Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation

The recent Surgeon General's Report calls for effective and readily available treatment approaches to help adolescent smokers interested in quitting. Schools are an ideal venue for connecting adolescent smokers with smoking cessation assistance. This study will adapt the Craving to Quit (C2Q) smartphone app, which integrates mindfulness training into a smoking cessation program, for teen smokers (C2Q-Teen). We will test how well this novel app helps teens stop smoking compared to another teen smoking cessation app that does not include mindfulness training, and to written cessation information alone. If effective, the C2Q-Teen would be relatively easy to disseminate widely and have tremendous public health significance

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Behavioral: C2Q-Teen app; Behavioral: NCI's QuitSTART app; Behavioral: Written smoking cessation materials only

Detailed Description

The new Surgeon General's Report (SGR), Preventing Tobacco Use Among Youth and Young Adults, highlights the addictive nature of nicotine and emphasizes the need for effective and accessible cessation treatment for the more than 3.6 million youth who smoke. This proposal is in response to PA-13-078, Behavioral and Integrative Treatment Development Program (R34), which supports the development and testing of behavioral interventions targeting substance abuse, including studies focused on Intervention generation and refinement (Stage IA), and pilot or feasibility (Stage IB), and research designed to "increase implementability of interventions with creative use of technology". We have developed Craving to Quit (C2Q), a smartphone intervention for smoking cessation for adults that integrates mindfulness training (MT) into a smoking cessation curriculum. While MT has been shown to be efficacious for smoking cessation in adults, it has not been tested in adolescents. In addition, dissemination of MT is challenging due to the need for experienced MT therapists, high time demand, difficulties in scheduling sessions, and high costs of in-person treatment delivery. Mobile, smartphone technologies provide a promising medium for overcoming these barriers to dissemination. We propose to adapt and refine our existing Craving to Quit (C2Q) app for use by adolescent smokers (Stage IA), and to conduct feasibility and pilot testing (Stage IB) in preparation for an R01 application to definitively test efficacy and probe psychological mechanisms of change resulting from MT. In the pilot test, six public high schools will be randomly assigned to one of three conditions, two schools per condition: (1) C2Q-Teen app (smoking cessation delivered through a smartphone app via MT), (2) NCI's QuitSTART app designed for teen smokers (NCI-QS) (smoking cessation delivered through a smartphone app without MT), or (3) written smoking cessation materials only (MO). One hundred forty four adolescent smokers interested in quitting will be recruited (24/school, 48/condition). School nurses will introduce the three interventions in the school setting. Our first primary aim is to adapt the C2Q app for use by adolescent smokers (C2Q-Teen). Our second primary aim is to evaluate the feasibility and acceptability of the interventions to ensure adequacy of each intervention for a larger RCT designed specifically to compare efficacy rates. Secondary aims are to assess relative efficacy of the three interventions and independent contributions of smartphone intervention delivery and mindfulness in increasing cotinine-validated 7-day point prevalence abstinence at 3- and 6-month follow-up in order to adequately power a larger trial, and to determine the relationship between C2Q-Teen usage and abstinence. If eventually found to be effective, C2Q-Teen offers an innovative and potentially powerful intervention for supporting teens in their efforts to quit that would be relatively easy to disseminate widely and have tremendous public health significance, addressing the SGR's call for readily available treatment for adolescent smokers wanting to quit

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• enrolled in grade 9-12
• smoked at least 5 cigarettes on average per day for the past 7 days
• interested in quitting smoking in the next three weeks
• have a smartphone on iPhone or Android platforms
• English-speaking

Exclusion Criteria:

• unable or unwilling to provide informed assent
• diagnosis of a serious psychiatric illness during the past 5 years
• developmental delay that would prevent study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C2Q-Teen app; Smoking cessation treatment delivered through a smartphone app via mindfulness training.	Behavioral: C2Q-Teen app; Commit to Quit (C2Q)-Teen app provides smoking cessation assistance incorporating mindfulness training.
Active Comparator: NCI's QuitSTART app; Smoking cessation treatment delivered through a smartphone app by NCI, without mindfulness training.	Behavioral: NCI's QuitSTART app; NCI's smoking cessation app
Active Comparator: Written smoking cessation materials only; Receipt of written smoking cessation materials.	Behavioral: Written smoking cessation materials only; Receipt of written smoking cessation materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of study recruitment into the three interventions	We will assess the ability to recruit 144 adolescents into the trial at baseline.	Baseline
Feasibility of retention of participants at 3-month follow-up	We will assess the ability to retain 80% of the 144 adolescents recruited at 3-month follow-up.	3-month follow-up
Feasibility of retention of participants at 6-month follow-up	We will assess the ability to retain 80% of the 144 adolescents recruited at 6-month follow-up.	6-month follow-up
Acceptability of the three interventions	Assess the percentage of participants in each condition that indicate high utilization and acceptability ratings (at least 80% hypothesized)	3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cotinine-validated 7-day point prevalence abstinence	Self-reported 7-day point abstinence confirmed by cotinine. Saliva samples will be collected from all participants prior to survey completion at each follow-up assessment. Samples will be analyzed for cotinine for all subjects reporting abstinence for the past 7 days. We will use cotinine-validated abstinence (cut-off of 11.4 ng/ml) and a cotinine-imputed abstinence when cotinine is missing.	3- and 6-months follow-up
C2Q-Teen program usage as a predictor of smoking abstinence	It is hypothesized that C2Q-Teen program usage, defined as self-report of the number of C2Q-Teen modules completed and informal mindfulness practice, will predict smoking abstinence at 3-month follow-up and at 6-month follow-up.	3- and 6-month follow-up

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: Judson Brewer, MD, University of Massachusetts, Worcester

Publications and helpful links

General Publications

• Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
• Pbert L, Druker S, Crawford S, Frisard C, Trivedi M, Osganian SK, Brewer J. Feasibility of a Smartphone App with Mindfulness Training for Adolescent Smoking Cessation: Craving to Quit (C2Q)-Teen. Mindfulness (N Y). 2020 Mar;11(3):720-733. doi: 10.1007/s12671-019-01273-w. Epub 2019 Dec 20.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: August 14, 2014
• First Posted (Estimate): August 18, 2014

Study Record Updates

• Last Update Posted (Estimate): August 26, 2016
• Last Update Submitted That Met QC Criteria: August 25, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: R34DA037886 (U.S. NIH Grant/Contract)