Trial Outcomes & Findings for Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial (NCT NCT02997657)
NCT ID: NCT02997657
Last Updated: 2023-03-01
Results Overview
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
271 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-03-01
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
131
|
|
Overall Study
COMPLETED
|
109
|
97
|
|
Overall Study
NOT COMPLETED
|
31
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self reported sex missing for one 1 participant
Baseline characteristics by cohort
| Measure |
Positive Psychotherapy for Smoking Cessation
n=140 Participants
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
|
Standard Smoking Cessation Treatment
n=131 Participants
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
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 12.1 • n=140 Participants
|
49.2 years
STANDARD_DEVIATION 12.0 • n=131 Participants
|
49.2 years
STANDARD_DEVIATION 12.0 • n=271 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=140 Participants • Self reported sex missing for one 1 participant
|
71 Participants
n=130 Participants • Self reported sex missing for one 1 participant
|
149 Participants
n=270 Participants • Self reported sex missing for one 1 participant
|
|
Sex: Female, Male
Male
|
62 Participants
n=140 Participants • Self reported sex missing for one 1 participant
|
59 Participants
n=130 Participants • Self reported sex missing for one 1 participant
|
121 Participants
n=270 Participants • Self reported sex missing for one 1 participant
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=140 Participants
|
6 Participants
n=131 Participants
|
14 Participants
n=271 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
132 Participants
n=140 Participants
|
123 Participants
n=131 Participants
|
255 Participants
n=271 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=140 Participants
|
2 Participants
n=131 Participants
|
2 Participants
n=271 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=140 Participants
|
2 Participants
n=131 Participants
|
4 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=140 Participants
|
0 Participants
n=131 Participants
|
2 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=140 Participants
|
0 Participants
n=131 Participants
|
0 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=140 Participants
|
17 Participants
n=131 Participants
|
29 Participants
n=271 Participants
|
|
Race (NIH/OMB)
White
|
119 Participants
n=140 Participants
|
111 Participants
n=131 Participants
|
230 Participants
n=271 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=140 Participants
|
0 Participants
n=131 Participants
|
4 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=140 Participants
|
1 Participants
n=131 Participants
|
2 Participants
n=271 Participants
|
|
Fagerstrom test for cigarette dependence
|
5.1 units on a scale
STANDARD_DEVIATION 2.0 • n=140 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 2.1 • n=131 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 2.1 • n=271 Participants
|
|
CES-D Total Score
|
13.1 units on a scale
STANDARD_DEVIATION 10.0 • n=140 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 9.5 • n=131 Participants
|
12.6 units on a scale
STANDARD_DEVIATION 9.7 • n=271 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Outcome measures
| Measure |
Positive Psychotherapy for Smoking Cessation
n=139 Participants
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
|
Standard Smoking Cessation Treatment
n=131 Participants
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
|
|---|---|---|
|
7-day Point Prevalence Smoking Abstinence at 12 Weeks
|
29 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: 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.
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Outcome measures
| Measure |
Positive Psychotherapy for Smoking Cessation
n=139 Participants
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
|
Standard Smoking Cessation Treatment
n=131 Participants
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
|
|---|---|---|
|
7-day Point Prevalence Smoking Abstinence at 26 Weeks
|
27 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: 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.
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Outcome measures
| Measure |
Positive Psychotherapy for Smoking Cessation
n=139 Participants
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
|
Standard Smoking Cessation Treatment
n=131 Participants
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
|
|---|---|---|
|
7-day Point Prevalence Smoking Abstinence at 52 Weeks
|
27 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: 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.
Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks
Outcome measures
| Measure |
Positive Psychotherapy for Smoking Cessation
n=139 Participants
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
|
Standard Smoking Cessation Treatment
n=131 Participants
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
|
|---|---|---|
|
Continuous Smoking Abstinence
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: During treatment - weeks 1-4 after quit datePopulation: 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.
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.
Outcome measures
| Measure |
Positive Psychotherapy for Smoking Cessation
n=87 Participants
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
|
Standard Smoking Cessation Treatment
n=74 Participants
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
|
|---|---|---|
|
Engagement in PPT-consistent Quitting Strategies
|
3.88 units on a scale
Standard Deviation 0.82
|
4.07 units on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Positive Psychotherapy for Smoking Cessation
n=88 Participants
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
|
Standard Smoking Cessation Treatment
n=74 Participants
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
|
|---|---|---|
|
Residual Attraction to Smoking
|
65 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Positive Psychotherapy for Smoking Cessation
n=88 Participants
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
|
Standard Smoking Cessation Treatment
n=74 Participants
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
|
|---|---|---|
|
Self-efficacy for Resisting Smoking
|
3.76 units on a scale
Standard Deviation 1.12
|
3.80 units on a scale
Standard Deviation 1.03
|
Adverse Events
Positive Psychotherapy for Smoking Cessation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Smoking Cessation Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Positive Psychotherapy for Smoking Cessation
n=140 participants at risk
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
|
Standard Smoking Cessation Treatment
n=131 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/140 • 52 weeks
|
1.5%
2/131 • Number of events 2 • 52 weeks
|
Additional Information
Christopher Kahler
Brown University School of Public Health
Phone: 401 863-6651
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place