Cigarette SmokingNCT02218281
Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation
A study testing C2Q-Teen app, NCI's QuitSTART app and Written smoking cessation materials only in people with Cigarette Smoking, run by University of Massachusetts, Worcester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- C2Q-Teen app, NCI's QuitSTART app and Written smoking cessation materials only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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
Read the 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
- Conditions
- Cigarette Smoking
- Being tested
- C2Q-Teen app, NCI's QuitSTART app, Written smoking cessation materials only
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2Q-Teen appBehavioural
Commit to Quit (C2Q)-Teen app provides smoking cessation assistance incorporating mindfulness training.
NCI's QuitSTART appBehavioural
NCI's smoking cessation app
Written smoking cessation materials onlyBehavioural
Receipt of written smoking cessation materials
| Study group | Role | What they receive |
|---|---|---|
| C2Q-Teen app | Experimental | Smoking cessation treatment delivered through a smartphone app via mindfulness training. Receives: Behavioral: C2Q-Teen app |
| NCI's QuitSTART app | Active comparator | Smoking cessation treatment delivered through a smartphone app by NCI, without mindfulness training. Receives: Behavioral: NCI's QuitSTART app |
| Written smoking cessation materials only | Active comparator | Receipt of written smoking cessation materials. Receives: Behavioral: Written smoking cessation materials only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study recruitment into the three interventions
We will assess the ability to recruit 144 adolescents into the trial at baseline.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 3-month follow-up
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3- and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Pbert, University of Massachusetts, Worcester
- Investigators
- Lori Pbert, PhD, Principal investigator, University of Massachusetts, WorcesterJudson Brewer, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218281
- Sponsor's protocol ID
- R34DA037886
- Status last verified
- Aug 2016
- First submitted
- 29 Jul 2014
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 35420700Pbert 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.
PubMed 33343761
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation
- ClinicalTrials.gov ID
- NCT02218281
- Acronym / sponsor ID
- R34DA037886
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C2Q-Teen app | Experimental | Behavioral: C2Q-Teen appSmoking cessation treatment delivered through a smartphone app via mindfulness training. |
| NCI's QuitSTART app | Active comparator | Behavioral: NCI's QuitSTART appSmoking cessation treatment delivered through a smartphone app by NCI, without mindfulness training. |
| Written smoking cessation materials only | Active comparator | Behavioral: Written smoking cessation materials onlyReceipt of written smoking cessation materials. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C2Q-Teen appCommit to Quit (C2Q)-Teen app provides smoking cessation assistance incorporating mindfulness training. | Behavioural | C2Q-Teen app |
| NCI's QuitSTART appNCI's smoking cessation app | Behavioural | NCI's QuitSTART app |
| Written smoking cessation materials onlyReceipt of written smoking cessation materials | Behavioural | Written smoking cessation materials only |
Primary outcome
Feasibility of study recruitment into the three interventions
Time frame: Baseline
We will assess the ability to recruit 144 adolescents into the trial at baseline.
Feasibility of retention of participants at 3-month follow-up
Time frame: 3-month follow-up
We will assess the ability to retain 80% of the 144 adolescents recruited at 3-month follow-up.
Feasibility of retention of participants at 6-month follow-up
Time frame: 6-month follow-up
We will assess the ability to retain 80% of the 144 adolescents recruited at 6-month follow-up.
Acceptability of the three interventions
Time frame: 3-month follow-up
Assess the percentage of participants in each condition that indicate high utilization and acceptability ratings (at least 80% hypothesized)
2 secondary outcomes
Cotinine-validated 7-day point prevalence abstinence
Time frame: 3- and 6-months follow-up
C2Q-Teen program usage as a predictor of smoking abstinence
Time frame: 3- and 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Derived from this study: PubMed 35420700Jackson 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.
- Derived from this study: PubMed 33343761Pbert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Pbert, PhD principal investigator
University of Massachusetts, Worcester
Judson Brewer, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C2Q-Teen app, NCI's QuitSTART app and Written smoking cessation materials only in people with Cigarette Smoking, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study recruitment into the three interventions (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02218281, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.