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| Name | Class |
|---|---|
| Truth Initiative | OTHER |
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Positive Psychotherapy for Smoking Cessation (PPT-S) addresses an array of risk factors for poor smoking outcomes (low positive affect, depressive symptoms, and cynical cognitions), while also providing skills that may buffer against stress and negative affect. The overall objective of this project is to conduct a randomized controlled trial to test the efficacy of PPT-S, enhanced with text messaging, compared to a time-matched behavioral smoking cessation treatment. Participants in both treatment conditions will receive nicotine replacement therapy and a validated text-messaging intervention for smoking cessation that monitors progress in quitting smoking and extends smoking counseling outside of the individual face-to-face context.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Psychotherapy for Smoking Cessation | Experimental | Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors. |
|
| Standard smoking cessation treatment | Active Comparator | Smoking cessation counseling that provides support and problem solving skills for avoiding smoking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Psychotherapy | Behavioral | Exercises designed to boost moods, positive behaviors, and positive cognitions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Point Prevalence Smoking Abstinence at 12 Weeks | Self-reported smoking abstinence biochemically confirmed with CO and cotinine | 12 weeks |
| 7-day Point Prevalence Smoking Abstinence at 26 Weeks | Self-reported smoking abstinence biochemically confirmed with CO and cotinine | 26 weeks |
| 7-day Point Prevalence Smoking Abstinence at 52 Weeks | Self-reported smoking abstinence biochemically confirmed with CO and cotinine | 52 weeks |
| Continuous Smoking Abstinence | Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement in PPT-consistent Quitting Strategies | Engaging in strategies consistent with the positive psychology exercises taught in the trial. Nine strategies are assessed on 1 to 5 scale with 5 reflecting greater use of the strategies. The total score is the average across the 9 item. | During treatment - weeks 1-4 after quit date |
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Inclusion Criteria:
Exclusion Criteria:
1. Contact study site for details
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Kahler, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partners Healthcare and Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Positive Psychotherapy for Smoking Cessation | Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors. Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions. Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation |
| FG001 | Standard Smoking Cessation Treatment | Smoking cessation counseling that provides support and problem solving skills for avoiding smoking. Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Psychotherapy for Smoking Cessation | Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors. Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions. Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation |
| 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 | 7-day Point Prevalence Smoking Abstinence at 12 Weeks | Self-reported smoking abstinence biochemically confirmed with CO and cotinine | 1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses. | Posted | Count of Participants | Participants | 12 weeks |
|
52 weeks
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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 | Positive Psychotherapy for Smoking Cessation | Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors. Positive Psychotherapy: Exercises designed to boost moods, positive behaviors, and positive cognitions. Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Kahler | Brown University School of Public Health | 401 863-6651 | christopher_kahler@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2022 | Dec 22, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2022 | Dec 22, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Standard smoking cessation counseling | Behavioral | Counseling designed to provide support and problem solving for smoking cessation |
|
| Residual Attraction to Smoking |
Self-report residual attraction to smoking. Three questions are dichotomized and any positive response indicating residual attraction to smoking is coded as a 1 with any having only negative responses is coded as 0 - no residual attraction. |
| At end of treatment (4 weeks after quit date) |
| Self-efficacy for Resisting Smoking | Self-reported confidence in remaining abstinent from smoking. The 9-item scale uses a 1-5 response scale and the total score is the average of those 9 responses, where higher scores represent higher confidence in resisting smoking. | At end of treatment (4 weeks after quit date) |
| Center for Alcohol and Addiction Studies, Brown University |
| Providence |
| Rhode Island |
| 02912 |
| United States |
| BG001 | Standard Smoking Cessation Treatment | Smoking cessation counseling that provides support and problem solving skills for avoiding smoking. Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Self reported sex missing for one 1 participant | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fagerstrom test for cigarette dependence | Self report measure of cigarette dependence with scores ranging from 0 to 10, where 10 is the highest level of dependence. | Mean | Standard Deviation | units on a scale |
|
| CES-D Total Score | Center for Epidemiologic Studies-Depression Scale, total score. This 20-item scale has total scores ranging from 0-60 with higher scores indicating more severe depresssive symptoms. A score of 16 of greater is typically used to indicate possible major depressive disorder. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Standard Smoking Cessation Treatment | Smoking cessation counseling that provides support and problem solving skills for avoiding smoking. Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation |
|
|
|
| Primary | 7-day Point Prevalence Smoking Abstinence at 26 Weeks | Self-reported smoking abstinence biochemically confirmed with CO and cotinine | 1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
|
| Primary | 7-day Point Prevalence Smoking Abstinence at 52 Weeks | Self-reported smoking abstinence biochemically confirmed with CO and cotinine | 1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses. | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
|
| Primary | Continuous Smoking Abstinence | Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks | 1 participant in the Positive Psychotherapy for Smoking Cessation condition died prior to the 12-week follow-up and was not included. All other participants were included in the primary analyses. | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
|
| Secondary | Engagement in PPT-consistent Quitting Strategies | Engaging in strategies consistent with the positive psychology exercises taught in the trial. Nine strategies are assessed on 1 to 5 scale with 5 reflecting greater use of the strategies. The total score is the average across the 9 item. | Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed. One participant in the Positive Psychotherapy condition completed the final session but did not complete this measure. | Posted | Mean | Standard Deviation | units on a scale | During treatment - weeks 1-4 after quit date |
|
|
|
|
| Secondary | Residual Attraction to Smoking | Self-report residual attraction to smoking. Three questions are dichotomized and any positive response indicating residual attraction to smoking is coded as a 1 with any having only negative responses is coded as 0 - no residual attraction. | Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed. | Posted | Count of Participants | Participants | At end of treatment (4 weeks after quit date) |
|
|
|
|
| Secondary | Self-efficacy for Resisting Smoking | Self-reported confidence in remaining abstinent from smoking. The 9-item scale uses a 1-5 response scale and the total score is the average of those 9 responses, where higher scores represent higher confidence in resisting smoking. | Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed. | Posted | Mean | Standard Deviation | units on a scale | At end of treatment (4 weeks after quit date) |
|
|
|
|
| 1 |
| 140 |
| 0 |
| 140 |
| 0 |
| 140 |
| EG001 | Standard Smoking Cessation Treatment | Smoking cessation counseling that provides support and problem solving skills for avoiding smoking. Standard smoking cessation counseling: Counseling designed to provide support and problem solving for smoking cessation | 0 | 131 | 0 | 131 | 2 | 131 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|