
|
| Secondary | Change in Scores on the PTSD Checklist for DSM 5 (PCL-5) | The PCL-5 is a 20-item self-report measure that assesses the severity of the twenty DSM-V symptoms of PTSD. Items are rated on a 1-5 scale and summed to compute a total score, with higher scores representing greater severity of PTSD symptoms. The total score can range from 0 to 80. This outcome variable will be reported as the difference in PCL-5 total score between the experimental treatment condition and the control condition. | The number analyzed varies because not all participants attended all sessions. | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 8, 12, and 24 |
|
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|
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| Other Pre-specified | Timeline Follow-Back (TLFB): Other Tobacco Products | Self-reported use of any other tobacco products will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in use of other tobacco products between the experimental treatment condition and the control condition. | Unfortunately there was a miscommunication between the study plan and the questionnaire and "Other tobacco use" was not collected. This was not a pre-specified secondary outcome measure per protocol, rather an exploratory measure. | Posted | Weeks 0, 8, 12, and 24 |
|
|
| Other Pre-specified | Proportion of Participants Recruited Based on Region | The difference in recruitment rates among residents of rural versus urban areas. Higher recruitment rates suggest greater study and intervention feasibility, and a large difference score would indicate greater feasibility based on type of residential area. | Participant census tract was not collected, so this measure cannot be reported. This was not a pre-specified primary outcome measure per protocol, and was originally an an exploratory measure. | Posted | over 8-week intervention period; calculated at Week 8 (post-treatment) |
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | VA Quitline | After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will also receive weekly proactive telephone sessions through the VA Quitline, a standard of care, proactive telephone quitline available to all veterans for up to eight weeks. Participants will initiate the first call and subsequent calls will be made by the Quitline counselor. VA Quitline: The SFVAMC's standard of care referral service, known as the VA Quitline which involves weekly telephone sessions through the VA's proactive telephone Quitline, available to all veterans for up to 8 weeks. | 0 | 32 | 0 | 32 | 0 | 32 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 24 |
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df = 1
| .19 |
Week 24 |
| Odds Ratio (OR) |
| 2.3 |
| 2-Sided |
| Superiority |
| Week 24 |
|
|
df = 1 |
| .17 |
| Odds Ratio (OR) |
| 2.52 |
| 2-Sided |
| Superiority |
| Week 8 |
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| Week 12 |
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| Week 24 |
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