Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation

Cigarette Smoking Clinical Trial

Official title:

Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218281
• Other study ID #: R34DA037886
• Status: Completed
• Phase: N/A
• First received: July 29, 2014
• Last updated: August 25, 2016
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• C2Q-Teen app
Commit to Quit (C2Q)-Teen app provides smoking cessation assistance incorporating mindfulness training.
• NCI's QuitSTART app
NCI's smoking cessation app
• Written smoking cessation materials only
Receipt of written smoking cessation materials

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of study recruitment into the three interventions	We will assess the ability to recruit 144 adolescents into the trial at baseline.	Baseline	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No