Clinical trial NCT02218281: Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation
Official title: Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 146
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of study recruitment into the three interventions
timeFrame: Baseline
measure: Feasibility of retention of participants at 3-month follow-up
timeFrame: 3-month follow-up
measure: Feasibility of retention of participants at 6-month follow-up
timeFrame: 6-month follow-up
measure: Acceptability of the three interventions
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Cotinine-validated 7-day point prevalence abstinence
timeFrame: 3- and 6-months follow-up
measure: C2Q-Teen program usage as a predictor of smoking abstinence
timeFrame: 3- and 6-month follow-up
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Lori Pbert, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: Judson Brewer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.