NCT02218281

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

July 29, 2014

Last Update Submit

August 25, 2016

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Cotinine-validated 7-day point prevalence abstinence

    3- and 6-months follow-up

  • C2Q-Teen program usage as a predictor of smoking abstinence

    3- and 6-month follow-up

Study Arms (3)

C2Q-Teen app

EXPERIMENTAL

Smoking cessation treatment delivered through a smartphone app via mindfulness training.

Behavioral: C2Q-Teen app

NCI's QuitSTART app

ACTIVE COMPARATOR

Smoking cessation treatment delivered through a smartphone app by NCI, without mindfulness training.

Behavioral: NCI's QuitSTART app

Written smoking cessation materials only

ACTIVE COMPARATOR

Receipt of written smoking cessation materials.

Behavioral: Written smoking cessation materials only

Interventions

C2Q-Teen appBEHAVIORAL

Commit to Quit (C2Q)-Teen app provides smoking cessation assistance incorporating mindfulness training.

C2Q-Teen app
NCI's QuitSTART appBEHAVIORAL

NCI's smoking cessation app

NCI's QuitSTART app
Written smoking cessation materials onlyBEHAVIORAL

Receipt of written smoking cessation materials

Written smoking cessation materials only

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (2)

  • 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.

    PMID: 35420700DERIVED

  • 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.

    PMID: 33343761DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Study Officials

  • Lori Pbert, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

  • Judson Brewer, MD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 29, 2014

First Posted

August 18, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 26, 2016

Record last verified: 2016-08

Locations

US(1)