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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Positive Psychotherapy; Behavioral: Standard smoking cessation counseling

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Partners Healthcare and Massachusetts General Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Center for Alcohol and Addiction Studies, Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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)

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: Truth Initiative

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: R01CA201262 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No