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Completed

NCT Number: NCT02997657

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Partners Healthcare and Massachusetts General Hospital, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Contact study site for details

Treatment and study plan

Positive Psychotherapy

Behavioral

Exercises designed to boost moods, positive behaviors, and positive cognitions.

Standard smoking cessation counseling

Behavioral

Counseling designed to provide support and problem solving for smoking cessation

Primary outcomes

  1. 7-day Point Prevalence Smoking Abstinence at 12 Weeks

    Time frame: 12 weeks

    Self-reported smoking abstinence biochemically confirmed with CO and cotinine

  2. 7-day Point Prevalence Smoking Abstinence at 26 Weeks

    Time frame: 26 weeks

    Self-reported smoking abstinence biochemically confirmed with CO and cotinine

  3. 7-day Point Prevalence Smoking Abstinence at 52 Weeks

    Time frame: 52 weeks

    Self-reported smoking abstinence biochemically confirmed with CO and cotinine

  4. Continuous Smoking Abstinence

    Time frame: 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 outcomes

  1. Engagement in PPT-consistent Quitting Strategies

    Time frame: 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.

  2. Residual Attraction to Smoking

    Time frame: 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.

  3. Self-efficacy for Resisting Smoking

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Truth Initiative

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2016
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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