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

NCT02997657 | Completed Results

• 1 other identifier: R01CA201262
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Engagement in PPT-consistent Quitting Strategies

  During treatment - weeks 1-4 after quit date

• Residual Attraction to Smoking

  At end of treatment (4 weeks after quit date)

• Self-efficacy for Resisting Smoking

  At end of treatment (4 weeks after quit date)

Study Arms (2)

Positive Psychotherapy for Smoking Cessation

EXPERIMENTAL

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; Behavioral: Standard smoking cessation counseling

Standard smoking cessation treatment

ACTIVE COMPARATOR

Smoking cessation counseling that provides support and problem solving skills for avoiding smoking.

Behavioral: Standard smoking cessation counseling

Interventions

Positive Psychotherapy BEHAVIORAL

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

Positive Psychotherapy for Smoking Cessation

Standard smoking cessation counseling BEHAVIORAL

Counseling designed to provide support and problem solving for smoking cessation

Positive Psychotherapy for Smoking Cessation; Standard smoking cessation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Contact study site for details

Sponsors & Collaborators

• Brown University: lead
• Truth Initiative: collaborator

Study Sites (2)

Partners Healthcare and Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Center for Alcohol and Addiction Studies, Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Christopher Kahler
• Organization: Brown University School of Public Health

christopher_kahler@brown.edu

401 863-6651

Study Officials

• Christopher Kahler, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 20, 2016
• Study Start: September 1, 2016
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)