SmokingNCT02134509
Smartphone Application for Smoking Cessation
A study testing Experimental App and Active Comparator App in people with Smoking, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Experimental App and Active Comparator App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoke 5+ cigarettes/day
- < 3 months abstinence in the past year
- Have a smartphone
- Score greater than or equal to 8 of 10 on the Contemplation Ladder (Biener \& Abrams, 1991)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06511
About this study
The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.
Read the detailed description
In this randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains behavioral strategies for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.
- Conditions
- Smoking
- Being tested
- Experimental App, Active Comparator App
- Keywords
- Cigarette smoking
- Medical subject headings
- Smoking, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental AppBehavioural
It is comprised of twenty-two modules of 10-15 minutes each, designed to teach behavioral strategies for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules
Active Comparator AppBehavioural
It is comprised of 6 prompts per day asking individuals about their experience, behavior, and smoking habits, for 22-days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental App | Experimental | This is a 3-week smartphone-based training program that trains behavioral strategies for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks. Receives: Behavioral: Experimental App |
| Active comparator app | Active comparator | This is a 3-week smartphone application for smoking cessation in which smokers self-monitor their smoking habits, mood, and experience, to quit smoking with a target quit date of 3 weeks. Receives: Behavioral: Active Comparator App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence abstinence at 6 months
Subjects will be assessed for smoking abstinence at a 6-month follow-up.
Measured: 6 months after beginning treatment
Secondary outcomes (1)
Point prevalence abstinence at 3 months
Subjects will be assessed for smoking abstinence at a 3-month follow-up.
Measured: 3 months after beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kathleen A Garrison, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134509
- Sponsor's protocol ID
- 1301011337
- Other IDs
- 2K12DA000167-26
- Status last verified
- Jan 2020
- First submitted
- 7 May 2014
- Last updated
- 16 Apr 2020
- 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 35420700Sala M, Roos CR, Brewer JA, Garrison KA. Awareness, affect, and craving during smoking cessation: An experience sampling study. Health Psychol. 2021 Sep;40(9):578-586. doi: 10.1037/hea0001105. Epub 2021 Sep 27.
PubMed 34570534Garrison KA, Pal P, O'Malley SS, Pittman BP, Gueorguieva R, Rojiani R, Scheinost D, Dallery J, Brewer JA. Craving to Quit: A Randomized Controlled Trial of Smartphone App-Based Mindfulness Training for Smoking Cessation. Nicotine Tob Res. 2020 Mar 16;22(3):324-331. doi: 10.1093/ntr/nty126.
PubMed 29917096Garrison KA, Pal P, Rojiani R, Dallery J, O'Malley SS, Brewer JA. A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol. BMC Psychiatry. 2015 Apr 14;15:83. doi: 10.1186/s12888-015-0468-z.
PubMed 25884648
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Application for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02134509
- Acronym / sponsor ID
- 1301011337
- Conditions
- Smoking
- Keywords
- Cigarette smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Heart Association, National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 May 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 purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.
Detailed description
In this randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains behavioral strategies for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental App | Experimental | Behavioral: Experimental AppThis is a 3-week smartphone-based training program that trains behavioral strategies for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks. |
| Active comparator app | Active comparator | Behavioral: Active Comparator AppThis is a 3-week smartphone application for smoking cessation in which smokers self-monitor their smoking habits, mood, and experience, to quit smoking with a target quit date of 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Smoke 5+ cigarettes/day
- < 3 months abstinence in the past year
- Have a smartphone
- Score greater than or equal to 8 of 10 on the Contemplation Ladder (Biener \& Abrams, 1991)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Experimental AppIt is comprised of twenty-two modules of 10-15 minutes each, designed to teach behavioral strategies for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules | Behavioural | Experimental App |
| Active Comparator AppIt is comprised of 6 prompts per day asking individuals about their experience, behavior, and smoking habits, for 22-days. | Behavioural | Active comparator app |
Primary outcome
Point prevalence abstinence at 6 months
Time frame: 6 months after beginning treatment
Subjects will be assessed for smoking abstinence at a 6-month follow-up.
1 secondary outcome
Point prevalence abstinence at 3 months
Time frame: 3 months after beginning treatment
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 16 Apr 2020.
- 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 34570534Sala M, Roos CR, Brewer JA, Garrison KA. Awareness, affect, and craving during smoking cessation: An experience sampling study. Health Psychol. 2021 Sep;40(9):578-586. doi: 10.1037/hea0001105. Epub 2021 Sep 27.
- Derived from this study: PubMed 29917096Garrison KA, Pal P, O'Malley SS, Pittman BP, Gueorguieva R, Rojiani R, Scheinost D, Dallery J, Brewer JA. Craving to Quit: A Randomized Controlled Trial of Smartphone App-Based Mindfulness Training for Smoking Cessation. Nicotine Tob Res. 2020 Mar 16;22(3):324-331. doi: 10.1093/ntr/nty126.
- Derived from this study: PubMed 25884648Garrison KA, Pal P, Rojiani R, Dallery J, O'Malley SS, Brewer JA. A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol. BMC Psychiatry. 2015 Apr 14;15:83. doi: 10.1186/s12888-015-0468-z.
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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.
Kathleen A Garrison, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental App and Active Comparator App in people with Smoking, run by Yale University 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 4 inclusion and 1 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 16 Apr 2020. 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?
Point prevalence abstinence at 6 months (time frame: 6 months after beginning treatment). 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 NCT02134509, which also lists 4 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 16 Apr 2020.