An interventional study of Positive Psychotherapy and Standard smoking cessation counseling in Smoking Cessation, sponsored by Brown University. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Brown University · Not applicable, Interventional, and Treatment
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.
Brown University is the lead sponsor of 282 studies on the registry; 42 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors.
Behavioral: Positive Psychotherapy · Behavioral: Standard smoking cessation counseling
Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.
Behavioral: Standard smoking cessation counseling
Exercises designed to boost moods, positive behaviors, and positive cognitions.
Counseling designed to provide support and problem solving for smoking cessation
7-day Point Prevalence Smoking Abstinence at 12 Weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Time frame: 12 weeks
7-day Point Prevalence Smoking Abstinence at 26 Weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Time frame: 26 weeks
7-day Point Prevalence Smoking Abstinence at 52 Weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Time frame: 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
Time frame: 52 weeks
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.
Time frame: During treatment - weeks 1-4 after quit date
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.
Time frame: 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.
Time frame: At end of treatment (4 weeks after quit date)
| Milestone | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment |
|---|---|---|
| Started | 140 | 131 |
| Completed | 109 | 97 |
| Not completed | 31 | 34 |
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
| Participants | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment |
|---|---|---|
| 7-day Point Prevalence Smoking Abstinence at 12 Weeks | 29 | 25 |
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
| Participants | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment |
|---|---|---|
| 7-day Point Prevalence Smoking Abstinence at 26 Weeks | 27 | 27 |
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
| Participants | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment |
|---|---|---|
| 7-day Point Prevalence Smoking Abstinence at 52 Weeks | 27 | 28 |
Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks
| Participants | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment |
|---|---|---|
| Continuous Smoking Abstinence | 13 | 12 |
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.
| units on a scale | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment |
|---|---|---|
| Engagement in PPT-consistent Quitting Strategies | 3.88 ± 0.82 | 4.07 ± 0.64 |
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 | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment |
|---|---|---|
| Residual Attraction to Smoking | 65 | 54 |
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.
| units on a scale | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment |
|---|---|---|
| Self-efficacy for Resisting Smoking | 3.76 ± 1.12 | 3.80 ± 1.03 |
Collected over 52 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Positive Psychotherapy for Smoking Cessation | 1/140 (0.7%) | 0/140 (0%) | 0/140 (0%) |
| Standard Smoking Cessation Treatment | 0/131 (0%) | 0/131 (0%) | 2/131 (1.5%) |
| Event | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment |
|---|---|---|
| VomitingGastrointestinal disorders | 0/140 | 2/131 |
| Age, Continuous(years) | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment | Total |
|---|---|---|---|
| Mean | 49.2 ± 12.1 | 49.2 ± 12.0 | 49.2 ± 12.0 |
| Sex: Female, Male(Participants) | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment | Total |
|---|---|---|---|
| Female | 78 | 71 | 149 |
| Male | 62 | 59 | 121 |
| Ethnicity (NIH/OMB)(Participants) | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 6 | 14 |
| Not Hispanic or Latino | 132 | 123 | 255 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 4 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 17 | 29 |
| White | 119 | 111 | 230 |
| More than one race | 4 | 0 | 4 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Fagerstrom test for cigarette dependence(units on a scale) | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment | Total |
|---|---|---|---|
| Mean | 5.1 ± 2.0 | 4.5 ± 2.1 | 4.8 ± 2.1 |
| CES-D Total Score(units on a scale) | Positive Psychotherapy for Smoking Cessation | Standard Smoking Cessation Treatment | Total |
|---|---|---|---|
| Mean | 13.1 ± 10.0 | 12.1 ± 9.5 | 12.6 ± 9.7 |
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