Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial

Study Overview
=================
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.

Official Title
-----------------
Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Positive Psychotherapy
* Behavioral: Standard smoking cessation counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be 18 years of age or older 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 have a baseline carbon monoxide level of at least 4 ppm be willing to use the nicotine patch report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking (where 10 = extremely important); 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Psychotherapy for Smoking Cessation<br>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<br>* Exercises designed to boost moods, positive behaviors, and positive cognitions.<br>Behavioral: Standard smoking cessation counseling<br>* Counseling designed to provide support and problem solving for smoking cessation<br>|
| Active Comparator: Standard smoking cessation treatment<br>Smoking cessation counseling that provides support and problem solving skills for avoiding smoking. | Behavioral: Standard smoking cessation counseling<br>* Counseling designed to provide support and problem solving for smoking cessation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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) |