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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997657
• Other study ID #: R01CA201262
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: November 15, 2021

Study information

• Verified date: February 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Partners Healthcare and Massachusetts General Hospital	Boston	Massachusetts
United States	Center for Alcohol and Addiction Studies, Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	Truth Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day Point Prevalence Smoking Abstinence at 12 Weeks	Self-reported smoking abstinence biochemically confirmed with CO and cotinine	12 weeks
Primary	7-day Point Prevalence Smoking Abstinence at 26 Weeks	Self-reported smoking abstinence biochemically confirmed with CO and cotinine	26 weeks
Primary	7-day Point Prevalence Smoking Abstinence at 52 Weeks	Self-reported smoking abstinence biochemically confirmed with CO and cotinine	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	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.	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.	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.	At end of treatment (4 weeks after quit date)