Smoking Cessation
Conditions
Brief summary
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.
Interventions
BEHAVIORALPositive Psychotherapy
Exercises designed to boost moods, positive behaviors, and positive cognitions.
BEHAVIORALStandard smoking cessation counseling
Counseling designed to provide support and problem solving for smoking cessation
Sponsors
Truth Initiative
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. be 18 years of age or older 2. smoke at least 5 cigarettes per day for longer than one year with no current regular use of other nicotine/tobacco products including e-cigarettes 3. have a baseline carbon monoxide level of at least 4 ppm 4. be willing to use the nicotine patch 5. report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking (where 10 = extremely important); 6. have an active cell phone and be willing to send and receive text messages for the duration of the intervention.
Exclusion criteria
1\. Contact study site for details
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point Prevalence Smoking Abstinence at 12 Weeks | 12 weeks | Self-reported smoking abstinence biochemically confirmed with CO and cotinine |
| 7-day Point Prevalence Smoking Abstinence at 26 Weeks | 26 weeks | Self-reported smoking abstinence biochemically confirmed with CO and cotinine |
| 7-day Point Prevalence Smoking Abstinence at 52 Weeks | 52 weeks | Self-reported smoking abstinence biochemically confirmed with CO and cotinine |
| Continuous Smoking Abstinence | 52 weeks | Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual Attraction to Smoking | At end of treatment (4 weeks after quit date) | 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. |
| Self-efficacy for Resisting Smoking | At end of treatment (4 weeks after quit date) | 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. |
| Engagement in PPT-consistent Quitting Strategies | During treatment - weeks 1-4 after quit date | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 140 |
| 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 | 131 |
| Total | 271 |
Baseline characteristics
| Characteristic | Positive Psychotherapy for Smoking Cessation | Total | Standard Smoking Cessation Treatment |
|---|---|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 12.1 | 49.2 years STANDARD_DEVIATION 12 | 49.2 years STANDARD_DEVIATION 12 |
| CES-D Total Score | 13.1 units on a scale STANDARD_DEVIATION 10 | 12.6 units on a scale STANDARD_DEVIATION 9.7 | 12.1 units on a scale STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 14 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 132 Participants | 255 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Fagerstrom test for cigarette dependence | 5.1 units on a scale STANDARD_DEVIATION 2 | 4.8 units on a scale STANDARD_DEVIATION 2.1 | 4.5 units on a scale STANDARD_DEVIATION 2.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 29 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 119 Participants | 230 Participants | 111 Participants |
| Sex: Female, Male Female | 78 Participants | 149 Participants | 71 Participants |
| Sex: Female, Male Male | 62 Participants | 121 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 140 | 0 / 131 |
| other Total, other adverse events | 0 / 140 | 2 / 131 |
| serious Total, serious adverse events | 0 / 140 | 0 / 131 |
Outcome results
Primary
7-day Point Prevalence Smoking Abstinence at 12 Weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Psychotherapy for Smoking Cessation | 7-day Point Prevalence Smoking Abstinence at 12 Weeks | 29 Participants |
| Standard Smoking Cessation Treatment | 7-day Point Prevalence Smoking Abstinence at 12 Weeks | 25 Participants |
p-value: 0.71Chi-squared
Primary
7-day Point Prevalence Smoking Abstinence at 26 Weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Time frame: 26 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Psychotherapy for Smoking Cessation | 7-day Point Prevalence Smoking Abstinence at 26 Weeks | 27 Participants |
| Standard Smoking Cessation Treatment | 7-day Point Prevalence Smoking Abstinence at 26 Weeks | 27 Participants |
p-value: 0.81Chi-squared
Primary
7-day Point Prevalence Smoking Abstinence at 52 Weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Time frame: 52 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Psychotherapy for Smoking Cessation | 7-day Point Prevalence Smoking Abstinence at 52 Weeks | 27 Participants |
| Standard Smoking Cessation Treatment | 7-day Point Prevalence Smoking Abstinence at 52 Weeks | 28 Participants |
p-value: 0.69Chi-squared
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
Time frame: 52 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Psychotherapy for Smoking Cessation | Continuous Smoking Abstinence | 13 Participants |
| Standard Smoking Cessation Treatment | Continuous Smoking Abstinence | 12 Participants |
p-value: 0.96Chi-squared
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.
Time frame: During treatment - weeks 1-4 after quit date
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychotherapy for Smoking Cessation | Engagement in PPT-consistent Quitting Strategies | 3.88 units on a scale | Standard Deviation 0.82 |
| Standard Smoking Cessation Treatment | Engagement in PPT-consistent Quitting Strategies | 4.07 units on a scale | Standard Deviation 0.64 |
p-value: 0.11t-test, 2 sided
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.
Time frame: At end of treatment (4 weeks after quit date)
Population: Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Psychotherapy for Smoking Cessation | Residual Attraction to Smoking | 65 Participants |
| Standard Smoking Cessation Treatment | Residual Attraction to Smoking | 54 Participants |
p-value: 0.9Chi-squared
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.
Time frame: At end of treatment (4 weeks after quit date)
Population: Participants were asked these questions at the final session of counseling. Therefore only participants attending that session were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychotherapy for Smoking Cessation | Self-efficacy for Resisting Smoking | 3.76 units on a scale | Standard Deviation 1.12 |
| Standard Smoking Cessation Treatment | Self-efficacy for Resisting Smoking | 3.80 units on a scale | Standard Deviation 1.03 |
p-value: 0.82t-test, 2 sided