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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02997657
Other study ID # R01CA201262
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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